Johnson & Johnson’s Ethicon unit has notified the U.S. Food and Drug Administration (FDA) that it plans to halt sales of many of its surgical mesh implant devices used for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP is a condition in which the internal organs bulge into the vagina causing pelvic pain along with bowel and bladder problems. SUI is the most common type of urinary incontinence in women in which physical activity, such as coughing, sneezing, or laughing, causes an involuntary loss of urine.
Problem with mesh
The FDA has received over 2,500 adverse event reports over the last 3 years from women who have suffered serious injuries as a result of transvaginal mesh implants. These injuries range from pain and infection to serious bleeding and organ perforation. In January 2012, the FDA began requiring new post-market studies by the manufacturers of surgical mesh devices used to treat POP and SUI in female patients. On January 4, 2012, the FDA sent orders for these post-market studies to 33 manufacturers of mesh products used for POP repairs.
Lawsuits are filed
Hundreds of lawsuits have been filed against Johnson & Johnson and its subsidiary, Ethicon, as a result of injuries associated with surgical mesh devices for the treatment of POP and SUI. Women have also filed lawsuits against other surgical mesh manufacturers C.R. Bard, American Medical Systems Inc., and Boston Scientific Inc. due to the same types of injuries.
Seeking new approval
Ethicon informed the FDA that it plans to phase out sales of its Gynecare TVT Secur™, Gynecare Prosima™, Gynecare Prolift™, and Gynecare Prolift+M™ surgical mesh systems. It has, however, requested FDA approval to continue to market its Gynecare Gynemesh® PS mesh product. The application that was filed sought approval for abdominal implantations only rather than the transvaginal method of implantation which is currently used. Company executives expect the phase out of all mesh products, other than Gynecare Gynemesh® PS, to be complete by the first quarter of 2013. A company spokesperson explained that the decision to phase out these devices was based on numerous factors and cited complexities of the regulatory environment—indicating the post-market studies of these products would present too large a burden for the company. By seeking approval for abdominal only implantations for the Gynemesh product, Ethicon would not be subject to the post-market study requirement.
What’s next
The FDA has continued to receive adverse event reports pertaining to transvaginal mesh from women who have been seriously injured by these devices. If you or someone you know is experiencing serious side effects from a transvaginal mesh product, contact us today to speak with an experienced product liability attorney to discuss your legals rights and seek compensation for your injuries.