New York, New York (PRWEB) June 27, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the victims of defective medical devices, is disturbed by a report that Johnson & Johnson continued marketing its Gynecare ProLift transvaginal mesh product for months, in defiance of a Food & Drug Administration (FDA) warning to halt sales of the device. According to a report from Bloomberg News, the FDA told Johnson & Johnson in a letter dated August 24, 2007, to halt Gynecare ProLift sales until the agency decided whether the device was "substantially equivalent" to other products on the market. But Gynecare ProLift remained on the market for nine months, before the device was finally cleared by the FDA. [bloomberg.com/news/2012-06-26/j-j-sold-vaginal-mesh-implant-after-sales-halt-ordered.html]
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). According to Bloomberg, Johnson & Johnson began selling Gynecare ProLift in 2005 without applying for FDA clearance, ostensibly because the device was similar to a predicate device, leading the company to believe FDA clearance was not needed. After learning of the device's existence in 2007, the agency informed Johnson & Johnson it was, in fact, required to submit a 510(k) application for Gynecare ProLift product. According to Bloomberg, the FDA's August 24, 2007 letter cited the "potential high risk for organ perforation" when surgeons insert the mesh vaginally to support weakened pelvic tissue. The letter stated that the company could "not market this device until you have provided adequate information" on 16 potential deficiencies and received FDA clearance. "If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act," the agency said.
The FDA cleared the Gynecare ProLift transvaginal mesh product in May 2008, nine months after telling Johnson & Johnson to halt sales of the device. According to Bloomberg, the agency never levied any sanctions against Johnson & Johnson for its failure to suspend sales of Gynecare ProLift following the August 2007 letter.
Johnson & Johnson’s Ethicon has been named in 1,400 lawsuits filed by women who allege Gynecare ProLift caused organ perforation, pain, scarring and nerve damage. On June 4, 2012, it was learned that Johnson & Johnson and Ethicon would halt worldwide sales of its the Gynecare ProLift device, as well as the Gynecare TVT Secur, Gynecare Prosima, Gynecare ProLift+ transvaginal mesh products by the first quarter of 2013. Johnson & Johnson maintained its decision to phase out the four transvaginal mesh devices was not prompted by safety concerns. [bloomberg.com/news/2012-06-04/j-j-tells-judge-it-will-stop-selling-vaginal-mesh-implant.html
About Transvaginal Mesh
In October 2008, the U.S. Food & Drug Administration (FDA) announced that it had begun a safety 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 Johnson & Johnson and Ethicon, 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. 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 http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney