February 2, 2012
Medical Device Defects: Congressional Committee asked to address potential danger of Pelvic Mesh
On Friday, Jan. 20, 2012, a U.S. Congressional Committee was again asked to further "examine medical devices that have developed serious defects after being implanted in patients. Pelvic mesh (transvaginal mesh/sling) was among the named devices. This request follows a similar Oct. 12, 2011, request for a hearing that the Committee failed to schedule.
In July 2011, the FDA issued an update on the "serious complications" linked to pelvic mesh implants following thousands of adverse event reports related to the device. Based on such reports and the rising concern within both the academic and clinical communities, the FDA recently announced that it was considering reclassifying pelvic mesh from a Class II to a Class III device. Thirty three manufacturers were also ordered to conduct post-market safety studies.
Pelvic mesh is implanted to help patients suffering from medical conditions such as stress urinary incontinence and pelvic organ prolapse. It is estimated that, in 2010, nearly 300,000 American women were implanted with pelvic mesh. The devices were permitted for sale and distribution under the 510 (k) clearance process, meaning the devices must demonstrate that they are "substantially equivalent" to one or more devices existing on the market. Although research may be required under this clearance, many candidates are approved without clinical trials, as was the case with the pelvic mesh implants.
The Congressional Committee was asked to hold hearings in advance of its reauthorization of the Medical Device User Fee Act to first examine "whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices … whether device manufacturers and the FDA are taking appropriate steps to keep hazardous devices from the market and to protect patients from marketed devices that are later discovered to be dangerous."
Read the full request for a medical device hearing.
Learn more about how our pelvic mesh lawyers fight for people hurt by potentially defective devices and work to hold accountable those responsible for negligent medical care, corporate wrongdoing, and inadequate warning, research and product development.