June 5, 2012
Pelvic Mesh Recall: Ethicon advises FDA that it is withdrawing products from U.S. market
On June 4, 2012, the judges overseeing the pelvic mesh multidistrict litigation in the U.S. District Court for the Southern District of West Virginia were notified that Johnson & Johnson subsidiary and pelvic mesh manufacturer Ethicon, Inc., advised the FDA of its plans to recall four of its transvaginal/pelvic mesh and sling devices from the U.S. market. Ethicon is named in one of four pelvic mesh MDLS, In re Ethicon, Inc., Pelvic Repair Systems Products Liability, MDL No. 2327)
Ethicon also stated its plans to discontinue or revise its marketing materials and change product labeling to limit the use of certain products to abdominal procedures. The company requested 120 days to "cease commercialization" of the products and allow time not only for the company to notify customers but also for hospitals and doctors to decide upon alternative treatments for their patients. The following products are being recalled:
- GYNECARE PROLIFT™ Pelvic Floor Repair System
- GYNECARE PROLIFT+M™ Pelvic Floor Repair System
- GYNECARE PROSIMA™ Pelvic Floor Repair System
- GYNECARE TVT SECUR™ System
Read the letter notifying the court of Ethicon's decision to withdraw its products from the market.
Motley Rice has been litigating pelvic mesh cases for more than four years, representing hundreds of victims alleging injury as a result of pelvic and transvaginal mesh devices and serving in leadership roles in the litigation filed in both federal and state court. We believe this news to be an important first step towards preventing future injuries in women already suffering from such conditions as pelvic organ prolapse and stress urinary incontinence.