Alonso Krangle LLP Disturbed by Report That Johnson & Johnson Marketed Transvaginal Mesh without FDA Approval

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According to Bloomberg Report, Johnson & Johnson’s Ethicon Unit sold Gynecare Prolift for two years prior to applying for FDA approval.

Contact Alonso Krangle LLP to discuss a potential lawsuit with one of the experienced and compassionate transvaginal mesh injury lawyers. Call toll-free at 1-800-403-6191 or visit our website, www.FightForVictims.com

Contact Alonso Krangle LLP to discuss a potential lawsuit with one of the experienced and compassionate transvaginal mesh injury lawyers. Call toll-free at 1-800-403-6191 or visit our website, www.FightForVictims.com

To discuss a potential lawsuit with one of the experienced and compassionate transvaginal mesh injury lawyers at Alonso Krangle LLP, please contact us at 1-800-403-6191 or visit our website, www.FightForVictims.com

The attorneys of Alonso Krangle LLP, a national law firm focused on fighting for the rights of people injured by defective medical devices, are disturbed by a recent Bloomberg article reporting that Johnson & Johnson’s Ethicon unit sold the Gynecare Prolift transvaginal mesh device for two years before it filed an application with the U.S. Food & Drug Administration (FDA) for approval of the product. According to the Bloomberg report, Gynecare Prolift was brought to market in 2005. However, it was only in 2007, when Ethicon applied for approval of the Prolift+M product, a similar transvaginal mesh device, that the FDA learned the company was selling Gynecare Prolift. At that time, Johnson & Johnson was notified that it would need to submit a 510(k) application for Gynecare Prolift, and it was finally cleared for sale by the FDA in 2008. [bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html]

According to the Bloomberg report, the FDA received 123 complaints about Gynecare Prolift from 2005 to May 15, 2008, when the device was finally approved. Gynecare Prolift has since been named in more than 500 transvaginal mesh lawsuits by women who were allegedly injured by the device. According to Bloomberg, many of those lawsuits are 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).

There is still time for women who have been injured by transvaginal mesh devices to file their own lawsuits against the makers of these products. To discuss a potential lawsuit with one of the experienced and compassionate transvaginal mesh injury lawyers at Alonso Krangle LLP, please contact us at 1-800-403-6191 or visit our website, http://www.FightForVictims.com.

About Transvaginal Mesh
Transvaginal mesh devices are used in surgical repair of pelvic organ prolapse and stress urinary incontinence. In October 2008, the FDA announced it was launching a safety review of transvaginal mesh devices. At the time, the FDA said the number of adverse events associated with the use of surgical mesh devices to repair POP and SUI reported to the agency during the previous 3-year period (2005 – 2007) was “over 1,000.” In July 2011, the FDA issued a Safety Communication after it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010, including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection and pain. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. [fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm; fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm]

In an update issued in January 2012, the FDA ordered 33 manufacturers of transvaginal mesh devices, including Johnson & Johnson, C.R. Bard, Boston Scientific and American Medical Systems, to conduct post-market safety studies on their products. The agency also said it was considering reclassifying urogynecologic surgical mesh used for transvaginal repair of POP from Class II to Class III. Class III medical devices have the most stringent regulatory controls, according to the agency. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm2025152.htm]

Alonso Krangle LLP continues to offer free lawsuit evaluations to women injured as a result of transvaginal mesh devices, including Gynecare Prolift. To discuss a potential claim with one of the experienced and compassionate transvaginal mesh lawyers at Alonso Krangle LLP, please contact us at 1-800-403-6191 or visit our website, http://www.FightForVictims.com.

About Alonso Krangle LLP
Andres Alonso and David Krangle, attorneys with almost 40 years of collective legal experience, have focused their law practice on the handling of significant personal injury cases, defective drug and medical device litigation, construction site accidents, nursing home abuse, medical negligence, qui tam/whistleblower actions and consumer fraud cases. A national law firm representing injured victims throughout the U.S., Alonso Krangle LLP is headquartered in Long Island, New York, with offices in New York City, and plans to open additional locations in New Jersey.

For more information about Alonso Krangle please contact us at 1-800-403-6191 or visit our website, http://www.fightforvictims.com or to join the fight and be a part of our team, http://www.fightforvictims.com/join-our-fight

Contact:
Alonso Krangle LLP
445 Broad Hollow Road
Suite 205
Melville, New York 11747
Toll-FREE 1-800-403-619
Tel: 516-350-5555
Fax: 516-350-5554

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