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M. Brandon Smith
M. Brandon Smith
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Mesh Implant Update: FDA Requires More Studies and Information From Manufacturers

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Following up on previous warnings about the safety of transvaginal mesh implants to treat pelvic organ prolapse, the FDA is now enlisting the research power of the manufacturers of these devices. On January 3, the FDA sent letters to 35 manufacturers of surgical mesh implants, mandating them to conduct a total of nearly 100 post-market studies. These studies are to address specific safety and effectiveness concerns related to surgical mesh devices used in POP treatment. Unfortunately requesting these studies comes a little too late. The products originally got approval without clinical testing and the results for many women have been disastrous.

Concerns about the use of transvaginal mesh to treat POP hit the news in July of last year, when the FDA issued a safety communication calling attention to the hundreds of reports of adverse outcomes that it had received. In just the two-year time span between 2008-2010, the FDA received 1,500 reports of complications related to mesh treatment procedures. Based on those reports and additional study, the FDA found that serious complications from the use of surgical mesh to treat POP “are not rare,” and that the use of mesh is not clearly more effective than other surgical procedures even though it may expose patients to greater risk. Since issuing that safety communication, the FDA has continued its review of the safety of transvaginal mesh implants.

Depending on the results of the review, the FDA is apparently considering reclassifying mesh implants as a riskier device than originally believed. As reported by Reuters, surgical mesh has been used since the 1950s to treat abdominal hernias, which meant that the manufacturers of transvaginal mesh implants originally got product approval without the need for doing clinical trials. But the use of those mesh implants for POP treatment only started in the 1990s and the flood of adverse reports now calls into serious question its safety. A reclassification of the device would mean manufacturers need to do clinical trials.

What does all of this mean for patients? The fact is that thousands of women—nearly 75,000 in 2010 alone—received a medical treatment that had never undergone significant safety testing. Many of them are now suffering because that treatment was unsafe and are seeking legal recourse to hold these manufacturers accountable for putting an un-tested and un-proven product on the market.