Vaginal Mesh, Other Medical Devices Are Often Based on Unsafe Products

A new report suggests that many medical devices, such as transvaginal surgical mesh, were approved by the FDA as a “substantial equivalent” to other products that were known to have substantial safety problems. 

The report (PDF), which was announced by Congressman Edward Markay on March 22, aims to bolster a bill that would give the FDA the power to require medical device manufacturers to address problems in previous versions of their devices before a new version can be approved.

At issue is the FDA’s controversial 510(k) approval process, which only requires manufacturers to show that a proposed device is “substantially equivalent” to another device that is already on the market, allowing them to introduce new products without rigorous pre-market studies to establish that the new design is safe and effective.

According to the report “Defective Devices, Destroyed Lives,” the 510(k) process leaves open dangerous loopholes that allow manufacturers to continue to get devices approved even when they know there is a safety risk and the FDA can do nothing to prevent it. Markay is introducing legislation that attempts to address these loopholes.

Markak indicated that the report was inspired by recent concerns over a number of dangerous medical devices, including transvaginal mesh products that were all approved under the fast-track process. However, thousands of women who had the surgical mesh implanted to treat pelvic organ prolapse (POP) or female stress urinary incontinence now suffer from severe complications from vaginal mesh that may be caused by the product’s design, including infections, erosion of the mesh through the vagina and other problems.

“Already, thousands of patients have been harmed — in some cases grievously and irrevocably — by medical devices that were modeled after recalled devices,” the report states. “Among the most prominent example is that of vaginal mesh implants, used to correct incontinence and weak pelvic organs.” The report notes that some vaginal mesh’s currently on the market were approved after being based on bladder slings that were recalled in 1999.

Public awareness about the risk of the vaginal mesh problems increased last year, after the FDA issued warnings about an increasing number of adverse event reports associated with the products and indicated that they were unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

Under a proposed bill introduced earlier this year, the Safety of Untested and New Devices Act (SOUND), medical device manufacturers would have to prove that new devices addressed problems that led to health concerns and recalls in the older versions when and if the FDA asked. Currently, the FDA has to approve new devices, even if they suspect there are problems and safety risks, as long as the manufacturers meet the “substantially equivalent” requirement.

The legislation, though born of concerns over transvaginal mesh products, also known as bladder slings, could affect numerous medical devices, from hip replacement systems to IVC filters.

In recent years, there have been several examples of dangerous medical devices being approved through the program and then used or implanted in thousands of consumers before serious design defects were discovered by the FDA.

A DePuy ASR hip recall was issued in August 2010 for a popular metal-on-metal hip implant system, which was found to be prone to failing within a few years of surgery.  The hip system was approved through the 510(k) process as a substantial equivalent to the DePuy Pinnacle metal-on-metal hip, which has also been the subject of a number of complaints involving early failure and loosening. The ASR hip was eventually removed from the market after it had already been implanted in about 90,000 people worldwide.

Similar concerns surfaced last year, when the FDA warned that inferior vena cava (IVC) filters, which are implanted to prevent a pulmonary embolism, may be prone to fracturing in the body, sending debris into the heart, lungs and other organs.  The Bard G2 IVC filter was approved under the controversial 510(k) premarket approval process, after the FDA deemed them to be substantially equivalent to the Bard Recovery IVC filter. However, the Bard Recovery IVC filter was also approved under the 510(k) process and the only clinical data submitted to FDA on the Bard Recovery filter was data supporting that it could be safely removed. The Bard Recovery filter has now been linked to a 16% failure rate, and the Bard G2 filter has logged a 12% failure rate.