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Free & Goss Attorneys

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The FDA has taken an unprecedented step to further evaluate vaginal mesh, requiring manufacturers to conduct postmarketing studies designed to gather more data on the safety and efficacy of vaginal mesh products for the next three years.  In all, 33 manufacturers of meshes for pelvic organ prolapse (POP) and seven manufacturers who make second-generation ‘mini-slings’ for stress urinary incontinence (SUI), are affected.  The mandate, however, does not include every type of vaginal mesh, most notably the traditional slings used for SUI.

Relevant to the issue is the fact the FDA never required manufacturers to conduct studies evaluating safety and efficacy prior to approval.  Instead, these devices were approved through the FDA’s 510(k) approval process, which only requires showing ‘substantial equivalence’ to devices already on the market.  One could argue these actions are long overdue considering approval was, and still is, based on mesh used for abdominal hernias, as well as the hundreds of thousands of patients who have had these procedures.  In the meantime, pro-consumer groups, such as Public Citizen, continue to call for a full recall of devices used for POP.

Additional information can be found here:

http://professional.wsj.com/article/SB10001424052970203513604577141080774088846.html?mg=reno64-wsj

http://www.bloomberg.com/news/2012-01-04/fda-orders-safety-studies-for-vaginal-implants-made-by-j-j-and-c-r-bard.html