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FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

FDA logo 200March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP)  and stress urinary incontinence (SUI). 

The experts  suggested that because of the number of POP complications at the time (1,503), that mesh for POP be reclassified from Class II to a Class III or high-risk device. That would require a rigorous premarket review process before mesh manufacturers could sell their product, unlike the pre-market notification that is required now. Many critics suspect POP surgical mesh would never be approved for safety and efficacy if that happened.

But no changes were made and at this time surgical mesh for POP and SUI remains Class II or a low-to-moderate-risk medical device.

The expert panel said it would further consider reclassifying SUI surgical mesh and the FDA promised an update at a later time.

With no notification, the FDA on Wednesday, March 27, updated its information on SUI mesh.

What Is New? SUI Adverse Events Increasing

The agency says it has analyzed adverse event reports, conducted epidemiological research on the safety and effectiveness of surgical mesh for POP and SUI and collaborated with professional societies to understand postmarket performance.

The timing is interesting on the latter point. It should be noted that the FDA update comes one day after the American Urogynecologic Society (AUGS) issued a new policy statement that resists any suggestion mesh use be banned or severely restricted. See it here.

What’s new is the FDA has continued to monitor SUI mesh injuries.

Back in July 2011 (here) when the second Safety Communication was issued by the FDA saying mesh complications were “not rare,” it released the number of adverse events that had come into the FDA at that time.

“From Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.”

The agency continued its review of SUI complications and now reports from January 1, 2008 through September 30, 2011, the FDA received “1,876 reports of complications associated with surgical mesh devices used to repair SUI.”

That represents more than a 36% increase in adverse event reports to the FDA in nine months.

Advocating SUI Mesh

While advising not every woman experiencing SUI will need surgery the FDA appears to endorse sling surgery over non-mesh repairs on the What is Stress Urinary Incontinence? page (here) by saying:

“The use of surgical mesh slings to treat SUI provides a less invasive approach than non-mesh repairs, which require a larger incision in the abdominal wall. The multi-incision sling procedure can be performed using three incisions, in two ways: with one vaginal incision and two lower abdominal incisions, called retropubic; or with one vaginal incision and two groin/thigh incisions, called transobturator. There is also a “mini-sling” procedure that utilizes a shorter piece of surgical mesh, which may be done with only one incision.”

Suggested Patient Questions

The FDA update on SUI includes an extensive list of questions a patient should ask her doctor when she’s considering an incontinence repair (here).  Without seeing the original page it is difficult to assess if this is new information. Questions into the FDA media office about that are pending at this time.

Considerations about Surgical Mesh for SUI

The newly updated FDA page (here) says 250,000 SUI surgeries were performed in 2010, according to the industry, and the FDA says the safety and effectiveness of multi-incision slings is well established among patients who were followed up to one-year.  Mini-slings for SUI safety and effectiveness “have not been adequately demonstrated” and have not been compared to multi-incision slings for safety and effectiveness.

Mesh sling surgeries for SUI have a reported 70-80 percent success rate at one year. A similar rate of success is reported at one year for non-mesh repairs. The FDA page does not say what constitutes “success.” As we’ve learned from testimony in the Linda Gross trial, success is sometimes defined as the correct placement of a pelvic organ and not the quality of a woman’s life after the surgery.

The most common complications coming into the FDA for surgical mesh slings for SUI repair, in descending order of frequency, include:

pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI.”

The FDA suggests partial removal may be a remedy.

Recommendations for Health Care Providers

What’s new may be an additional recommendation to health care providers that encourages the surgeon receive specialized training for each SUI mesh placement technique. The American Urogynecologic Society (AUGS) in its policy statement just released also recommends more specific training for doctors.

The FDA also encourages doctors to be fully informed about:

  • The likely success of transvaginal SUI surgery compared to a non mesh surgery
  • The potential postoperative complications and its effect on the quality of lift
  • That  there is limited information about outcomes after one year
  • The specific product to be used
  • That a mesh sling is a permanent implant
  • That SUI surgery using mesh can make any future surgeries more challenging and can “put the patient at risk for additional complications and surgeries.”
  • Ensure the patient understands the post-operative risks and potential complications
  • Provide the patient with the labeling or brochure

You’ll recall that during the Linda Gross v. Ethicon case, it became clear that there was a “failure to provide adequate warning” to her implant surgeon Dr. Benson by a jury vote of  7-yes and 2-no. That means the surgeon also may not have enough information to provide an adequate “informed consent.”

*Editors Note* Without being able to compare the original FDA pages to this newly updated information it is difficult to determine which represents a departure for the FDA in terms of SUI mesh. MDND requested a comparison to answer that question on Thursday. We’ll update you when that is forthcoming. #

10 Comments

  1. Kathy says:

    Specialized training is what one would assume such a surgery would offer. What must be addressed is ” mesh”.

    Until the FDA faces the fact that implanting mesh without also specialized training to remove it is a crime in itself.

    I have never heard of another health crisis where the patient is left in pain, most of us for years, trying to get our health back,with so few doctors removing mesh.

    I was a perfect,healthy, vibrant, positive woman, with a bit of SI in 2007. I now spend my day in pain, fighting for my health, fighting for medical help and trying to understand how the FDA can with any respect for life, not address this with immediate removal.

    The FDA also need to include the loss of a sexual life that many of us have lost. Mesh erosion and pain make it impossible. The tears I have shed for this alone have made the last six years a nightmare. To be in a wonderful marriage and because of mesh lost the most intimate and loving gift.

    All because of a wee bit of leakage.

  2. Kathy says:

    Can someone explain the Mini- sling comparison in greater detail for me ?

    • Jane Akre says:

      Kathy-

      The best explanation I’ve seen comes from Miklos and Moore, surgeons from Atlanta. they call the mini-sling the latest innovation in SUI treatment in that one incision is made versus the TOT and TVT which are multi-incision. The same polypropylene mesh is used, however there is less of it. See their website here:

      http://www.miklosandmoore.com/mini_sling.php

  3. Follow the money. The politically powerful, entitled medical device industry lobby insists that it cannot pay a paltry 2.3% tax that would barely support FDA oversight. The FDA, an underfunded, legislatively castrated & financially conflicted regulatory agency does not protect patients from harm. Repeat the profit. Repeat the harm.

  4. AnnMarie says:

    Joleen, The FDA is underfunded, corrupt, legislatively castrated and we women who have been raped by mesh are just plain castrated! I am so sick of this I could just SCREAM!!! Nobody has any BALLS to do anything to keep this from happening to women. What is it going to take????? I have been robed of life as I once knew it, what kind of grand mother am I going to be, I will not be able to play, run, pick-up my kids because of this medical disaster. I am so full of scar tissue, just mutilated. Had a wonderful love life with my loving husband. Was an athletic 40+ yr old. Can’t work as an RN. Where is Michelle Obama? Oprah, NOW (National Assoc of Women), the View Women? Please someone tell me? WTH!

  5. DebC says:

    This is ridiculous and an outrage. I can not believe they are still advocating the use of mesh for SUI or POP. Both are causing horrific and well-reported complications!! How many lives have to be destroyed before they finally say “Enough!”.

    Using mesh for SUI is simply wrong. Since when is it ok to let the risk of the surgery outweigh the original problem? Lets face it, while SUI is a problem, most of the time it is NOT nearly as bad as the complications that mesh complications impose. Why take that risk, especially when there are alternate methods that do NOT have such terrible risks. Sure, every surgery has risks, but mesh implants risks go above and beyond normal risks. Traditional surgeries using your own tissues may have risks of failure – so does mesh! And, the FDA report even said that there is no evidence that mesh worked any better than traditional non-mesh repairs. They also would not pose the risk of FBR and mesh eroding through vaginal walls, organs, tissues… etc. So WHY keep using mesh??? Greed. Money. That is why. I didn’t want to believe that… but, the more I learn, the more I can not come to any other conclusion.

    This is all about marketing, disguised as helping more people. It’s all about making money, and NOT about what is best for the patient. They market this as less invasive. Quick. Easy. Safe. Lets face it – we like “quick and easy”. “Quick and easy” sells! We don’t want to have to interrupt our lives, and time is always a factor. I was worried about taking time off from work for the surgery. Now, I’m on disability and haven’t worked in months, have had to make 3 trips to UCLA for treatment, and have months more of recovery (hoepfully!) ahead of me. So, how is THAT for “quick and easy”?

    What good is “quick and easy” if it results in poor quality of care?

    What good is it to be sent home the same day, if it then creates years, or even a LIFETIME of problems afterwards??

    Why don’t they tell you about how serious the complications will be if there are complications?

    Why don’t they tell you how common those severe complications are?

    Why don’t they tell you how there are no “less invasive” and “quick fixes” if you are one of the MANY women who wind up with mesh complications? Matter of fact, you will have trouble finding anyone who can really help you!

    Call me crazy, but I would rather have a scar on my stomach with a longer recovery in the hospital using the traditional NON mesh surgery for SUI repairs – then to use mesh in order to go home the same day, but also have the HUGE and often PERMANENT life-quality-threatening risks that go with it.

    I am 46. My life has completely turned upside down since I had my mesh sling for SUI put in last year in Feb 2012. I walk with a crutch, and the help of pain pills. I can’t work. Can barely take care of myself let alone my family and house. Everything is a struggle. I went all the way to UCLA this past Jan 2013 to have the mesh REMOVED when I could not find a doctor locally who could help me. This was eleven months after it had been put in. Now, the mesh is out. Some of the constant pain, that felt like a steak knife stabbing in my groin from the inside, is gone. I am a little better, however, I am still in major pain. Still using a crutch and pain meds. I will start PT and Chiro treatments soon, now that my incisions are healed. I hope that will help.

    I hope that I will be one of the lucky ones to actually recover from mesh complications, but, I can’t know that yet. I’m looking at months more of recovery. I am determined, though. I am not ready to be disabled the rest of my life even though I know that is a possibility. I know that if that happens, I am sadly and certainly NOT alone. However, I am not at that point. I have kids, a husband, a life with lots of responsibilities, plans, dreams… and I have a lot of hope, especially since I was able to get all the mesh out by one of the best surgeons alive (Dr. Raz), and in a relatively short (compared to most) time period after it was put in. No matter what happens, I know that I am one of the “lucky ones”.

    Full mesh removal, as well as “hope”, are luxuries many women with mesh complications do not have. Many suffer for years longer than I have, with much worse complications – sever life-altering complications from mesh used for SUI, POP, and even hernia mesh. There are thousands of injured people out there and more keep surfacing – yet they STILL KEEP PUTTING THIS CRAP INTO PEOPLE left and right. ?!?!

    It is so NOT right. It’s sad… very sad that our system is allowing this… and there are many hands in the pot that are enabling this disaster to keep happening. Hands that we should be able to count on to help us, to protect us. I’m just sick to death over the whole ordeal.

    • Lucille says:

      Ifr i had the money, i wld pay for wome to get on a bus and go to the manufacture,er and rally right there on the spot until we get someones attention and something done! The news media or talk shows wld rather talk about male baldness and what that wld entail in ones health or other things that are a waste of money in stoopid surveys. This is real issues with real women suffering and what is it ….its like we dont exsist. I think everybody is scared of the big companies and dont want to step on toes as maybe they are sponsored through them or have some form of involvement!! Why is it that there seems to be ONE qualified DR that is so willing to remove the mesh from women all over the world and yet other doctors still seem to sit on the side lines and not try and help these women by maybe using modern instraments and learn how to do do explants from a devious device that shouldnt have been put in, in the first place. We were definately an experiment gone wrong and now we have to fight for our life and health so that just maybe , we may gain some quality or form of life back.

  6. Alette Orie says:

    Ik ben 49 jaar twee liesbreuk matten ik verga van de pijn. Kan nauwelijks lopen. Niet meer zitten. Was altijd gezond. Die matten een nachtmerrie

    • Jane Akre says:

      Translation:
      I am 49 years old two hernia mesh I perish in pain. Can hardly walk. No longer sit. was always healthy. These mats nightmare

    • Jane Akre says:

      Do you have any understanding doctors you can see? Please advise. And tell us where you are so others can join in. They may know of someone.

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