FDA Proposes New Regulations To Address Safety And Efficacy Of Vaginal Mesh Products

In a press release dated April 29, 2014, the U.S. Food and Drug Administration (FDA) announced that it has issued two proposed orders to address health risks associated with surgical mesh products used in the transvaginal repair of pelvic organ prolapse (POP). If the orders are finalized, surgical mesh used for transvaginal POP repair will be reclassified from a moderate-risk device (class II) to a high-risk device (class III). Mesh manufacturers would be required to submit a premarket approval application (PMA) for the agency to evaluate the safety and effectiveness of these products. Surgical instruments, packaged and sold with some mesh products as a kit, would be reviewed as part of the mesh PMA. The FDA also proposed that separately sold mesh surgical instruments would be reclassified from low-risk devices (class I) to moderate-risk devices (class II).

The FDA first reported in a July 2011 safety communication that a search of its safety database identified 2,874 adverse events including reports of injury, death, and mesh failure for women undergoing pelvic organ prolapse and stress urinary incontinence surgeries. At that time the agency concluded that serious adverse events related to the use of vaginal mesh for repair of POP are not rare; and it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair and that it may expose women to a greater risk. Since that time, thousands of women have filed vaginal mesh lawsuits in both federal and state courts seeking compensation for injuries related to the use of vaginal mesh products marketed by multiple manufacturers including American Medical Systems, Boston Scientific, Bard, and Johnson & Johnson.

The FDA will take comments on the proposed orders for 90 days (ending on 7/30/14.) To read the orders in their entirety or submit a formal comment, please see:

FDA: Proposed Order – “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation”

FDA: Proposed Order – “Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”

Contact the Law Firm of Eric H. Weinberg for a Free Mesh Lawsuit Evaluation

The Law Firm of Eric H. Weinberg is currently assisting women who have been injured by a vaginal mesh product. For a free legal case evaluation, please submit the easy to use Mesh Lawsuit Case Evaluation Form found on this page, or contact us toll free at 877-934-6274. Our phones are answered 24/7.


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