Yesterday, January 20, 2012, Representative Henry Waxman of California led House Democrats from the Energy and Commerce Committee in writing a letter to several chairmen, requesting that the Committee hold hearings to review the safety of medical devices implanted into patients.
In support of their petition, the congressmen cited problems associated with medical devices, such as transvaginal mesh implants, which have caused serious injuries to patients. According to the congressmen, these harms demonstrate the need for regulatory reform.
In highlighting the need for regulatory reform, the congressmen examined transvaginal mesh implants. According to the congressmen, complications and adverse side effects associated with transvaginal mesh provide a clear example of why regulatory reform is warranted. As discussed in great detail in the letter, transvaginal mesh implants received market clearance from the U.S. Food and Drug Administration (“FDA”) through the expedited 510(k) process. By utilizing this process, manufacturers of these devices did not have to conduct clinical testing in order to receive approval.
Since transvaginal mesh was introduced into the market, the FDA has received thousands of adverse event reports, and issued a series of alerts to warn consumers of dangerous complications associated with vaginal mesh. In fact, the FDA is still conducting an ongoing safety review. The FDA estimates that 300,000 women were implanted with vaginal mesh in 2010. At the same time, according to a recent article in Bloomberg News, there are more than 650 transvaginal mesh lawsuits currently pending against manufacturers, including Johnson & Johnson and C.R. Bard.**
Sat, Jan 21, 2012
General