FDA Tightens Rules on Surgical Pelvic Mesh

The U. S. Food and Drug Administration (FDA) just announced stronger regulations on surgical pelvic mesh devices used to treat pelvic organ prolapse. Pelvic organ prolapse occurs in women whose pelvic floor can no longer support their pelvic organs, and surgical mesh is implanted to help strengthen the pelvic wall and hold pelvic organs in place.

Although surgical pelvic mesh was used for decades by surgeons to repair pelvic organ prolapse through the abdomen, health complaints began surfacing after 2002 once surgical mesh devices began being surgically inserted through the vagina, rather than the abdominal wall, to repair pelvic organ prolapse. The transvaginal mesh procedure was marketed as a quicker and easier alternative to traditional abdominal repair due to a smaller incision and quicker healing time, although the FDA denies makers of the device have ever proven these claims. Post-operatively, women complained of pain, bleeding, infection, urinary problems, and organ perforations after the mesh eroded or moved out of the original implantation site, sometimes requiring additional surgeries to remove or replace the mesh implants.

Re-classified as high-risk medical device

Following years of complaints, post-market studies, increased safety warnings and thousands of injured women, the FDA has concluded transvaginal mesh repair of pelvic organ prolapse carries greater complications for women than surgical mesh used with traditional abdominal repair, and will re-classify vaginal mesh from a “moderate-risk” or Class II device to a “high-risk” or Class III medical device. High-risk medical devices are subject to greater scrutiny by the FDA and carry a higher risk of injury.

Additional safety & effectiveness data required

Under the new regulations, manufacturers must submit a premarket approval application, demonstrating the safety and efficacy of their surgical mesh products, specifically addressing some of the consistent complaints of transvaginal mesh products including pain and organ perforation. Manufacturers of existing surgical mesh products will have 30 months to submit their application, while manufacturers of new surgical mesh products must provide safety and effectiveness data as part of their original application for approval.

These stricter regulations affect only surgical mesh used for transvaginal pelvic organ prolapse repair, and not for mesh used with abdominal repair of pelvic organ prolapse, hernia repair or stress urinary incontinence.

The FDA wants to hear from you.

If you have had surgical repair using transvaginal mesh, and have suffered with any post-operative problems, the FDA would like to hear about your experience. Please contact the FDA at 1-800-FDA-1088 to report by phone, or you can file an adverse event report online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.

If you are considering surgery to repair pelvic organ prolapse, we strongly recommend you discuss with your doctor the type of surgery proposed, whether abdominal or vaginal repair is planned, and whether transvaginal mesh will be used, and all the risks and benefits associated with using transvaginal mesh. You have the right to be informed of any and all risks before you consent to any kind of surgery because it is your body and ultimately your decision.

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