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FDA: *IMPORTANT* How To Weigh in on Reclassifying Pelvic Mesh To High-Risk!

Prolene mesh

Prolene mesh

*NEW*  Readers of Mesh News Desk understand that the Food and Drug Administration has allowed  the polypropylene-based material onto the market to treat pelvic organ prolapse and incontinence with very little scrutiny.  In fact, the 510(k) approval process is an approval to sell, and does not require safety and efficacy assurances.

Now the agency is proposing reclassifying pelvic mesh from Class II (moderate risk) to a high-risk Class III which would require Premarket Approval  and clinical trials for safety and efficacy!  This was initially suggested in an FDA White Paper issued in August 2011. See back story here.

But this is the first time a formal proposal will allow Americans to weigh in. What’s significant is the presumption if pelvic mesh had been tested prior to being marketed it would never have been sold. The comment period will last 90 days only and industry and lobbyists who oppose the reclassification will

 

Here is how you make your voice heard!  Click HERE to enter your comments on Reclassification with the FDA. Here is the proposal.

What is prompting this proposal?  The agency has received 20,000 additional adverse events reports from from 2011 to 2013, according to Susan Laine of the Press Office to MND.

THIS INVOLVES MESH FOR POP (pelvic organ prolapse) NOT SUI (stress urinary incontinence!

Citizens can make their voices heard over the next 90 days about this important issue. Should a medical device that is intended to be permanently implanted not undergo clinical trials required under Premarket Approval?  Please let the FDA know what you think. May 1 the link will be established to let you weigh in.  Here is the Federal Register Post. Submissions will be taken starting May 1.

From: FDA Office of Media Affairs <FDAOMA@FDA.HHS.GOV>

Date: April 29, 2014 at 9:54:54 AM EDT

To: <afavaro@ctv.ca>

Subject: FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse

Reply-To: FDA Office of Media Affairs <FDAOMA@FDA.HHS.GOV

 

“The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” provide premarket clinical data to demonstrate a reasonable

Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).

Beginning in Jan. 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

In Sept. 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an Oct. 2008 FDA Public Health Notification.

Surgical mesh indicated for surgical treatments of SUI, abdominal POP repair with mesh, hernia repair, and other non-urogynecologic indications are not part of this proposed order.

The FDA will take comments on the proposed order for 90 days.”

Here is the Federal Register that walks you through the submission comment which begins May 1, 2014 for 90 days. I seriously urge you to let this agency know your thoughts including those of you with mesh for incontinence which this proposal does not address!  Here is a direct link.   Thank you.

 

Learn More:

Enter your comments into the Federal Register for Reclassification –  HERE!

The FDA had in January 2012 ordered mesh manufacturers to study complications in women with implants. Those results should be available in January 2015 if the studies got started on time. They did not.  Here is a background story:

http://meshmedicaldevicenewsdesk.com/media-reports/1351/

 

August 2011, FDA considers changing mesh classification.

http://meshmedicaldevicenewsdesk.com/fda-notices/fda-classify-surgical-mesh-devices-for-pelvic-surgery-as-high-risk-class-iii/

 

33 Comments

  1. Jane Dowdall says:

    This is a response that I will posting on May 1st.

    I am writing in reference to the April 29, 2014 news release, “Risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse.”

    I strongly agree with the proposal that surgical mesh for POP be reclassified as a high-risk device (Class III) and that manufacturers be required to submit premarket clinical data demonstrating reasonable assurance of safety and effectiveness.

    I also agree that the surgical instruments used for insertion, placement, fixation and anchoring of the mesh in the body should be reclassified to Class II. (Actually, I believe they should also be upgraded to Class III)

    I believe that this proposal should be expanded to include SUI mesh slings, especially since the TVT-O was ruled as having a ‘defective design’ in the trial of Linda Batiste v. Ethicon on April 3, 2014.

    I am one of the MANY whose health and quality of life has been severely affected by complications/side effects from a TVT-O sling. I am unable to work, on long-term-disability, and am in constant pain. Because the TVT-O is designed as a permanent implant, only the centre section of the mesh tape could be removed, leaving the ‘arms’. Unfortunately, this has not made any difference in the pain I continually experience.

    Not only should the procedure be in question, but the polypropylene used in surgical mesh needs to be studied and tested for foreign body response and its long term effects on human bodies due to shrinkage, hardening and the degradation.

    In conclusion, I support the proposal of April 29, 2014 concerning the reclassification of mesh and surgical instruments for transvaginal repair of POP, but STRONGLY feel this should also be applied to ALL mesh implants including slings that are used to treat SUI.

    • Jane Akre says:

      Thank you Jane for providing a template for others. Just cut and paste into the comment box and voila!

    • Carly says:

      Hi Jane, I was reading your story and i see you are getting long term disability can you give me some input on how you got it. I apply and got denied twice back to back……Nov this year it will be two years and I still don’t have a court date. I am so far behind on bills now I have to move in a month and don’t know how I’m going to do that. I do have a lawyer but I getting no where, Is there some things I should be saying that maybe I not. I really think the problem is they don’t know about the Prudential Nerve….that is what I have (entrapment). I call my lawyer a few days ago and ask her how much longer do I need to wait for a hearing and she said about six months…..this is bs…I will take any advice I can get. Thank you, Carly

  2. vicky says:

    Thank you Jane A for the updates.

    Now my comment:

    WTF…women that had SUI don’t count? So once again they are deciding who can live and who can NOT

    I suffer every damn day from an SUI implant, I cry out and beg to die,I can’t urinate or poop like a regular person, I have to live off of narcotics and they have the gull to say not SUI, try living one day as I do and then let me here you say no to SUI. I am tired of hurting, some days I can’t even eat or drink, I have a constant limp, some days both legs are effected. Today I am in extreme and swollen to point of looking pregnant. Try walking around with swelling in ur buttocks, thighs, it hurts like HELL, I beg to die!!!

    What has been taken from me, here they are:

    The joys of going for a walk to enjoy the nice weather

    Sitting

    Driving-cant drive more than 45mins if I do I can’t sit or go to the bathroom for close to 3 hours!

    Sex life- extreme pain, no sexual excitement for me!

    I loss the will to live-i fight hard everyday to be alive!

    I can’t hold anything more than 5lbs without being in severe pain

    Can’t walk much

    UTI almost 1 a month

    Urinating and bowel complications

    The list goes on!

    When getting implanted with this crap we should have the right to end our lives!!

    This is my own personal opinion and I am commenting without naming blame, just saying what my life is like NOW never had any of these complications prior to implant. I have had one removal and now I am searching to find away to remove the rest.

    Oh also I am from Canada where there is no HOPE or HELP thus far!

    • Carly says:

      Vicky, it sounds like you have Prudential Nerve Damage……That is what I have my is an (Entrapment). If I were you I would find a Dr to order you a MRN and that will tell. I can.t sit,walk,stand in one place for about 20 mins same go for the sitting and standing and the PAIN IS THE WORST PAIN OF MY LIFE AND I ALSO TAKE MEDS AND STILL CRY IN PAIN, GOOD LUCK, CARLY

  3. Dawn says:

    This is a great step forward ! And yet I am so sad that it does not include SUI or HERNIA MESH.

    MESH IS MESH IS MESH !!!!!!!!!!!

    AUTOIMMUNE DISORDERS ARE GOING TO SKY ROCKET !

  4. stopmeshimplants says:

    I am not sad that his does not include SUI mesh or hernia mesh. I AM MAD AS HELL! How on earth can they say that the mesh needs reclassifying for only one specific medical condition? Mesh is mesh. It is in our bodies and it should not be. Never mind the reason why it is was implanted. It is there and it is causing havoc. I urge every single person to respond on this FDA link, when it becomes available, that this small step is a step in the right direction but ALL MESH needs to be reclassified. This is totally unacceptable and absolutely unbelievable.

  5. Annie says:

    My suffering never ends. I’m disgusted that this product was ever allowed to be put in our bodies. My doctor did not tell me I had the option of having surgery using my own skin. I dumped that doctor after he said it was not possible that my pain is from mesh. He knew it was you could see the panic when he spun around in his office chair telling me stories of other women who thought it was mesh damage I got up and walked out on him. I have had thigh hip and butt pain since the very start after my surgery then came the pulling and poking pain which feels like stabs. I have been in the hospital and out. I have nerve damage. Its been proven by my neurologist no faking those tests that I have damage it feels like a splinter pearced by buttox from my groin incisions back to my butt. I know their is infection going on under the tissue. Spent weeks in physical therapy with no relief. I see a pain specialist monthly. I have gotten steroid injections nothing works. My very beautiful teeth started breaking off for no reason. I’m having trouble with vision in my right eye. No joke I’m 42 and never had any of these problems. I get bad rashes weird ones. I am seeing a surgeon who requires me to go to pelvic floor therapy before he does my partial removal, he says he cannot remove what’s in my groin I can bleed way to much, so am I expected to live with mesh in my body. He will do repair with my own tissue after I recover from my partial removal. I can’t sit or drive at times to much pain and I limp. I ask that this mesh be taken off the market but I doubt it will be. My emotional well being is destroyed I cry constantly and at random times out of frustration. I’m not ready to die. I’m only 42 I love life.

  6. HE says:

    Thank you so much Jane. Your tireless work is being paid off. Yes this is HUGH! How the mesh for SUI or hernia’s can be overlooked as requiring a class III device designation is beyond reason and common sense. I have experienced mesh for SUI only and my life has been devastated. My husband’s life has been devastated. How can they miss this??? I have been mutilated and my sister who is a nurse was appalled at the latest surgery. She had a hard time figuring out where the urethra is – no wonder cathing has become a nightmare. I have so many stitches in my labia, vagina and urinary system that it is hard to tell what is what. What a nightmare. To say that a permanently placed device is a class II and the problems are manageable is a straight out lie!!! It is no easier to remove than the POP mesh and it also causes many (if not all) of the dangerous side effects that the POP mesh causes. How can any Dr. in his/her right mind allow this to continue? My life as I knew it is over. Of course, I have faith in God and this is not the END OF THE STORY. I am hoping for a miracle not only for myself but others as well. I don’t understand that around 200 differences in signatures led to such a sharp difference in answers to the issues. Of course we do know that the almighty dollar has a great say in all of this. I am very happy to hear that they are finally acting on this. Why there are no sanctions against the companies that failed to follow through is unconscionable. Where else could you ignore a government order, blow it off and not worry about consequences. I sure wish I could blow-off my tax returns with no sanctions. I don’t and I won’t – it isn’t the right thing to do. Medical bills are robbing us off our life style. I pray for justice for all. This is a start – a small start – but a start none-the less.

    God Bless You Jane and others behind the scene who are working so hard to make a difference! You are greatly appreciated!

  7. Mary Pat says:

    I too, suffer and live in the mesh prison of pain. Please, everyone, send your comments to the FDA. This is a start. An opening in the the barricade that we have been hoping, praying and working for. I agree that SUI and hernia mesh needs to be included. Seize the opportunity. The FDA has invited comments. DO IT!!!!!!! COMMENT!!!!!!! Tell them about your mesh problems and include ALL mesh problems! They will not be able to ignore your comments. Seize the day!!!!!!! COMMENT!!!!!!!!! I am going to write a letter that my co-workers and friends and family can sign. I will mail the letter with hundreds of signatures. If every mesh injured person wrote a letter that their family and friends signed, we will flood the FDA with comments. DO IT!!!!!!!!!! The FDA will be shocked at the response to their open invitation. PLEASE, PLEASE, I BEG YOU ALL, DO IT!!!!!!!!!

  8. Mary Pat says:

    I have encouraged our mesh injured community to support Jane Akre’s work. I hope you all are doing that? I just donated. I know we are all struggling with medical bills, loss of income, etc, but just imagine where we would be without Jane’s reporting. If all 60 thousand of us donated even $1 dollar a month, hopefully, she will be able to continue to be the stellar, most amazing, most wonderful, most caring journalist on the face of the earth.

    Jane Akre – you are my hero! I loved seeing you in the J&J Hurts women video. You really are as beautiful outside as you are inside. A very rare quality. Someday, I hope to meet you in person. You are dearly loved and respected by everyone in this mesh community that you have brought together.

  9. Richard M Howden(AMU) says:

    Kicking and screaming the FDA has to make designation changes. I have made my comment at regulation.gov. I hope you all do too. I am, again going to say that TVT or whatever design Polypropylene comes in, for whatever use, it is the PP that is doing the damage not the design! If you have been damaged by a mesh product, look up that product and find out what it is made of. Polypropylene(PP), Polyethylene(PE) or a Polyester(Dacron) are your main materials. PP is the main culprit in most of the Gynecological and Hernia mesh complaints. It is therefore my contention that the FDA should be looking at ALL PP mesh products as a Class III hazardous material and treat it as such. It is at that point that ALL mesh victims will be recognized instead of just a few. Make your feelings be known and post your comment at regulation.gov. We should all be in this together, as a group and as victims(guinea pigs) of the largest medical fraud in U.S. history.

  10. Richard M Howden(AMU) says:

    Went back into regulation.gov and I see that there are only 14 comments on there so far. 14! For a group that should be hell bent on changing things for mesh victims, 14 comments will not do diddly. We have 10’s of 1000’s of women alone that are suffering not to mention all the folks with Hernia mesh. 14 comments is embarrassing. It’s no wonder we cannot get a thing done! People can complain all they want but until they participate in the process, please do not expect much. I have people ask me for help and info all the time on TOPIX and then they go away never to be heard from again. They go on with their lives as best they can.

    But for those of us that have been fighting for many years( I’ve been at it for 7 years!) to see change and to educate the victim’s, it becomes very disheartening when you see such a dismal participation rate when we need it so desperately. If you cannot or will not help with this cause when you are needed, then do not complain, cry or whine about your mesh problems. Make a comment today and get your friends to participate as well. Fight or just give up and shut up.

    • marilyn says:

      I posted a comment on the FDA site. Someone needs to take out an ad during prime time viewing letting everyone mesh victim know about the FDA open period for comments. I just stumbled on it. No wonder there are so few comments on the FDA site.

      I PROPOSE starting a crowdfunding campaign to educate consumers and another to obtain financial help so we can say NO to low settlement offers and hang on longer until fair trials and/or larger settlements that actually pay for pain and suffering are offered.

  11. pam says:

    Richard, I HAVE MADE SO MANY CALLS TO USA AMERICA LEADERS, CONGRESS, SENATORS, REPS, GOVERNORS, AMD MORE. i AM NOT GETTING STRONGER AT ALL, SO MUCH WEAKER. . Fighting infections, and pain constantly for over 5 years, has took a toll, so bad on my health. I am spending more time in bed now, getting off my feet, and swelling now in stomach and buttocks, hurting to sit, long, stand long , up and down. I have even e mailed the president, do you think obama cares? he placed judges and more over these cases, and most got money from the chemical companies in campaigns. Richard we are weak, and still going through hell from doctors, that also do not care what they have done, as most would rather see us dead than get money from the greedy lying scum that did this to us, to many in power paid off, and lawyers not fighting for us as they should. THIS IS THE BIGGEST DISGRACE TO AMERICAN LEADERS EVER IN THE HISTORY OF THIS NATION. A SHAME TO PAY LEADERS IN AMERICA, BUT THOSE WE PUT INTO OFFICE CHANGED LAWS WHERE TRUTH CAN BE COVERED UP IN AND OUT OF COURTS. BOTH DEMOCRATS AND REPUBLICANS..

    LIKE DOCTORS AND NURSES THAT HAVE LIED FOR YEARS NOW TO COVER UP TRUTH AND COLLEAGUES, SO ARE THE ATTORNEYS AND JUDGES AND ABOVE ALL OUR PRESIDENT. THAT ALSO GOT A LOT OF MONEY ALSO FROM CHEMICAL COMPANIES. . DON’T TELL US TO SHUT UP, ! EVEN WEAKER , i STILL WARN OTHERS NOT TO HAVE MESH IMPLANTED.. WHAT MORE CAN WE DO AS COURTS FRAG. SEEMS THEY WOULD HIRE SOME FEDERAL DOCTORS THAT WON’T LIE, EXAM WOMEN, AND TAKE EVERYTHING ALL INVOLVED GOT, AND EVERYTHING THEY OWN, AND PUT THE MURDERING LOW LIFE CON SCUM FOR LIFE IN PRISON. MEN AND WOMEN BOTH. DOCTORS WITH THEM, MEDICAL BOARDS IN EVERY STATE WILL NOT DO ANYTHING, MEDICARE WILL NOT DO ANYTHING TO TAKE BACK THE BILLIONS DOCTORS AND NURSES MADE OFF MESH, TELL ME RICHARD WHAT MORE CAN i DO AND OTHERS.?LOOK WHAT ATTORNEYS HAVE DONE, JUST AS EVIL, THEY KNOW LIFE TIME DAMAGES WARRANT MORE THAN A MILLION FOR OUR LIFE, AND THE FDA, DURING ELECTION YEAR OBAMA PLACED MORE THAN JUDGES, AS THOSE THAT ANSWERED THE PHONES , AND HUNG UP ON ME. i was nice too, until it happened 3 times, guess they didn’t like my voice? .IT WAS BEFORE i EVEN KNEW ABOUT MESH CASES, i WANTED TO KNOW WHAT HAPPENED SINCE DOCTORS WOULD NOT TELL ME AND NURSES TOO.those that give their profession a bad name..

    • Richard M Howden(AMU) says:

      Dear Pam, I apologize that my posting may have seemed a bit brutal concerning the lack of comments made so far at regulations.gov.. As you stated, you have been fighting, as many others have, to find out about what is happening to you and to stop the use of mesh.

      I have also been doing this for over 7 years now. My life as I knew it is gone, along with with most of my worldly goods, my ability to work as I did, my sex life is almost non-existent and I live each day with pain. I consider myself lucky. I have corresponded with so many mesh victims that are suffering from mass infections, open wounds, loss of organs due to mesh migration and are bed ridden. They have no hope of ever being well again as many mesh victims are discovering. Once you have been implanted with a mesh ‘product’ you will never be the same as you were before the mesh implant. It is at those times that I try to listen, help and understand what these people are and will go through that I appreciate the life I do have now.

      In the past, I was so filled with rage as I hit one wall after another when trying to get information, cooperation and understanding from the Doctors I was seeing. I could not (and still can’t) get a lawsuit against ANYBODY involved with my 5 surgeries and 2 mesh ‘products’. As many victims understandably believe, as I did, you have been implanted with a faulty medical device that has ruined your life so you MUST be able to sue the manufacturer or the Doctor that told you it was safe. Only to find out that we are wrong.

      I have talked to the FDA’s Criminal Investigative Division and cooperated as fully as I could with what I believe is fraudulent advertising by the Mesh manufacturers, in particular J&J. I have provided documentation, medical records and correspondence to them in the hope of having criminal charges brought up against J&J. I have called 26 State Attorney General Offices to complain about and ask about mesh litigation. I have contacted Medical Boards in 10 States. With all of this, I have never received any positive feed back or a promise of investigations and possible prosecution.

      Today I have written to 2 victims. One in Tennessee and the other in Singapore. Both were Hernia Mesh implants and women. POP and TVT mesh is now in the spot light and gaining more and more notoriety and Thank God for that. I sympathize and understand what all of you women who have been implanted with mesh are going through. But remember that there is more to the mesh problem than just the Gynecological mesh. Solidarity in the fight against all mesh should center on the materials these little monsters are made of. Else wise we will be split up into groups, as the MDL’s are doing, and the proper recompense, rehabilitation and retribution will be given to the few and not the entire community of mesh victims as it should.

      I hope that in time the true nature and scope of the damage mesh is doing to men, women and some young people will become common knowledge. I hope then that the FDA and the manufacturers will be prosecuted to the fullest extent of the law for what has to be the biggest cover up of the largest medical device fraud ever known. At that time all the officials I have talked to will have to acknowledge that they were wrong and were part of the problem.

      I do not let the hate and rage about what has happened to me guide my day or my life. I try to recognize the life I do have, the friends and loved ones around me and the activities that I enjoy so much. I hope and pray that maybe someday I will see some justice for me and all the victims of mesh. I refuse to be hostile and filled with rage any more. But in it’s place I have brutal honesty about mesh, it’s dangers and what victims can expect for the rest of their lives. I refuse to pitty pat around about the horrible possibilities because I will not be like the Doctors that lied to me by lying to victims. And that goes for all the victims that come on line, complain, cry and whine about what is happening to them but will not take the time to be pro-active about their situation. Nor do they become part of the anti-mesh movement because they are so tied up with hate, rage and self pity. I believe that by empowering yourself and not letting the the Doctor’s, Lawyers and the Manufacturers negate your life, you can become a happier person. Even with the mesh. Best Wishes to All and Thanks again to Jane Akre for all she does for ALL of us.

      • pam says:

        Richard, I am not meaning to be mean, thank you for sharing your story , . I know men have been damaged too, I THINK WE ARE ALL TIRED, . &years, , mine has been 5 and and a half years , and having red flags put up on me by doctors and their lies, read over some I just got yesterday, to doctors saying no mesh protruding out, and I have records that showed and a doctor told me truthfully how in 3 places it was and said it was more than what I thought. but as soon as she told me the truth red flags went up, and she said she could not see me again because of what her colleagues at clinic and hospital said. lies and sarcastic remarks, I admit I have cussed, and some I CALLED THEM WHAT THEY WERE. ESPECIALLY WHEN i FOUND OUT THAT A STUDENT IN COLLEGE WAS ALLOWED TO DO SURGERY NOT THE DOCTOR , NEVER WOULD i HAVE ALLOWED A STUDENT TO TOUCH ME AT ALL KNOWING THAT EVEN DOCTORS THAT HAVE BEEN IN UROLOGY FOR YEARS ADMITTED THEY DID NOT HAVE KNOWLEDGE TO REMOVE MESH, i know a sorry low life lying county clerk, that told me about this doctor, that he removed mesh successfully from her friend,, not knowing hse was an enemy of lies, because I told the truth years ago in this county on those around court house, after the surgery , knowing again, and I doubted that doctor she told me about had ever removed mesh at all. when I again was lied too, I called her and asked her who her friend was that the doctor she told me to go to, , that lying low life scum of the earth, said, I don’t know what you are talking about, I called her a few names, as she put a black woman on phone that said the same thing, covering for her. I said I ST5ILL HAVE THEB PAPER YOU WENT OUT OF THE ROOM AND MADE ME A COPY OF THE DOCTOR , WHERE HE WAS AND MORE, NOW TELL ME AGAIN YOU LYING ———- , YOU DID NOT TELL ME , THAT HE DID NOT REMOVE THE MESH AS YOU TOLD ME FROM A FRIEND OF YOURS. YES, OVER 5 YEARS OF THIS AND MORE , i sure am glad the bible nowhere says that those that tell the truth go to hell, or those that cuss. besides jesus called some names and what they were too. calling people what they are liars and more is not a sin, it says be angry but sin not, , I haven’t murdered anyone . and lied about any thing. so now FDA, finally says a high risk, so when do mesh people see justice for all the lies and pains of those doctors and nurses that put us through hell , with medical boards, since the courts will not allow women to get mental stress damages from doctors and nurses that lied , trying to make sure some do not get a doctor that will be truthful and talk to them like a human, if we do find one , their colleagues come down on them. and they all come against you. JANE LET ME FAX SOME PAGES OF DENIAL OF MESH AND THOSE ADMITTING , AND YOU NOW AS WELL AS i DO, IT IS NOT WHAT SOME ARE PUTTING IN THEIR RECORDS AND SAYING, IT IS WHAT THEY ARE NOT SAYING, THAT THEY DO NOT MENTION. DISTORTED TRUTH. THAT COURTS WILL NOT ALLOW A WOMAN TO TELL THE TRUTH OF ALL THAT HAPPENED AND WAS SAID IN EXAMS AND MORE. THAT PROVOKED PURPOSELY TO ANGER,.i am not going to stand and let someone kick me, and me not at least defend myself in words. Richard, I DON’T KNOW ABOUT YOU BUT i AM WORN OUT, YOU HAVE GOT TO BE, SO TIRED OF PAIN, MESH MOVING, INFECTIONS, AND ALL THE HELL WE ARE PUT THROUGH. AND NOW COURTS AND ATTORNEY’S HOW DO WE GET MEDICAL BOARDS ALSO TO LISTEN TO THE HELL THEIR COLLEAGUES HAVE DONE TO MESH IMPLANTS, THEY ALREADY KNOW! i WOUDL LOVE TO CONFRONT EVERYONE OF THE DOCTORS , WITH MEMORIES IMPLANTED OF THEIR CRUEL AND SARCASTIC WORDS TO ME, THAT i TOOK.

  12. karen says:

    Hi everyone I just finished my reclassified fda comments its 32 so far as of yesterday . We need everyone one to go do this!!!! If I can you can just take a minute. Please if this is want its going to take let them have it, look how far we’ve gotten. This time its for real we are here !!!! Im crying with Hope right now!!! There’s no time like now !!!We have to keep this going . We have to keep telling our stores so they can stop this Butchering on us. If we stop now thats its , all this for nothing!!! For once in your life fight. Don’t give up!!!! It’s easy just go to the website and tell them about these monsters that have Butchered us too the bones. You know its funny we all got comments on a lot of things , Now some of the head people want to know. Back when I was a girl this is what made America writing and telling law maker what we wanted!!!! I will have hope that my grand daughter., my niece, my daughter, my aunty, my sister ,my sons, my uncles, my nephews want ever have to live with Monsters butchering them their bodied at any age. Get up and go fill out this form. Get some one to help you. But move it. Don’t you want to be apart of history one day. CHANGE IT !!!!!!! Thanks Jane your wonderful

    • Jane Akre says:

      Karen- it is so important to comment and it’s easy! The best move you can do with the least amount of effort. Thank you..

    • Mary Pat says:

      Hey Karen,

      We all agree that Jane is wonderful! You are pretty wonderful, yourself! Thank you! We will comment!!!!!!!

  13. Mary Pat says:

    Hey Ladies,

    I read about the Endo settlements on Thursday night, last week. On Saturday, I read about an 8 year old African American boy who was murdered while he was trying to protect his 12 year old sister who was being brutally raped. On Sunday night I watched “12 Years a Slave”. At the end of the movie, I wept. The reality of this world is that bad things to happen to good people. There is so much evil in this world! Ironically, being butchered by mesh makers, unscrupulous lawyers exploiting mesh victims in the Endo settlement, 8 year old boys getting murdered while they watch their 12 year old sister being brutally raped….it all feels the same. It is evil. It hurts. It makes good people weep. WE have cried our tears for the atrocities that have been done to us and to our sisters. What counter balances the evil on this planet is good people, who care like Jane Akre and Aaron Horton and all the others who have stepped up to advocate for victims. Let me challenge each and every one of you. For all the evil that has been done to you, do a kindness for someone you know or even a perfect stranger to counter balance the evil. Do not be dismayed. The good people far out number the bad. Don’t give up. Don’t be discouraged. Stay strong in your faith. Stay strong in your motivation to do good. Keep you chin up in spite of your pain. Keep loving. Keep trying when you have the strength. Write your letters to Eric Holder, file your complaints with Attorney General’s Office’s, file your complaint with the FDA, submit your comments to the FDA regarding reclassifying mesh. Watch the “Clouds” video on UTube if you need inspiration. Look at the amazing message that Zach Sobiech taught us. Find strength in the companionship and love that the mesh sisterhood offers you. The mesh broke our bodies and our spirits. RISE UP and find strength in goodness. Be the goodness that this world needs!

  14. karen says:

    The comments are up its at 39 today . With as little effort as it takes to keep on the FDA. Their watching us all 60, 000 women who have lawsuits in the United States Of America. Someone will Win !!!

  15. karen says:

    Hi mary pat b.

    I’m sorry to hear about all those sad stories you saw, but what does that have to do with Mesh victims? We believe in God and goodness and defense called Home land security at home.

  16. karen says:

    Hi mary pat

    I’m sorry to hear about all those sad stories you saw, but what does that have to do with Mesh victims? We believe in God and goodness and defense called Home land security at home. Do u work for the Mesh Corp?

  17. Kitty says:

    DON’T BE AFRAID This was a quote from Marty Burns Wolf –a successful News Woman in Milwaukee She was the guest speaker for the All girl’s High School graduating class at St Mary’s Academy in Milwaukee –1987. It’s such a simple phrase and seems so stupid until it really come to life—like now!. DON’T BE AFRAID to go to regulations.gov and make your comment like I finally did this week

    • Kitty says:

      I went to regulations.gov and the comments are up to 62. It is so important that we comment. Everyday someone gets the courage to speak.

      • Kitty says:

        WENT TO regulations.gov COULD NOT FIND THE SITE FOR TRANSVAGINAL MESH TO HIGH RISK WHAT IS GOING ON !! PLEASE ADVISE THIS IS VERY WEIRD BECAUSE IT USUALLY COMES UP READILY

        very scarey

  18. palady says:

    Kitty:

    It’s for POP mesh. They are not considering the trans-vaginal mesh.

    I did write my comment- intertwining my issue with TVT-O .

    • msm says:

      Actually, the FDA is concerned with the transvaginal placement of surgical mesh for pelvic organ prolapse (POP). The mesh used for mid-urethral slings for urinary stress incontinence is what the FDA is choosing not to consider but is requiring further studies. Hopefully they’ll get a clue that it is the polypropylene material that is the problem regardless of the application.

      • Jane Akre says:

        The only way they will get a clue is if YOU clue them in. Please add your comments to this important petition. They are dividing the baby in half and thinking SUI mesh is okay, unless you tell them. Please do so. Thank you.

  19. Anonymous says:

    I submitted my experience or should I say nightmare. We need folks to speak up please!

    • Jane Akre says:

      AND Please check to see if it was posted! This is important. We want to make sure your comments are making it to the Federal Register… Thank you for taking an active part in the future of medical devices!!

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