J&J Notifies Court of Its Intent to Voluntarily Recall Trans Vaginal Mesh Products
By: chris.placitella @ Jun 05, 2012
Cohen, Placitella & Roth has just received reports that 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-Securâ„¢ sling system, the Prosimaâ„¢ Pelvic Floor Repair System, and the Proliftâ„¢ and Prolift +Mâ„¢ Pelvic Floor Repair Systems.
Ethicon will also be revising the product labeling for the Gynecare GynemeshÂ® system to restrict the indication for use to abdominal sacrocolpopexy procedures only. A copy of the communication from counsel for Ethicon is appended below.
Ethicon’s decision to cease commercialization of these products follows the hundreds of lawsuits filed in the centralized pelvic mesh litigation in the Superior Court of New Jersey, where the first bellwether trial is set for November 5, 2012, as well as the recently created Ethicon MDL in the Southern District of West Virginia.
Notably, Ethicon has also requested that the FDA place on hold its existing orders that Ethicon conduct postmarket studies on these POP and SUI products. Ethicon was ordered by the FDA in January 2012 to conduct these postmarket surveillance studies, along with several other pelvic mesh manufacturers. In total, the FDA issued 88 postmarket study orders to POP product manufacturers and 11 postmarket study orders to SUI product manufacturers.
The orders were issued as part of the FDA’s continuing assessment of the safety and efficacy of mesh devices, and as the FDA considers reclassifying surgical mesh products from Class II to Class III devices. Class III devices, unlike Class II, require a premarket approval application, or PMA, demonstrating the safety and effectiveness of the product.
Transvaginal placement of surgical mesh has received significant attention following the FDA’s October 20, 2008 Public Health Notification warning consumers and health practitioners about serious complications associated with the procedure, and the FDA’s July 13, 2011 revision of its previous safety communication to inform the community that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. In September 2011, the FDA’s Obstetrics & Gynecology Devices Advisory Committee held two days of meetings regarding the risks and benefits of the use of surgical mesh for POP and SUI treatment.
The FDA has estimated that 30 to 50% of women may experience POP in their lifetime, and hundreds of thousands of woman in 2010 alone underwent surgery to repair POP and SUI conditions. From 2008 to 2010, the FDA received thousands of adverse event reports associated with mesh used for POP repair. Frequently reported complications from these mesh products include mesh exposure or protrusion through the vaginal tissue, also known as erosion, mesh concentration or shrinkage, chronic pain and infection. Many side effect victims have been forced to undergo at least one revision surgery to remove portions of the mesh product, and the side effects suffered by victims can be permanent and debilitating.
Christopher M. Placitella, a shareholder of Cohen, Placitella & Roth, serves on the Plaintiffs’ Steering Committee in the federal litigation, In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327); the federal litigation is pending in the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin. Jillian A. S. Roman, an attorney with Cohen, Placitella & Roth, serves as Plaintiffs’ Co-Liaison Counsel in In re Pelvic Mesh/Gynecare Litigation, the centralized litigation pending in the Superior Court of New Jersey before Judge Carol E. Higbee.
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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 SECURâ„¢ system, GYNECARE PROSIMAâ„¢ Pelvic Floor Repair System, GYNECARE PROLIFTâ„¢ Pelvic Floor Repair System, and GYNECARE PROFIT+Mâ„¢ 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 GYNEMESHÂ®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 GYNEMESHÂ®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