Transvaginal Mesh Recall Urged by Consumer Group Public Citizen

The prominent consumer advocacy group Public Citizen is pushing the FDA to issue a recall for transvaginal mesh used to treat pelvic organ prolapse, citing data that suggests the bladder suspension surgery products carry a high risk of permanent injury while providing no significant benefits. 

In a petition filed with the FDA on Thursday, Public Citizen indicated that a transvaginal mesh recall should be issued to prevent the needless exposure of patients to a substantial risk of serious and life-altering complications.

The request comes a little more than a month after the FDA issued a warning about the risk of vaginal sling problems. However, Public Citizen indicates that the agency needs to do more than just warn about the transvaginal mesh dangers and the group is asking the FDA to remove the surgical mesh products from the market.

Transvaginal mesh products, which are sometimes referred to as a bladder sling or vaginal surgical mesh, are designed to support organs that have begun to fall in older women or women who have had children, to prevent them from pressing on the bladder and vagina.

The products are sold by a number of different companies, including Ethicon, C.R. Bard, American Medical Systems (AMS), Boston Scientific and others. They are made of non-absorbable synthetic material that is permanently implanted using small incisions as an alternative to other methods of treating pelvic organ prolapse.

Despite limited evidence to establish that the products provide any benefits over other treatment options, an estimated 75,000 women undergo surgical procedures to have transvaginal mesh implanted each year.

Thousands of reports of been filed with the FDA involving serious and potentially life-altering transvaginal mesh problems, including erosion of the mesh into the vagina, shrinkage of the mesh, infection, bleeding, organ perforation and other complications.

Public Citizen wants the FDA to recall transvaginal mesh from the market and require any future surgical mesh products designed to treat pelvic organ prolapse to be classified as class III medical devices, requiring them to undergo a rigorous premarket approval application (PMA).

Most, if not all, of the transvaginal mesh slings currently on the market went through the FDA’s expedited 510(k) accelerated approval process, which only requires that a product is substantially equivalent to a medical device already on the market in order to be sold in the U.S.

A number of women throughout the United States who have experienced problems are pursuing a transvaginal mesh lawsuit against the makers of the products to secure compensation for painful and often disfiguring injuries caused by the bladder slings.

6 Comments

  • Flor MariaDecember 2, 2012 at 3:41 pm

    I had surgery for bladder prolapse in 2008 ,now I have problems with frequency urinary and a very strong smell like plastic I also not able t to empty all my bladder, my lower side and my lower back with my legs hurt, Dr said the mesh is falling she send me to another Dr but he said he can find the reason for the smell , told me to come back another time,I ask the Dr who did my surgery what can w[Show More]I had surgery for bladder prolapse in 2008 ,now I have problems with frequency urinary and a very strong smell like plastic I also not able t to empty all my bladder, my lower side and my lower back with my legs hurt, Dr said the mesh is falling she send me to another Dr but he said he can find the reason for the smell , told me to come back another time,I ask the Dr who did my surgery what can we do about it she answer me how many times you think a have to do the operation thank you please help to find the right person to help me.

  • JudyJune 27, 2012 at 10:14 pm

    I had my surgery April 13 2010 and 6 -8 months later I started to notice the symtoms starting to return of the bladder incontinence(frequency,ergency.I also have been getting frequent pain, discharge,bladder infection, Intercourse is almost an unknow practice because it has become uncomfortable as time goes. My legs and back hurt alot but do not if one has too do with the other. Is this lawsuit o[Show More]I had my surgery April 13 2010 and 6 -8 months later I started to notice the symtoms starting to return of the bladder incontinence(frequency,ergency.I also have been getting frequent pain, discharge,bladder infection, Intercourse is almost an unknow practice because it has become uncomfortable as time goes. My legs and back hurt alot but do not if one has too do with the other. Is this lawsuit only for the U.S.

  • marilynJune 5, 2012 at 11:07 pm

    i had my surgery for viginal prolapse in sept 2008. starting having the same problems in 2009 and now they are getting worse everyday. back hurts, intercourse hurts, legs hurt, just misable, now in the last 6 months adominal pain. had infections dr can't explain the cause or not sure. yes i hurt. at this point don't know what to do.

  • SpringOctober 7, 2011 at 8:50 pm

    I had surgery for a bladder and rectal prolapse 8/27/2010 It was a long recovery (3 months) and when my Dr finally allowed us to have sex again after 5 or 6 times my husband started complaining of getting scraped or scratched. At first he thought I was somehow doing it with my fingernails. The surgeon thought I was crazy and said everything was fine when I went back telling her. We moved to a dif[Show More]I had surgery for a bladder and rectal prolapse 8/27/2010 It was a long recovery (3 months) and when my Dr finally allowed us to have sex again after 5 or 6 times my husband started complaining of getting scraped or scratched. At first he thought I was somehow doing it with my fingernails. The surgeon thought I was crazy and said everything was fine when I went back telling her. We moved to a different state in Jan 2011 and I went to see a new Dr in March. She immediately knew it was mesh erosion. Surgery was scheduled and the mesh was revised in July/2011. The surgery was so minor compared to the original. She simply put more tissue over the exposed mesh and after 2 months gave it the all clear. I believe the 3rd time we had sex he screamed in pain. it was even worse than before he was bleeding from where the mesh cut him. So now I am scheduled for my 3rd surgery in 14 months due to this stupid mesh. OH and the leaking is back after the revision. and I have had bladder infections and an almost constant discharge since the 1st surgery. my vagina is all nubbly inside now like its been sliced and diced, Probably going to have to have 4 surgeries total.

  • NancyAugust 29, 2011 at 10:33 pm

    I had a prolapse surgery in Oct. 2009, using mesh and my life has been a living hell ever since. Or should I say, "life" I used to have. I am in severe pain in my lower left side and groin area, painful intercourse, I literally live neat the toilet, as I have had problems with urinary and fecal incontinence and varying constipative episodes. I would like to know what brands of Mesh are involved i[Show More]I had a prolapse surgery in Oct. 2009, using mesh and my life has been a living hell ever since. Or should I say, "life" I used to have. I am in severe pain in my lower left side and groin area, painful intercourse, I literally live neat the toilet, as I have had problems with urinary and fecal incontinence and varying constipative episodes. I would like to know what brands of Mesh are involved in class action suits. I know in the beginning there was just Bard brand but understand there are now many more included and more reports are coming in daily. It seems to me, as big as this has become, "any" brand should be subject to scrutiny at this point. I find it hard to believe that there is "one" magical brand that is ok when all these others are clearly failing and ruining many women's lives, including mine.

  • ArmandoAugust 26, 2011 at 8:55 pm

    my mom has had this implant, but has been ill since and is required to under go another surgery to correct this problem (s) what is her options?

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