Transvaginal Mesh Recall Urged by Consumer Group Public Citizen
Published: August 26th, 2011
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.
Related Articles
- Transvaginal Mesh Problems Causing Doctors to Think Twice: Study (1/3/2012)
- Transvaginal Mesh for Pelvic Organ Prolapse Should Be Limited: Medical Grps (12/8/2011)
- Advisory Panel Backs FDA Plan for More Transvaginal Mesh Studies (9/9/2011)
- Transvaginal Mesh Failure Risk Being Reviewed by FDA Panel (9/8/2011)
- Transvaginal Mesh for Pelvic Organ Prolapse Shouldn’t Be Used, Group Warns (7/19/2011)
Comment by Armando on 26 August 2011:
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?
Comment by Nancy on 29 August 2011:
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.
Comment by Spring on 7 October 2011:
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.