FDA Panel Backs Proposal to Reclassify Transvaginal Mesh Devices as “High Risk”

<"http://www.yourlawyer.com/topics/overview/transvaginal_mesh_injuries">Transvaginal mesh devices used to treat pelvic organ prolapse (POP) need more regulatory oversight, a federal advisory panel said yesterday. According to a report from The Wall Street Journal, the group of outside medical experts backed a proposal by the U.S. Food & Drug Administration (FDA) to require premarket studies before transvaginal mesh products can be approved for POP repair.

Since 2008, the FDA has warned twice that use of transvaginal mesh had been tied to serious complications, including mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence. According to its latest warning in July, the FDA has received more than 2,800 complaints about transvaginal mesh complications since 2009. Of those, more than 1,500 were associated with POP repair, and three involved fatalities. The July alert also raised doubts as to whether transvaginal mesh devices offered any additional benefit over other procedures.

Transvaginal mesh products for POP repair were approved under the FDA’s 510(k) clearance program, which does not require human tests. It is used when a device is “substantially equivalent” to another product that was previously approved by the agency. The 510(k) program is a frequent target of critics, who say it is too lax. Earlier this summer, the Institute of Medicine even used problems with transvaginal mesh to highlight deficiencies with 510(k) clearances and recommended that the FDA scrap the program entirely.

In an FDA staff report released last week, the agency proposed that transvaginal mesh devices for POP repair be moved to the highest-risk category for medical devices, Class III. That would mean they would be ineligible for 510(k) clearance, and manufacturers would need to conduct clinical trials in order to have them approved for that use.

During the first day of a two-day hearing of its Obstetrics-Gynecology Devices Panel, the FDA’s advisors backed that idea. While no formal vote was taken, a majority on the panel of outside medical experts said they supported the FDA’s proposal, according to The Wall Street Journal. The panel also backed the agency’s proposal that manufacturers conduct postmarket studies of devices currently on the market.

The FDA is not legally required to follow the recommendations of its advisory panel, but does so in most cases.

According to a report from Bloomberg News, Johnson & Johnson and other makers of transvaginal mesh devices agreed that the products should be subjected to more studies. They also backed labeling changes to warn of potential risks. But they want transvaginal mesh to remain in the Class II, moderate risk category.

During an interview at the hearing, a director from Endo Pharmaceuticals claimed that a reclassification would be too burdensome for manufacturers.

But an FDA reviewer told the panel that reclassifying would give the FDA control over clinical trials the companies must conduct. Allowing them remain in the lower-risk category “would mean a new device only needs to be as good as a device currently on the market and we are concerned that is not good enough,” the reviewer said, according to Bloomberg News.

A physician speaking for the American Congress of Obstetricians and Gynecologists told the panel that more clinical trials are needed to establish whether the benefits of transvaginal mesh devices outweigh their risk. According to Bloomberg, the group’s representative also pushed for a registry to follow patients already with implants.

Representatives from national surgeons groups told the FDA advisors that transvaginal mesh devices should be used in limited numbers and only by well-trained physicians on carefully chosen patients, Bloomberg said.

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