Transvaginal Mesh Debacle a Symptom of Shoddy FDA Approval Process

The recent safety concerns surrounding <"">transvaginal mesh devices have, once again, put the U.S. Food & Drug Administration’s (FDA) medical device approval protocols in the spotlight. In particular, the high number of complications related to transvaginal mesh is raising questions about the FDA’s 510k approval process, which does not require that a device undergo human testing.

Transvaginal mesh is one of the many categories of medical devices that don’t have to undergo human tests before they come on the market. Earlier this month, the FDA warned that complications associated with transvaginal mesh products used in pelvic organ prolapse (POP) is repair is not rare. According to the agency, it has received more than 2,800 complaints about transvaginal mesh complications since it last issued a warning in 2008, and of those, more than 1,500 were associated with POP repair. In three of those cases, women died. The agency also it was not clear that POP repair involving transvaginal mesh was better than traditional non-mesh procedures, and may actually expose patients to greater risk of complications.

In September, the FDA is scheduled to hold an advisory panel meeting to debate whether transvaginal mesh devices should be required to undergo more testing.

According to the a report from MSNBC, only medical devices that are deemed the most risky – things like pacemakers and breast implants – actually go through any type of human testing. This means only about 10 percent of newly marketed devices are put through such trials. Most of the rest – like transvaginal mesh – gain approval through the FDA’s 510(k) approval process, reserved for products that are substantially similar in design to devices already on the market.

Unfortunately, medical devices that undergo the streamlined 510(k) approval process tend to be recalled more frequently, according to recent research. A study published last month in the journal Archives of Internal Medicine found that of 113 medical devices recalled between 2005 and 2009 because they could cause serious health problems or death, 80 had undergone 510(k) approvals. Eight didn’t have to go through any testing all, according to MSNBC.

The good news is that the FDA is looking at 510(k) approvals. According to a Reuters report, a year ago the agency proposed changes to the program, including the possibility of creating a new category of more risky devices that would require more data to win approval. Tomorrow, the influential Institute of Medicine will release its long-awaited review of the FDA’s medical device approvals, and is expected to recommend reforms to the 510(k) process. Among other things, the report will address the idea of a new medical device category.

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