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Panel Agrees with FDA Recommendations for Increased Study and Regulation of Transvaginal Mesh

Panel Agrees with FDA Recommendations for Increased Study and Regulation of Transvaginal Mesh

September 8, 2011 Wall Street Journal Article: Today, the eyes of the medical field turned towards Maryland, where a public advisory panel convened to discuss the safety and effectiveness of transvaginal mesh in pelvic organ prolapse repair. At the end of the day, the panel ultimately agreed with the arguments of the Food and Drug Administration — transvaginal mesh products need further clinical study and tougher regulations.

Non-FDA experts convened today in order to evaluate research and listen to testimony from mesh manufacturers, FDA officials, surgeons and patients. In the end, the panel agreed with the FDA’s prior recommendations for the need for additional clinical research and stricter regulations on transvaginal mesh devices, when used in pelvic organ prolapse repairs.

In particular, the panel backed FDA plans for pre-market approval studies on new transvaginal mesh products. Furthermore, the panel recommended products currently on the market remain available, but should undergo post-market study.

Transvaginal mesh is produced by several companies including C.R. Bard, Boston Scientific Corp., and Johnson & Johnson.

While manufacturers have lobbied to keep transvaginal mesh as Class II products, the FDA initially proposed a reclassification of the transvaginal mesh products from Class II to Class III. As current Class II products, transvaginal mesh devices do not require pre-market clinical tests in patients in order to be cleared for market use. Instead, under the 510(k) process, they must only prove the product is “substantially equivalent” to an existing device. Because mesh products have been used in hernia repair for years, when doctors made the transition into using mesh to treat pelvic organ prolapse and stress urinary incontinence, the products entered the market under the 510(k) process without issue.

However, a reclassification to a Class III medical device would label transvaginal mesh as a highest-risk product. Reclassification to a Class III would require companies to conduct clinical trials and submit findings to the FDA for approval.

There was no formal vote by the panelists on whether to reclassify the drugs, but the majority of the non-FDA experts said they agreed with the FDA recommendation.

The current 510(k) system has recently come under fire as the safety of products, including transvaginal mesh, come into question. The number of transvaginal mesh-related complications has increased in recent years, raising FDA concerns about the safety of the devices. Possible side effects caused by transvaginal mesh failure include the mesh protruding through the vaginal tissue, pain, infection and bleeding. The FDA reports more than 75,000 women had transvaginal surgical mesh procedures last year. Between 2008 and 2010, approximately 1,503 patients experienced complications after pelvic organ prolapse repairs.

In July, the Institute of Medicine, an independent group that shapes government health policy, recommended a complete overhaul of the 510(k) process. Public Citizen, a public interest group, demanded a recall of all transvaginal pelvic organ prolapse mesh.

While manufacturers don’t agree with a reclassification of transvaginal mesh to Class III, they do agree that additional clinical research needs to be done and there is a need to design training programs for surgeons who use the devices.

Do I Have a Transvaginal Mesh Lawsuit?

The Schmidt Firm, PLLC is currently accepting transvaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by transvaginal mesh, you should contact our firm immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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