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January 4, 2016: FDA Strengthens Vaginal Mesh Safety Requirements For Pelvic Organ Prolapse Repair

According to a previous U.S. Food and Drug Administration (FDA) announcement, between the years 2008 and 2010 there were 1,503 adverse event reports identified for women implanted with vaginal mesh products while undergoing transvaginal pelvic organ prolapse (POP) surgery. These adverse events included reports of injury, death, and mesh failure. The FDA has reported that “serious complications associated with surgical mesh for pelvic organ prolapse transvaginal repair of are not rare”.

In response to this growing safety concern, today the FDA alerted the public and mesh manufacturers that it had issued two orders that include a mesh medical device reclassification, and more stringent data requirements for the vaginal mesh used to transvaginally repair pelvic organ prolapse.

New Transvaginal Mesh Data Requirements

To address safety concerns regarding the mesh products used in transvaginal POP repair, the FDA issued an order to “reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices.”

In its second order, the FDA strengthened marketing requirements for some vaginal mesh products by mandating that manufacturers submit a rigorous “premarket approval application [PMA] to support the safety and effectiveness of surgical mesh for the transvaginal repair of pelvic organ prolapse.” Manufacturers of mesh products used for transvaginal POP repair that are already on the market will have 30 months to submit a PMA, while manufacturers of new POP transvaginal devices must submit a PMA before their mesh product can be approved for marketing by the FDA.

The FDA will continue to assess vaginal mesh safety requirements. According to William Maisel, M.D., M.P.H., and deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse.” Doctor Maisel also stated ” We intend to continue monitoring how women with this device are faring months and years after surgery through continued post market surveillance measures.”

Contact The Weinberg Law Firm Now for Vaginal Mesh Lawsuit Help

The Weinberg Law Firm is currently assisting women who have been injured by vaginal mesh products. If you have experienced complications following transvaginal mesh surgery, and would like a free mesh lawsuit evaluation, please select Vaginal Mesh Lawyer, or call our law firm 24/7 toll free at 877-934-6274. You can reach us online by submitting the easy to use mesh lawsuit evaluation form found on this page.

The Risks Concerning Vaginal Mesh Products

Pelvic Organ Prolapse occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina. To address this condition, a synthetic mesh may be implanted into the vagina to reinforce the pelvic floor.

In some cases, however, the mesh may cause organ perforation, bleeding, chronic pain, mesh exposure or extrusion into the vagina and/or visceral organs, infection, atypical vaginal discharge, painful sexual intercourse, self-catheterization, recurrent prolapse and/or incontinence, additional corrective surgery, and other permanent and/or life-altering adverse events.

If you have a case-specific question, or a question regarding our legal services, please select
Contact Weinberg Law Firm. You may also call us 24/7 at our toll free number, 1(877) 934-6274.