FDA Requires Transvaginal Mesh Makers To Conduct Safety Studies
Bernstein Liebhard LLP reports that on January 3, 2012, the U.S. Food and Drug Administration (“FDA”) ordered Johnson & Johnson and C.R. Bard Inc., manufacturers of vaginal mesh implants, to study rates of side effects such as organ damage, infection and painful sexual intercourse, which have been linked to the transvaginal mesh implants.* In addition to Johnson & Johnson and C.R. Bard, 31 other manufacturers of transvaginal mesh were contacted by the FDA. The FDA requested the manufacturers to provide up to three years of data on the safety and effectiveness of transvaginal mesh implant procedures. The companies have 30 days to comply with the FDA mandate.
The FDA estimates that 300,000 women were implanted with vaginal mesh in 2010. According to Bloomberg News, there are more than 650 lawsuits currently pending against manufacturers, including Johnson & Johnson and C.R. Bard. In response to the latest FDA action, Bernstein Liebhard Partner Jeffrey S. Grand, who is also serving as Co-Liaison Counsel in In re Pelvic Mesh/Gynecare Litigation (No. 006339-10 (NJ. Super. Ct.)), currently underway in the Superior Court of New Jersey, stated, “ A comprehensive safety review is urgently needed. We’re seeing terrible injuries and chronic pain in our clients that have been implanted with these devices, whether as a result of prolapse treatment procedures or to treat urinary incontinence. We believe a properly conducted safety review will demonstrate that the safety concerns for transvaginal mesh outweigh the products’ benefits.”
Prior FDA Safety Review Of Transvaginal Mesh
Prompted by a dramatic spike in deaths and injuries stemming from transvaginal mesh, in July 2011, the FDA issued a safety communication** advising doctors and patients to consider alternative treatments to transvaginal mesh. At that time, the FDA also announced plans for an advisory panel meeting to determine whether transvaginal mesh should be removed from the market. As part of the FDA’s ongoing review, in September 2011, the Obstetrics and Gynecology Devices Advisory Panel to the FDA met to discuss whether transvaginal mesh should be reclassified as a high-risk device, which would require manufacturers to undergo rigorous clinical safety testing to continue marketing these products. The panel supported the FDA’s proposed requirement that any new transvaginal mesh devices undergo extensive safety testing before receiving approval. According to William Maisel, deputy director of science for the FDA’s device approval center, this latest mandate will provide “additional data to help guide the clinical community.”
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 firstname.lastname@example.org.
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