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Shapiro & Appleton

FDA Panel Looks at Closer Regulation of Surgical Mesh After Deaths and Injuries

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Surgical mesh has been widely used in hospitals as a less invasive treatment for a painful condition suffered by women called pelvic organ prolapse. But years after it was embraced by the medical profession the questions are coming in thick and fast. On September 8, 2011, following many reports of injuries and seven deaths, a U.S. Food and Drug Administration advisory panel announced it would discuss whether the mesh should be more closely regulated, the Wall Street Journal reported.

 

Makers of the mesh, including Johnson & Johnson and Boston Scientific Corp., also face lawsuits from women who say they were injured when the procedure failed and a consumer campaign against the mesh is gathering pace. In August 2011, Aboutlawsuits.com reported that consumer advocacy group Public Citizen is pushing the FDA to issue a recall of this transvaginal mesh product, citing data that suggests the bladder suspension surgery products have an inherent risk of permanent injury but provide no significant benefits. 

See this video about surgical mesh concerns.




There are also questions about the regulatory process itself because the mesh was introduced via a fast-track regulatory process that requires few if any clinical trials prior to product licensing.

"The debate over use of the mesh has renewed criticism from watchdog groups and doctors about the 510(k) process, through which a device can be introduced, marketed by industry and taken up by the medical community without much data on its safety and efficacy,"  the Wall Street Journal reported.

As experienced Virginia (VA) attorneys who deal with dangerous drug and product cases, my colleagues and I are extremely concerned about reports that have linked transvaginal mesh to deaths and injuries. In 2010 we reported on a West Virginia (WV) woman who filed a defective medical device lawsuit against a company that produces surgical mesh. She is one of scores of women who say that the Bard Avaulta product caused them significant pain and other complications.

In July 2011 we reported that the FDA issued a public notice encouraging doctors and patients to explore alternatives to surgical mesh when repairing pelvic organ prolapse and stress urinary incontinence. These conditions frequently occur after childbirth and pregnancy and thousands of women suffer these problems. In 2010 more than 75,000 women underwent transvaginal surgery to implant surgical mesh.

Our law firm's attorneys are increasingly concerned about the injuries and deaths that appear to be linked to this device and hope an alternative treatment can be found.

DM
 

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