FDA Seeks Stricter Transvaginal Mesh Regulations at Meeting

An advisory committee was convened on September 8, 2011, by the U.S. Food and Drug Administration (FDA), that discussed the safety and effectiveness of transvaginal mesh devices. The meeting was intended to determine the future of such devices, therefore a federal advisory panel collected data in an attempt to determine if transvaginal mesh has a favorable risk/benefit profile. Subsequently, industry leaders and consumer representatives presented the panel with relative information pertaining to the future of transvaginal mesh products. After receiving significant evidence, the federal advisory panel, on Thursday, called for more clinical studies and tougher regulation of certain surgical mesh products used to treat pelvic organ prolapse (POP).

Thursday witnessed the FDA panel support plans by the agency to require pre-market approval studies for new transvaginal mesh devices when used in the treatment of POP. According to current FDA regulations and their 510(k) device clearance process, companies are allowed to gain the proper device clearance needed to market their product, without pre-market studies, if they can demonstrate that the product is “substantially equivalent” to an existing device.

While existing products will be allowed to stay on the market, future transvaginal mesh devices may have to endure stricter regulations pertaining to medical device classification and clearance. The FDA has proposed that transvaginal mesh devices be moved to the Class III medical device category that profiles the products with the highest rate of risk. Doing so would require manufacturers to conduct clinical trials in people, before submitting an application to the FDA. As of Thursday night, the advisory panel hasn’t taken a formal vote on whether to reclassify the devices, however a majority of the panel has already suggested that they would support the FDA’s future proposal.

In an attempt to avoid overwhelming repercussions, industry leaders have requested that transvaginal mesh devices retain their Class II medical device status. However, they do agree with the FDA’s idea to conduct pre-market clinical studies and design training programs for surgeons who use the devices.

The meetings move to update the current 510(k) medical device regulations should come at no surprise to the healthcare community. Many 510(k)-approved products have received an intense amount of scrutiny. As recent as July 2011, the Institute of Medicine, an independent group that advises the government on health policy, issued a report recommending an overhaul of the FDA’s medical-device process to require more oversight.

Recent years suggest that transvaginal mesh products may have been the deciding factor in updating 510(k) regulations. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, which was five times as many as the agency received from 2005 to 2007. Medical device reports identified numerous complications associated with transvaginal mesh products. The most severe of which was caused by mesh erosion. However, the reports acknowledged frequent injuries, bleeding, infection and at least five confirmed deaths.

AdvaMed, a Washington trade group comprised of industry leaders, said that complication rates have improved as newer and better mesh products have been developed. The group said serious side effects were less than 2% of reported side effects.

Do I Have a Transvaginal Mesh Lawsuit?

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Again, if you or a loved one has been injured by transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.