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Congressional Report Findings May Bolster Transvaginal Mesh Lawsuit

A Congressional report that reveals vaginal mesh devices were fast-tracked to FDA approval even though their predecessors were recalled may bolster the cases of plaintiffs filing a transvaginal mesh lawsuit. The report was released on March 22, 2012.

The report focuses on the fast-track FDA approval process known as 510(k), which is reserved for products that are similar to products that were previously approved and put on the market. Products that are approved through this process don’t require clinical trials to prove they are safe. The assumption is that if their predecessors were approved, these products are worthy of being approved as well.

But the Congressional report discovered something shocking: under the 510(k) process, products are approved even when their predecessors were recalled for being unsafe. In the words of the report: “The FDA must approve a substantially equivalent 510(k) medical device even in cases where the new product repeats the same flaws of an earlier model that was recalled for major safety problems.”

Vaginal mesh devices based on defective recalled product still fast-tracked to approval

The report goes on to specifically target vaginal mesh devices, saying, “Among the most prominent examples is that of vaginal mesh implants, used to correct incontinence and weak pelvic organs. Despite the original device’s recall in 1999, a number of subsequent meshes—some still on the market and being implanted in patients—trace their FDA approval back to that defective product.”

In 2011, the FDA warned of serious vaginal mesh side effects like erosion, protrusion, bleeding, pain, and infections, warning that these complications are “not rare” and that even multiple surgeries may not correct the problems. The FDA warning strengthened the case of women filing lawsuits over these faulty devices, and many of them have won substantial compensation for vaginal mesh injuries. The additional evidence provided by the congressional report is likely to further bolster this type of lawsuit.

Congressman introduces bill to allow FDA to deny fast-tracking if product’s predecessor was recalled

Congressman Edward J. Markey of Massachusetts has introduced a bill that would prevent such problems in future. Called the Safety of Untested and New Devices Act (aka the SOUND Devices Act), the bill would allow the FDA to deny the 510(k) application of any product that contains the same defects that resulted in its predecessor being recalled. The bill would also require the FDA to maintain a database of products that manufacturers could consult to see if an existing product is eligible to be used as a predicate in a 510(k) application, and it would require the FDA to review high-risk products if any of their predecessors were recalled.


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