Hundreds of thousands of women across the United States have had surgical devices implanted to correct pelvic organ prolapse and stress urinary incontinence. These devices are often referred to as trans vaginal mesh and bladder slings.
The attorneys at the Law offices of Michael Serling have just received reports that one of the manufacturers of these devices, Ethicon, Inc. (“Ethicon”), a subsidiary of Johnson & Johnson (“J&J”), has advised the Food and Drug Administration (“FDA”) it will stop commercializing in the United States several pelvic mesh products intended to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”): the TVT-Secura sling system, the Prosima Pelvic Floor Repair System, and the Prolift and Prolift A Pelvic Floor Repair Systems.
Ethicon will revise the product label for the Gynecare Gynemesh® system for use only in abdominal sacrocolpopexy procedures. The text of the letter from Ethicon’s lawyer to The Honorable Judge Carol E. Higbee, P.J.Cv. is listed following below.
June 4, 2012
The Honorable Carol E. Higbee, P.J.Cv.
New Jersey Superior Court
Atlantic County Courts Building
1201 Bacharach Boulevard
Atlantic City, NJ 08401
RE: In Re Pelvic Mesh/Gynecare Litigation – CT 291
Discontinuation of product sales
Dear Judge Higbee:
The purpose of this letter is to notify the Court that Ethicon has advised FDA that it will stop commercializing the GYNECARE TVT SECUR system, GYNECARE PROSIMA Pelvic Floor Repair System, GYNECARE PROLIFT Pelvic Floor Repair System, and GYNECARE PROFIT+M Pelvic Floor Repair System in the United States.
Ethicon has no present intention to commercialize these products in the future, but it has requested that FDA allow it 120 days to cease commercialization. This time period would permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients. Ethicon will also discontinue or revise, as appropriate, all marketing materials during this time. Ethicon will continue to report adverse events and provide medical communications for these products, consistent with applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold. Ethicon is awaiting written confirmation of that plan.
Ethicon also plans to update the product labeling for GYNECARE GYNEMESH PS, including the Indication for Use, to restrict the indication for use to the abdominal sacrocolpopexy procedure for the treatment of pelvic organ prolapsed. In order to allow customers continued access to this product for patient treatment, Ethicon has requested that it be allowed to continue the sale of GYNECARE GYNEMESH PS using the current Instructions for Use until FDA responds to this proposed plan.
Although FDA has not yet responded to these proposals, we thought it appropriate to advise the Court and counsel of these decisions. In light of the litigation pending before this Court and the MDL, we anticipate that there may be publicity about these decisions. By copy of this letter, we are simultaneously advising Plaintiffs’ Liaison Counsel of these decisions.
As always, we very much appreciate your time and consideration in this litigation. We will be happy to answer any questions or furnish any additional information that you may require, and we will be prepared to discuss these issues at the next conference.
Kelly S. Crawford
CC:Adam M. Slater
Jeffrey S. Grand
Jillian A.S. Roman