Bernstein Liebhard LLP reports that 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, which have caused serious injuries to patients. According to the congressmen, these harms demonstrate the need for regulatory reform.

Claims In Pelvic Mesh Litigation Points To Flawed FDA Approval Process

In stressing 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 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. 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.

In response to this latest call for congressional review of the safety of medical devices such as pelvic mesh, Bernstein Liebhard Partner Jeffrey S. Grand, who is serving as Co-Liaison Counsel in In re Pelvic Mesh/Gynecare Litigation (No. 006339-10 (NJ. Super. Ct.)), which is currently underway in the Superior Court of New Jersey, stated, “We agree with Representative Waxman that regulatory reform is needed. Presently, the Agency lacks the resources and authority to insure that manufacturers are adequately testing the safety of medical devices they place on the market.”

The lawyers at Bernstein Liebhard are actively filing cases on behalf of individuals allegedly injured by vaginal mesh implants. For more information about filing a vaginal mesh lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at

About Bernstein Liebhard LLP

Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.

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Published February 5, 2012 by