January 4, 2016: FDA Expands Vaginal Mesh Data Requirements

According to a U.S. Food and Drug Administration (FDA) report, between 2008 and 2010 there had been 1,503 adverse events identified for women implanted with vaginal mesh products while undergoing pelvic organ prolapse surgery. These adverse effects 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 the data requirements for surgical mesh to repair pelvic organ prolapse transvaginally would be made more stringent in order to address these concerns.

Contact The Weinberg Law Firm Now for Vaginal Mesh Lawsuit Help

The Law Firm of Eric H. Weinberg 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 fill out the easy-to-use Lawsuit Evaluation Form found on this page. You can also call us 24/7 toll free at 877-934-6274.

New Vaginal Mesh Data Requirements

In an effort to properly inform the public of the risks involved in the use of surgical mesh to repair pelvic organ prolapse transvaginally, 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 a second order, the FDA strengthens requirements for vaginal mesh manufacturers by requiring that the drug companies submit a rigorous “premarket approval application to support the safety and effectiveness of surgical mesh for the transvaginal repair of pelvic organ prolapse” within the next 30 months.

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 correct this, a mesh may be implanted into the vagina to reinforce the pelvic floor to correct this prolapse.

In some cases, however, the mesh may malfunction, possibly causing 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.

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