National Transvaginal Mesh Law Firm Announces That Johnson & Johnson’s Ethicon Inc. Will Halt Sales of Four Gynecare Transvaginal Products

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Ethicon Inc., a Division of Johnson & Johnson, Has Confirmed it will End Worldwide Sales of Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift, Gynecare Prolift+ Products by the First Quarter of 2013. Ethicon and Other Makers of Transvaginal Mesh, Including American Medical Systems, C.R. Bard, and Boston Scientific, are Named in Hundreds of Lawsuits Alleging their Products Caused Women to Suffer Serious Injuries.

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Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, continues to investigate lawsuit claims on behalf of women who were injured, allegedly by transvaginal mesh products marketed by Johnson & Johnson's Ethicon Inc. division, as well as American Medical Systems, Boston Scientific and C.R. Bard. On June 4, 2012, it was learned that Ethicon would halt worldwide sales of its of its Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift, Gynecare Prolift+ transvaginal mesh products by the first quarter of 2013.    Despite the fact that transvaginal mesh devices, including those marketed by Ethicon, have been the subject of an increasing number of injury reports and lawsuits, the company maintains that its decision to end sales of the four Gynecare products is not motivated by safety concerns. [bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html]

Ethicon revealed its plan to stop selling the four transvaginal mesh devices in a letter filed with U.S. District Judge Joseph Goodwin in the U.S. District Court for the Southern District of West Virginia. Currently, Ethicon and Johnson & Johnson are named in some 600 lawsuits pending in a multidistrict litigation before Judge Goodwin (MDL No. 2327). Judge Goodwin is also presiding over multidistrict litigations involving transvaginal mesh products made by American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326), and C.R. Bard (MDL 2187). All of the lawsuits pending in the litigations allege that the transvaginal mesh devices used in pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repair surgeries caused women to suffer serious complications, including vaginal erosion, inflammation, infection, chronic pain and organ damage.

Parker Waichman LLP is already representing several women who have filed claims in the transvaginal mesh multidistrict litigations pending before Judge Goodwin. The firm continues to investigate potential lawsuit claims involving the following transvaginal mesh products:

  •     American Medical Systems: Elevate, Perigee and Apogee transvaginal mesh products.
  •     Boston Scientific: Advantage Transvaginal Mid-Urethral Sling System, Pinnacle Posterior Pelvic Floor Repair Kit, Obtryx Transobturator Mid-Urethral Sling System, Polyform Synthetic Mesh, Prefyx Mid U Mesh Sling System, Prefyx PPS System, Uphold Vaginal Support System.
  •     C.R. Bard, Inc.: Avaulta, Pelvisoft BioMesh, Pelivicol Acellular Collagen Matrix, Pelvitext, and Pelvilace Products.
  •     Johnson & Johnson/Ethicon: Gynecare, Gynemesh, Gynecare Prolift, Gynecare Prolift+M, Gynecare Prosima and Gynecare TVT

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).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
(800) LAW-INFO
(800) 529-4636
http://www.yourlawyer.com

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Gary Falkowitz, Managing Attorney
Parker Waichman LLP
(800) 529-4636
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