New York, NY (PRWEB) September 09, 2011
Bernstein Liebhard LLP is excited to report on the outcome of yesterday’s meeting of the Obstetrics and Gynecology Devices advisory panel to the U.S. Food and Drug Administration (“FDA”).* The advisory panel supported the FDA’s proposed plan** to conduct clinical studies and reclassify transvaginal mesh implants as high-risk devices. During yesterday’s meeting, the panel reviewed randomized control trials and reports of vaginal mesh complications and concluded that premarket approval studies for new transvaginal mesh implants should be conducted, as well as post-market studies for existing products.
Additionally, the panel concluded that a reclassification of the medical devices is warranted because of the high incidence of vaginal mesh complications experienced following procedures to repair pelvic organ prolapse. A reclassification would prevent medical device manufacturers from utilizing the FDA’s 510(K) process, which allows companies to receive market approval by claiming that their product is substantially similar those already on the market. In other words, the import of a reclassification would be that manufacturers would be required to demonstrate the safety of transvaginal mesh implants in prolapse situations and for bladder control before they are introduced to market. Under the current classification, medical device manufacturers can claim that their device is substantially similar to one previously approved by the FDA, and are thereby relieved of conducting any safety testing before releasing these products on the market.
Bernstein Liebhard LLP partner, Jeffrey S. Grand, who was recently appointed Co-Liaison Counsel in the consolidated In re Pelvic Mesh Litigation (No. 006341-10 (N.J. Super. Ct.)), commented, "While we are pleased that the Advisory Committee has recognized that these mesh applications are dangerous, we believe the FDA must reclassify these products as Category III devices and also insure that adequate safety tests are conducted moving forward. Until the safety and efficacy of these devices is proven, our clients urge the FDA to recall the mesh products currently on the market."
FDA Recommends Patients Should Consider Alternatives To Transvaginal Mesh
On July 13, 2011, the U.S. Food and Drug Administration (“FDA”) issued a transvaginal mesh warning*** advising patients and doctors to consider alternative treatments to transvaginal mesh. At the time, the FDA also announced that it would convene to discuss whether transvaginal mesh should be removed from the market or reclassified as a high-risk device. Although the advisory panel did not officially vote on the matter during yesterday’s meeting, a majority of the committee members agreed with the FDA’s recommendation to reclassify transvaginal mesh implants as high-risk devices.
In 2008, the FDA issued its first communication regarding the dangers associated with transvaginal mesh, and has since continued to review the safety of the devices. Since that time, Bernstein Liebhard LLP has provided a wealth of consumer information concerning transvaginal mesh on its website, http://www.consumerinjurylawyers.com. If you or a loved one underwent a surgical procedure and have been implanted with transvaginal mesh, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.
For more information about filing a transvaginal mesh lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at info(at)consumerinjurylawyers(dot)com.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP