Top 10 Myths Woman are Told Today about Pelvic Mesh

//Top 10 Myths Woman are Told Today about Pelvic Mesh

Top 10 Myths Woman are Told Today about Pelvic Mesh

jane three

MND Editor, Jane Akre

Mesh News Desk readers frequently share what they’ve been told during the consultation process with a doctor who is encouraging them to have a mesh implant as a treatment for incontinence or prolapse.  Unfortunately the stories have not changed much since this story first ran in April. If you have been diagnosed with incontinence or prolapse and bring your concerns about polypropylene mesh to your doctor’s attention, the following are some of the responses you may hear.  Any patient should ask first and foremost,  “Is the implant made out of polypropylene?”  

True informed consent would provide all of the information on mesh complications including an admission that no one really knows what happens when polypropylene mesh is implanted after many years  because there were no clinical trials.   Please feel free to share your stories of  the mesh sell. Here are some of the things women are still told today by their  doctors:


Myth #1 –  “Don’t worry- It’s lawyer generated hype.”

Love this one. See this link from the Cleveland Clinic as an example.

In this June 2013 post, the Cleveland Clinic tells “The Truth About Vaginal Mesh” blaming sensational news coverage and ads by law firms for spreading fear among women about vaginal mesh.  Not leaving it there, the CC also blames the “inexperience of many physicians” using vaginal meshes. (Note CC also makes reference to “Early meshes were not well designed for acceptance into the body” even though early meshes were polypropylene too.)

Fact: The implication is the “highly skilled” surgeons at Cleveland Clinic are your best choice. Never mind that Dr. Goldman years ago proposed partial removals which experienced physicians agree do not relieve pain. See an interview with Dr. Goldman from April 2012 here.  And never mind that there are 100,000 lawsuits filed in courts around the globe.  That’s a lot of hype by attorneys, not to mention a lot of unskilled surgeons.

Another ad by Mount Sinai here.

Fact: Please note neither ad mentions that the FDA in 2011 said complications are “Not rare” reversing itself on its 2008 public health alert.  How is that fully informed consent?


Prolene mesh

Prolene mesh

Myth #2 – “That mesh is off the market/ recalled.”

Fact: Few meshes have been recalled and almost all pelvic meshes, whether for stress urinary incontinence, or prolapse (as well as hernia repair) are made from polypropylene, aka Prolene, which may ultimately prove to be the problem since is the consistent element of complications, no matter how the mesh is used. Fact: Most mesh remains on the market.

There were two notable recalls.

Boston Scientific’s ProteGen Sling that was recalled by its own manufacturer in a letter to the FDA on January 22, 1999. The reason stated in the FDA’s March 17, 1999 Enforcement Report was “Use of the ProteGen in female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.” The FDA had received many adverse event reports like this one.

In other words, it was defective. Despite that designation, the ProteGen remains the “grandmother” mesh that has been named as the “predicate” for at least 60 other meshes that have been marketed after it.

ObTape by Mentor was removed from the market in 2006 after the company received reports like this one.  Note that the manufacturer gets to decide if the death, in this case, was related to the mesh. Mentor says it was not.

In June 2012 many of the mesh kits were voluntarily removed by the manufacturers, purportedly because they were no longer “financially viable.”  C.R. Bard took its Avaulta mesh off the market around the same time. it too was relieved of the burden of conducting post-approval studies.

Gynecare, Prolift (J&J)

Gynecare, Prolift (J&J)

Removed by Ethicon were Gynecare Prolift Kit, Gynecare Prolift +M kit, Gynecare TVT Secur, Gynecare Prosima Pelvic Floor Repair System Kit.

Suzanne M  did an excellent review of how meshes make it to market here.

Fact: The FDA has required mesh makers to conduct post-approval surveillance of their mesh products to see how many women were experiencing complications. Instead of complying with the mandate, the makers simply took them off the market and in doing so, relieved themselves of that FDA order. The FDA required no further follow-up despite the fact that the mesh remains in the pelvis’ of many suffering women.  DrugWatch did a good review of recalled meshes here.


Myth #3 – “We don’t use that mesh in this country.”

Mesh News Desk has heard this one  time and time again from Canadian women and that  the mesh problem was a U.S. problem, not Canadian.

Fact: Surgical mesh is made by major medical device companies, not Bob’s Mesh. U.S. manufacturers, and there are now seven of them involved in litigation, export their products globally. Even though the Prolift is not sold in this country, you can still buy it on eBay.  Ethicon has identified exports as a renewed market for medical devices. For a glance at the names of mesh makers, look at the FDA’s order issued January 2012 for them all to conduct post approval monitoring. (522 studies)

FDA January 2012- 522 studies ordered here

MDND- Mesh Makers Who Received 522 orders


Myth #4 – “It’s a “Tape” or a “Sling” not mesh.” 

This one came to light recently by a woman who contact MND with a pitch she received from a doctor. She was told it wasn’t mesh it was “tape.”

TVT-O from TVT Meshed Up Mesh, UK

TVT-O from TVT Meshed Up Mesh, UK

Fact:  “Tape” is another word for transvaginal tape (TVT and TVT-O) and it is transvaginal mesh! This appears to be intentional confusion.  A bladder “tack” or suspension surgery is another confusing term.  Traditionally, incontinence surgery involved tacking up the urethra using sutures and was the standard of care before transvaginal mesh. This group is intentionally confusing the issue and in doing so is not providing its patients true informed consent. Shame on them. See here.

The Mayo Clinic here is more clear though it does call these “low-risk” surgical alternatives.  The FDA has said that surgery using mesh results in complications that are “not rare.


Myth #5- “We can take it out if there’s a problem.”

Don’t worry, if there is a complication we can take the tape out has been heard by many MND readers. This is a dangerous myth and is not true informed consent.

Fact:  Mesh is intended  to be a permanent medical device implant. It incorporates with the body eventually and removing the mesh that has integrated with the body is likened to removing gum from hair or reinforcing bar from cement. Only a few of the more experienced surgeons in the would can attempt this and most will say at most they can remove 95 percent. This dangerous myth is given to assure women their choice is reversible. Unfortunately after women are told to “give it another 6 months” after experiencing complications, they not only experience more pain but the mesh continues to integrate with the body.  Pain indicates mesh should be removed according to expert surgeons.


Myth #6 – “Mesh is FDA approved.”

Fact: Not really. It’s is approved for sale, not for safety.  It might be hard to believe but the U.S. Food and Drug Administration only classifies pelvic mesh surgical mesh as a Class II moderate risk device, even though it is a permanent implant. It does not require clinical trials (human testing) which would most likely have shown the complications such as mesh erosion, infection, mesh shrinkage, nerve entrapment, etc.  That is the FDA’s own 510(k) approval process that allows manufacturers to take the “least burdensome” route to approval.  Nevermind that the “burden” then rests on the poor patient who discoverers after the fact that their device received no assurances for safety except from the manufacturer who has the most to gain by its marketing.


Myth #7 – “Mesh Complications are rare.”

Fact: While that was what the FDA first said in 2008, what followed was a five-fold increase in the reporting of mesh-related complications. By July 2011, the FDA reversed itself in July 2011 and said in its advisory that mesh complications are “not rare.”  See it here:

   “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.

The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.”

Fact: (Still waiting for that later date) hernia mesh has not received any similar warning, though these pages are full of many reports from those who experience the same symptoms as pelvic mesh patients including pain, erosion, infection, nerve entrapment etc.  Full informed consent needs to include the fact of this FDA warning.


Myth #8 – “The Problem is with Pelvic Mesh Not Slings.”  

Fact: As you see above, the FDA has taken a hands off approach to the issue of slings. That promise to get back at a later date has not materialized. All MND readers need to know, is the polypropylene is the same and has the same qualities of mesh erosion, infection, shrinkage, pain, nerve entrapment. Studies on the effects of polypropylene in human bodies is almost non-existent – Including its oxidative properties, degradation, continuing foreign body response and shrinkage, the treatment with surfactants and cleaning agents, the estrogen mimicking properties of polymers (plastics), the oxidative stress,  the lack of biocompatibility tests, the mechanical properties of plastic teeth that wear into tissue. Readers of MND are not making a distinction between pelvic and incontinence mesh, nor have the legal trials on polypropylene mesh so far. The research of Nonie Wideman and her Links on Mesh are notable here.

And her Links to Medical Mesh Research is here.


Myth #9 – “It’s bad doctors who had the complications, not the good doctors.”

Fact: This defies logic.  With 100,000 plus lawsuits filed- are there that many bad doctors?  During the Linda Gross v. Ethicon trial in February 2013, Ethicon did note that some of the doctors taking weekend cadaver clinics hosted by Ethicon and Gynecare, a division of Johnson & Johnson, were not catching on as fast as the Top Tier docs.  See Linda Gross Trial Day 19 here.

If a product cannot safely be used in the hands of a medical doctor and the company knows this, why would it continue to market the product to them anyway?


Myth #10 – “Mesh has been used for 50 years without problems.”

Fact:  This statement has been repeated by the defense lawyers for mesh makers at trial.  The quantity of mesh is part of the issue. That statement, parroted by many, refers to polypropylene sutures used in hernia repair.  They have been around since the 1970s that is true.  Heria mesh implants were never tested by the FDA like pelvic mesh and MND hears from many hernia mesh injured patients who are experiencing life-altering complications. Unfortunately, the FDA has not issued any warning about the rate of complications for this same polypropylene mesh.


And Last But Not Least – Okay Myth #11 – “Don’t Read the Internet.”

Fact: Mesh News Desk is laughing over this one. If there were true informed consent, Mesh News Desk would not be necessary. Women are desperately trying to find answers their doctors are not providing.  The information here is intended to help augment the discussion a woman has with her doctor and is not intended to substitute for medical advice. A truly informed patient, in fact, can help inform her doctor about the myths and misunderstandings surrounding pelvic mesh.

Enjoy these graphics by a valued MND reader! See if you have heard the same.

Doctors say the Darnedest Things

Doctors say the Darnedest Things

Jay lee graphic



By |2016-03-23T12:13:31+00:00March 17th, 2016|News|106 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Sandy April 8, 2014 at 5:21 pm - Reply

    This just made me laugh and cry. Laugh at the stupid comments doctor give us, cry because the bottom half states every last thing is about me and things that have happened to me. I feel so alone. I feel people looking at me like they question what I am telling them. They tell me the mesh is out how can I still be in pain. Nerve damage and or entrapment is why. Number 1 is exactly were I am at and now I can’t work. People think I should be able to but when you can’t walk or sit who is going to hire you! The only thing that has gotten me through this far is my faith that God will make this ok. At least that is what I am able to tell my self most days. I wake up knowing it will be just another day of existence. Praying for good news from some where, praying for a little less pain today, praying that I can find hope in my future. Most days are harder and harder as time goes by.

    But I thank God for Jane, because when I read this I cried because I know I am not crazy. I know I am not alone in the symptoms i have. I would have to think the doctors know what they are talking about if it was not for Jane. But here at this site I am able to find out that my symptoms are like other women’s. that it is not just in my head. People think you are crazy or emotionally unstable because you are depressed, because you cry when you talk about it. Thank God I can cry because if I didn’t I would exploded some day. When there is pain every minute of every day and you can no longer function in a normal life any more what the hell do people expect! Yes I am down yes I cry I have lost my life and I am fighting to get it back or at least lose no more of it. No one has a right to destroy a persons life yet they did. I just pray they don’t get away with it. I pray they will have to pay big time for what they did. I can only leave it in God’s hands and try to hang on the best I can. Damn you to hell to those companies that hurt so many women and destroyed their lives. Be responsible adults and step up and do the right thing.

    Thank you Jane from the bottom of my heart for this site. You save people by having this site here and letting them know they are not the only ones.

    • Jane Akre April 13, 2014 at 11:02 pm - Reply

      Sandy- Let’s not give up medically…. do you have access to competent medical help? Do you have your records? you can email me privately if you want and tell me where you live…. thank you!

  2. stopmeshimplants April 8, 2014 at 6:02 pm - Reply

    OMG! This article is your best yet. Before anyone reads anything else they need to read this article. No one should listen to anything or anyone except this website and the article above. Congratulations Jane. You hit it out of the park with this one! So very true ….Every single word. I can only hope and pray that women read this and spread the facts as you have stated in this article. Thank you.

  3. Lynn April 8, 2014 at 9:46 pm - Reply

    I have heard those lines from doctors and a few more:

    Line #11: “You will be back to work within 3 days”………That was over 2 years ago…..3 surgeries….and awaiting surgery #4.

    Line #12: “I didn’t go anywhere near that area………..don’t know why your rectum is hurting………You need to go to a colorectal specialist.”

    Line #13: “I have only seen (1)”…or some doctors REALLY exaggerate “(2) patients with mesh problems”………and, me (a mesh victim) getting calls constantly from mesh victims wanting to know where to go for help.

    Line #14: “I got all the mesh out”…………then go to 2nd doctor who gets out 4 cm. on each side…..How much mesh do you think the 1st doctor got out?

    Line #15: “We don’t use any diagnostic equipment to detect mesh”.

    As a mesh victim, I want the TRUTH. I am tired of the lies. And, I want transvaginal mesh permanently removed from the market, so no other human being has to suffer as I have. Here in America, we are supposed to live in an industrialized nation…….and, I feel as if I am an unwilling participant in a cruel experiment.

    • Jane Akre April 8, 2014 at 10:06 pm - Reply

      Lynn- LOVE- the additions… any more? Keep em coming…. there must 100 or so… Yeah I left out “How about some Pain Management” ? Funny- my dog recently tore his ACL and the FIRST thing the docs said was ‘He’ll need surgery”… it was $2,500… I said ahhh…So I went online ( don’t go on the internet)…. and I found a website devoted to ACL tears in dog. “The first thing the doctors will say is “you need surgery’ the writer said. It rang so true that I went with his recommendations. No surgery. Take it easy, Wait 6-8 weeks and see how he does.. walk on grass.. etc. Well you know, that writer on the “internet” was right and the dog healed on his own and I saved $2,500 and possibly my dog’s life. He’s 13 and don’t think surgery is good for an older dog. OKAY I’m off point here, but sometimes you find something on the “internet” and it is EXACTLY what you are hearing in real life and it rings true! So perhaps this story will do that for someone….

      • msm December 17, 2014 at 8:43 am - Reply

        I just went through the exact scenario. I guess it doesn’t matter if it is a DVM or MD. So glad I didn’t put my 11 yr old pup through it. He’s doing fine.

        I also would like to see statistics on how quickly people are pushed toward surgery according to what insurance they have. For instance, Medicare will reimburse more for surgical procedures than for conservative treatment as long as the surgeon can justify the “need”. (With the exception of physical therapy for which the patient pays half out of pocket and is not financially feasible for most patients)

    • Becky McIntosh April 8, 2014 at 11:58 pm - Reply

      Don’t give up Lynn, there is a light at the end….

      You just need the right doctor to remove it…..get it out of you!!!!! When you find a doctor, ask how many times have they removed a mesh and how many were successful. E-mail me and I will tell you my horror story……but thank God, after approx. 3 years of pain I’m almost back. Getting my resume back in shape, working in my garden, getting ready to go to Louisville, KY to the KY Derby, etc, etc. Things I thought I’d never do again. SEE THE RIGHT DOCTOR!!!!

      • Jane Akre April 9, 2014 at 10:56 pm - Reply

        Becky… would you provide other questions that should be asked? thank you… anyone else? Thanks… Ive always thought if a doctor becomes defensive and doesn’t want to answer your question, you have your answer.

  4. Becky McIntosh April 8, 2014 at 11:43 pm - Reply

    Dear Jane,

    As I sit here recovering from the pain I have experienced for the last three years I find no humor in the doctor comments I have just read……maybe in a year or two.

    I have had approx. 12 doctors and I have heard every one of the comments. I want to add one, # 21. “YOU NEED BOTOX”. I tried it 4 times at $500 a pop (copay)……and guess what? No help. I feel sorry for most of the doctors. They were sold a bill of goods that didn’t work….and because of the newness they didn’t know how to remove it. It was too new. The doctors that tried anyway just made things worse.

    There are only a handful of doctors who can and has removed the mess successfully. One is Dr. Raz in California who has a patient whom I communicate with, One in Atlanta and another is my doctor……….My Heavenly God sent doctor, Dr. Christopher Walker in Orlando. I drive 10 hours to see him and his staff. They are all wonderful. He has removed the mesh and I went back for the POP surgery this last month.

    And let me add…….

    If there are any husbands out there reading this and your mate has experienced this please help her get through it. There is light at the end of the tunnel……..took me three years to find out. Thank God I have an understanding husband …’s so bad ladies are ending their lives that can’t deal with it. Get on the computer and learn about it.

    When she tells you she’s in pain you can bet your last dollar she has BEEN in pain for months before she ever complained to you.

    Just thought I needed to say something,

    Becky McIntosh

    Pensacola, FL

    • Jane Akre April 9, 2014 at 11:00 pm - Reply

      Becky- I wish it was humor… these are actual things women have been told… It’s hard to believe there is such a disconnect between the patient in pain and the doctor who doesn’t believe them, and/or doesn’t know what to do..I hope you were not offended… ~ ja

    • Julia November 17, 2016 at 8:24 pm - Reply

      I just had the first surgery to remove what the Dr could get of the mesh. Almost all the things on the list I have had happen. After going back for a check up on the surgery the doctor told me she could one get it all. Made light of the fact The mesh poisons your body ,told my husband and myself that they still use the mesh. They put another sling in but it was not mesh. I do however still have mesh on the back side her could not get out. Since the surgery is have had to live on the blue pill that help the burning. This is not a funny thing and why in the world would they still be using It? I have a lawyer and I think the Dr is not happyet that the claim has been made and she had to sent a sample .

  5. Dawn April 9, 2014 at 12:53 am - Reply

    Another myth: only a 1% adverse reaction.

    I live in a small town of 9000.. So figure 4500 are females, I now gave 2 other women about my age (48) who have the exact same SUI sling , different Dr.’s, except 1.

    And we are all experiencing the same horrible pains !!!!

    Coincidence ????????? 1% ??????? I think their numbers are way off the mark !

    • Jane Akre April 13, 2014 at 11:10 pm - Reply

      Dawn- I’m assuming your doctor can read. I’m also assuming he/she does not keep up with the information that is being revealed from these mesh injury trials. Remember that when Ethicon conducted a study, it had set a parameter of 15% for injuries (NOT ONE PERCENT) and the trial had to be halted when the mesh erosion rate came in at 15.6 %. Here is the story. Share it with your doctor and maybe he/she will have time to read it!

  6. HE April 10, 2014 at 3:10 am - Reply

    Wow! What a great read. Too true! I’ve heard every one of them. And I can add – you’re pain is “too high” to be mesh related. You’re too far out from surgery – it worked well for almost 2 years – if it’s going to fail, it’ll be right away. I had another “veteran Dr.” with so many letters after his name (and he exuded that he knows everything there is to know about mesh) tell me that Dr. Raz is an idiot! I know who sponsors his paychecks. This Dr. also said “Mesh has never caused pain”.

    This has gone way past incredulous to no mans land. I cannot believe that this product is still out there. I am finding hurt women at least weekly now, many of them want to be in denial. They certainly don’t want to go through 10 surgeries (4 with Dr. Raz) estrogen cream is much cheaper. It’s eroded twice? That’s no big deal, we’ll cover it over with your “stronger muscle” from the thigh. I’ve also had women tell me that they didn’t have mesh put in, it was a sling. This same woman told me she had been back to her surgeon over 4 times in the last 6 months and he keeps telling her the sling if just fine. The problem is her back. She told me when he used the forceps she about hit the ceiling and he said “you’re just a little tight”. I think she really wanted to trust her Dr. She was a very sincere person. The really sad thing about mesh is that once it starts causing problems if they’re not taken care of quickly and with an expert, that the decline in quality of life is exponential. I have another fritend who has had hernia mesh and a lap band made of mesh. She is now seeing a physical therapist who has told her that her problems are that all of her internal organs are glued to the right side of her abdomen. She’s working on breaking up the scar tissue. It’s not the mesh – she didn’t have a sling or POP repair. ARE WE CRAZY?

    My PT asks me to talk to her patients because she’s seeing many mesh patients who are being referred to her by the surgeon who implanted the mesh. Who do I send them to??? That question has been asked so many times by the walking wounded. That is perhaps the first and most important question to have answered when you find yourself a victim of negligence on a grand scale. Negligence on the part of the pharmaceutical companies in failure to do their due dilligence. Negligence on the part of the FDA who “clear” almost any product on the market which gives the product a measure of seeming “integrity” while not concerning themselves with safety in any way. Negligence on the part of the Dr.’s who, by now, have to know “the dirty secret”. This has gone on way too long for any kind of “good faith” to be in place. The larger looming issue that is running under the mesh and other scandals is the lack of true concern for one another. To take one’s oath seriously and have your name mean something. To do no harm – period. The benefits do not over weigh the risks. We are talking about incontinence! Incontinence – the word that brings fear to the soul of every woman. Oh my gosh – to be incontinent is to lose your life! That is such a sad state of affairs in our modern world. To me it seems like we’re back in the dark ages. But this is how it is being treated. The Dr.’s who use the mesh are saviors and we can be young and beautiful again. We’ve bought into a great big lie. There are many other solutions than mesh. Try to think of them or search for them – not much to be found. But they’re there. My PT has cured so many women of incontinence in 6-8 weeks. One lady was 88 and had been incontinent for over 50 years and it took her 12 weeks of PT. Now why is this option never brought up???

    Sorry for the rant – post surgical with 9 pain and cannot sleep. Just some thoughts to add to the discussion.

  7. christine wendt April 10, 2014 at 4:53 pm - Reply

    I was told by the implanting surgeon that ” you may have a little mesh peak through into the vagina and chances are that your partner will be the only one to notice and we can just trim that right out in the office and send you on your way.”

  8. guest April 10, 2014 at 10:27 pm - Reply

    TY, JANE, How much longer do judges have to listen to cases and women the way they are suffering from infections, pain and cruelty, sarcastic remarks they get from doctors and nurses , doing without no funds to even buy the best of bladder leakage products needed , even worse since mesh implanted in them, It has been years only lies, cruel treatment , courts dragging, not caring, I am so sorry that the woman in Texas did not get punitive damages that she deserved also, IT HAS BEEN SAID BEFORE, these companies paid political leaders millions for their campaigns > millions they had, The million that women are getting they truly need and deserve knowing that it will go back into medical till the day they die, paying money to find a doctor, nurse that will talk and be truthful with them and treat them like a human being that has a mind to speak and talk. THE MENTAL STRESS, ADDED TO THEIR TRAUMA OF MESH . TY, Jane for standing for truth, not many like you in this world would be nice if all would learn when lies are told and covered up, innocent people suffer.

    IT HAS BEEN HELL, FOR YEARS NOW FOR SO MANY , and still it is a struggle so much of our life taken, so long to even get confirmation from a doctor that will even tell the truth in his records to confirm mesh protruding out, then still getting lies that blood in urine, we do not have infection, but mesh scraping there is no infection,, but infection is very apparent. to there is no mesh after 1 confirms it, messing with people’s minds, mind games, is cruel. not a good person in the way I see it, HOW CAN YOU TRUST AGAIN??? i PRAYED GOD HOLD MY MIND TOGETHER THROUGH THIS TOO, My anger is great,



    Truth and justice for all men too damaged by mesh. THANK GOD FOR THOSE THAT TELL THE TRUTH.


  9. Marie April 11, 2014 at 2:50 am - Reply

    Well written, truth speaking article! If this is the precursor for the movie, ENMESHED, it’s going to be a BOMBSHELL! I hope all mesh kits are collecting dust on the manufactures shelves!

  10. sheryl teague April 11, 2014 at 3:06 pm - Reply

    I just would like to have someone to talk to regarding my mesh. I don’t want to talk about all of the legal stuff….that is not my concern right now…I just want to talk to someone who has been or may be going through what I have as the medical community really treats you so distantly when you try to address this. Amazingly so…I am a registered nurse of 22 years…and continue to work….but I can really feel myself slipping away. I had the mesh put in 10/12/2010 as my gyn. felt this was the way to go since I was a practicing nurse. My life has been hell ever since….erosion throughout, 3 surgeries attempting to remove the mesh as well as reconstruction of my urethra (ouch), multiple hematomas, cauterizations, nerve damage with beginning foot drop…and now there is even more problems starting with my back/pelvis (including incontinence…even after 6 mos. of vaginal physical therapy (omg)….please, if there is anyone that is going through this as well….who would just like a friend to talk to regarding everything….feel free to forward them my email.


  11. charles April 11, 2014 at 10:06 pm - Reply

    With regard to diagnostics it seems to me that toxicology tests to blood and tissue would show abnormal levels of petroleum products related to polypropholene. Has this been tried to anyones knowledge? My wife had mentor ob tape placed in 2004 and attempt removal in 2008 with additional revision surgeries mostly to no avail. She battles constant autoimmmune problems now. We dont know what to do. Im afraid the mesh is so grown into her tissues after 10 years it cant be removed . But i still think the degradation of the mesh would show abnormal toxicology levles

    • Jane Akre April 13, 2014 at 10:47 pm - Reply

      Charles- You are right. There are far too many people developing autoimmune issues likely related to the PP… it can’t just be a coincidence. As far as I know, there is no lab or scientist that is looking into this. If a law firm attempted it, it would be enormously expensive but also likely to yield new answers in the search for the causation, not just correlation. Anyone with a successful Mentor OB tape removal, please respond here….thank you~ja

    • Jan Urban December 18, 2014 at 8:19 pm - Reply

      Charles, What kind of autoimmune problems is your wife having? I have had some weird, out of the ordinary things happen to my body since the mesh implant. Within a few weeks after implant the itching started around the area I pee and it progressed to the vulva and rectum area. For a time several doctor’s thought a hormonal cream would take care of it. No.It is Lichen Sclerosus. They do not know the cause. But the research says autoimmune caused by all those nasty germs called staph and what nots. I had a home catheter for a while and who knows with the surgery it was a busy time for surgeries the end of year and they had patients stacked everywhere. I also have another Lichen effecting my toe nails that started about the same time. I never had any problem with my feet. Severe swelling of the legs, feet and abdomen. I’ve gained 60 pounds Itchy rashes, lesions, boils, open sores all over my body. trouble breathing and acid reflux along with a hiatal hernia and gall bladder, bowels giving me a lot of problems with the belly being so large. pushing things up and down and all around. But I’m with you Charles. There has to be a specialist that can order this type of blood work or even your family doctor? I have to many medical procedures going on right now to add one more I’d be really nuts. But it is something I need and would like to find out. Allergies and sinus problems also.. Charles you are a good man and a wonderful husband. I appreciate your comments and concerns as well as your caring suggestions. Thank you Jan Urban

      • Kim December 18, 2014 at 9:57 pm - Reply


        I just got back from the doctor today. I have an itchy rash all over my body. They call it “stress eczema”, and yes, stress is a TRIGGER, but the cause is autoimmune. I also had thrush following the mesh implant. This morning one foot wasn’t behaving right. What is foot drop? Is this something else caused by mesh? Life has become a living hell.

        • msm December 19, 2014 at 1:07 pm - Reply

          After going through every antifungal antiseptic and antibiotic it was determined i have developed an allergy to Propylene Glycol which is in nearly every vaginal preparation from hormone cream to lubricant and even yeast remedy. Itching from the inside out and losing my mind until I learned that. Wonder how i acquired this allergy when never allergic to anything. It is a polymer used as a preservative. Same family as the mesh. A polymer. Plus it is acquired so it is most likely from constant exposure to it just like the medical professionals acquire latex allergy from using the gloves everyday. Wonder if i acquired it because of the polypropylene in me for five years now. Wonder how many other have similar issues.

          • Jan Urban December 20, 2014 at 12:45 am

            Kim and MSM, I just looked at the tube of Clobetasoi Propionate cream use for the Lichen Sclerosus of the vulva and it has that propylene glycol, stearate/polyethylene glycol 100. I use it once a week when there are no flare ups. I never had any yeast infections before the mesh, I took a lot of antibiotics most of my life that never gave me a yeast infection. But I have had 6 since the mesh. I can’t tell what I am itching from. I hear they make you itch. When the lichen flares up it is severe itching to where it bleeds because at my age you know everything shrivels up, dries out. thins out, can’t wear clothing near this area. My skin just peels off of me it is so dry. I’m a wreck and I hate it. My weight gain (60 pounds) and the belly bothers me the most, I am so depressed for I never had a weight problem. I need a make over to learn how to dress for this kind of shape. any suggestions?Well, I guess will make it somehow. Thank you everyone for listening and commenting. I appreciated it. Jan

          • Jane Akre December 24, 2014 at 10:52 am

            Very interesting alt… symptoms are extreme itching inside….. That should be added to the list of potentials. thank you for sharing that… no doubt you are not alone on those symptoms …

      • me August 7, 2015 at 8:28 am - Reply

        Jan Urban Please call me! Please I need to talk to you, I have LS and am a mesh victim. Please I feel as if I’m going crazy…9896193872

      • linda August 19, 2015 at 9:19 am - Reply

        I am also having the same issues as u and keep thinking how can a person have so many things happening at the same time. I have been to so many doctors back n forth spending money getting nothing. I think I need to have the mesh out again.

        • Jane Akre August 19, 2015 at 9:24 am - Reply

          Linda- Yours is an example of why it’s so important to get a complete and full removal, if needed, with as few surgeries as possible. Understanding that the pelvic region is very complicated, not every doc is capable of doing that. Anyone reading, you must check references on the doctor and check with former patients. Please consider using the facebook option associated with this site to pose general questions or if you want to remain anonymous, I will post the question on facebook on your behalf. write at

          • Anita S November 18, 2016 at 11:05 am

            Please,any doctors in the Cleveland,Oh area to remove this? Have been suffering for six years,having biopsy and told if it is cancer we can cure it, if it is mesh nothing can be done. I cannot go on much longer like this,no sleep,constant pain and have had to quit work!

          • Jane Akre November 19, 2016 at 1:31 pm

            Don’t know of anyone in Cleveland… Dr. D. Veronikis in St Louis would be the closest I’m aware of. Anyone else?

  12. guest April 11, 2014 at 11:48 pm - Reply

    I have got information from this web site and reading what others have gone through, home remedies , better than what doctors and nurses were saying , I have heard all of the above and more, (lies). but this is a question that bothers me, I have had a first attempt removal, and lied to, it is still infections , pain and not knowing 1 day from another , some severe some not as severe but every day in pain . continuously .

    I was told mine could not be removed, they waited too long and it took to long to even get a doctor to tell me truthfully about the mesh, so many lies one doctor to another.I have read that the mesh has grown into body parts, so more surgery they would have to cut into body parts it has grown into to remove it. more damage. weakened badly for years now. Some say do not have it removed grown into other body parts, more surgery will not help.

    I read here that a doctor found to remove Becky’s mesh , after surgeries , had it grown into other body parts,? She did not mention how long she had her mesh implant (years) It t seems the sooner those women that got to raz and doctors that were truthful with them, they got it out before it got into other body parts. THOSE WOMEN THAT IT HAS GROWED INTO OTHER BODY PARTS AND MOVED EVEN MORE, wouldn’t they have more severe damage if they have to cut into those places to cut it out, more damage.

    VERY HARD DECISIONS. anti biotics for the rest of your life for temporary relief , very little relief , never stopping. they know that no humanbeing can live like this. I HAD TO BACK OFF, KNOWING ANTI BIOTICS TAKE AMMUNE SYSTEM DOWN, IT SEEMS LIKE A D—- IF YOU DO AND D—– IF YOU DON’T. for those that it has not got into other body parts, believe me you know, not just in vagina, buttocks and legs, Get it out before it does. HOPEFULLY MORE WOMEN FIND OUT SOONER WITH WARNINGS THAT SOME OF US DID. , A SHAME THIS WAS NOT BLASTED WARNING WOMEN AND MEN OF MESH, BY STATES EVERY WHERE AND STOPPED.


    i want to know, , I WAS TOLD MINE CANNOT BE REMOVED, IF A DCOTOR TRIED , WOULD MORE DAMAGE CUTTING THE MESH OUT BE DAMAGE TO THOSE PARTS IT HAS GROWN INTO/ i WOULD HAVE TO SAY NO, if I have to face more damage to other parts that would cause more pain and suffering. I COULD NOT TAKE IT.

    • Jane Akre April 13, 2014 at 10:44 pm - Reply

      So what did you do? Yes it integrates with the body.. You can also take probiotics to counter the antibiotics which supposedly help somewhat. Please let us know what you decided… Mesh manufacturers never considered what the plan B would be if mesh needed to be removed, even though they forecast there would be complications. (Linda Gross trial) ~unbelievable…..

  13. guest April 15, 2014 at 1:57 pm - Reply

    At this point so many years, and being told the mesh cannot be removed, hard to trust like others. My hope is to get to Dr Raz , or find a doctor that lets us make our own decisions and talks to us , I WANT TO SEE THE ULTRA SOUNDS THAT i HAVE HAD MANY OF OVER THE YEARS. I want a doctor to show what I HAVE TO FACE TO REMOVE IT, HOW MANY MORE SURGERIES, What damages can i expect, and possible further damage, will it stop infections, and pain or add to what I now suffer. will I gain strength back that I had even at least before I had the attempt to remove some of the mesh. I WANT A COMMUNICATION THAT WITH QUESTIONS ASKED TO ME, AND MY QUESTIONS ANSWERED ALSO.

    I KNOW MY BODY BETTER THAN ANYONE, AND WHAT COMMON SENSE TELLS ME THAT i CAN TAKE AND WHAT i cannot. I AM NOT A DOCTOR, BUT i HAVE COMMON SENSE, KNOWING THAT EVERYONE’S BODY IS NOT MADE OF LIKE MINE. We all have differnt systems , what you can take I might not can and visa virsa. I want straight answers. I HAVE A MIND AND CAN SPEAK ALSO. I do not need anyone to make my decisions. What is wrong with straight truthful answers both ways, to the best of their knowledge , their opinion and let me decide.

    RIGHT NOW, MY FEET CANNOT MAKE THAT STEP TO DO ANYTHING, FOR REASONS OF LIES AND CRUEL TREATMENT OF DOCTORS AND NURSES, i want closure, , to know , what I HAVE TO FACE, and to know what damage has been done not just in vagina but a ultra sound has never been done in the buttocks and other areas . I WANT TO KNOW THAT ALSO. For me to trust ,I HAVE GOT TO HAVE QUESTIONS ANSWERED , , MORE THAN ANYTHING i want closure, of what questions that I deserve to be answered , by a doctor that can treat us like a human not an animal , that says do as I say or I won’t see you again. that just provokes me to more anger. when they will not answer questions. not even to tell us of tests done. having to learn the hard way. I AM SO SICK OF PEOPLE THAT ABUSE THEIR POSITIONS OF AUTHORITY. GIVING THOSE OF THEIR PROFESSION A BAD NAME. I APPRECIATE THOSE THAT STAND ON THEIR OWN MERIT BEING TRUTHFUL AND DOING THE BEST OF THEIR KNOWLEDGE THEIR BEST ,

    i HAVE SAID , I could have forgiven those that lied to me of implanted mesh, but they did nothing knowing at 6 weeks infections had already started , but said nothing, but gave sarcastic remarks and their nurse, when I called and asked after months , TIME BEFORE THE MESH GOT INTO OTHER BODY PARTS , WAS SO CRUCIAL TO HELP ME GET THE MESH OUT. TIME, SO CRUCIAL DENIED AND LIED TO BY THEIR COLLEAGUES, ONE AFTER ANOTHER, , i will pay for the rest of my life for their sarcastic lies, I TELL GOD I CANNOT FORGIVE THEM AT THIS POINT , I ABOVE ANYTHING WANT CLOSURE WITH MY QUESTIONS ANSWERED, i haven’t got there yet. I am so happy for those that have got there to doctors, to help, some of us haven’t got there yet. It takes money to get there also. bills that ins . are not paying, are coming in. I AM SURE A LOT OF WOMEN ARE IN THE SAME BOAT.

    Those women like me, love to hear from those women that succeed, feeling like on the side line, cheering them on, knowing their pain and suffering is and has been hard. so few doctors , so far away for some women to get help and truthful answers. Those get see closure, somewhat , in courts and with getting to doctors, we yell, YES.

  14. msm December 17, 2014 at 8:22 am - Reply

    Bard claming removal because their product was no longer “financially viable.” C.R. is true if Bard knew it was defective and would potentially cost them billions in court. Amazing that Bard would believe that move to be shrewd rather than transparent manipulation that it is.


    The claim of “removal” of tape is interesting. After reviewing surgical records, it seems some docs consider removing the portion of the tape that can be accessed through the vagina to be “complete” removal.

    In reality, it is only removal of 3 to 4 centimeters of a strip of mesh that could be more than 15 cm. This “complete removal” leaves the majority of the mesh somewhere between the bladder and pubic bone in the retropubic space.

    Realizing that this mesh is not anchored in most cases, there are now two peices of mesh free to migrate, abrade, erode, hardened, etc. No one knows the longterm effects of leaving the majority of the TVT in the retropubic space other than the fact that removing the remaining mesh is made exponentially more difficult.

    Legal review of records claiming “complete removal” could result in an assumption that the patient is “cured” and no longer can be affected by mesh so the potential award (and attorney %) will be less and not worth their time to pursue whole-heartedly. Considering the people reveiwing records have liittle to no medical training and only look for key terms, this is a significant issue.


    The idea that mid-urethral mesh slings or “tape” do not cause the damage that POP mesh causes is ludicrous. In applying for patents, the applicant must declare a necessity for the new product.

    One manufacturer claimed that their product could make it easier for surgeons to implant the mesh without excessive tension. They further stated that the tension could cause distortion resulting in reduced pore size (increased risk of infection) and cause the sides of the mesh to curl resulting in sharp edges that could abrade tissue.

    This makes it obvious to me that the manufacturer knew exactly the damage that could result. The warnings in the IFU to the physician only warns of the possibility of urinary retention from excessive tension. Pretty obvious why they might want to settle quickly.

    Great article.

  15. justme December 17, 2014 at 1:27 pm - Reply

    “Your mom has the “she wants to have a baby syndrome”. “She thinks she is pregnant and that is why her belly pokes out like that and the pain is in her head. She needs to see a shrink. It is NOT the mesh (he was screaming at us, loudly over and over, it is not the mesh. He ended with, I have never heard of this before”. He was a surgeon.

    I have been told by every doctor and their STAFF I have been too seeking help, “You are the only one we have heard this from. There is no problems with your mesh sling.”

    The other doctor was let go from the hospital group he was associated with and threw all of the patient files in the dumpster. He performed unnecessary surgery on me telling me he would try and remove the mesh, knowing he could not. He was being nosy.

    After the surgery, he dismissed me. After he called me a fat pig. A fat lazy moron, and nothing was ever done to him by the Medical Board.

    I have another doctor stalking me. He dismissed me too. And then, he had me dismissed from every primary doctor, every surgeon and every doctor I have tried to see for the past 3 years. He follows me on the state database. He is trying to put me in jail. He lied on me. He set me up. I am telling the truth, and I wonder if he is being paid by the mesh maker to do this.

    Now, he started stalking my 86 year old Mother who is dying, and my children too.

    So go ahead and tell me again how mesh does no harm. I am dying from the pain from mesh. I have never known so much pain and suffering in my life. Everything listed in the myths and the bottom banner I can relate too.

    Please pray for me and my family. We are being denied medical care, medicines and have been left to die. We have no money and no hope at this point.

  16. justme December 17, 2014 at 1:35 pm - Reply

    To the Mesh Companies, If mesh is so safe, and does no harm, why do you go to unheard of great lengths to discredit patients who have it, deny their pain and suffering, and do everything you can to discredit them?” If mesh is so wonderful you should be asking for testimonials. I have YET to see ONE positive testimony from ANY mesh patient.

    Why is Capital Hill not involved with this yet? Where are the advocates for patient health care? Where is Hillary? Why is the Human Heath not involved yet?

    What is going on? Investigations should have started years ago.

  17. Karen December 17, 2014 at 2:55 pm - Reply

    Becky, I too had a revision by Dr Christopher Walker, he has been a god send to me. Just wish I had found him sooner.

    • Jan Urban December 17, 2014 at 5:14 pm - Reply

      Your at the ER bleeding from the vagina and rectum. You inform the ER Doctor that you have a Mesh Sling for SUI. Oh, ” We don’t deal with Mesh issues here”

  18. Jan Urban December 17, 2014 at 5:30 pm - Reply

    Implant Surgeon can’t believe I have total incontinence. ” I think it’s you interstim system”. Calls in head tech with Medtronic Interstim Systems for over active bladder.. Has tech change device to 2 programs causing more pain of the rectum and vagina. yee…ouch…s#$@*& what the heck are you doing to me? Turned the damn thing off!!!!!!!! I had the interstim implant for over active bladder before the mesh implant. I’m glutting for punishment.

  19. David December 17, 2014 at 7:58 pm - Reply

    CDRH Director Jeffrey Shuren, M.D., J.D. stated, in his December 9, 2014, FDA Voice blog post, “Implementing the Unique Device Identifier System into health care systems is critical for reaching its potential to benefit public health” that “[the FDA] commissioned the Brookings Institution to create a ‘roadmap’ for provider systems, patients, payers, supply chain personnel, and many others, to adopt and utilize UDIs. This report, released on Friday, December 5, provides 17 recommendations for adopting UDIs across three major intersections of the health care system—providers (e.g., electronic health records, hospital inventory management, billing records); administrative transactions (e.g., claims data and payment information); and patient-directed tools (e.g., mobile apps and public awareness campaigns).”

    Under “Integrate UDI into Patient-Directed Tools” the Brookings Institution summarized theses “patient-direct tools” as follows:

    Patient advocacy groups, FDA, and other strategic partners should develop awareness among patients to request the UDIs of their medical devices from providers (i.e., “Know Your UDI” campaign); efforts could be led by patient advocacy organizations

    Patient and provider checklists and questionnaires should include the capture of UDIs for high-risk implantable medical devices

    PHR developers should integrate UDIs into PHR implementations

    Consumer medical application developers should work in collaboration with patients, patient advocacy groups, and FDA to integrate UDIs into their web resources and applications

    Patient advocacy groups, the National Library of Medicine (NLM), and the FDA should work in collaboration to develop tools that increase the accessibility and openness of federal databases containing UDIs and medical device information

    It is interesting to note that this suggested “‘Know Your UDI’ campaign” (as it is currently suggested) will only happen after a violation of a patient’s Human and Constitutional rights potentially occurs by the device manufacturer, via use of the physician perpetrator. And more importantly, only after that patient has the device implanted into his/her body. Why is this “‘Know Your UDI’ campaign” not being suggested pre-surgically, so patients can mitigate an immediate, unreasonably dangerous, indiscriminate surgeon abuse of non-effectively regulated, dangerous medical devices and then unwarranted life-time of accompanying device/procedural risks? (The former campaign would seem like a more logical endeavor if the intent here was to bring about meaningful change for the benefit of future patients.)

    Patient knowledge of the understood current least risky device or ‘effectively safer’ device will create quality, non-substantially equivalent device market monopolies…If every rationally thinking patient would only want the understood least risky device (or hypothecated ‘effectively safer’ device – addressing the limitations of the comparative least risky device) responsibly implanted, societies formed between device manufacturers and leading industry physicians would then be unable to set their own guidelines – to promote their own best practices – for surgeons in clinical practice to indiscriminately abuse patients with both dangerously approved and cleared devices as their “standard of care”.

    Fundamental to regulating the long-term/permanently implanted (L-T/PI) medical device – to a reasonable assurance of safety and effectiveness, is to legally bind the first half of the UDI (“the device identifier”) into an effective, two-part patient informed consent process. Legally binding the UDI, however, will create a big problem for those who seek to continue to further preying upon the vulnerabilities of more future patients for own self-serving gain.

    Finding 2-5 from the Institute of Medicine’s (IOM) July 2011, FDA sponsored report “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years” found that: “with limited exceptions, a determination by the FDA that one device is “substantially equivalent” to another device does not reflect an FDA evaluation of the safety or effectiveness of either device.” The 1996 Supreme Court opinion: Medtronic, Inc. vs. Lohr found that (in regards to the

    510(k) clearance of devices) “…the later device is no more dangerous and no less effective than the earlier device” (518 U.S. 470 (1996), Id. at 493-94).*

    *I think the Court should have said “no [less] dangerous and no [more] effective” (…21 U.S.C. § 360c(i)(1)(A)(ii)(I)), as “a determination by the FDA that one device is “substantially equivalent” to another device does not reflect an FDA evaluation of the safety or effectiveness of either device.” This is because neither device was approved for safety and effectiveness. And even more so, because the principal of “substantial equivalence” is so fundamentally, inherently flawed that it cannot even maintain safety and effectiveness in legislative control confines – with creep of the next 510(k) “predicate device” reiteration away from a “substantially equivalent” comparison to the previous “predicate device” (in part or whole) – threaded through industry’s and FDA’s historical manipulation of “same [510(k)] intended use,” and then back to the preamendment device’s assumed 1976 market performance. Legally binding the UDI device identifier into patient informed consent is “the linchpin” that will collapse the 510(k) process like a “house of cards” – as 510(k) predicate devices are irrationally daisy chained together with only a “substantially equivalent” facade (IOM report finding 4-2 -to- Conclusion 7-1). Patients will act out of self-preservation; device manufacturer greed is the facet of the problem which inflicts unreasonable device and surgical implantation risk onto patients.

    With creation of an FDA UDI entry portal, integrated to an effectively functioning patient informed consent process, patients will be able to enter the legally bound UDI device identifier to obtain risk/benefit information independent of individual physicians’ bias and marketing skill entrenched in indoctrinated intent – with conditioning of clinical practice – to habitually undermine their patient’s rights. By circumventing “the physician learned intermediary,” this disruption to the status quo will place liability where it first belongs: directly upon the device manufacturer. And then on the physician, only with a very much needed patient complain mechanism through the Civil Rights Division the U.S. Justice Department, to circumvent both standard of cares (creating these primitive surgeon behavioral norms) and the unjust harbor by state medical boards (to support the plight of the repeat offender physician from accountability).

    A manufacturer mandate to discloser, in real-time, their knowledge of evolving adverse event harm from their devices, via statistical adverse outcome rates (now no longer left antidotal as “rare” and “not rare”), will help prevent the device industry’s undermining of the patient/doctor relationship, to continue to unjustly enrich itself, with ability to exercising its control over practices of medicine. Legally informed patients will then tell an industry how it will practice medicine! This new reality will be a very rude awakening to an industry that is use to getting what it wants through manipulation, fraud, deception and ability to maximize profits off of its despicable conditioning of regressive physician behavioral norms (in the medical schools and with reinforcement in clinical practice, via fraudulent marketing tactics, under “substantially equivalent” device cover) which collaboratively follows the manufacturer/physician’s widespread, systematic violation of patients’ Human and Constitutional rights.

    Could the real reason for this suggested “‘Know Your UDI’ campaign” be – through electronic health records – to again find more “justification,” to further streamline the device industry’s least burdensome efforts to market* (per FDASIA SEC. 602(b)(2)(ii) CLARIFICATION OF LEAST BURDENSOME STANDARD, with “‘necessary’ [to mean] means the minimum required information that would support a determination of substantial equivalence between a new device and a predicate device.”*) And, with “[the exciting UDI possibility]” of using electronic health records (in the way I understand that they will be used), the current status quo of widespread, systematic practices of patient exploitation will be left undisrupted; while at the same time, also prevent the burden to the physician of the patient questioning if they can even act in their (the patient’s) best interest – when the reality is the surgeon regressively trained to indiscriminately abuse a L-T/PI medical device approved neither for safety nor (patient) effectiveness can only carryout their own best practices.

    *And with FDASIA SEC. 602(b)(2)(iii) continuing on to state: “nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device,” the pre-FDAISA legislative control language, via 21 U.S.C. § 360c(i)(1)(A)(ii)(I), “…that demonstrates that the device is as safe and effective as a legally marketed device” – once needed to “(II) […] raise different questions of safety and effectiveness than the predicate device” – was rendered useless, due to the fact (as previously mentioned), “nothing in this subparagraph shall alter the standard for determining substantial equivalence between a new device and a predicate device.” Contradictory to current U.S. law, but appearing anyways in the FDA issued July 28, 2014 guidance document, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] – Guidance for Industry and Food and Drug Administration Staff, was both the apparent need and understanding by the FDA to add “Decision 1” (before all other decisions) to its new 510(k) Decision-Making Flowchart: “Is the predicate device legally marketed”.

    The Members of the U.S. Congress should be ashamed of themselves – not even for their failure to have acted to protect the American public, but to have offered up more future U.S. patients to be deceptively, predatorily targeted for widespread exploitation by the medical device industry’s least burdensome intent. The Human and Constitutional rights of any nations citizens are not up for debate. There was and can be no greater consideration for any government to balance. Inalienable human rights are inseparable to the need of another. The medical device industry’s history of preying upon unsuspecting patients – with intent to exploit a profit opportunity in a patient’s body, is not justification to continue the status quo.

    • msm December 17, 2014 at 9:24 pm - Reply

      Well said, David. Just an aside relating to electronic health records…

      There are multiple systems with no standardization. If you have 3 doctors, you may have a different record in each system.

      There are apparently no limits on who can access your records. Your permission in the form of a signed release is no longer required.

      You have a right to review your records and correct any errors. However, while docs have free access, you’ll have to pay for a copy of your records to review.

      If Congress doesn’t get a handle on this soon and stop this open exchange, our health records could be exposed to insurance companies, employers, and any entity willing to pay for it. There is nothing to stop moonlighting docs called “consultants ” from misusing the data in an EHR system for personal gain.

      Then there is the general security of the data as a whole. It takes no time to aquire an entire database once a hacker gains access to a system or network. With so many different EHR systems, security is questionable at best. Once data is exposed, there’s no way to “undo” it. It will have been sold multiple times before a breach is discovered.

      One more demonstration of a government that cares nothing for its citizens. Is it stupidity? More likely it is $$$$.

    • Amanda January 20, 2016 at 5:29 pm - Reply

      I would love to be able to talk with someone that has the CR Bard pelvisoft vaginal mesh I feel like I’m the only one and I do not know what to do! You can email me at Amandatizer777 @,

  20. Jane R. December 17, 2014 at 11:07 pm - Reply

    Are there any women out there that the mesh for incontinence and prolapse have worked?

    What is the percentage of good results? It doesn’t sound like too many. Has anyone ever said?

    Was it ever mentioned anywhere? I have a friend that had it done years ago but not the mesh. And the doctor was

    from Europe. She’s had no problems. She can go I swear days without going to the bathroom.

    I’m running every 1/2 hour. My doctor suggested Botox too. Glad I didn’t go for that.

    My doctor also said the mess wouldn’t cause pain there. Excuse me, if I was a doctor

    whether I thought it was the mess or not, I would try to find out what is causing my patient pain. I’ve been sent to the pain management center to receive meds that either don’t help or make me a zombie. So I’m pretty much house bound because I can’t drive on these.

    The complications are not just pain and erosion, it’s a multitude of complications. And our autoimmunue

    system doesn’t like the mesh. Wages are lost, the government has to pay for SSDI if you can get it, insurance has to pay for all our surgeries and doctor visits, our spouses, our children have to pay for our lost wages and have to watch us in pain or not being able to do things. Where is there a solution? Stop the implants would be a great start. And award those injured a sum so they do not have suffer hardship and can get the help they need. There are treatments that help me and I can’t afford them. I have insurance but big copays and deductibles. I’m scared to even have surgery because of what happened and I don’t know what will happen. Some outcomes are good, some worse.

    • Jane Akre December 18, 2014 at 4:20 pm - Reply

      Unofficially about 30 percent work for awhile, but no one knows the long-term effects of polypropylene…. it is an experiment… my opinion.

  21. sandy December 19, 2014 at 9:56 am - Reply

    lets just say the doctor could get the mesh out so what there is still damage done many times to the nerves where the anchors went in(I live this) it will not and should not make the settlement any less if there’s mesh in or out damage has been done to our bodies permanent life altering damage some of us have lost everything and my family were not even making it anymore we’re borrowing money from relatives to make things happen so regardless if you have mesh in or not if you had it in you and it caused you damage than you should be entitled to just as much as the women who go in front of a court do none of us deserved what happened to us. lights have been altered forever for the rest of our lives will never be the same at least I won’t again I ask you how much is 40 years of life left to live worth How much is all your dreams lost, your golden years taken away worth all these things were priceless to me. While the government and the medical companies systematically destroy lives our lives slip away and greed is at the core and doctors who won’t listen to patients who know more than they do

  22. Disgusted December 20, 2014 at 1:42 pm - Reply

    Good points. It has crossed my mind that we are not all being treated equally. Most of this seems to be on the amount of “damage” that has been caused. The problem is there is no conclusive answer. Whether the mesh has been ex-planted in whole or partially removed. Or even if it has been left intact. (Some of the lawyers have insinuated that having it removed makes us worse). We have heard of plenty of women saying it worked well for 2, 5 and even 10 years or more. Since some of these cases have cleared the courts, they were based on the conditions at that time. As we know this can change. For those who have had their cases dismissed, I can only hope that they’ll be able to get good medical care and that things will not get worse. For those who had a “settlement” made without their consent. I hope they will not have financial issues for the rest of their lives. I have met many women who have a sling that hasn’t caused problems – yet. Maybe some never will. This does not justify the harm done to so many. It is anything but “minimally invasive”. It is not a gold standard. I want to know who besides the pharmaceuticals and their “hype” claims this to be true. This should be investigated for accuracy – if they claim it is the “gold standard” they should have to “back up the claim”. If it’s in words then it must be true. Poppycock. The same reason we’re being told to avoid the internet. Dr.’s who testify should have to be able to back up their claims. For those who testified that they haven’t seen these issues, each of their patients should have to be consulted. I’m sure there is a great divide in reality. The idea to tell the whole truth and nothing but the truth is laughable in our day and age. But it isn’t funny. It is so sad.

    • Jan Urban December 21, 2014 at 1:33 am - Reply

      Why should we avoid the internet? If I did not have the internet and the information available about this horrible destructive mesh I can honestly say I not sure if I could cope. Why is it that we can not voice our opinions? IT is bad enough being tortured everyday by this mesh and because you are suing these manufacturers we are to be gagged. We suffer everyday and our friends and families try to understand, but they really don’t. I do not believe anything I have said or will say is wrong.

      We all have been injured severely and our lives changed forever with no regard to our liberties. We have asked for help and have been ignored for many years now. It seems that the good old boys way is still prevalent in the year 2014 and probably will continue into 2015. They used to put us in institutions and such during menopause..Well now we are imprisoned within our bodies and homes because of mesh. The Gold Standard. The only Gold is the dollars everyone is raking in from these mesh devices. Tis the season to be jolly. Bah Hum Bug!!!!!!

  23. sandy December 21, 2014 at 7:46 am - Reply

    They imprison us in our homes. They take away our lives. Thanks to Jane’s site I know what is killing me with pain every day. We are asked to jump thru hoops for the doctors –the one who took my mesh out once told me you have tried everything we asked you to do –a year later still in pain and no answers. We try to cope and gang on — some times I wonder if a settlement is just a dream I have to keep me living. The internet has made it possible to hang on because of all the generous support I have received from all of you. But we are suppose to pull the shades, lock the doors and talk to no one! WHY — tell me why when nothing has been offered to me no promises made– hell no help given that I haven’t found myself with the help of this web site and the people out here. I agree Jan we need the support from Jane’s site. I have never said any thing out here that I would not say in a court of law. AMS has destroyed my life and i am sick of the good old boys taking their sweet ass time in getting me some financial help. But they don’t care we are crazy ass women who are just after a pay day right! I say put a mesh in yourself and have a doctor hurt the nerves in your groin then be told you have to live this way the rest of your life. In pain, not able to work or even walk. Not being able to shop or have fun! No you just get to exists trapped in a body that knows nothing but pain. Then you tell me not to reach out for support. How would you like my case to go up to a wrongful death suit! Because with out the support and knowledge of what is going on I think I would rather just give up.I am sick of being told hang on maybe next fall nobwaut maybe next spring — well the judge just set it back to next fall again. I want to be well but now I’m told that because I can’t pay 300 dollars to have one of the procedures done that would help me heal faster it won’t be done. With every passing day I get more and more hopeless. I have borrowed money from people that expect me to start paying then back from my little check that I get for disability. Point is u was never looking for a pay day! But it sure would help with all the medical expenses I am trying to pay. Nothing will ever put my body back to normal! BUT I SAY TO YOU AMS YOU CAN NOT TAKW MY RIGHT OF SUPPORT AWAY! These beautiful damaged women and men understand my pain, frustrarion and hopelessness. Moat days this site is all I have

    • msm December 21, 2014 at 2:18 pm - Reply

      What did the judge set back to next Fall?

  24. sandy December 21, 2014 at 2:36 pm - Reply

    this was back over 2 years ago just seems like every thing gets pushed back

    • msm December 21, 2014 at 3:39 pm - Reply

      Thanks, Sandy.

      Judge Goodwin is holding a status conference on the morning of January 29th of the following players :

      (1) defendant client representative(s) with full authority to make all decisions related to MDL 2325;

      (2) in house counsel with full authority to make all decisions related to MDL 2325;

      (3) settlement counsel (if any); and

      (4) lead counsel for defendant(s)

      Then he’s holding a meeting of the above players for ALL of the MDL’s together in the afternoon.

      On January 30th, he’s holding separate meetings of each of the other MDL’s.

      Since AMS is the first meeting before ANY others, maybe he’s wondering why the settlements haven’t gone forward. It would be nice if Judge Goodwin would also find out why clients are not receiving any sort of status reports.

      • msm December 21, 2014 at 3:51 pm - Reply

        Well, now I’m confused. I just read a similar order for another MDL.

        According to that order, the morning meeting on 1/29 is a “status conference” for all MDL’s. The afternoon is a “private conference” for all MDL’s.

        Here’s my further confusion. On the 30th, there are separate meetings listed for each of 5 MDL’s but there is NOT one listed for MDL 2325 (AMS).

        Maybe the outlook isn’t as bright as first thought.


      • Jane Akre December 24, 2014 at 10:50 am - Reply

        Absolutely .. this is where they read whatever we all can contribute from tight-lipped attorneys….. Don’t you deserve status reports? Don’t you deserve the respect of consulting on a case outcome? One would think so….

        • Jan Urban December 27, 2014 at 4:01 pm - Reply

          As the Client in this MDL Action. Representation by the attorney of such a case needs to give special attention to their clients. The legal matters are vast and we must be guided through the process so as to understand exactly what is happening and how these Bellwether cases work to our best interest. As for my legal representation even though mutual, seeking new counsel and several rejections feels like I’ve been Black Listed. The reject letter I received today along with the reasons why. Told me that the attorney was totally oblivious of the facts that were given to their intake person. NON Attorney. It explained that if I wanted to file a claim it better be done soon for the statue of limitation is near etc etc blah blah?????? We are not interested but does not mean you don’t have a case. blah, blah. I would not have signed with this attorney. So what is going on? What and who and is anyone listening when you give them a MDL# etc, etc. Not in this case. When I hire a lawyer that is who I expect to talk to. No if’s or buts, no chain of command a Lawyer. So, like the Doctors, Attorney’s also become silent in the matter of mesh. NOT BEING INFORMED (Hey…… isn’t that one of the reasons why this mesh ordeal happened? It just blows my mind. Jan Urban Kitty. yes I am thankful for Jane and Mesh News Desk and all of the mesh readers/survivors.

  25. sandy December 21, 2014 at 5:39 pm - Reply

    I will be forwading this information to my attorney to see if he’s heard about this. I’m not sure what’s going on but I’m not going to worry until I talk to you my attorney I’m thinking it’s because AMS already has then in conferences with other attorneys as far as I know until my attorney says yes to an agreement and I say yes to an agreement we still have the right to go after settlement


    • Jan Urban December 22, 2014 at 1:41 am - Reply

      This mesh is awful, from the moment it was implanted something was wrong and then the evening came a the deepest excruciating pain began in my lower back. I could not sit, lie or stand up straight, I crawled around with a catheter for 6 days, and the Surgeon said my problems needed to be addressed by my Family Doctor. Six weeks after, the pain radiating down both legs began when I laid down along with total incontinence. Then the Lichen, and toenail thing, itching boils, lesions, sores, severe swelling of the legs and abdomen, insomnia 2-3 days at a time, anxiety and depression, can’t stand or walk for more the 5-10 minutes and the weight gain of 60 pounds., the flare up of acid reflux and hiatal Hernia, breathing problems and allergies. The Doctor’s all say it’s not the mesh, I don’t know much about mesh, we do not deal with mesh here. One doctor after another, one ER to another ER, one test after another, and one procedure after another and I still feel worse then when I started, Lets check this or that? Come on your the Doctor and a scientist. Then you have the legal system, sign here and give me 40% plus, and have no communication from a lawyer and massed together as if we were clones to consider our injuries and damages. What about our future medical needs caused by this mesh, for most are permanent. Will I have to Pay top dollar for supplementary insurance when forced onto medicare? I kept myself in shape and ate a good diet, smoking is my BIG no no!! I worked at a physical job. My only worry was Cancer for it runs in the family. Mom died after Breast Cancer at 62, But the others were in their 90’s. Now with autoimmune and being out of shape with no physical activity a lot can go wrong on top of the mesh issues. The denial of proper after care from this gold standard mesh implant is criminal and negligent. No Doctor wants to treat you because of the mesh. If tort reform and it’s statue of limitation were not 2 years here in Ohio, proper medical attention might of occurred. I feel so humiliated. I sat down at my computer today and the chair beneath me collapsed into pieces, totally destroyed, both me and the chair. Never weighed 239 pounds and growing since mesh. So with all that has been said I believe we all our still suffering in silence. Who really cares? Can you here me now? Are you really listening? I also feel that being our own advocate and the knowledge we have about mesh intimidates the medical and legal profession. Once again thanks for listening. Hugs for all!

      • Jan Urban December 22, 2014 at 7:57 am - Reply

        I’m wondering……….what should we do if we are organ donors? Also blood and plasma donors. Of course the way I feel these days I would not even consider donating anything from my body. I will need to change that information.

      • Jane Akre December 24, 2014 at 10:49 am - Reply

        There is absolutely nothing good about these outcomes…. and just to top it off, the incontinence often returns. This was a condition, an inconvenience, and for the latest greatest medical device invention, women are being led to a less than optimal life (putting it mildly)…..What for? For profits alone, there is no other explanation.

  26. justme December 22, 2014 at 2:50 pm - Reply

    Jan, you are not alone. I could have written everything you said word for word. The mesh is pulling on my organs so bad. I know exactly how much pain you are in and I feel your pain every minute of every day.

    You are not depressed Jan, you are in despair. You are trying so hard to understand how this could happen to you and to all of us and no one in the medical field, including the The Department of Human Health cares about us getting treatment or getting us well.

    Doctors only believe what they read in the journals and hear at the conferences from their colleagues. They don’t listen to us as patients. They don’t think outside the box. if the Urologists are telling them it is in our heads, and we are not suffering due to mesh, they believe them over us. Crazy huh?

    Attorney fees: 40% plus what some States collect from patients,which is another HUGE percentage on any settlement, leaves patients with virtually nothing if the settlement is not substantial. Insurance Companies are ignoring the dangers of mesh and that right there baffles me.

    However, mesh victims as a whole are all alone. No one wants to hear from or about us, and honestly, no one really cares. It is not a money maker like other diseases or cancer and does not involve children, so it will never get the attention it deserves. Not now anyways….

    I don’t know what the hell is wrong with doctors. They have lost site of patient care. They want the money and that is all they want.

    They hold the rx pads hostage, they don’t treat anymore, they deny patients claims and they don’t touch you at all. The staff takes the weight, the BP, the blood, ect., and doctors no longer do anything. They don’t go over your MRI’s, your tests results, your x-rays, nothing. They tell you what the tech report says and that is it. They dismiss us, lie on us, and refer out when they get tired of listening to you.

    Other mesh patients, beware: if you have yet to experience this type of treatment, don’t think it can’t happen to you, give it a minute.

  27. justme December 22, 2014 at 2:57 pm - Reply

    every day is surgery day for me. that is what it feels like every single day, like I just had the surgery. the doctor who did this to me was a jerk and only was a doctor for TWO YEARS before he ruined my life. OMG he lied so bad, and said he would tack me up and I would be good as new. When I called immed about the pain, he called me a drug addict and labeled me for life.

    Oh, and he dismissed me. He KNEW that mesh was a killer. He didn’t care. He wanted to play the mad scientist with his robots and putting mesh into women with NO experience.

    Doctors are evil.

  28. justme December 22, 2014 at 3:07 pm - Reply

    Thank you for this website. I stayed silent as long as I could. Now I don’t give a damn. When you hurt in pain this bad, nothing else matters and you know in your heart, help is never coming..and just maybe this site will save future women from so much harm from mesh. There is no such thing as a safe mesh, no such thing.

  29. justme December 22, 2014 at 3:21 pm - Reply

    Sandy, I don’t want to go on either. My body can’t take anymore, not much more, but anymore. Especially with this doctor stalking me, trying to put me in jail, calling other doctors and having me dismissed saying I am lying about the mesh pain and suffering. Lying about needing the reversal surgery and he does not deny he wants me to die. He don’t care. He is very young, grew to a multi million dollar practice over night and thinks he is a G-d now. he knows I can’t go up against him. I am garbage under his feet.

    But I am not ready to die and neither are you. We think about ending it all, as we fell so hopeless, but you and i both know we have to try and see this shit through.

  30. Sandy December 22, 2014 at 4:37 pm - Reply

    You have to get to a doctor that can help you. You still have mesh in right. Get it out. I had to go hungry and go with out, maxed all my credit cards finally my mother in law helped a little and I got to Phoenix to Dr. Hibner. One look at me and even the PT there said she couldn’t even touch me until I had surgery. I have spasms all the time. With out addressing the nerve first there would be no healing. I know when you can’t work and have no resources it is terrible. Thank God my mother in law is there for me. She has fronted the money to go back to Phoenix and I have to pay her each month. AMS has ruined my life and made me feel ashamed. Am so broke now. I can’t work at all. Any ways Hun, you have to yell and complain and go to a different city if you need to. No one needs to know which doctor put it in! Just get it out. Then find out if you have pudendal nerve damage or any other damage. From the sounds of the pain you are in you do.

    Jane is a wonderful source of information on where to find docs that might help you. I am a fighter but if this turns out bad and I end up crippled and no money the only thing I have left is a death benefit. I can’t put everyone in the poor house because of the human experiments that were done on me. Yes EXPERIMENTS done by the doctors I have seen. For a year I went thru everything to get better, try this, oh it didn’t work, try this, oh sorry that didn’t work either. You get tired fast of doctors. I am afraid of this surgery and I am never afraid. I am afraid of the trip home and how do I fly with tubes coming out. This is just so all insane! Where is the justice for us where?!!!!!! Where are the doctors who go into medicine to help people rather than just make money. This is a nightmare i am afraid I will never wake up from.

  31. David December 22, 2014 at 9:58 pm - Reply

    No where else in medicine can there be found such a widespread, systematic attach against unsuspecting patients as deceptively inflicted by the surgical mesh industry.

    Benjamin F. Pease, Jr. stated, in his Dec. 8, 1951 patent application, for his March 9, 1954 U.S. patent for a “Nonmetallic Mesh Surgical Insert for Hernia Repair” (patent # US 2671444 A) that there was a need for a bridging agent insert in “older patients and [patients with] large hernias [where] surgical repair is less likely to be successful.” It was, via his limited 1950’s understanding, his belief that “the incidence of large, direct or recurrent hernias in this [older patient] age group is considerably higher then younger men.” And his, I believe, well-meaning intent, subsequently grounded his intellect into a rationale that “suggested that the percentage of successful hernia repairs by surgery could be greatly increased and the probability of recurrences reduced to an absolute minimum if some strengthening agent or structure could be actually inserted in the body at the time of the operation to hold the hernia and promote the growth of strong fibrous tissues.”

    Mr. Pease laid out the following “very exacting requirements which must be fulfilled by any such surgical [mesh] insert”: “The material of which the insert is composed must be completely compatible with living tissue and body fluids so as to eliminate any likelihood of toxic or allergic reactions on the patient.” “The material of which the insert is composed must not react or alter its characteristics, even after years in intimate contact with body tissue and fluids. “[The] insert must be sufficiently porous to prevent the formation of fluid pockets against its surface, while during the healing to permit growth through itself of the fibrous tissues to form a strong solid mass.” “The material should not be adversely affected or become brittle by repeated flexing or working due to movement of the patient in his everyday activities.” “It is highly desirable that any such insert be completely permeable to X-rays or other radiation.” “The insert should be capable of being readily trimmed to the desired size and contour by the surgeon in the operating room without causing unraveling of the material so as to yield a strong edge no matter where cut to permit firm suturing in place without danger of the threads pulling loose.” “The insert must be able to provide suitable support and protection close to the spermatic cord, or other cord of the body, which passes through it without likelihood of causing additional irritation or injury, it being noted that usually there is postoperative swelling of the cord.”

    In other words Mr. Pease understood that the mesh material “[MUST BE]” inert.* Polypropylene mesh is NOT inert. And this is why, in my opinion, the reason for the FDA’s ongoing understanding that performance standards are not applicable to surgical mesh. As relevant today as it was in the 1950’s, is Mr. Pease’s understanding that “no satisfactory structure has ever heretofore been created to fill this [insert’s] long felt need” (to address his understanding of need in “older patients and [patients with] large hernias [where] surgical repair is less likely to be successful”). I do not think Mr. Pease could have ever anticipated this current manmade “treatment” plague which is being deceptively inflicted upon unsuspecting patients – spurred by the heightening of the surgeons’ “blind” efficacy self-gratification – with reckless indiscriminate surgical mesh abuse. It is my opinion that current predatory practices of medicine entrenching industry’s indoctrination of primitive surgeon behavioral norms – conditioning into standards of care for physicians absolved from peer group accountability to mindlessly follow – is “cannibalistic” to the future of humanity.

    * As you cannot build a house on a shaky foundation, you cannot create a complex device design with non-inert materials. It defies scientific rationale to think and continue to do otherwise. And, if the reason for the complexity of device design differentiation is only for a manufacturer to get their own “footprint” in the marketplace – with a “proprietary firewall” around a “different enough device” (to thereby prevent a patent infringement) – is this increased risk to patients even warranted to “drum-up” more profit from purporting the “next best thing on the block”? With a device’s market clearance, was it only with that manufacturer’s “least burdensome” intent to leverage the marketing of their “substantially equivalent” device as “better” than that of the next manufacturer’s device? And, if the then cleared or approved device is not ‘effectively safer’ than a comparative device’s understood market performance (when there is a same intended use device in the market place or otherwise comparative native tissue control), a manufacturer’s effort WAS NOT innovative!

    Because polypropylene mesh is not inert, it is not fit for its intended use as a permanently implanted medical device. A “black box warning” and accompanying contraindications –to propagate responsible, real-world use (via erection of a legal patient-direct informed consent means – with intent to disrupt these current manufacturer-to-surgeon-to-patient predatory marketing practices), is the first of the many necessary steps towards the effective, future regulation of any dangerous medical device. Although the greater reality – effective legislative control parameters must be formed that data mine “the [510(k)] predicate device debris field,” to capture the current, least risky (demographically relevant) surgical mesh design understandings needed to potentially build the ‘effectively safer’ meshes of the future. Current surgical mesh labeling is, therefore, grossly legally inadequate across all patient population indications without a patient disease/condition severity classification threshold – relational to a patient demographic device refinement consideration.

    If the former is not the appropriate, long overdue FDA action desperately needed RIGHT NOW, for the recognition of the rights and safety of future patients, the following statement would be false: “The primary purpose of a classification for any disease is to stratify for severity so that reasonable comparisons can be made between various treatment strategies” (Fitzgibbons RF Jr. (2002) Editor’s Comments in Nyhus and Condon’s Hernia 5th edn. Lippincott, Williams & Wilkins, Philadelphia, pg. 79). The regressively trained surgeon reduced to indiscriminately, recklessly abuse a dangerous surgical mesh device makes no “reasonable [comparison…] between various treatment strategies,” in their patient’s best interest. They can only indiscriminately inflict or not inflict (with inaction) own best practice!

    The Shouldice Hospital, a center of excellence for the Shouldice tissue repair (the gold standard for non-mesh hernia repair), states on their website: “Not every hernia can be repaired with a natural tissue technique. Shouldice surgeons have the expertise to perform a mesh repair but use it only in special cases, such as when the natural tissue has been destroyed by earlier surgical repairs at other hospitals.” (Shouldice surgeons CAN MAKE a “reasonable [comparison…] between various treatment strategies”!) “Over 95% of [their] repairs are pure natural tissue, with no mesh implants required.” The Shouldice Hospital bases its 99.5% success rate for primary inguinal hernias (the most common kind of hernia) “on data collected from [its] over 300,000 operations”.

    On their website, the Shouldice Hospital goes on to state: “Any hernia repair may cause complications for the patient. However, mesh repairs are associated with additional complications….” And, if the goal for the patient balancing risks/benefits, is to mitigate the specific risks from unwarranted surgeon device abuse (as the potential for benefit is probable while risk remains the ongoing reality regardless of outcome), “low risk, proven success and no artificial or foreign material implants are three reasons why many [legally informed] patients prefer a pure, natural tissue Shouldice repair over a mesh repair or laparoscopic mesh surgery.” “Time and results are our guides.”

    If the ideal of “the best interest of the patient” is to be found in current hernia repair, it is my belief that the responsible use of mesh by The Shouldice Hospital is the patient-care model which the greater hernia industry would again need to follow as the gold standard of care. It is my opinion that it is medical malpractice to unjustly subject a patient to an unreasonable, heighten level of risky/dangerous device and preferential surgeon surgical procedural risk when there is no justifiable individual patient need for that increase of risk. This would be tantamount to the physician malpractice of staring a “stage 1” cancer patient out with a “stage 4” treatment regime.

    The current standard of reckless, indiscriminate surgical mesh abuse – with its blatant disregard for classification of a patient’s disease/condition severity – is a best physician/manufacturer practice. The two main reasons, I believe, for why this crime is being perpetrated against patient-orientated medicine are: 1) the profit opportunity the mesh industry exploited in the human body and 2) the restriction of surgeon efficacy (via a non-proficiency of clinical practice competency) to only recklessly, indiscriminately abuse surgical mesh.

    With regards to #1: This current, heightened manufacturer profit recognition could never have been achieved via a roll of stitches. It was only upon creation of the mesh device (while marketed under “substantially equivalent” cover), when reinforced through regressive surgeon training (via manufacturer societal control over the standard of care – to thereby insulate the individual surgeon perpetrator from medical malpractice liability) that this industry can sustain its “exploited profit opportunity bubble”.

    With regards to #2: I believe surgical mesh functions as “an ego buffer” for the regressively trained surgeon. In that, following a surgeon’s excessive use of force (upon unwarranted, indiscriminate mesh abuse), if a patient has a hernia recurrence, that surgeon can then blame the mesh or patient response. Because if that surgeon performs a tissue repair, and that repair failed, the truth may be that it was their lack of competency which caused it to fail. So the mindset of the regressively trained surgeon is to swat flies with a sledgehammer, (since that surgeon can only dangerously fixate on their own, one-sided self-serving efficacy benefit), because if the hernia fails they should have used mesh and then more mesh. When does enough risk subjected to the patient become more than enough benefit for a surgeon?

    As the surgeons at the Shouldice Hospital clearly demonstrate with their responsible use of mesh (in both intent and practice), it is not a technique issue, as it would relate to a gold standard of care (when the patients’ best interest is in mind), but a surgeon competency problem (relational to the condition severity/patient demographic consideration). Therefore, every potential mesh implant patient must decide if they are willing to unnecessarily sacrifice their life-time of safety compensatory to a surgeon’s need to regressively act out their patient abusive training limitations? Or more correctly stated: every patient must pre-surgically, legally consent to the understanding that they are willing to make the surgeon’s lack of competency problem their own life-long problem.

    • msm December 23, 2014 at 1:01 pm - Reply

      I don’t know if fascia is ever used instead of mesh for hernia repair as it is for MUS slings. But the fact that few med schools are teaching more conservative and non-mesh alternatives speaks to the lack of intelligence in our educators of future surgeons. Even if the procedures are taught briefly in a classroom, practice in the lab is rare. Why spend the time and money when mesh companies will foot the bill to learn mesh implantation ( not repair, in my opinion).

      A med student asked my surgeon why he used fascia instead of mesh to replace the MESH that had been removed. My surgeon just looked at him and asked him if he would want mesh after mesh failed. And that doc will be operating on people without consideration or forethought. Scary….

  32. Dedra Wilson December 24, 2014 at 10:57 am - Reply

    Went to the doctor last week to review findings of bladder cystoscopy and ultrasound. The urogynecologist saw a bladder stone at the neck of my bladder. I did some research on the internet and found out that these stones are rare for women and a sign that there is nerve damage and the bladder/urinary tract system is not functioning properly. The signals sent to the brain are affected. My doctor and care team are in denial of my findings and for that matter anything I have to say about my own body.

  33. Dedra WILSON December 24, 2014 at 4:40 pm - Reply

    Went to the (Urologist) a week ago and found out through bladder cystoscopy an ultrasound that I have a bladder stone at the neck of my bladder. I did a little research and found out that bladder stones are uncommon in women and bladder stones are a sign that the bladder/urinary tract are not functioning properly. The signals to the brain are messed up. I have a lot od swelling in my feet so my primary doctor is running a microalbumin test to see my kidneys are filtering properly. I bam very concerned as for a long time the bladder sling I had put in over ten years ago had eroded and pushed my bladder out of place. In so many words my bladder was anatomically not in the right place. God Bless Us All!

  34. kitty December 25, 2014 at 9:41 pm - Reply

    Thinking of all of my network friends and hope you get thru the holidays with some comfort knowing that we have each other in some small but significant way

  35. kitty December 30, 2014 at 10:02 am - Reply

    Sometimes the mesh can be completely removed’-but if one has in for so many year’s—it is so entrapped that an iliostomy and colostomy could likely ensue. It’s a horse a piece——–do we do or die or just die anyway?

    • kitty December 31, 2014 at 9:58 am - Reply

      What I meant to say is:


  36. cybil December 30, 2014 at 1:10 pm - Reply

    Just discoverd this online Season’s Greetings from Boston Scientific to their “partners-in-crime” doctors in Women’s Health and Urology. So nice to see that BS is looking forward to another good “meshed-up” year in 2015. Funny, no mention made of owning up to the many women who have suffered by their hands and their prostituting doctors! Notice this message is global – marketing to many other countries than the USA – many of which are not as aware of the devastation their mesh kits have caused here.

  37. Sandy December 30, 2014 at 3:16 pm - Reply

    Kitty even if mesh is taken out we die any ways. I was suppose to making lots of money right now. We hung on and worked through the hard times, planning, counting the months until we would have a foot up. Drove old cars and waited on big purchases for this time now when we would be making good money, traveling having good times finally.

    I may be living but I am dead. My family is over as I knew it, my marriage gone. It’s only a matter of time before he has to leave forever. The love is gone. i will be alone but alive. Alive but dead. Alone with my pain. Who wants to be with us? We can’t have sex, we can’t take car rides, can’t dance or hike or go to the store, share time with freinds. We hope and pray for a settlement that we wonder if it will ever come. We try to have faith that all will be ok some day. Some day when things are right again then we will be happy. Some day when we feel better we can enjoy life again. We do all we are asked to do and try hard to keep going on. I have tried to be the cheer leader and be positive and believe in some day. But some day is a dream that I have while I am a sleep. Some day will never come for me. Mesh in or out some day will never come. My life has been destroyed by this mesh issue I have been forced to live. One last time I will try to face the hope of some day but I’d rather just go to sleep and have the dreams of some day forever.

    • Jan Urban December 30, 2014 at 11:35 pm - Reply

      Sandy, My dear Sandy, it has been a tough year for you and I pray that next year will be a better one. A new beginning for you and all of us mesh survivors. Our goals are to stop this mesh and continue fighting with all our might. To all I pray that in the new year all of our pain will be taken away and that we are treated with acceptance, compassion and understanding in the care we seek. Happy New Years, Everyone…….Jan

  38. kitty December 30, 2014 at 11:13 pm - Reply



  39. kitty December 31, 2014 at 10:42 am - Reply

    Sandy”’what I meant to say was:


  40. Sandy December 31, 2014 at 11:33 am - Reply

    I know kitty no need to explain my phone messes up on me a lot. I wish you all the best this next year. I pray that you find help, that you all find help. On Jan 9 th I go for surgery and although not wanting to die if something goes wrong and I just keep sleeping I would not mind. I am tired and from what I have been told after this surgery things will not be easy for at least a year if —if it helps at all. There’s not even hope of a settlement that has been given to me. But then again money can never replace what I have lost. A life with promise and hope. A life lived loving every minute of the time I spent believing in tomorrow. People don’t understand because they can not see our deformities and our injuries. Our pain is silent to everyone but us. I don’t know how to come out of this. With faith and prayer I thought there would be a miracle but I have nothing has shown me that that will happen. I don’t understand how in the USA this can happen to us. I feel devalued by everyone. I long for sleep where as I said before I can dream of happier days.

  41. All Meshed Up December 31, 2014 at 11:39 am - Reply

    The lies that are being told to women today are basically the same type of lies given to many Hernia Mesh victims. As I read through the posts I recognize many of the same excuses, misdirection and out and out lies that Doctors have told me about my mesh problems.

    I am recovering from surgery performed on December 8th where I lost part of my Sesmoid Colon and about 10 inches of large intestine. I have been having these ( and other ) reoccuring infections since 2007 after my first implant. I have asked many Doctors whether or not my mesh could be responsible for the infections. All but one has said no. My belief is that the mesh I have now ( Bard/Kugel Small Oval with Ring ) could be pumping out the infection into my intestines. My immune system is not what it used to be as it fights the foreign object in me and the little stupid infections that keep cropping up. This latest surgery did show that the infection I had completely encompassed my large intestine which includes the area where the mesh is at. My Surgeon said that the extent of infection was not normal and Diverticulitis is not normally that wide spread.

    As far as Immune System disorder is concerned, I am surprised that there has not been any study of long term implantation of Polypropylene mesh and possible chemical leeching. I have talked to many Mesh Victims ( Hernia and Gynecological) who describe very similar symptoms that they believe is a result of of their Mesh implant. Many years ago when I first started researching Mesh problems the thought of chemical leeching was a bit far fetched. But now, 8 years later, I am convinced that there is a connection to Auto Immune suppresion and Polypropylene Mesh. I also believe that the Mesh Manufacturers are aware of this and would not want a Scientific Study done or publically exposed unless it was THEIR Scientists doing it and controlling it. The FDA won’t even acknowledge that there are inherent problems with PP mesh so they sure as heck won’t pony up for a study themselves.

    David’s posting concerning the original Patent application for Surgical Mesh shows that even back then, in the 1950’s, there were concerns about implanting a piece of plastic in the human body. And Mr. Pease’s concerns are spelled out without any doubt in the application. All 5 of his main concerns are now known as the problems with Mesh that 100’s of 1000’s of Mesh Victims are experiencing and suffering with everyday. Those concerns were ignored because the profit factor was way to high to pass up.

    As we go into yet another year where thousands of the unsuspecting will become a Mesh Victim, we need to renew our efforts to change the FDA’s policies concerning Surgical Mesh. There is another J&J Stockholder meeting in April that I hope will be attended by Mesh Victims of both genders and ALL types of Surgical Mesh. We Hernia Mesh Victims have been around longer than Gynecological Mesh Victims and have been shoved aside by the new mass of Victims screaming out for compensation and retribution. I would hope ( again ) that ALL Mesh Victims will be part of ANY public discourse, protests or Hearings. We are ALL in this together as a Group. We have ALL been experimented on, lied to and abused by the Manufacturers and the Medical Community that has profit as it’s goal, not our health or well being.

    Happy New Year to you All…………Richard M Howden, aka All Meshed Up

  42. kitty December 31, 2014 at 6:23 pm - Reply



  43. Margaret December 31, 2014 at 7:06 pm - Reply

    I am concerned that I may have problems, but I had my surgery in 1997 and I don’t know what type of bladder sling I have. I am having pain in general but mostly after I urinate. I also have to urinate more often or feel like I do. I was checked for an infection but do not have one. The pain is just increasing. When I make an appointment with my doctor is there certain things I should ask or insist she do?

    • Jane Akre January 1, 2015 at 1:22 pm - Reply

      Margaret- Please try and obtain your medical records-Make the hospital dig for them including operative notes. If nothing else, the insurance provider may have them since they had to pay. In 1997 are you sure you have a polypropylene mesh implanted? There were not many on the market then. ProteGen was on the market and of course docs still use them even though they’ve been removed from the market. Use up the supplies they have on their shelves. You will need to find an expert- a urogynecologist and perhaps seek out a transvaginal ultrasound since a CT scan cannot see mesh. Pain is a sign of something for certain….You will have to become as knowledgeable as you can and advocate for yourself. some doctors are totally clueless about mesh complications. Let us know if we can help. please use the Facebook page to ask questions and get answers. Thank you Margaret for reaching out. ~ j. akre

  44. All Meshed Up January 2, 2015 at 12:24 pm - Reply

    So screemng (screaming) and protests are now labeled as Lawsuits? If that is true then they are a dismal failure because the FDA still refuses to do anything Kitty. I’m talking about about a thousand or more people, with signs and banners, in front of the Capital Building in Washington. I’m talking about a gauntlet of Mesh Victims at the J&J Stockholders meeting where there is no doubt in their minds that we are a well organized group that in 2015 is going to cause them hate and discontent until the acknowledge the dangers of PP Mesh! I’m talking about a letter campaign to all of our Senators to tell them our stories concerning Mesh!

    You can protest with your “Lawsuit” if you want but as far as I am concerned that is pretty self centered. Those of us with Hernia mesh that have suffered for many years without any chance in Hell of a “Lawsuit” are sick and tired of being waylaid by the FDA, the Manufacturers and those within the Mesh community that are more concerned about their “Lawsuit” than helping ALL MESH VICTIMS. We are sick and tired of being in the back of the bus and the last to be included in discussions, meetings or protests. Mealy mouthed platitudes and meaningless gestures are worthless. As is the the idea that a “Lawsuit” is a “Protest”. That is why nothing is being done by those in power to help us. They see that the promise of a “Substantial Settlement” keeps the Mesh injured subdued and impotent.

    • Jan Urban January 4, 2015 at 12:09 pm - Reply

      All Meshed Up: I spent quite a bit of time writing letters to my congressmen and senators asking for an investigation/congressional hearings with little acknowledgement my requests pretty much were ignored. I forwarded plenty of articles regarding mesh and it horrors. I asked why implementation of changes at the FDA from a group of FDA Scientists asking for restructuring mainly concerned with approval of medical devices were not acted upon. No response to this issue. I just get basic info to file an adverse effect report which I did several years back. We need Ted Kennedy back at the helm………He has got to be watching from heaven…….Come on Ted be our guardian angel and help us with our fight. It appears that the House Energy and Commerce Committee has been flip flopping on the wrong doings at the FDA by which very little has changed except for the House Committee is now pushing for quicker approval times without making any changes in the approval process regarding medical devices. It stayed the same. Commerce over SAFETY. Manufacturers win BIG. But you are correct in that letters and emails, phone calls to law makers need to be a priority the more the better. Who knows if and when will hear about the results of the 3 year study that the manufacturers were order to conduct by the FDA. As mesh survivors we all should take a few minutes to write our Representatives this year. This is my wish for the new year.

    • kitty January 4, 2015 at 9:33 pm - Reply

      I WOULD

      like to know where this protest took place?

      I have been I DC the last 3 weeks. Why didn’t anyone

      Inform us? I have been suffering a in silence and ignorance a lot longer than you Richard

    • Jane Akre January 5, 2015 at 9:19 pm - Reply

      Meshed up- I think even the ones who have been compliant are getting sick of being good mesh victims and sit quietly and wait for a settlement. It is not time to be quiet in my opinion….All mesh survivors deserve compassion, no one is more deserving than anyone else though I understand your frustration… Time to flood the FDA with adverse events from hernia mesh complications…. Has that been done before?

      • Jan Urban January 6, 2015 at 12:49 am - Reply

        Compliance to what and why?. Where was the compliance of these Mesh Manufacturers to test and test their mesh medical devices with the utmost regard to the patients health, safety and welfare. No, producing their Ultimate Gold Standard for POP and SUI, herding us through a BLIND 20 minute procedure as fast as they could book an OR resulting in a life of debilitating pain and major health issues which are on going and mostly go untreated. I feel that our comments are justified for we mesh survivors live with mesh 24/7 and its effects and we have done our homework, and networking for nearly a decade now! Can they hear us now. Jane, your dedication and devotion to us all is like having our own guardian angel. Thank you for keeping us informed with the latest information. Happy New Year……..Jan

  45. sandy January 5, 2015 at 10:11 am - Reply

    We all wish that there was more that we could do. as for myself I have talked to my senator about this and their response was we don’t want to get involved in any kind of litigation. I understood that I just wish there was something more they could do but to be honest with you the mesh issue is not on the forefront of anyone’s mind. it will take many many many years for anything to happen with this even if it does we all know there are lobbyists out there making sure people are well taken care of so that they vote the way the big companies want them to. Washington weather not you want to believe it is still a good ole boys club. I’m sorry I can’t go to Washington or anywhere else I can barely move these days so my only protest to these companies is to wait for a lawsuit to be finalized. I will not take to make your panties they’re trying to throw me my pain my injuries are just as bad as anybody who’s gone to court with the exception of Linda Gross. I’m sorry this may not be enough for any of you but I’ve done what I could when I first lost the ability to work I yelled and screamed I talked I wrote letters and like everyone else I was told her I could file my protest. I am NOT being selfish I care about all women and men who had to go through hell because of mesh. has anyone contacted the people who actually make domestic product like Chevron. I think many of us are either at the point where we want to break down the walls of Washington or we’re just so frustrated by the lack of advancement in these cases did you just get worn out. but please please I beg of you let’s not attack one another nothing is productive when we do that. I think we’re all doing the best we can right now and maybe there’s more we can do maybe we just don’t know it I don’t know each individual’s thoughts and actions on these cases. but I know one thing united we stand divided we fall

  46. sandy January 5, 2015 at 10:13 am - Reply

    I beg your forgiveness again what I meant to say is I will not take the pennies they are offering me my pain and injuries are as bad as anybody who has gone to court

  47. All Meshed Up January 6, 2015 at 11:13 am - Reply

    Now I am seeing the frustration I have felt for several years expressed in the last couple of posts. THANK YOU Ladies! In answer to Janes question about flooding the FDA MAUDE data base; I tried organizeing an effort 4 years ago with Bruce’s help. I have submitted 5 reports myself just to get an FDA letter telling me that 2 or 3 “confirmed reports” would generate an Alert to the Public. Liar, Liar pants on fire to the FDA. Nothing was or has been done.

    Today is the 6th of January and it was reported to day that PetCo and other pet stores are now going to stop selling Chinese Pet Treats because of the “possible” link to approx. 1000 pet deaths since 2007 according to the FDA. We have discussed this before but here again is another perfect example of the FDA coming to the rescue of cats and dogs but totally ignoreing the 100’s of 1000’s of serious injuries caused by Surgical Mesh. Priorities, priorities. Family pets get more FDA attention than we do.

    In response to getting in touch with Senators etc, I have contacted 20 Offices of prominent Senators and have talked to Aides that sound as if they are straight out of high school. When they find out that I am not a constituent of their State, you can pretty much tell that my message was headed for the garbage. The same with the 23 State Attorney General offices I contacted who told me I should talk to the FDA!

    • Jan Urban January 6, 2015 at 7:46 pm - Reply

      All Meshed Up, Remarkable to say the least. Maybe we need to start barking and clawing our way to the bureaucrats and beg for a way to get inside to get the acknowledgement, attention we deserve and are owed. I had my Congressman check to see if any of my adverse reports were acknowledged and none were found. He sent a paper one to fill out. A lot of good that will do for it will take forever to receive it because of the way they have to check each piece of mail before it is delivered in any government agency these days. Those darn mesh terrorists. But my online reports did not get recorded. I don’t know how many times I have to file it.. One would think they would have a special reporting system just for mesh devices seeing how over the past decade the FDA has been aware of our mesh adverse events. I guess they are afraid to hear from all of us?.

  48. David January 6, 2015 at 3:52 pm - Reply

    In my August 20, 2012 letter, to FDA Commissioner Margaret A. Hamburg, M.D., entitled “An Open Letter to the U.S. Food and Drug Administration,” I wrote the following, documenting my efforts to follow-up on my written correspondence with the FDA’s Freedom of Information Branch (FOIB) between the dates of October 1, 2009 and August 10, 2011:

    “I initiated this correspondence to first find out if adverse event reports had been filed with the FDA to report the severe adverse event complications that resulted from an April 18, 2007 surgery I underwent to repair a small hernia containing fat, in which two large 4.3” x 6.3”, three-dimensional, 510(k) cleared, polypropylene mesh implants were permanently implanted into my groin.* And, then on what date MEDWATCH reports: 1213643-2009-00127 and 1213643-2009-00126 (submitted by Davol Inc., Sub. C.R. Bard, Inc., the manufacturer of the two Bard 3DMax Mesh implants) were entered into the FDA’s MAUDE database. Please refer to my June 28, 2011 letter entry for my rationale in pursuing a correspondence I continue to understand was not ‘moot’.”

    “(* The 04/18/2007 mesh implantation surgery mandated Medical Device Reporting (MDR) because it resulted in: ‘serious injury’ […] but required 30 day mandatory reporting, only because of the: ‘surgical intervention’ [21 CFR §803.3(aa)(1)(2)].)”

    Mailed a letter dated: October 1, 2009 to the FDA’s FOIB to inquire if adverse event reports had been filed to report the serious adverse events (“surgical intervention”) which resulted from the 04/18/2007 mesh implantation surgery. (10/01/2009 letter date stamped received by FDA: 10/08/2009.)

    Received a letter dated: December 15, 2009 from Jasmine Ritchwood, Paralegal Specialist for the FOIB of the FDA’s CDRH, in response to my 10/01/2009 inquiry. Ms. Ritchwood stated in this 12/15/2009 letter: “After searching our files, we did not find the requested records.”

    Mailed a second letter dated: March 1, 2010 to the FOIB, to inquire if adverse event reports had been filed to report the serious adverse events (“surgical intervention”) which resulted from the 04/18/2007 mesh implantation surgery. (03/01/2010 letter date stamped received by FDA: 03/10/2010.)

    Received a letter dated: March 20, 2010 from David R. Bruno, LT, USPHS, Senior Regulatory Research Officer for the FOIB of the FDA’s CDRH, in response to my 03/01/2010 inquiry. An X was marked in front of: “We are enclosing the requested record(s).”: “MEDWATCH report 1213643-2009-00127” and “MEDWATCH report 1213643-2009-00126”. The two 3500A forms were both dated by the manufacturer Davol Inc., Sub. C.R. Bard, Inc., and date stamped received by the FDA on 03/11/2009.

    Mailed a follow-up letter dated: May 26, 2010 to Mr. Bruno (as an “appeal”) asking what were the ‘determining factors’ that allowed the FDA to locate on 03/20/2010 the two adverse event MEDWATCH reports: 1213643-2009-00127 and 1213643-2009-00126 date stamped received by the FDA on 03/11/2009; but were not able to be located by the FDA on 12/15/2009?

    Received a letter dated: June 9, 2010 from Carol Maloney, Director for the Division of FOIA Services (Freedom of Information Act) in response to my 05/26/2010 appeal. Ms. Maloney stated in this letter: “Please note that after FDA had already responded to your first request, FDA received two adverse event reports on Form 3500 concerning Bard 3DMax Mesh.”…“In light of the records provided by FDA, I am closing the appeal, as moot.” Understood Ms. Maloney to be defining “moot” as “deprived of practical significance”.-(Webster’s Dictionary)

    Mailed a follow-up letter dated: June 17, 2010 to Ms. Maloney (as a ‘formal complaint’) assuring her that the FDA’s lack of ability to be able to locate the adverse event reports on 12/15/2009, the FDA’s contradictory answer as to the reason, and the FDA’s belief that my questioning was “moot”, was not void of a practical significance; but very relevant (…in revealing a more significant issue).

    Received a follow-up letter dated: July 30, 2010 from Ms. Maloney, in response to my 06/17/2010 ‘complaint’, in which she stated: “Your question about the inconsistency of FDA’s responses to your two FOIA requests, is outside the scope of the FOIA. However, I previously explained the inconsistency in my June 9, 2010 letter.” She went on to suggest “The Office of Government Information Services (OGIS), National Archives and Records Administration was created to offer mediation services to resolve disputes…”

    Mailed a letter dated: June 9, 2011 to the FDA’s FOIB to ‘formally request the date’ MEDWATCH reports: 1213643-2009-00127 and 1213643-2009-00126 ‘…were entered into the FDA’s MAUDE database.’ (06/09/2011 letter date stamped received by the FDA: 06/16/2011.)

    Received a letter dated: June 16, 2011 from Mr. Bruno in response to my 06/09/2011 request. An X was marked in front of: “We are enclosing the requested record(s).” The CDRH records: “MAUDE EVENT REPORT (FOI), SORTED BY DATE ENTERED” were enclosed. The “Date FDA Added” “MFR Report No: 1213643-2009-00127” and “MFR Report No: 1213643-2009-00126” was “17 Mar – 2009”. Six days after it was date stamped received by the FDA on March 11, 2009 (and “Date FDA Received” reports documented in MAUDE event reports).

    Mailed a follow-up letter dated: June 28, 2011 to Mr. Bruno, ‘…asking for further clarification by the FOI Branch of the FDA to address this discrepancy’: (the different possible dates FDA could have received the 03/11/2009 FDA date stamped reports) ‘with an explanation as to why the FDA is now stating that Mfr Reports # 1213643-2009-00126 and 1213643-2009-00127 were entered into the MAUDE database on March 17, 2009, not during the window of time between the dates of December 15, 2009 and March 1, 2010 (as indicated by Director of FOIA Services, Ms. Maloney on June 9, 2010 and again on July 30, 2010). I am also asking for a willingness by the FDA to address the reason for the continued inconsistency of their past and present contradictory responses. I would like to give the FDA another opportunity to respond to my belief (as I stated in my June 17, 2011 letter to Director Maloney) that the “inconsistency” of these contradictory responses by the FDA is ‘deceptive’.

    The unanswered question here begs an unspoken question of why this continued deception is necessary.’(?) ‘More so, than just a greater understanding for the reason behind this deception, truth is needed to understand how rampant a problem this “inconsistency” is at the CDRH. An “inconsistency” problem that compromises the safety of future patients, by denying a patient’s right to know the grossly under reported number of actual adverse event outcomes being reported from the known or unknown risks following the implantation of medical devices is NOT “moot”; it is rather of great significance for the patient considering a surgery implanting an understood risky medical device.’

    Mailed a follow-up letter dated: August 10, 2011 (via certified mail, return receipt requested) indicating ‘…still awaiting a formal response.’ To date have not received a response back from the FDA on this matter.

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  50. Cookie January 12, 2016 at 5:53 pm - Reply

    I had vaginal mesh surgery in October and wrote in. Since them my email has crashed and I’ve lost the information where I wrote. My new email is I just received my records from the hospital today with all notes and have questions. Please have someone contact me. I had mesh used that was from Boston Scientific Upsylon mesh? Do you know if that is on any of these websites or lawsuits as one of the ones where there have been problems? Thank you so much for your help in this issue. It has been about 14 weeks and I cannot go without adult diapers and still have a lot of issues with discomfort and pain. The doctor refused to give me pain meds after 3 weeks saying there was no way I could still be in pain. I’m so frustrated and feel so alone. My husband and I are considering hiring an attorney. Any thoughts or suggestions would be greatly appreciated.

    • Jane Akre January 13, 2016 at 11:42 am - Reply

      Hello Cookie- Your Upsylon Y mesh was approved as a Class II device in December 2012. It is a polypropylene mesh used during sacrocolpopexy procedure….(I’m assuming it was not placed transvaginally right?) Here is the 510(k) approval, which did NOT require any clinical trials for safety.
      It is one of the newer meshes and there are adverse event reports with the FDA. Go to their site and put in Upsylon. the MAUDE reports come up. Please make sure you too register your adverse event!

      • Cookie January 13, 2016 at 12:29 pm - Reply

        Thank you so much for your prompt reply. I will check out the website. I am seeing my surgeon again in two weeks and she is talking about injecting plumper to stop the urine leakage. I just want to feel normal again. Still have occasional twinges of sharp pain in the lower left quadrant of abdomen. They claim I should have NO pain whatsoever, but nevertheless, it is there, along with major urine leakage It was NOT done transvaginally. Surgery was done initially with DaVinci robotics machine but after 3 hours she had to end up cutting and surgery continued for an additional 3 hours until it was completed. I did get copies of my complete medical records. They are showing they gave me IV meds while I was in the hospital room and I never got them. They ONLY gave me pills by mouth, the ONLY time I got IV meds (after surgery) was in the recovery room when they gave me Toradol and Zofran and that was the ONLY time After that, every single medication I got was oral. I think it would be my word against theirs at this point and the cost is inconsequential, however, it is the principle that matters to me.

        • Jane Akre January 13, 2016 at 1:35 pm - Reply

          You might ask your doctor if she is aware that under a Class II requirement, the FDA does not require clinical trials to prove safety and efficacy. That is reserved for Class III. Many doctors, who are the end users of a medical device, think FDA clearance means some assurances of safety have been verified by the agency. Many doctors do not realize that FDA clearance, means a clearance to sell only. Just curious what she says.

          • Cookie January 13, 2016 at 3:55 pm

            I will ask her. I’m seeing her January 27th. I will mention it and see what she says. I myself, am very curious as to her answer.

  51. ItsJust All OverForMe February 11, 2016 at 4:03 pm - Reply

    I am so very angry, however I don’t have the strength to be angry. I had a Hysto and a sling put in fot UIS 7 yrs ago Dec. After the surgery I return home with two caths because I was unable to urinate on my own and had to cath mysel, which is incredibly difficult for any woman to do by herself. After two months I was finally able to urinate. I was not being intimate 4 months out because I thought I needed to heal because of Pain. I started developing problems which spiraled me to where I am today I worthless 49 year old woman, mother of three sons (one who graduates UMMS as an MD in 2 months) and grandmother of one beauiful grand-daughter.

    I am not even sure why I am posing this. I guess just maybe someone will hear my story. I am going to digress a little and start from the beginning. I have worked most of my life in many areas, I served on our Fire Dept. for 7 years, I moved on to a Deputy Sheriff, I have worked at our Hospital in the Lab., Prior to all of this I was an Office Manager for two companies, ect. I was/am a mother of three. I was single and doing great. I met my now Husband Ronnie ( A handsom 6′ 6″ Teddy Bear) in 1994. We married after a long courtship in July 1998. He is a great husband and man. He was incredible to even have me since he is 12 years my senior and had grown children. He never hesitated t step in as provider and father to my three young sons. He gave them and I a very good life.

    I was always extremely Hyper an Active. I could not stand to watch TV or sit around. I was a typical middle-upperclass soccer mom. Taking my sons to all there sports practices and events. Cooking, cleanng, raising children and never was seen as a unkempted peerson.


    Seven years ago I had this done. Why you ask? Because I was having three periods a month and it was really causing havic in my relationship. I also had UIS put in.

    Now I will try and share to all those interested in my demise, I appoligize for any spelling, grammar errors, and the length of this post.

    Post OP:

    1. I could not urinate for several months and had to use a cath.

    2. Could not have intercourse due to extreme pain.

    3. Began having exteme bowl problems IBSD.

    4. I had extreme unknown leg pain.

    5. I could not stand or walk for more than a few minutes.

    6. I had a PE which I almost died.

    7. I started having extreme Cruelty Level Undetermined Abdominal Pain.

    8. Suffer depression (cause- the way my life was or the lack of it).

    9. Losed all my muscles because I can not walk, work, clean, cook,have a relationship with my husband, and am

    basically confined to my bed or chair.

    Now I will tell you doctor reports when I seen my PMM, Procedures I have had, and Causes and EFFECT from all.

    1. PMM puts me on (1) Pain Med. Norco 1 every 4 hours.

    2. PMM puts me on Valium for stress/headaches/anxiety

    3. Hospitalized over Sudden loss of leg control (could not walk or stand) 7 days.

    4. Hospitalized over PE in Intensive Care for 9 days.

    5. PMM sends me to have Colonoscopy.

    6. PMM does not know why I am having AP and Extreme uncontrollable Diarrhea that OTC nor prescription level meds

    wont help.

    7. Pain worsening in my abdominal area. I beg PMM for relief just for holidays.

    8. Prescribes Fentynal Patches 75mcg/72

    9. PMM sends me to have another Colonoscopy and a Throat Scope (sorry dont know what it is called) and biopsy my

    colon and stomach.

    10. PMM decides it's best to keep me on all meds.

    11. PMM sends me to a Gastroenterologist (G I ).

    12. GI MD does 4000.00 in bloodwork plus office visit.

    13. Pain increasing still even with meds.

    14. Hospitalized over depression 7 days.

    15. PMM still keeps me on all meds.


    17. I discuss isssue with PMM. He assures me all is fine nothing he is doing wrong>>>>> MY PMM OFFICE CALLS ME AND TELLS ME THEY NO LONGER WANT ME OR MY

    HUSBAND AS PATIENTS. I plead with the lady, WHY? Because you owe us $43.00) even though a bill from

    Oct. still was pending insurance, CAN I TALK TO MY PMM (NO), CAN I SEE MY PMM (NO). I Try to ask what to do

    my meds (NOTHING YOUR PROBLEM!) I explain it is very dangerous to stop suddenly stop taking these meds,



    NOT A DRUG ADDICT). My 17 year PMM Abandons me most likly because of his questional meds for me.

    31. I go through horrific drug detox on my own at home.

    32 After stopping all meds I suffer so great I welcome death now,

    33. Husband sleeps 20hrs a day and drinks a fiifth of Ten High a day.

    34 Christmas NOT ONE of our children even calls because of money and situation.

    35 I am now suffering extreme debilitating pain and have NO PMM.

    36 I start bleeding from my vagina and realise that all that blackish/purplish stuff was not my urine.

    37. I see my OBGYN (whom did NOT do my surgery) He informs me that he sling was eroded into my vaginal wall and is

    bleeding. He prescribes hormone cream, F/U 3 wks. Back to OB, No improvement. He prescribes more cream. I then

    ask him, what can I do about this? STATEMENT>>>>PLEASE READ SLOWLY>>> Well we could do a surgery to

    remove the Mesh, however you need to know up front that it can actually make you alot worse. It is not an easy thing

    to do. As far as your bleeding, it may never stop without surgery. As far as sex well you ARE 49 is it really necessary?)


    WHY I HAD IT DONE IN THE FIRST PLACE!!!!!!!!!!! SECOND IS SEX REALLY NECESARY????? I swear I wanted to BITCH SLAP him kick him in the nuts and ask him if his sex life was really necessay!!!!!!!!!!!! And I know he is at a minimun

    my age.

    Okay Okay, so with that all being said let put this all into prespective. Bleeding, have this procedure, Lost all our money on debt, lost my husband as a partner, lost our children because they lost me and could not deal with it, lost my PMM, lost

    my ability to work, clean my home, drive, cook, shop, walk any distance, have severe breathing issue from lack of exercise.

    all muscle mass is gone, I am pretty much bed bound, no pain meds because no PMM yet, live in extreme pain, poop my pants, severely depressed, have high blood pressure now, vision problems and on and on and on. Now if this is hard for anyone to understand, let me put it another way. SEE THE IRONY

    Problem: Bleeding

    FIX: Procedure

    Problem: -$300,000.00 for seven yrs of thousands of dr visits hospital stays, test, ect

    – Happy healthy Husband

    – lost relationship with children

    – live in extreme pain

    – loss of my PMM

    – loss of earning potential


    Problem: BLEEDING

    Now do you see how this circle went?? I have ZERO hope, I truly feel as if I am currently dying, WHO KILLED ME?


    ME LIKE A CAR. And just so you all know, I did apply for SSI and DI and was denied because they telly me there is no clinical evedence t support there is a problem. WHAT????? yes people true. Okay sorry so long, I will return to dying slowly with no hope in sight.

    Will anyone ask WHO KILLED ME WHEN I AM DEAD?

    • Jane Akre February 11, 2016 at 10:48 pm - Reply

      Its just, do you have a doctor? can you find an expert who knows what they are doing? Please advise. Are you represented in court? You need hope AND you need help.

      • ItsJust All OverForMe February 18, 2016 at 2:02 am - Reply

        No I am not represented by anyone. I do not have a personal physician. I do have a OBGYN doctor, however he stated that it would be nearly impossible to remove the mesh and that I could end up a lot worse. That I will never stop bleeding nor be able to have a sexual relationship. His office called me two days ago and informed me that now my pap came back positive for cancer. I asked how could this be since I had it all removed? They stated that it is most like in my vaginal wall. They also stated that it most likly is not just local that it most likly has spread. So I am dealing with this as well. Now I have to wonder if they did cause cancer as well with the osculator ( if that is how it is spelled). I do not know if one was used but if I had to guess I would say yes.

        • Jane Akre February 18, 2016 at 8:56 am - Reply

          All over- please let us know where you are located….. there might be a doc aware of mesh in your area…. I hate that they give you such a poor prognosis. Very little is known about mesh and certainly little about its link to cancer.

          • ItsJust All OverForMe February 19, 2016 at 7:23 pm

            Columbus Indiana

    • Still Standing March 26, 2016 at 6:40 pm - Reply

      Dear its NOT Just All Over. i have read your post many times, and didnt know how to reply, but I want you to know that, yes, I will ask your question…I ask it now. I hear your great pain and believe you. I dont know how to,give you hope, but I do believe it is there inside you. It has been silenced by so many tragedies. Im so sorry for everything that has happened to you. We have all traveled that lonely road made of mesh. How can I help you? I truly want to know. It you need a sounding board, I will listen. If you need help sorting out so many issues, I can do that. If you need an advocate, I will do what I can. I just wanted to let you know that your life matters, even now, when you feel hopeless, broken, and out of strength. You are in my prayers and have been since you first posted your heartbreaking story. Be strong. I care.

  52. Pain shots for Mesh June 9, 2017 at 8:43 pm - Reply

    dr. azadi wanted to do pain shots. I have ventralex mesh from a LSH partial hysterectomy. Still have right ovary and cervix. Constant pain since Bard polypro mesh put in 2012. Now 1 1/2 years right kidney same side as mesh, put in under neath back side of morcelator opening. No one can order me a 3d translabial ultrasound. Got a 2d done couldn’t find my ovary. Almost 5 years gone by … in ky need help and resources

  53. Isabel Lucas July 24, 2017 at 9:10 pm - Reply

    Thanks to Dr_mack@yahoo. com for getting me my man back. I appreciate all his time, effort, and energy he puts during the spell cast

  54. Louise January 25, 2018 at 9:20 am - Reply

    Hi! Jane I have a question for you…Is it true that because Canada has OHIP we Canadian Women can’t have more than $ 30.000.00 in settlement? That’s what my Lawyer told me… I find this ridiculous because we suffer, have pain, had surgeries, it’s affecting us mentally, physically, emotionally just like American Women…We will have problems for the rest of our lives and we are also humans just like them…I’m 66yrs old and my Health is getting worst…and it is caused by this horror in our bodies and it’s also affecting my Family, also…My Mesh was done in 2008, still waiting for my settlement…My email address doesn’t work all the time so I will give you my phone number, in case my email acts out again…Telephone # 1-613-679-2800 Thank You Jane …

    • Jane Akre January 25, 2018 at 10:57 am - Reply

      The story talks about caps. Unfortunately in Canada, the manufacturers face only a limited liability. That is the point of the story. How that makes sense for citizens is beyond me.

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