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FDA Rules To Reclassify POP Vaginal Mesh as High Risk!

Uphold, Boston Scientific, still on the market

Uphold, Boston Scientific, still on the market

January 4, 2016 ~ An expert panel convened by the U.S. Food and Drug Administration (FDA) decided in September 2011 that mesh used to treat pelvic organ prolapse (POP) should be reclassified as high risk from its moderate risk (Class II) status.

Today, the FDA announced POP mesh would finally be reclassified as a high risk device.

The makers of POP pelvic meshes still on the market will have 30 months to submit proof their devices are safe and effective as proven by clinical trials or other evidence. The FDA requires PMA or Premarket Approval of drugs and class III medical devices. It is considered a more stringent requirement to assure patient safety.

New POP meshes will require the manufacturer to submit a PMA before they receive FDA approval.

Whether manufacturers will be able to demonstrate safety and effectiveness through existing clinical trials remains to be seen since that was not previously a requirement for entering the market.  Clinical trials to assure safety can run into the millions of dollars and are required of drug makers.

*Update* -An FDA spokeswoman tells MND the evidence coming into the 522 post approval monitoring studies the FDA required of manufacturers in January 2012, may suffice as evidence of a device’s safety.

TVT Secur, Megamed Service

TVT Secur, Megamed Service, SUI tape or hammock

SUI MESH

The order covers the larger pelvic meshes used for POP and not those used to treat stress urinary incontinence SUI.

Often called “hammocks” or “ribbons,” referring to their smaller amount of polypropylene mesh, SUI mesh remains in a Class II status or “moderate risk.” SUI mesh can continue to be introduced into the market once the manufacturer claims to the FDA it is the” substantial equivalent” of another mesh already being sold. The FDA’s 510(k) approval process, as it is known, relies on the integrity of the manufacturer to assure patient safety and does not require clinical trials to back up that assurance.

When MND reviewed FDA data in March 2013, SUI injury reports to the agency were up 36 percent. Reclassifying SUI mesh has not be proposed by the FDA. See the background story here

 

POP MESH INJURIES

FDA's Dr. William Meisel

FDA’s Dr. William Meisel

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, MD, MPH, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, in a news release.

“We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”

The FDA says it has received thousands of reports of complications associated with pelvic mesh including mesh migration, erosion into other organs, chronic pain and infection, and autoimmune reactions to the polypropylene mesh.

This order does not include POP meshes implanted abdominally, just those that are implanted through the vagina or transvaginally.

The move to reclassify follows on the heels of two other FDA decisions regarding pelvic mesh.

In  2008, the agency said complications from all meshes were “rare” and that the benefits likely outweighed the risks. By July 2011, the FDA did an about face and announced POP complications with mesh were “not rare” and that the risks likely outweighed the benefits. That after the agency noted a five-fold increase in the number of reports of complications coming into the FDA representing thousands of complaints.

Between 2008 and 2010 there were seven reported deaths associated with pelvic organ prolapse mesh repairs.  Two included towel perforations and one hemorrhage. Four deaths were due to post-operative medical complications, according to the FDA’s website.

There were approximately 300,000 POP repairs in the U.S. in 2010 with about 70,000 using polypropylene POP mesh.  Additionally, thousands of POP repairs occur internationally. Many meshes taken off the market in the U.S., continue to be sold globally.

POP MESHES

POP mesh, Elevate by AMS, still on the market

POP mesh, Elevate by AMS, still on the market and trocars

Pelvic organ prolapse meshes are generally larger and have arms that anchor them into deep tissues, muscles and ligaments.  Mesh removal experts consider them particularly difficult to remove.

POP meshes include the Perigee, introduced by American Medical Systems in 2004; Prolift was introduced by Ethicon in 2005; the Elevate by AMS in 2008 and the Pinnacle/Uphold was introduced by Boston Scientific in 2007 and 2008.

Elevate and Apogee (AMS) are still on the market. Restorelle by Coloplast is still used for POP repair. Prolift was quietly removed by Ethicon (J&J) in June 2012. C.R. Bard took its Avaulta mesh off the market in 2012.

Manufacturers moved to remove their POP meshes from the market after a January 2012 mandate by the FDA that required three years of post-approval monitoring of the health of women implanted with POP mesh. By removing the mesh from the market, the manufacturers were relieved of the monitoring requirement, though the mesh remains in the women’s bodies.

*Update**– On February 26, 2016, the agency will convene an expert panel to review the safety of trocars, used to place the mesh transvaginally. The are stainless steel hooks and instruments used to place the mesh during the blind pelvic procedure. #

 

LEARN MORE:

FDA News Release, Jan 4, 2016

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm

July 2011 FDA White Paper on Pelvic Mesh

http://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf

MND, Jan. 2012, Mesh Makers who Received 522 PostMarket Surveillance Orders  

http://meshmedicaldevicenewsdesk.com/mesh-makers-who-received-fda-letter-requiring-follow-up-tests

MND, March 2013, SUI Injury Reports to FDA up 36 Percent 

http://meshmedicaldevicenewsdesk.com/fda-stress-urinary-incontinence-sui-surgical-mesh-reports-up-36-percent-the-fda

FDA Federal Register, Final Order, January 5, 2016

https://www.gpo.gov/fdsys/pkg/FR-2016-01-05/html/2015-33165.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

 

 

 

39 Comments

  1. Jane Akre, is it your understanding that manufacturers will not be legally responsible for PMA patient outcome post-market surveillance for another 30 months (June 2018)? Until then, “business as usual”?

    • Jane Akre says:

      Apparently. During that time they can submit proof from their clinical trials, if they have them. Likely they don’t since it was not a requirement. The FDA says information coming in from their 522 post monitoring studies may suffice.

  2. Aaron Leigh says:

    FINALLY!!!!!!! Now, Jane – can you tell us, practically speaking, how this decision will affect the sale and use of new POP kits by manufacturers and doctors. Obviously it helps possible future victims, but how does it help the community of those already injured. Does it help them?

    • Jane Akre says:

      I’m not a mesh maker but if you know about 30% have complications, if you know you could be sued, if the market for these items isn’t huge anyway, if your 522 studies are not showing positive results, which may suffice for 522 studies, and if you don’t want to spend $ ion new clinical trials, they may be shipped off to Zimbabwe or Australia. That could be seen as a viable position of someone just interested in a return on investment.

  3. Toni says:

    Well this is great news for women who may face surgery in the future. So now what happens to us who suffer because we were the guinea pigs and the testing grounds for the greedy pharma companies who knew it would affect us but chose money over safety? We need so much to have our day in court. Send us all back to our own jurisdiction so we may be heard.

  4. anonymous says:

    Hallelujah hallelujah now let’s get the rest off the market because it’s all bad bad bad

  5. Mary Pat says:

    So the FDA continues to ignore the mesh injuries caused by SUI mesh? Outrageous!

  6. Jane, this is Linda I have Attorney Muller and Muller in Texas … Do you know when they will be making settlements on the TVT made but Ethicon & Johnson Johnson

    • Jane Akre says:

      I really do not know… no one does. but their accountants are working on it all the time… How much is this costing us……

  7. Suzanne McClain says:

    Finally, they threw the dog a bone. What about the women who have been injured by the meshes for SUI? These meshes are made from the same materials, and placed in the same area of the body as the POP meshes. Frankly, my research shows that the majority of adverse event reports filed with the FDA have been for the SUI meshes, not the POP meshes.

    Ladies, this means the FDA is still minimizing the injuries caused to SUI patients, and leading us to believe they are actually taking the bull by the horns by agreeing to have the POP meshes reclassified. Though I am happy they have recognized there is a problem with the POP meshes, they should really look at their own adverse event files to see that this will only minimally help women injured by transvaginal meshes for SUI.

  8. Stopmeshimplants says:

    Relieved for those with Prolapse issues that their agony has now been substantiated and

    manufacturers will now have to change. Angry and confused that those of us who suffer from SUI would

    be treated or classified differently. All mesh complications are extremely painful and life altering no matter

    the size of the mesh kits. Listen up FDA. This is a small step in the right direction. You have more work to do!

  9. Bejah Blue says:

    This is wonderful news but bitter sweet because it has taken so long and because it excludes groups of victims that should be considered. The material is dangerous and should not be used in the human body, that means that it is not appropriate for incontinence issues either. This FDA representative is not a person I personally have any respect for, for many reasons and I feel he did this only because he was dragged kicking and screaming to the decision. We must not let him rest on this decision. More must be done. There has been untold suffering by men and women because of these products and I believe we will NOT rest until it is banned from the market.

    Bejah

    Jane, thanks for this news!

    • K says:

      Bejah, I read that report about FDA representative I think you are speaking about and wow I am shocked this has not been discussed before. Obviously, no respect for women! Why has that been kept so quite? I pray this all ends soon so everyone can get the help they need and more doctors will become educated about how women are being effected. It is so hard to find the help you need and doctors that understand.

  10. Anon says:

    Fox News, CBS, ABC and The Wall Street Journal are reporting this finally. Wish someone could contact the Wall Street journal reporter and show her where J & J said they tried to do the right thing by taking Prolift off the market during the Punitive phase of

    Hammond trial.

  11. Tammy Ky says:

    One small step. MUCH more to be done. ALL MESH HARMS HUMAN LIVES. It was never meant to go into the HUMAN BODY. Thanks Jane for the report.

    • Jane Akre says:

      Tammy- I wish it was that simple. for some people, their mesh is okay and doing its job as its supposed to do. For the short run at least. That’s the problem- we have no idea who will be a sufferer and who will not! Until that is determined it is difficult to justify putting mesh in as a first option. Patients should definitely consider their other options as there are other options. If your doctor is not aware how to perform surgery with sutures only or using your own fascia, perhaps you have the wrong doctor! Also be sure to ask if they are a preceptor, consultant or have any conflicted relationship with any manufacturer. They are less likely to consider any adverse events if that is the case.

  12. Iris says:

    What are they going to do about the people suffering from hernia mesh…it should not just be for transvaginal mesh

    • Jane Akre says:

      Iris- there is n o question that hernia mesh sufferers are being overlooked and we at Mesh News Desk are very aware of that. I’m sorry the litigation so far has focused on pelvic mesh…. I ask attorneys about hernia mesh victims all the time. The answer I get is that there is no mass tort however, the more complaints that are registered with the FDA, the more likely the agency cannot continue to ignore you all. I’m sorry. It is not fair…. but that is what turned the tide with pelvic mesh,,, an unbelievable number of complaints. Have you registered your complaint with MAUDE database and followed up to make sure it reflects what you wrote? Bruce Rosenberg is the hernia mesh expert I rely on and have sent countless people to. He is overwhelmed but is very knowledgeable. 954-701-5094.

      • Iris says:

        Thank you for that comment.. I will call him

      • Andrea hawes says:

        This is a subject I have been wondering about. I have POP mesh from 96, umbilical hernia repair mesh from 99; as well as SUI tape from 2004, which is being handled by Freese & Goss. I have no idea what the mesh has done to me or what kind of a life expectancy I have, I would just like an idea of what to expect considering how long I have had mesh in my body.

        • Jane Akre says:

          You do not say if you have complications. Just because you have mesh does not mean you WILL have complications…. Some do not.

    • DEe Freeman says:

      Hello Iris, I totally agree with you. I am a Bard Hernia Mesh (2008) victim. I am also Guilty of not filing an FDA adverse effect report, but will be filing Today. 2013 I did contact Bruce Rosenberg who gave me a quantity of good resources which I have followed through on. Thus far experiencing debilitating genitofemoral nerve entrapment pain has been Few but the Hematuria/uti’s with blood occurrences has been relentless and all have been non-related to aspects of personal hygiene,hormonal imbalance, or intimacy with spouse of 32yrs. There’s been no shortage of dealing with non-infectious and infectious complications resulting from this hernia mesh implant. I was on Nitrofurantoin/Mono Mac 500mg. antibiotic regime twice daily (since October 2014) when my urinalysis results reveal (December2014) an enterococcus faecalis infection. The urologist was insistent on prescribing this same medication apparently now antibiotic resistant. I questioned this. Mind you speaking up causes annoyance….Lol. The Urologist Phones me. You read correctly the Urologist Phones me and “says you have a choice of taking the Nitrofurantoin/Mono Mac 500mg medication(medication I was already taking) or Ciprofloxacin.” Ciprofloxacin bka Cipro, catapulted me into four tenosynovectomy(2013-2015) surgeries. The culprit for Tenosyvitis was unbeknownst to me at the time but I later discovered during my post-op ACDF( July2014) surgery. Ciprofloxacin and other antibiotics in the Flouroquinolones group are dangerous, have delayed effects and long term negative impacts, even so says the Grand Poobah FDA…Lol. Yet the Urologist insists on prescribing me this dangerous medicine why?? Oops him nor his staff did not look at what’s documented in my medical charts and bringing this to attention was such a naughty thing to do! Frustrated, yes I was. Seeing that I am symptomatic Urologist should’ve been frustrated as well. It’s apparent his ego status is more important than his Patient-Centered status. According to my new urologist profile he delights in working with patients whose proactive about their health and well being, I’m praying that he’s a man of his word. I’m searching for a new naturopathic physician my previous one retired but not without stern recommendations of getting the mesh removed. So a consult with Dr. Kevin Petersen is on the horizon. If so be it my 2016 itinerary will be

      under going hernia mesh explant surgery via Dr. Kevin Petersen. Sooner or later Anyone who have a mesh implant no matter what type, will have to contend with the onslaught it’s going to put you and you’re love ones through so be prepared to do battle. Thanks to Jane Akre creating forums like this and to Bruce Rosenberg resources we have armor that didn’t exist prior to internet. So forward march I go to the FDA(adverse effect report) battlefield.

      Prayers for all Fellow Mesh Warriors and their Love Ones.

  13. Louise says:

    What are they saying? That SUI , will not be in this lawsuit…Are you kidding me? I have complications ever since this mesh was inserted in my body and they won’t pay me and other women because they decided that Stress Urinary Incontinence is not in this lawsuit? Come on! First of all my In continence has been worst right after I had this Mesh,surgery not to mention that it created bowel incontinence right after that surgery. Also, I have endured pain, stress, anxiety, surgeries, autoimmune diseases, groin pain, hip replacement surgery, Twice …nurses at home and intravenous antibiotics for 2 months, with a bag I had to carry, all the time…etc…and they won’t give me any compensation…DO YOU KNOW HOW I CALL THESE MANUFACTURERS, I CALL THEM ” TERRORISTS,.THEY’RE NO BETTER THAN ISIS…

    • Samantha says:

      Louise,

      The article is NOT stating SUI impacted women will not be included in these lawsuits. Rather, the FDA will finally reclassify POP mesh to a high risk device and require safety testing. I suggest reviewing Jane’s article again or asking your attorney, as these type of statements are taking as “gospel” and they cause more confusion and frustration with the whole mess.

      • Louise says:

        Samantha, I’m French and speak a bit of English, but I really thought, that they meant, SUI, would not be included in the lawsuits. Also,do you have any idea when CANADIAN WOMEN get their compensations.Will it be this year, at least? It’s been years, now and we don’t even have any new updates, yet…Why don’t they put a chart with the plaintiffs, name and the dates of when it will go on trial. (just to give us, hope, that they’re working on our case) …And,why are there more winning cases in America and just a few from, Canada? It’s not fair…We are suffering, too. Thank you, Samantha for clarifying my question.

  14. Jane Akre says:

    Please note that the Federal Register says on February 26, 2016, the FDA will convene another expert panel to discuss whether trocars should also be reclassified. Trocars are those large stainless steel needles that place mesh transvaginally during the blind procedure. It is not uncommon to nick an organ or nerve during the process.

  15. Toni says:

    Jane, thank you for all you do as we would all be left in the dark with no idea how to get help and believe these drs when they treat us so poorly due to the ignorance of the effects of mesh on our bodies . So I know you are kept from court feed on KC trial but is there word on how it’s proceeding? Also how can I find other local women in Kansas who are going through this hell? I would drive the 3 hrs to watch but barely keeping my job through all this medical nightmare.

    • Jane Akre says:

      Yes the judge has not yet ruled and day after day it makes it less likely we’ll get access. I think at the end of the day he wants to protect the attorneys from any harsh words. Attorneys are anything but delicate flowers…. so that is sort of amusing. I believe it should be close to wrapping up…. I will try and find out.

  16. kitty says:

    It’s the nerve baby!

  17. Anon says:

    With the new FDA ruling do you think doctors will be more accepting of the idea that the mesh is the real culprit and really causing problems? Will this help step up research into ways that the medical community can actually help us instead of shunning us? Now that the government has legitimized the injuries women are suffering do you think the public perception will change about how lives have been destroyed by mesh?

    • Jane Akre says:

      Yes, I believe the public will begin to understand that mesh put on the market without proper testing was a very bad idea. We still have the smaller meshes for sui which many doctors downplay and with this ruling will continue to downplay its dangers. “See they took the bad stuff off the market,” whereas as many on these pages will attest, SUI mesh is also problematic. This is my opinion. SUI mesh complications too needto be registered with the FDA to make sure they have an accurate picture of what is happening.

      • Bejah Blue says:

        And let us remember that it is not just the polypropelene mesh that is a problem, it is also the subsequent need for narcotic pain medication that we must take because we were implanted with the suspect mesh. We have many problems related to the pain issues including chronic constipation and long term damage to our bodies and clearance organs like kidneys and liver because of the continuing need for pain medication. There is also the diagnoses of mental health issues that we face when we are implanted. I expect most of us suffer now from chronic Depression and Anxiety. And there is the exhaustion, the nerve damage, the loss of appetite, the bloating and the development of inflamation, Peripheral and other Neuropathies, and Immune System diseases and the fear of developing Dementias of some kind. To limit this change to Category III classification to only those who had vaginal implants is only a beginning, there is much more that needs to be done. This is just the beginning of what needs to happen. We must maintain vigilance. We must remain steadfast and awake!

        With love and pride,

        Bejah

  18. Andrea says:

    Now that the FDA has proven the vaginal mesh surgery is high risk, do you think this will expedite our cases?

  19. Anon says:

    Just curious: J & J attorneys admitted (in their arguments against punitive damages being awarded in Hammons) that they tried to do the right thing by taking Prolift off the market implying they knew it harmed women. In previous trials the plaintiff has not been allowed to bring up the fact that J&J removed Prolift from the market because they swore it was strictly due to financial market considerations not because they knew it was a bad product. Did this attorney open the door for future plaintiffs to use? Can they bring it up in trial now and depose J & J employees regarding the decision to remove Prolift from the market and what they knew at the time? Will plaintiffs be allowed to bring this up now?

    • Jane Akre says:

      I believe it depends on the judge. Motions in Limine mean some information is limited presumably to keep the trial moving along… previously the J&J destruction of documents has not allowed to be entered, so that was a first too!We have another Ethicon case coming up in Pennsylvania Jan 25th and two more in February…. so that is a good thing to watch for.

  20. Angie says:

    What about the Bard3D Max Mesh used to repair inguial hernia? That mesh almost killed my husband! Now he is left with permanent damage for the rest of his life! I am just thankful he has gotten it removed before it did more damage to his body ! But yet I am left with a 43, year old husband who can not work and is barely able to get around and will never be the man I married! The FDA should remove all mesh! Hernia mesh is the same as the other! It’s polypropylene too! But yet no one seems to care

    • Jane Akre says:

      Angie- Have you found helpful medical docs…? There is still so much denial that mesh can cause havoc in a body….. hernia as well!

  21. […] POP mesh was finally reclassified in January, 2016. At the same time, mesh makers were given 30 months to prove their mesh was safe and effective by requiring it submit the medical device to premarket approval (PMA), the most stringent review by the FDA that also applies to pharmaceuticals. […]

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