After an FDA warning this year about the safety risks of using transvaginal mesh devices to repair pelvic organ prolapse, many people are trying to find out whether the mesh implant they received is included in the warning and what legal rights they have for their injuries.
Pelvic organ prolapse (POP) is a condition in which organs like the urethra or bladder fall into the pelvic cavity due to stretched or weakened pelvic muscles. The condition affects nearly 1 out of every 10 women in the United States after childbirth, a hysterectomy or menopause.
The FDA recently warned that the transvaginal implant of surgical mesh devices to repair conditions like pelvic organ prolapse could cause severe side effects like vaginal mesh infection. These injuries could affect hundreds of thousands of women who underwent the procedure.
A judge has set the first trials in the much-publicized transvaginal mesh litigation for late next year. The trials are scheduled to take place before a jury in New Jersey Superior Court.
Judge Carol E. Higbee is presiding over more than 350 cases filed against Ethicon Gynecare, which were centralized in her district to allow for easier preparation and trial by the parties.
Representatives from several manufacturers of controversial transvaginal mesh surgical devices told FDA officials at a panel meeting last month that they agreed further testing of the devices and label warnings may be warranted.
The concessions followed an FDA warning on July 13, 2011 that use of the devices in pelvic organ prolapse surgeries could cause more side effects than other surgical methods.