A Surge in Avaulta TVM Claims and Reclassification

Washington, DCAs attorneys are dealing with a deluge of Bard's Avaulta transvaginal mesh claims, even manufacturers of transvaginal mesh—including Bard—agree that more safety studies (clinical trials) and labeling changes warning of potential risks are needed.

More TVM clinical trials beg the question: Why was the mesh FDA-approved and implanted in thousands and thousands of women without establishing first the clinical effectiveness of surgical mesh for pelvic organ prolapse (POP)?

The Avaulta TVM and other TVM products—currently classified as "moderate risk devices"—became available without rigorous studies and trials thanks to the 510(k) process, which means that a new device only needs to be as good as a device currently on the market. All that Bard had to do was to show that its Avaulta mesh was "substantially equivalent" to other meshes already FDA-approved and on the market.

In September 2011, an advisory panel and the FDA decided that the mesh should be reclassified from moderate to high risk (Class III) of harming patients if it fails, and require more studies to determine if it's safe and effective. This reclassification means that pre-market clinical testing for new mesh products is mandatory and mesh manufacturers can no longer race their product to market under the 510(k) process.

Last year alone, more than 75,000 women had the mesh vaginally implanted. The FDA received 1,503 reports of injuries or malfunction between 2008 and 2010, which is a five-fold increase from the two previous years. Now, more than 600 lawsuits have been filed against the two biggest manufacturers—Johnson & Johnson and C.R. Bard Inc. Still, Bard representatives and other industry members, including J&J, told an FDA advisory panel that using mesh in transvaginal procedures is safe and effective, and serious injuries are rare.

Bard fell 64 cents to $93.57 on the New York Stock Exchange. After having estimated its global POP market at $175 million, the company reported its mesh market fell about 30 percent in 2010 due to "regulatory delays" on product approvals.

The FDA now has the opportunity to protect women and warn of transvaginal mesh adverse events, but the warning has come too late for thousands of TVM recipients who have reported that Avaulta mesh did nothing to help their condition. Rather, the mesh resulted in even more suffering, including chronic infections and pain and painful sexual intercourse (or no sex). Some women are facing surgery to remove the mesh…Bard is likely facing many more lawsuits.