On 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 Rep. Waxman, these harms demonstrate the need for regulatory reform. Some of the vaginal mesh implants that have been the subject of ongoing lawsuits include the Gynecare Prolift, Gynecare TVT, Bard Avaulta, American Medical Systems Perigee, Apogee and Elevate, and Boston Scientific Obtryx and Pinnacle.
Claims In Pelvic Mesh Litigation Point To Flawed FDA Approval Process
In stressing the need for regulatory reform, Rep. Waxman examined transvaginal mesh implants. According to Rep. Waxman, complications and adverse side effects associated with transvaginal mesh provide a clear illustration as to 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 or demonstrate their safety. 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.
If you or a loved one has already had a vaginal mesh product manufactured by Gynecare, Ethicon, Johnson & Johnson, C.R. Bard, American Medical Systems or Boston Scientific and have had mesh complications such as mesh erosion, contact a vaginal mesh lawyer today for a free consultation.