Public Citizen, a consumer advocacy group representing more than 225,000 members and supporters nationwide, has petitioned the U.S. Food and Drug Administration to ban the current use of surgical mesh products that are labeled and designed for transvaginal repair or pelvic organ prolapse (POP).
The estimated use of surgical mesh products in women just in the United States is just under 70,000. Public Citizen is urging the FDA to ban the use of these medical devices due to the high number of serious complications, many of which have required additional surgeries and can result in permanent life-altering pain or harm. They also claim that because there has been no evidence established of any clinically significant benefit for the use of surgical mesh products used to repair POP as compared to other surgical repairs used for POP which do not require surgical mesh, the products should not be offered.
According to Public Citizen, this situation presents, “an unreasonable and substantial risk of illness or injury.” This is the standard FDA uses to institute proceedings to ban a device under the device law, 21 U.S.C. Section 360f and 21 C.F.R. Section 895.21(a).
It was in July of 2011 that FDA issued an alert explaining the serious complications with transvaginal mesh patches when used to treat POP or stress urinary incontinence (SUI). This warning came after FDA received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch during surgery.
According to the FDA’s warning, significant complications that may result from transvaginal mesh patches are not rare. Moreover, the complications which the FDA warned of and which many of our clients have shared with us they are experiencing are devastating. The main side effects include: organ perforation from surgical tools during the placement of mesh; infection; bleeding; spotting; abdominal and lower back pain; erosion of vaginal tissue; pain during sexual intercourse; and urinary problems. Other complications from the surgical placement of mesh include emotional problems; vaginal scarring/shrinkage; neuro-muscular problems; and/or the return of POP.
In addition to the Public Citizen’s petition to the FDA, they also ask that the FDA order all of the manufacturers of these surgical mesh products to recall their products, specifically the surgical mesh products designed for transvaginal repair of POP.
The current companies marketing the transvaginal mesh products here in the U.S. are:
- Gynecare Prolift +M Total and Prolift Total, Anterior, and Posterior Pelvic Floor Repair Systems by Ethicon, Inc., Somerville, NJ
- Gynemesh Prolene Soft Nonabsorbable Synthetic by Ethicon, Inc.
- Pinnacle Pelvic Floor Repair Kits by Boston Scientific Corp., Marlborough, Ma
- AMA Elevate Anterior and Apical Prolapse Repair System by American Medical Systems, Inc., Minnetonka, MN
- Avaulto Support System by C.R. Bard, Inc., Covington, GA
- Poloyform Synthetic Mesh by Proxy Biomedical, Ltd., Galway, Ireland
Finally, Public Citizen requested that the FDA require that all non-absorbable surgical mesh products specifically designed for the transvaginal repair of POP be classified as a class III device and be approved for marketing under a premarket approval application. This application includes data from clinical trials that will provide reasonable assurance that the surgical mesh products be marketed as effective and safe. To date, the FDA has not required this heightened requirement. As such, the current surgical mesh products out on the market and which are being designed and sold have not undergone well-designed clinical trials or stood up to scrutinized research showing that the products are safe and effective.