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Hernia Mesh Patient Advocate – Many Questions, Few Answers for those Patients

Bruce Rosenberg, patient advocate

Bruce Rosenberg, patient advocate

Mesh Medical Device News Desk, March 23, 2016 ~ They call every day.  Mostly men but sometimes women who have had a hernia mesh implant and are experiencing complications.

What doctor will see me, they ask.   Who is taking these lawsuits?

The answer is there are few answers for hernia mesh patients.  For some reason, a number of people who receive a polypropylene hernia mesh are experiencing the same pain, infection and inability to move that pelvic mesh women are experiencing.

But unlike TVM cases – where are the lawyers?

Bruce Rosenberg, himself injured by hernia mesh, could be called an expert on the subject,  but even he comes up empty.  Rosenberg fields calls from Mesh News Desk and other sources. People tell him they have pain at the site of their hernia repair. He says it’s due to mesh erosion, migration, adhesion to nerves and the spermatic cord, the erosion of mesh into the bladder and into the colon.

Hernia mesh patients have just as many systemic issues as pelvic mesh women but consider that hernia mesh is generally larger than a “sling” used to support the urethra, they are facing a larger volume of inflammatory material in the body.   Take a little strip of incontinence mesh and multiply it times 20-30.

Dr. M. Tom Margolis

Dr. M. Tom Margolis

As mesh expert Dr. M. Tom Margolis told the FDA in 2011, “The more mesh, the more mess.”

Rosenberg should know.  Injured by hernia mesh years ago, today he is disabled. See his Profile here.

Prolene mesh

Prolene mesh

As a result he’s made it his business to understand polypropylene (PP) mesh and its complications.  PP hernia mesh was fashioned into pelvic mesh by consultant/industry doctors in the 90’s, so its not surprising  the reactions are the same women are experiencing.

The mesh is the same as polypropylene pelvic mesh- made of the polymer polypropylene, the same plastic used in carpet backing and the top of a Tick Tac box.

Rosenberg regularly attends the American Hernia Society meetings and confers with doctors around the country who are dealing with complications. He has testified before  and FDA expert panel on mesh and brought a vidotape to FDA regulators of Dr. Heniford, hitting a plasticized piece of explanted hernia mesh on a table in a Johnson & Johnson promotional ad for its new larger pore mesh.

Every week he fields at least a dozen calls from the injured community.

“It used to be a search for a removal doctor.  Now the first question is about litigation.  They’ve been to so many doctors they are exhausted. They are not getting better and they are running out of money, patience and time,” he says.

“The typical person says their life has been ruined and they need help they are tired of being in pain. They’ve lost everything is the most common statement I have heard. They have no life, relationships have been ruined, they have nothing.”~ Bruce Rosenberg, patient advocate. 

Hernia mesh survivors believe filing a legal action will get them the medical care they need.   Rosenberg points to the few doctors he knows who can help – Dr. Kevin Petersen, Dr. Bruce Ramshaw, Dr. David Chen at UCLA, Dr. John  Galloway in Atlanta,  Dr. Todd Heniford in Charlotte, NC, Dr. Richard Miller in Tennessee and Dr Peter Billings in Washington State.

Prolene hernia mesh removed after 1.5 yr.

Prolene hernia mesh removed after 1.5 yr.

Rosenberg says these are hernia surgeons who remove mesh and have had good outcomes, or at least some good outcomes.

Many injured patients have tried to return to their implanting physician, but oftentimes, says Rosenberg, “Their complaints fallen on deaf ears. They are told to go to pain management.”

bruce 2“They are told it’s in their head, it’s going to get better, all the while their statute of limitations is running out and their injuries are increasing due to mesh migration and failure.”   

Why are trial attorneys not jumping on the hernia mesh cases?  There is money to be made, speculates Rosenberg. “They’ve been led astray by an FDA trying to cover its mishandling of this and additionally by the sheer marketing power of the industry.”

Dr. Uwe Klinge, hernia mesh surgeon

Dr. Uwe Klinge, hernia mesh surgeon

The volume is there. There are an estimated one million hernia implants a year, according to the  American Hernia Society.

Court testimony in pelvic mesh cases have shown that hernia mesh seems to have the same reaction once implanted in the body – it contracts, shrinks, encapsulates nerves. The small pore size prevents tissue incorporation and allowing the mesh to curl, contract and degrade, according to expert testimony was given by hernia mesh surgeon Dr. Uwe Klinge in a number of pelvic mesh trials.

Dr. Klinge has collected hernia mesh explants to study what happened while in the body. He testified at the Linda Gross trial against Ethicon he knew the polypropylene mesh was defective and tried to warn Ethicon /J&J before it was sold. See the story here. 

Dr. B. Todd Heniford, MD

Dr. B. Todd Heniford, MD

According to Dr. Heniford, the mesh shrinks with scarification and that in turn pulls the mesh with it.  Even lightweight mesh has caused injury says Rosenberg, who himself is implanted with the Ethicon UltraPro, which was supposed to be an improvement over heavy weight mesh.

The lightweight mesh is not the answer,” he says. “Patients still get infections and meshoma injuries.”

A meshoma is a mesh contraction moving away from the pubic bone and inguinal ligament causing the mesh to wrinkle or ball up which can cause the recurrence of the hernia. In Bruce’s case, the meshoma had eroded through the peritoneum, the lining of the abdominal cavity.

What is the answer?

Collagen fibers, University of Lancaster

Collagen fibers, University of Lancaster

A better product? A non-mesh repair?  Sure, says Rosenberg, but that’s not for everyone. Some people do need a mesh, he believes. It’s identifying the patient who is appropriate, that’s the answer. Patients who might not do well without mesh are those who are obese, who smoke, who have a high activity level or work in jobs where there is heavy lifting.  Rosenberg and others have observed those are factors that increase the chance of a failure.

Also some people naturally have a weak collagen matrix, the natural fibrous protein in connective tissue that supports skin and tissue.

Rosenberg has a nonprofit organization, The Meshoma Foundation. He says he needs to set up a website and work on doctor and patient education.  “There needs to be a school that teaches tissue repair so residents could have the choice to learn that as part of treatment protocol, to learn both mesh and non-mesh repairs.”american hernia society meeting

And he plans to attend the American Hernia Society conference in Washington, D.C. March 30 to April 2, 2016. Rosenberg is a member of the group. Specifically you will find him in seminars that address chronic pain and he will look for any new devices patients can ask their doctor about so they are not subject to what is pushed on them.

The former social workers also continues to think about others.  Too many patients cant afford to go for an initial medical consultant with an expert. He would like fundraising for that purpose to be part of the bigger plan.   #

 

LEARN MORE:

Americas Hernia Society conference, March 30-April 2, 2016, Washington, D.C.
http://americanherniasociety.org/conferences/hernia-repair-conference-information/

 

Hernia Repair Program
http://americanherniasociety.org/images/uploads/Program_No_IDs_3_Sheet2.pdf

 

Mesh News Desk, Patient Profile on Rosenberg, Jan. 6, 2014
http://www.meshmedicaldevicenewsdesk.com/wp-admin/post.php?post=5474&action=edit

 

Day 16: Linda Gross v. Ethicon, Scientist Knew Prolift Transvaginal Mesh was Defective, February 4, 2013 ~ 
http://www.meshmedicaldevicenewsdesk.com/day-16-linda-gross-v-ethicon-scientist-knew-prolift-transvaginal-mesh-was-defective/

 

Dr. Kevin Petersen, No Insurance Surgery, Las Vegas, NV
http://www.noinsurancesurgery.com/about-us.htm#gsc.tab=0

Dr. Bruce Ramshaw, Knoxville, TN
http://www.healthgrades.com/physician/dr-bruce-ramshaw-x6wpd

Dr. David Chen at UCLA,  Santa Monica CA
https://www.uclahealth.org/provider/david-chen-md

Dr. John Galloway, surgeon at Emory University in Atlanta,
http://www.surgery.emory.edu/about-us/faculty_directory/faculty_profile_john_galloway.html

Dr. B. Todd Heniford, Charlotte, NC
http://www.carolinashealthcare.org/b-todd-heniford-general-surgery-research

Dr. Richard Miller, Nashville, TN
https://medschool.vanderbilt.edu/trauma-and-scc/person/richard-s-miller-md-facs

Dr. Peter Billing, Washington State
http://www.healthgrades.com/physician/dr-peter-billing-3×632 

North Penn Hernia Institute and more recommendations
http://www.network54.com/Forum/557220/thread/1349886920/Referral+Resources+for+Post+Hernia+Surgery+Pain-Problems

More chat rooms on hernia mesh
http://www.network54.com/Forum/557220/thread/1238954793/last-1239385792/Hernia+Mesh+Removal+Experience-

 

58 Comments

  1. Denise Schrader says:

    I hope you can get something done Bruce, I’m right behind you been dealing with this for almost 6 years after removal of the Ethicon mesh that was only in for 8 days, 3 operations, 1 to put in and make a bigger hernia mess that shouldn’t have been done, 2 to take this miserable mesh out only 8 days after 1st surgery, 3 rd surgery was to make me look human again after they cut all the ab muscles out in 2nd surgery and they grew outward and it was so bad I couldn’t see to tie my shoes, looked like I was 8 months pregnant, but now since I was fixed with the human mesh I feel like I have a metal corset on….I can’t get even Cleveland Clinic to do something about the hernia that is protruding above the human mesh corset, they tell me that I should put a elastic belt on , mind you I feel like I’m in a corset now, did you ever try to breath with a corset and elastic belt on, well its getting bad, last year I sat in the hospital for a week with a suction tube down my nose into my intestine eating nothing but ice chips and hurting…..I was told that it was ‘my fault’ by the dr’s partners that did the first disaster, getting introduced and having them say “Oh, this is the ms.schrader ” when I don’t even know them….. But they don’t like it when I show the pictures of the giant hole that was left after removal of the Ethicon mesh out…. If you need someone that has been through all of this to write a letter or look at our hernia mesh sites on fb… Thank you and GOOD LUCK Bruce …. 😉

  2. robbi says:

    My son’s mesh implants were successfully removed but there are lingering issues that will be a problem the rest of his life. Bruce? contact me when you get a minute.

    • Jane Akre says:

      Bruce can be reached at 954-701-5094. Keep trying him.

      • Angie Shackelford says:

        I have called Bruce several times and spoke to him once and he was busy and suppose to call me back! I still have not gotten a return call! I have even emailed and called Jane! I’m needing some advice for my husband who is a mesh victim!

        • Jane Akre says:

          Angie- Keep trying Bruce 954-701-5094.. I will send him this email as well.

          • Angie says:

            My husband just keeps getting worse and we can’t find a doctor to help him and no luck with a lawyer! I still can’t get in touch with Bruce!

        • Joe Vickers says:

          Angie it only gets worse. I don’t even have to ask the problems because all are having the same problem. Swelling ,pain and nerve damage that no drug relieves the pain. I had a Ethicon mesh system implaned in 2013 and had to have it removed in 2015. I did file a formal complaint with the FDA and they claim i am the only one complaining about prolene mesh hernia implants. They (FDA) will not follow up unless your surgeon or hospital report the mesh failure. I checked and no complaint from any doctor or hospital. I notified the doctor and hospital to make that complaint and notify me in writing. I went back to 2010 and quit looking. I did not know this but it is mandatory that the doctor or hospital has to report such failures. Mine did not. The fda is investigating now why they did not report. FDA will not investigate the manufacturer unless the Dr. sends a report. No lawyer will look at it unless there is a recall. If you could get a thousand complaints to the fda lawyers will be all over. No one knows there is a problem except the ones suffering. Contact me i will show you how to make a formal complaint with the fda if interested. Nothing will be done until the complaints start flowing in at the fda.

    • Angel says:

      If it is not too personal, may I ask what some of the lifelong lingering effects are? Was this a procedure your son’s surgeon does routinely? I am looking for information on how difficult and successful removal is. I know it is case dependent. It seems surgeons say it causes and creates more problems than leaving it. But there are some days I cannot imagine that to be the case. But I do not know.

      • Jane Akre says:

        Removal of mesh is difficult is my understanding, because it is meant to be a permanent implant. Any doctor who tell you it can be easily removed, run, don’t walk.

      • Joe Vickers says:

        Angel I recently had my Ethicon hernia mesh system removed. Yes in is a lot harder to recover than the first. But my mesh had come undone on the ends and shrunk almost to the point of exposing the hole in my intestines. Don’t have to tell you how dangerous that would be. Now the pain is more severe and the swelling unreal. Now i have low blood flow to the left testicle which causes severe pain. It will have to be removed if i can’t stand the pain or dies from low blood flow to left groin area. If you are hurting bad enough you will have the mesh removed. May i suggest looking at some of the inguinal hernia mesh removal surgery. When you see what the mesh looks like after removal you will understand the pain. Please contact the Fda and complain . No one complains to the fda and that is why they are not looking into prolene hernia mesh. I found out that the surgeon is suppose to send in notification to the fda if there is a complaint or mesh failure. They never do fearing a lawsuit. If you need info on how to file a formal complaint to the FDA contact me.

        • Dee says:

          Hello Mr. Vickers,
          I had inguinal hernia implant in
          August 2008. I had a Hernia Mesh
          Removal Surgery January 2015 due
          to a onslaught of complications.
          Dr. Grischkan in Ohio successfully
          removed the Mesh without another
          implant.
          Surgeons I consulted in the
          Dallas Texas Metro Area would not
          remove the mesh without
          another hernia mesh implant.
          I am needing correct information on
          how to file a FDA report on the
          Hernia Mesh. Thank you.

          • Jane Akre says:

            Here is a story on how to report:
            http://www.meshmedicaldevicenewsdesk.com/fda-pelvic-mesh-today/

            You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:
            By phone- 1-800-FDA-1088
            By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
            By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
            MedWatch Online Voluntary Reporting Form (3500) is in the story linked above.

            Or you or your doctor could report directly to the Manufacturer and User Facility Device Experience (MAUDE) database on medical devices that have caused injury.
            Here is the database. Here is reporting information for pelvic mesh. Hernia mesh is also polymeric.

            The FDA’s MAUDE database is not easy to figure out. You would not call it user friendly. You will need your medical records to find:
            Manufacturer’s name
            Product name (brand name)
            Catalog number
            Lot number
            Size
            Date of implant
            Date of explant (if mesh was removed)
            Details of the adverse event and medical and/or surgical interventions (if required)
            Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
            Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
            Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
            Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment

            Here is what one woman entered into MAUDE for her pelvic mesh implant injury.
            1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
            2.) Brand Name: Tension Free
            3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
            4.) Records Per Report Page: Change to 500 and click Search.
            One telling factor is that the FDA says it takes the “least burdensome approach to regulating.” That’s right! The “least burdensome” on the manufacturers, not on you, the end recipient of the devices they oversee. Here is the language from the FDA:

    • Joe Vickers says:

      Robbi surely your son was having a problem or the mesh would not have been removed. I had my mesh removed 6 months ago. I was hoping for relief but is worse now. Hard nerve pain and swelling that pain meds want relieve . Looking at the net it seem everyone is having the same problems post opp. Here is the problem Dr. want you to just go away and lawyers only want to deal with it if it is recalled. I contacted the FDA and it took me two days to figure out how to make a formal complaint to MAUDE..This is part of the fda that investigates issues with medical device. My complaint is the only one on record from 2010 to present. They FDA told me it is mandatory for Dr. and Hospitals to report device (mesh) failures. Not one record for Hernia mesh even though the mesh is the same as the vaginal mesh that has been recalled. Check with your surgeon and hospital and make sure the mesh failure is reported to the FDA and make them give you a copy. According to the fda unless the Doctor or hospital send in a notification of the mesh failure they will not contact the manufacture . This formal complaint is manditory according to the FDA. I checked fda records and there is no complaint filed for any hernia mesh by any Dr. or hospital. This is like a bank robber calling the police to have himself investigated. Tell everyone you know to make sure to file a formal complaint to the Fda and have your surgeon and hospital do the same. If i can be of help please contact me.

      • Jane Akre says:

        I believe the ignoring of the hernia mesh injured will soon change…. lawyers are starting to notice and some are leading the way. Stay tuned for some exciting news on that front!!!

      • Lesley Oldaker says:

        Thanks Joe for the info. I too had a large piece of mesh implanted for a small hernia. Ha d a whole year of pain and complications…first they removed the 14 metals pins and trimmed the mesh, thinking they were the problem…eventually 6 months later they decided to remove all the mesh. The lab reports said there was extensive scarring and foreign body reaction present , including 2 broken metal pins and 2 neuromas!. I am still in pain espeially in my low ribs, but nowhere near the pain I had with the mesh inside me. The DR said he had to shave off the fascia to make sure he removed all the mesh and it was probably still swollen but it still painful 12 weeks post surgery. I would like to register my complaint to the FDA because I had Dynamesh (Germany) implanted, a large pore mesh which is supposed to be non-reactive with the least amount of scarring etc and clearly its not what it says on the packet! The implanting surgeon said it is the best mesh on the market and that i was a rare case of rejection but I bet I am not…Can you give me details of what i need to do with the FDA please

        • Jane Akre says:

          Try MedWatch and MAUDE data bases in the FDA. Hernia Mesh polymeric, surgical are the terms they use. Make sure you get a complaint number AND make sure to follow up to see if it reflects what you entered….. anyone else can chime in here who has filed an adverse event report through MedWatch and MAUDE… go to FDA.gov and do a search to find the fields. You can also call in a complaint but I would REALLY do a followup then to make sure it reflects what you said!

  3. Disgusted says:

    Thank you Bruce for being there for so many. I’m sorry for what has happened to you and so many others. This subject is so controversial. It is hard to get to the bottom line. I am injured by TVM. Pain is pain. The medical system needs to be educated and overhauled. The FDA too. I pray you’ll make headway into these dark waters.

  4. Barb says:

    I’m so glad these people with Hernia meshes gone wrong!! Why hasen’t any attorney firm looking into this?? Maybe now they will take a step in to the Hernia mesh injured as they finally did with mesh injured woman. You all need justice as well!! God Bless you all

  5. Incredible!
    Nearly 10 years ago I had an umbilical hernia repair with the surgeon using the Ethicon Prolene mesh. Here is a very short sequence of events:
    2006-Umbilical hernia repair surgery using Prolene mesh patches.
    Next 18 months- Almost immediate problems, pain, stabbing feeling in the repair area, massive infection with blood & fluid discharge through the belly button occurring area every 2-3 weeks like clockwork. Doctor visits every 3 weeks, antibiotics, steroids. 12th month-my original surgeon injects a local anesthetic & cleans and inspects the area the area. (3 surgeons hovering over me) After the procedure we walk out the door & my surgeon tells me that he cut the nerve in this area. Numb from my belly button to my penis after that procedure.
    6 more months of continued infection & bloody fluid discharges through the belly button.
    18 months after- A new surgeon specialist is finally found that will remove the mesh. He examines me and says “My God how long have you been like this?”.
    Mesh finally removed 3 days later. BIG hole, muscle tissue removed, patched using real human tissues. After surgery consultation he states how incredibly bad the mesh had become curled/damaged tissues and extreme difficulty to remove. He states I will be back for more surgery as it will always reoccur.
    Continued problems ever since then. Pain, inability to lift anything, progressed to short bouts of extreme ill sick feeling when I was bending/lifting (even 5 pounds).
    2015- Another surgery, reoccurring hernias in the umbilical area. Surgeon states what a tissue mess and I will never be able to work or lift again. Unsuccessful surgery followed by nearly 5 months of laying on my back. Poor poor body condition/shape from inactivity followed by a heart attack at the first time I over stressed my body.
    Still to this day- reoccurring hernia, extreme episodes of incredible sick, ill feeling when attempting just the very simplest of tasks.
    First surgery was at the age of 40 with a successful local building contractor business.
    Now age 50- my house is falling down. We have no money or means for me to make any. No disability or help assistance. My wife has RP and is so near complete & total blindness, and I am of no help as a money earner, or even a homemaker.
    Gee, what did Johnson & Johnson pull in last year? I always say the drug companies rule the world. How so very true.

    • Angel says:

      I was devastated when I read your story. I have advanced RP. You and your family are in my thoughts and prayers

    • Joe Vickers says:

      Brad i have seen this story a hundred time. I had a inguinal hernia repair in 2013 and removed in 2015 making me totally disable. I also was implanted with the Ethicon hernia mesh system. Been left out to die. No doctor can relieve the pain and no lawyer will look at it unless there is a recall on the product. I recently contacted the fda to file a complaint and found no one has a complaint filed on any prolene mesh used for hernia repair. Now there is one -mine! Fda will not investigate a medical device failure unless the surgeon or hospital sends them(FDA) a notice of failure. I also was told that it is the responsibility of the doctor and hospital to send a notice of failure so the FDA can notify the manufacture of a investigation. I check records with the fda and neither file a report. My mesh had come undone and srunk into a ball of mush. This is a device failure and should have been reported . Now the fda said they have turned over to MAUDE a dept of the FDA that follows up on complaints If the mesh fail and had to be removed it is a failure and should have been reported by the surgeon and hospital. I have notified my surgeon and hospital to file a report of medical device failure to the FDA and a copy to me. Johnson and Johnson Ethicon mesh used for hernia repair is very dangerous. If not properly installed will destroy your life. I bet you can guess why i loss a thirteen year relationship with the love of my life. Please make sure you file a formal complaint and find out why your surgeon and hospital failed to report the failure of a medical device. I know they did not cause i checked and the only complaint on record of a hernia mesh failure is mine. Like i am the only on in america having a problem with the ethicon mesh. Contact me if you need help on filing a formal complaint with the fda. It took me 2 days on the computer to get to the complaint part. Follow up demanding that the hospital and the surgeon file a medical device failure. It is mandatory according to the FDA Prayers for you brother; I totally understand what your going through.

      • Brad S. says:

        Hi Joe,
        Thank you for your response and others within, as I do very much appreciate the sharing of knowledge concerning FDA reporting and will be right on that task.
        In April 2007 I had the J&J Ethicon Prolene Mesh placed within me for an umbilical hernia. Unable to work for way over 1 year, much of my time was spent looking for others on the internet who were having the same J&J nightmare mesh problems. In early 2008 I found the online FDA website, and spent countless hours navigating through their intentional very user unfriendly site, attempt to report my J&J Ethicon Prolene mesh failure. Back then I do believe that the FDA already had a good share of individuals reporting the J&J Ethicon Prolene Mesh failures.
        After navigating through the FDA site I found the area to report J&J Ethicon Prolene as a failed medical device. After several personal info boxes & a lower section in which I was able to type in the Mfg., name & product info, date of surgery, and my resulting health complications. This report was then submitted directly through the FDA online site.
        I recall reading a few additional FDA bad medical device bulletins/reports/posts concerning various types & brands of polypropylene hernia meshes used in males & females. Back then I was not familiar with the mesh manufacturers, brands, and types used at that time, let alone what was the cause of my really wild health problems.
        (At that time I subscribed to the FDA’s bad drug & bad medical device email notification)
        In 2012 I went on the FDA site hoping to update my mesh report with further health complications.
        After an hour of FDA site searching I was unable to locate my previous report info and just a very limited amount of reports concerning reported mesh failures.
        I’m not a conspiracy theorist but I do believe the FDA failed mesh reports are out there somewhere, possibly filed somewhere between the Twilight Zone and the X Files

  6. dan says:

    Hi Bruce,
    I’m looking for more ways to get
    involved to try to get this monster on
    a leash. I have also been disabled like
    you have from the mesh. I have already filed a report with the FDA and they did what they could by telling me ;sorry about my luck. I just want to get more involved! If there is something more I should do? Dan

    • Joe Vickers says:

      Dan from one who knows your pain. I know what you and thousands more are going through. I am sorry to inform you that you have no formal complaint with the FDA. I just filed one and found out i am the only one on MAUDE (division that follows up on complaint with the FDA) with a written formal complaint. I also found out that it is the responsibility of the surgeon and hospital to file a complaint to the fda should a there be a medical device failure. I had the Ethicon prolene hernia mesh system implanted in 2013 and removed after years of pain in 2015. Now i am totally destroyed both physically and financially. Just calling in a complaint want work. it has to be written on their web site. I found it strange that there is only one complaint(mine) on the hernia mesh implant device. The FDA will not investigate unless it is a formal written complaint , or one from the surgeon or hospital . There is none filed by any doctor or hospital on file with the FDA medical device . It is however required by FDA that the doctor or hospital file a notice of failure of any medical device. They want do it for fear of being sued. No lawyer will touch it unless there is a recall. If you need info on how to make a formal notice of failure on a medical device contact me I will help you. Make your doctor and hospital send in a device failure and send you a copy that they did it. That will make FDA investigate the manufacturer. Hope this will help you . If enough people have a complaint it will be investigated . Talking with someone on the phone is a waste of time. A proper filed written complaint will get it turned over to MAUDE for investigation.
      There is a site on Fda Medical device section to write your complaint. Don’t forget it is mandatory for the doctor and hospital to foward a device failure, but they never do.

  7. dan says:

    I am grateful for mesh news desk! I no
    longer must suffer alone when there ar
    others suffering just the same way. In the 14 years I have had the mesh implants
    for a hernia, Doctors have told me that
    the mesh is great stuff and not the prob
    lem or there is no proof, one in a million
    or we are treatment not a prevention facility. My thoughts and hope go to all the people who have been destroyed by this disaster to somehow find peace in there lives! God Bless

  8. Glen says:

    I had hernia surgery in 12-2013 and mesh installed: How do I find out if mine is faulty?
    Shortly after the surgery I unknowlingly had A-Fib which resulted in a stroke, luckily with very small damage: Since then I’ve had other health problems:
    I need to know if mine is bad or not:

    • Jane Akre says:

      Kugel mesh was recalled but then put back on the market. Atrium is facing litigation over its mesh…. Basically all of synthetic meshes are made from polypropylene and most remain on the market. Some would say its the polypropylene which is bio incompatible in some people… so please don’t rely on the FDA to tell you which is bad and recall it…. that simply is not happening. Is your mesh painful? Are you unable to move? Do you have autoimmune issues after its placement that is, rashes, joint swelling, body swelling?

    • Desmond Mc says:

      Hi! I had several bad hernia mesh devices implanted in me that have made me very sick. Can anyone tell me who to contact in Texas or what steps to take? I need get this handled asap.

      • Jane Akre says:

        contact bruce rosenberg 954 701-5094

      • Joe Vickers says:

        Desmond. Start immediately by contacting the Fda and make a formal complaint to the medical device failure section (MAUDE). Talking to someone about your complaint does nothing. If you had to have a mesh removed it was a medical device failure. That requires your doctor and hospital to file a notice of failure of a medical device section of the FDA. As of today i am the only one with a formal complaint of record with FDA. Demand your doctor and hospital file a medical device failure and you a copy of this complaint filed. If the doctor files a notice of failure it has to be investigated by the FDA. Otherwise nothing happens. I have MAUDE (investigation dept. at the FDA) trying to find out why my device failure was not reported. I can tell you why! Legal action on the supplier of the medical device. Are you tired of Doctors telling you there is nothing they can do or a lawyer saying only if they have a recall. Well if enough people file a formal complaint in writing on the FDA medical device failure list the manufacturer will be investigated otherwise we’re stuck waiting for the statue of limitation to run out and loose your right of future medical and compensation. Contact me if you need more info on making a formal complaint to the fda. took me 2 days on the computer to get to the section to make a written complaint. If it is not in writing there is no record of the device failure.

  9. Glen says:

    I need info

    • Joe Vickers says:

      Glen i had Ethicon hernia mesh implanted in 2013 . Pain and swelling so severe had to have mesh removed 8 months ago. Had a medical device failure. The mesh came undone on the ends and shrunk into a ball of mush. I just recently contacted the FDA and made a formal written complaint to the medical device section (MAUDE). If you are having a problem your doctor is required to make a written notice to the fda . This is the only way to get the fda to investigate the manufacturer about the failure of a medical device. Talking with someone on the phone at the fda is wasted time. If you need help making a formal complaint contact me. Make sure your doctor and hospital report the medical device failure to the fda and send you a copy. If your tired of your doctor telling you there is nothing you can do or a lawyer saying only if the fda makes the manufacturer recall. Your stuck like everyone else . Just waiting on the statue of limitation to run out.
      If your hurt by prolene mesh make the formal notification. Don’t talk with someone make a written formal complaint . Followed by a written notice of failure of a medical device from your doctor and hospital. They can’t refuse it is required by the fda that the doctor and hospital file a written notice of a medical device failure. If i can help contact me.

      • Jane Akre says:

        Joe you provide a valuable service to help walking people through the reporting process. Please provide an email or phone so folks can contact you. thank you!!!

        • Joe Vickers says:

          You may contact me at josephv@copper.net

          • Tessa says:

            Hi I’m new to this site and looking for information as all of you are. I had hernia repair in 2008 and have had complications since than. I haven’t filed a complaint but would like to do so. Any information would be appreciated. I am also looking for a doctor to remove the mesh. I’m in the New York area.

            Thanks in advance

          • Jane Akre says:

            You might want to reach out to Bruce Rosenberg 954-701-5094, who is a patient advocate and hernia mesh injured. He knows doctors around the world… keep trying he is difficult to reach.

        • Joe Vickers says:

          Jane you can contact me by email and i will give you the phone number and discuss what it takes to get a formal written report to Maude (fda) . contact me at josephv@copper.net

  10. Angel says:

    I am seeking a doctor in the Houston Texas Medical Center. There was a Dallas position mentioned somewhere on this site, but I have read so much, I cannot recall the doctor’s name. Any information is greatly appreciated.

    • Jane Akre says:

      Hi Angel…. I wish there were as many docs dealing with complications as there were putting in mesh. Here is a partial list from folks who have had good outcomes. It is NOT a guarantee this doctor will work for you however. I have no financial relationship with any of these docs!

      Dr. Charles Butrick in Overland Park, KS.
      Dr. Michael Hibner in Phoenix. (602) 406-6017. Dignity Health
      Dr. Raz, Urology Department, UCLA. 310-794-7700
      Dr. Lennox Hoyt, Tampa, 2 Tampa General Circle, 4th Floor Tampa, FL 33606 (813) 259 – 8500
      Dr. Christopher Walker in Orlando, private practice, UroGyn Specialists 407-648-9400
      Miklos and Moore in Atlanta, 770-475-4499,
      Dr. Veronikis in St. Louis – dveronikis@stlgynsurgery.com (He works with Sara Wood MD, also doing pelvic mesh surgeries)
      Dr. Phillippe Zimmern in Dallas. U Texas Southwestern Medical Center, Professor Urology, 214-645-8765, 214-648-4765
      Daniel Elliott, Urology at Mayo Clinic, MN 800-446-2279, referring a pt 800-533-1564
      Dr. Ali Azadi in Louisville, Norton Healthcare, U of Louisville School of Medicine, Ob-Gyn, 502-409-5600
      Dr. M. Tom Margolis in SF Bay area, private practice, Bay Area Pelvic Surgery, 650-228-4052
      Dr. Bruce Rosenzweig, Rush University, Chicago, Ob-gyn, 888-352-RUSH (7874)
      Dr. Jerry Blaivas, New York City Urology, 212-772-3900
      Dr C. Y. Liu, gynecologic endoscopic surgery, private practice, NYC 212-988-1444
      Dr. Robert Furr, Women’s Surgery Center, Chattanooga, TN 866-899-0679.
      Dr Una Lee, Virginia Mason Clinics in Seattle, 206-341-0560
      Dr. Greg Vigna, 318-548-2649, pudendal neuralgia damage
      Dr. Christian Twiss, Tucson, U of Arizona
      Dr. Jeffrey Snow, Pembroke Pines, colorectal surgery and hernia mesh http://www.jeffreysnowmd.com/ 954-450-1617
      Dr. Francisco Orejuela, Baylor Hospital, Houston, Tx

      Docs I’ve heard reports on:
      Dr. Robert L. Summit, urogyn, Memphis
      Dr. Val Vogt, Memphis
      Dr. Bob Shull, a urogyn from Temple, Texas.
      Antonio Pizarro. Shreveport, LA 318-221-0021. http://www.pizarromd.com/ Excellent doc says TJ
      Dr. David Ellington, U Alabama says DJ, http://www.healthgrades.com/physician/dr-david-ellington-gcjpc
      Dr. Colleen Fitzgerald, Maywood, Chicago says DJ, physical rehab and MD http://www.vitals.com/doctors/Dr_Colleen_Fitzgerald.html
      BM says anyone in Oregon and Washington I would highly recommend Dr.Susan Hobson and Orthpedics Dr Freeze they were amazing and very gentle with my body

      • Angel says:

        Thank you for taking the time to compile the list. Are those doctors both TVM and hernia mesh specialists? I called Dr. Ramshaw’s Office yesterday to seek a consultation. Hopefully, with this new appointment to the university he remains accessible. Thank you for your quick reply.

        • Jane Akre says:

          No those are TVM, transvaginal mesh specialists. Dr. Ramshaw is a hernia doc. I would not go to Dr. Ramshaw with transvaginal mesh complications…..Please be clear on what you are looking for.

          • Angel says:

            Thank you, I will. My issue is hernia mesh related. I apologize for not making that more clear.

      • Charity says:

        Dr Sara Wood doesn’t perform mesh removal surgeries. I’m a patient of Dr Veronikis and he told me she doesn’t do them.

        I’m curious to know how you found out about the two doctors in Memphis. There’s not much about them in cyberspace and there’s no mention of mesh with either one of them. They’re at the same practice and that’s about all I know.

        I’m asking because I live in the county north of them. Memphis is where I had my implant done by a pretty popular urologist last December. I started to have issues within weeks. True to form of many doctors in his field, he just gas-lighted me. He had every excuse for all of my pain and threw some pills at me. He finally agreed to do a removal at an outpatient surgery center this past April. Such places are like an express lane for operations. A bunch of people sit in a waiting room for their number to be called. Once its their time to go back, they lie on beds in one prep room with just curtains between them for so called privacy. When I mentioned this to Deb on “Mesh Me Not” she was leary about it and kindly gave me questions to ask Shappley. I’m in pre-op in just my gown and an IV. The anestheolgist is on his way and the doctor comes in before surgery. By my second question Rusty’s chin hits the floor like “Who the eff have you been talking to?!” He then comes clean and tells me that he only does partials. He left for me to think about whether or not I still wanted the surgery. I started to cry and told hubs to get my attending nurse. I had her unhook me, got ready and left.

        I went round and round with Tricare to cover my removal because I wanted Veronikis to do it. And though he takes my insurance, I am in the South region and he is in the West region. They didn’t want to initially pay for medical treatments/surgery because he is much further than a hundred miles away from me. However, they did eventually approve it beforehand.

        After a month to month and a half struggle with my travel claim, my insurance has denied my reimbursement. They’re stating that there is someone who could have done my removal in Memphis . I passionately (and was not exactly nice about it yesterday on the phone) disputed this with them. I wonder if they were referencing the two you mentioned. However, they were the ones who finally approved and paid for my removal. I just don’t know how I could have known anything about those two on my own. It honestly makes me question just how experienced and thorough they are if there is nothing out there about them removing mesh.

        • Jane Akre says:

          Wow Charity- so smart of you to follow your common sense and get the hell out of there. Sounds like a spay neuter clinic for animals. That scares me. Let’s work on your insurance claim. I’m not aware of any docs doing mesh removals in Memphis… so please forward the names. I might have them tucked away somewhere…. without personal referrals I do not pass along names. I have no personal experience you understand and I’m not a doctor or lawyer. Tricare needs to be alerted that not everyone can or should do these surgeries.

          • Charity says:

            Hi Jane,

            I was questioning the doctors you mentioned above….

            Dr. Robert L. Summit, urogyn, Memphis and
            Dr. Val Vogt, Memphis

            Are you saying that they do complete mesh removals?

          • Jane Akre says:

            The first doc received a favorable review from one reader…. that’s all I know. Best to ascertain what exactly they do on the phone. Ask how many removals they have done, how many are full removals, what type of mesh, can they get out anchors and arms, POP and SUI mesh? Once they see you have done your homework, they may not want you as a patient. Others may welcome your involvement. You will quickly see which camp they fall into in my opinion.

  11. Lana W. says:

    We are going to Canada – have to be there for a meeting – so are setting up a consultation with the Shouldice Clinic for my husband. Has anyone else been to this clinic in Thornhill?

    • Jane Akre says:

      I have not but hear wonderful things. Dr. Robert Bendavid is a leader in non mesh repairs and preaches to his cohorts at professional meetings about non mesh repairs.

  12. Jeff S Brent says:

    Like so many others on this site, I am having mesh complications.
    I had bilateral inguinal hernia repairs 10 yrs ago and now would like them out.
    Can anyone recommend the best surgeon they know of for inguinal hernia mesh removal? I have spoken to Dr. Petersen in Las Vegas, but does anyone have any personal recommendations? I will travel anywhere for the best as I know this is not your everyday surgery.

    Thank you!

    • Jane Akre says:

      Hi Jeff…. please contact Bruce Rosenberg. 954-701-5094 to get the latest recommendations… He may know someone near you. Keep trying Bruce, heis sometimes tough to reach… I will send him an email about you….. thanks and I’m sorry.

      • Jeff S Brent says:

        Thanks Jane. I spoke with Bruce. He is a great resource for mesh sufferers.
        I would like to hear from people who have actually had mesh removed as well.
        How are you doing now? Are you better?
        The surgeons make a lot of promises, but I haven’t actually heard of anyone that is better, specifically after inguinal hernia mesh removal.
        Is anyone out there that can comment on their experiences and who their surgeon was?
        I think secrecy is the medical industries best weapon. The less we know, the more they can prey on us. So thank god for this website and people like Bruce. We need more of this stuff and we need to hear more of the voices out there that have suffered, even if they are better. Don’t forget about the people that are stiff suffering and will suffer in the future. Mesh is being placed to the tune of 100,000 patients per year. Most won’t have an issue, but for those that do, the suffering is tremendous. Let’s get the word out!

        • Jane Akre says:

          So right Jeff. I’d like to have a regular video feature here so folks can hear from others… if you are capable in that area please let me know. I wish you well.

        • Brad S. says:

          Hi Jeff,
          I am among one of the few that have had their mesh removed. I had an open Umbilical Hernia mesh repair using J&J Ethicon Prolene mesh. Large oval mesh sections were applied to the outer and inner abdominal muscle cavity. Beautifully accented with a “simulated belly button” mesh section connecting the outer & inner mesh layers.
          My problems started right after surgery, staph 3 weeks later, doctor & surgeon visits were every 2-3 weeks, for nearly 16 months. Pain, immediate loss of 16 teeth, 20/20 vision to 2.75 power reader glasses, tested 60% loss of hearing, skin problems +++ and my belly would swell up and blast fluid out like Old Faithful!
          12 months post- surgeon wants to drain the wound-after procedure surgeon states he decided to cut the nerves at mesh location due to entanglement problems!!!
          14 months post- still a continuous open surgical incision area, but the worst was the awful awful rotten smell coming from inside me. I was at the point of live or die due to the infection. A visit to my family doctor and told him it was life or death time- help me find someone to remove the mesh.
          -Within 4 days I met a S.D. surgeon for an evaluation. He lifted my shirt and encountered the smell of roadkill!. Within 2 days and 2-1/2 hours on the table, the mesh, and an additional hernia were removed. Upon waking from surgery the doctor said “I Think I Got It All” and guaranteed a recurrence of additional hernias due to the amount of muscle tissue loss & internal damage.
          2007- 1st surgery hernia
          2008-mesh removal & hernia repair
          AFTER REMOVAL:
          2008-2017- I am still suffering from major health complications, gradually worsening over time. Previous Lakes Area Building Contractor, now I can’t mow my own yard. 18 months now I am totally unable to work. No disability income- denied benefits 3 times the SS disability system is genuine B.S.
          My doctor states I am unable to work
          Constant chronic abdominal pain
          Major Vision loss
          60% hearing loss
          Continued skin rashes/breakouts
          Chronic breathing problems COPD
          Diminished motor skills hands use
          Enlarged spleen diagnosed in 2007
          -Unable to bend, reach, or carry items or I experience incredibly extreme attacks of nausea. Think back to your lifetimes worst flue & vomiting moment and that is exactly what I experience with bending, carrying, showering, etc.
          3rd surgery 11/1/2015. Very difficult recurrent hernia surgery. I laid flat on my back for nearly 5 straight months to recover.
          -First bit of light exercise I am finally able to do in mid March 2016 leads to A heart attack at just 51 years old!! A blood clot developed & lodged within one of the smaller arteries of my heart.
          -Tinnitus- CONSTANT loud ringing within my ears that developed shortly after my first surgery-Anybody else experience this?
          -Oh there is more but I am so slow at the keyboard now it not happening.
          -MY CONCLUSION -unless the polypropylene mesh is removed soon after it’s surgical implantation, bits of the J&J Ethicon Prolene human poison mesh will remain within your body till death do you part. I know for a fact my surgeon was unable to remove all of the mesh due to several reasons. –
          -Due to the Meshoma process, including erosion, migration, and dissolving of the specially applied mesh “coatings” I say, and absolutely know that once this mesh product is surgically placed within the human body it’s game over.
          -Bits of the mesh are very easy to overlook during the surgical removal process. Now add the well known mesh erosion & migration process that occurs within a very high percentage of those surgically afflicted with this Johnson & Johnson human “Rat Poison”
          -MESH VICTIMS OF THE WORLD- We say to J&J, and all other Pharmaceutical companies like them. True success in life should not be judged solely by year end profit margins, but should be judged by honest human care for all.
          -By the sale of known to be defective “Human Poison” medical products, What honestly separates the mentality of the Johnson & Johnson Pharmaceutical Co. from the Syrian chemical attack killing their own people.

  13. Ben Adams says:

    Lawyers have caught on in a big way. Our firm is one of many investigating these cases. People can go to TheLawFirm.com for more details.

    • Jane Akre says:

      Hi Ben- perhaps you would like to advertise on the front page rather than through the back door? Just saying…..we could use the support

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