Parker Waichman LLP Warns that Johnson & Johnson Marketed Gynecare Prolift Transvaginal Mesh Device for Three Years Before FDA Granted Approval

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Gynecare Prolift Transvaginal Mesh Brought to Market by Johnson & Johnson's Ethicon Unit in 2005, but Company Did Not Apply for FDA Approval Until 2007. Device Finally Received FDA Clearance in 2008.

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Hundreds of women may have paid with their health for Johnson’s & Johnson’s failure to comply with FDA regulations when it marketed the Gynecare Prolift transvaginal mesh device."

Parker Waichman LLP warns that the Gynecare Prolift device, a transvaginal mesh product marketed by Johnson & Johnson's Ethicon unit, was sold for three years before it was approved by the U.S. Food & Drug Administration (FDA). According to a report from Newsinferno, Johnson & Johnson did not apply for FDA approval of the Gynecare Prolift device prior to its 2005 introduction, ostensibly because the device was similar to a previously-approved product, leading the company to believe FDA clearance was not needed. It was not until 2007, when Johnson & Johnson cited Gynecare Prolift as the predicate in the 510(k) application for another transvaginal mesh product, Prolift+M, did the agency learn that it was being marketed. At that time, the agency informed Johnson & Johnson it was, in fact, required to submit a 510(k) application for Gynecare Prolift product. The FDA cleared both the Gynecare Prolift transvaginal mesh product and the Prolift+M device in 2008, according to Newsinferno.

According to the site Public Health Watchdog, the Gynecare Prolift and other transvaginal mesh devices are generally implanted by surgeons in women to treat Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). Johnson & Johnson now faces more than 550 lawsuits filed by women who allege it was responsible for their persistent pain, infections, disruption of a normal life, and rising medical costs. According to a blog written by attorney Gary Falkowitz, lead attorney for the Transvaginal Mesh Litigation Group at Parker Waichman LLP, Johnson & Johnson’s apparently unauthorized sales of the Gynecare Prolift Device might cost it more to resolve those lawsuits. The claims are currently pending in state court in Atlantic City, New Jersey before Superior Court Judge Carol Higbee (In Re: Pelvic Mesh Litigation/Gynecare, Case No. 291 CT, Master Case 6341-10).

"The FDA pre-market approval process exists to protect consumers from dangerously defective medical devices,” Falkowitz said recently. "The fact that the FDA appears to have been unaware for two years that Johnson & Johnson was selling Gynecare Prolift is inexcusable. Now, hundreds of women may have paid with their health for Johnson’s & Johnson’s failure to comply with regulations."

Mr. Falkowitz further discusses the health concerns associated with transvaginal mesh products, such as Gynecare Prolift, in this YouTube video produced by Parker Waichman LLP.

About Transvaginal Mesh

In October 2008, the FDA announced that it had begun a review of transvaginal mesh products, after receiving more than 1,000 reports of complications related to the use of the devices in the surgical repair of POP and SUI. In July 2011, the FDA announced that it had received an additional 1,503 reports of transvaginal mesh complications associated with POP repairs and an additional 1,371 reports associated with SUI repairs. The most common side effects reported to the FDA included erosion through the vaginal tissue, pain, infection, bleeding, pain during intercourse, organ perforation during placement, and urinary problems. The FDA also emphasized that POP transvaginal mesh complications are not rare, a change from the position it took in 2008. [http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

On September 8 and 9, 2011, the FDA's Obstetrics and Gynecology Devices Advisory Panel met to discuss the safety of transvaginal mesh devices in POP repair. Though no formal vote was taken, the majority of outside medical experts on the panel backed the FDA's proposal to reclassify transvaginal mesh devices as high risk, which would make such devices ineligible for the agency's 510(k) protocols. In January 2012, the FDA directed the makers of transvaginal mesh products, including American Medical Systems, Boston Scientific and Johnson & Johnson, to conduct post-market safety studies of their products in order to enable the agency to better understand the safety and effectiveness profiles of these devices. [http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with transvaginal mesh, please visit the firm's transvaginal mesh injury page at http://www.yourlawyer.com. Specific information on Gynecare Prolift and other Johnson & Johnson transvaginal mesh products can be accessed here.

Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

For more information regarding transvaginal mesh lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).

Contact: Parker Waichman LLP
             Herbert Waichman
             (800) LAW-INFO
             (800) 529-4636
             http://www.yourlawyer.com

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Herb Waichman, Partner
Parker Waichman LLP
(800) 529-4636
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