Public Citizen calls for mesh recall; prolapse advocacy groups to present at FDA meeting

September 1, 2011

Surgical mesh products that are used during transvaginal surgery to repair pelvic organ prolapse (POP) should be recalled, consumer advocacy group Public Citizen said in a petition sent to the FDA.

Surgical mesh products that are used during transvaginal surgery to repair pelvic organ prolapse (POP) should be recalled, consumer advocacy group Public Citizen said in a petition sent to the FDA.

Meanwhile, two patient advocacy groups-Women’s Health Foundation and the Association for Pelvic Organ Prolapse Support-said they will be presenting stories from female patients who have undergone transvaginal mesh treatment for POP at an upcoming FDA meeting in Washington.

The FDA meeting will gather experts in obstetrics and gynecology on Sept. 8-9 to discuss the safety and effectiveness of surgical mesh used to treat POP and stress urinary incontinence. The meeting is in response to a July 13 updated safety communication from the FDA warning health care providers and patients that transvaginal placement of mesh to repair POP may expose patients to greater risk than other surgical options.

In a statement released last week, Public Citizen said all surgical mesh products made of non-absorbable synthetic material that are used during transvaginal POP repair should be recalled "because they offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm."

Public Citizen said it is calling on the FDA to ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for transvaginal POP repair, to order the manufacturers of these products to recall them, and to require that any future versions be classified as a class III medical device and be subject to more stringent approval requirements.

Joining Public Citizen as co-petitioners were urologist Daniel S. Elliott, MD, of Mayo Clinic, Rochester, MN, and L. Lewis Wall, MD, an OB/GYN at Washington University, St. Louis.

"It is my conclusion… that the use of non-absorbable mesh kits for transvaginal POP repair should be, at a minimum, banned until further data is derived from multiple independent, non-industry-supported research groups which prove a clear benefit without unwarranted risk," Dr. Elliott said in a statement. "Anything less would be surgically irresponsible and ethically unacceptable."

Missy Lavender of Women’s Health Foundation said, "It’s important for us to be a voice for women who have found relief from this particular treatment along with those who have reported complications. Any surgical procedure is risky; it’s important that patients have a knowledge base of the 'what ifs' and have exhausted other less invasive treatment options."

Jeff Secunda of the Advanced Medical Technology Association (AdvaMed), which represents medical device manufacturers, said, "For women suffering from pelvic organ prolapse or stress urinary incontinence, surgical intervention and the use of mesh is an important treatment option. The use of surgical mesh has an established track record and the 510(k) process has enabled great learning and innovation in this field. We look forward to continuing to discuss this matter with FDA and other stakeholders."