FDA May Revoke 510(k) Approvals for Transvaginal Mesh

<"http://www.yourlawyer.com/topics/overview/transvaginal_mesh_injuries">Transvaginal mesh devices could soon be subject to more regulatory scrutiny, according to a report issued last week by the U.S. Food & Drug Administration (FDA). The report recommends that transvaginal mesh devices be re-classified as high risk, revoking their 510(k) approvals. To remain on the market, makers of transvaginal mesh devices would be required to submit new safety data to the FDA.

The FDA report was released last week, in advance of a meeting of the agency’s Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee scheduled to begin on Thursday. Among other things, the panel will be asked to provide input on the risks and benefits of surgical mesh used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repair. The panel will also be asked if the devices should be reclassified.

Transvaginal mesh devices are currently classified as “moderate risk” devices. Such products are currently reviewed under the FDA’s less stringent review known as 510(k) approval, which generally does not require human testing. The 510 (k) process is reserved for products that are substantially similar in design to devices already on the market.

Over the past couple of years, transvaginal mesh products have been the subject of growing safety worries. The FDA first issued a warning for transvaginal mesh complications in 2008. Then in July, the agency issued a second warning, stating complications associated with transvaginal mesh products used in POP are not rare. In that alert, the FDA said it had 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 most recent alert also stated that it is “not clear that transvaginal POP repair with mesh is any more effective than traditional [transvaginal surgery without mesh] … and may expose patients to greater risk.’

Late last month, the consumer advocacy group Public Citizen petitioned the FDA to issue a recall of transvaginal mesh products, asserting the devices “offer no significant benefits but expose patients to serious risks and the potential for permanent life-altering harm.”

According to the FDA report released last Thursday, the most frequently reported transvaginal mesh complications with both POP and SUI repairs included mesh erosion, infection, pain, dyspareunia, vaginal scarring, urinary retention or urinary incontinence, and recurrence of POP and/or SUI. The report goes on to state that “rate and severity of mesh-specific adverse events following vaginal POP repair with mesh calls into question the safety of these devices.”

According to a report from Bloomberg News, it may take several years to complete a reclassification of the devices. The FDA said it could consider a grace period for makers of products on the market to submit data to comply with a more stringent review.

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