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FDA Convenes Committee to Discuss Safety of Transvaginal Mesh

FDA Convenes Committee to Discuss Safety of Transvaginal Mesh

September 2011 — The FDA has asked a public advisory committee to convene September 8-9, in order to discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). More than likely, the meeting will probably be the deciding factor if transvaginal mesh implants are safe enough to use in POP and SUI procedures.

In order to better understand the risks and benefits of transvaginal surgical mesh repair in pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the FDA is asking for both the opinion of experts and the public.

On July 13th, the FDA released a Safety Communication, warning of the risks of the transvaginal placement of surgical mesh for POP. The warning stated that post-surgical complications, including mesh erosion, are not rare in patients. Other side effects include pain, bleeding, pain during sexual intercourse, organ perforation and urinary problems. Some patients require hospitalization or additional surgery to remove the mesh. The FDA also warned transvaginal mesh surgeries may expose women to greater risk than other surgical options.

Since 2008, the FDA has received 2,874 adverse event reports from patients who had complications following surgery. 1,503 adverse event reports were associated with transvaginal implants used in POP repair and 1,371 were associated with SUI repair.

The Committee — called The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee — will convene September 8-9 from 8 a.m. to 6 p.m. in Gaithersburg, Maryland.

The first day of the committee will be devoted to describing the procedure, risks, benefits and clinical findings of transvaginal surgical mesh use in POP procedures. The second day will be devoted to discussion of transvaginal mesh procedures to repair SUI.

The meeting will be open to the public and time will be set aside for public comments. Members of the public who wished to speak needed to notify the FDA event coordinator beforehand with general information about the information they wished to present, including details about their evidence or argument. While the FDA has not released which members of the public might be presenting, the FDA suggested if too many people wanted to present, the committee would not be able to accommodate them all and a lottery would be held.

The FDA recently released a draft of the agenda for Day 1 and 2 of the committee meeting. Possible topics that may be covered include: the procedure for reclassifying an FDA approved product, the need for postmarket studies, a presentation from members of the industry, an overview of reported adverse events associated with transvaginal mesh, a report on the FDA’s conclusions and a discussion of next steps.

A block from 9:10-11:00 a.m. on September 8 and a block from 9:00-10:30 a.m. on September 9 has been set aside for public statements. Each person has a limited amount of time to speak; however, the committee chair may ask the public presenter to stay if the committee panel has any follow-up questions based upon the presenter’s statement. If time allows, unscheduled speakers who did not notify the FDA beforehand may be able to make remarks.

The committee of experts will also discuss and give input on the changes proposed by the FDA.

Prior to the committee’s meeting, the FDA proposed the need for increased premarket and postmarket regulations on the transvaginal mesh products. They have suggested reclassifying mesh products from Class II to Class III, which would require manufacturers to submit premarket approval applications. The FDA may also push specific product improvements and postmarket surveillance studies.

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