On February 28, 2012, Bloomberg News reported that Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (“FDA”), voiced his support for a new bill to revise the FDA device approval process in light of increasing reports of problems from vaginal mesh and other medical devices. The bill would allow the FDA to reject devices with designs based on past products that were recalled for safety issues. Advocates for the bill cite the failings of vaginal mesh and hip replacement implants, which previously led to an FDA review of vaginal mesh and a hip replacement recall, respectively. The bill attempts to fix the loophole in the 510(k) process which currently gives the FDA little authority to reject devices based on previously approved versions, called predicates. This process allows medical device manufacturers to base designs even on predicates that were voluntarily recalled. According to Bloomberg News, Jeffrey Shuren said of the bill: “It’s good for patients and it’s good for companies and it assures that if there’s a problem with the new device, it gets addressed before it goes to market.”

Problems From Vaginal Mesh Cited As Example Of Flawed FDA Approval Process

The bill’s sponsors cited the recent FDA review of vaginal mesh as well as metal-on-metal replacement hip problems as reasons to reevaluate the approval process. The FDA approved vaginal mesh implants even though some models were based on a design recalled by Boston Scientific Corp. According to Bloomberg News, vaginal mesh implants were used by 300,000 women to treat conditions such as Pelvic Organ Prolapse and Stress Urinary Incontinence. According to an FDA review of vaginal mesh in October 2008, more than 1,000 women have developed one or more problems from vaginal mesh over the last three years, including internal injuries, infection, incontinence and painful intercourse. In a July 2011 advisory, the FDA told doctors and patients to consider alternative treatments to transvaginal mesh, and revealed that numbers of vaginal mesh complications were greater than previously reported. Hundreds of vaginal mesh lawsuits have been filed by patients who experienced problems from vaginal mesh. The new bill, by giving the FDA more authority in the approval process for devices with predicates, may help prevent such incidents in the future.

FDA Review Of Vaginal Mesh Complications Could Spur Regulatory Changes

The FDA’s 501(k) program is used to clear 90 percent of medical products in the U.S. each year. If the FDA deems the devices “substantially equivalent” to predicate versions, the devices are allowed on the market without human testing. Bloomberg News reported that on average, there are 3,000 devices reviewed annually through the 510(k), 28 of which are based on predicates known to be recalled. According to FDA records, a device is five times more likely to be recalled if it was based on a predicate recalled for safety problems. Products approved through the 501(k) process include defective models of metal-on-metal hip replacements and vaginal mesh implants. The FDA device chief, Shuren said that changing the law “will bolster the strength of the 510(k) program, which repeatedly comes under criticism, and oftentimes, it’s just for a handful of cases.”

Experienced Problems From Vaginal Mesh?

If you experienced problems from vaginal mesh, contact a Bernstein Liebhard LLP lawyer today for a free case evaluation. Our lawyers are actively filing cases on behalf of clients who suffered from vaginal mesh complications and can help you collect compensation for medical expenses, lost income, and pain and suffering. The Firm has has recovered over $3 billion on behalf of its clients. Contact us today to learn more about your legal rights and options.

Published March 9, 2012 by