FDA Criticized For Approving Controversial Vaginal Mesh

By Margaret Hartmann  |  September 8, 2011 | 3:58am
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Thanks to a surgical mesh that was implanted in 2007, 65-year-old Marci Sutin Levin is in such excruciating pain that she can’t work, sleep through the night, or have sex. “The pain of childbirth was finite, and you’re delivering a child,” she says. “This was very, very different. It’s relentless, and it’s untenable. And it doesn’t lead to anything.” Levin is one of hundreds of women suing the makers of a vaginal mesh used to hold a woman’s organs in place after pelvic floor muscles weaken. Between 2008 and 2010 the FDA received 1,503 reports of injuries, malfunctions, and deaths associated with the product, and now many are blaming the agency for not testing the mesh thoroughly before approving it.

In July, the FDA announced it would investigate claims that the mesh, which is inserted vaginally, is too dangerous. Bloomberg Businessweek reports that tomorrow, a panel of outside FDA advisors will begin a two-day hearing on whether the product is safe enough, or if manufacturers should be required to submit new safety data to keep the products on the market.

The mesh was okayed under a process known as 510(k), which allows the FDA to approved devices without rigorous testing as long as the company shows they are “substantially equivalent” to products already on sale. In July, the Institute of Medicine recommended that the FDA stop using this process for moderate-risk devices. Adam Slater, an attorney who represents about 100 women suing one of the manufacturers, says:

“The 510(k) process utterly failed to protect the thousands of women who were implanted … Now the FDA now has the opportunity to at least protect women on a going-forward basis.”

The agency hasn’t set a time frame for deciding the fate of the vaginal mesh, or the 510(k) process. Manufacturers are insisting that there’s nothing wrong with the devices. An industry working group that’s representing a number of the mesh makers still insists that the device is “safe and effective,” and serious consequences are rare. Instead, the group suggests, “Key to the successful treatment of POP with surgical mesh is appropriate patient selection and surgeon experience.” In other words, doctors are the cause of problems experienced by hundreds of women, not a faulty device that was never properly tested.

J&J Vaginal Mesh Faces FDA Panel’s Review Today as Lawsuits Rise [Businessweek]

Earlier: Vaginal Mesh: Proceed At Your Own Risk

Image via CLIPAREA l Custom media/Shutterstock.

 
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