Pelvic Organ Prolapse (POP) is a condition in which the bladder, vagina, uterus, rectum, or bowel has dropped from its normal position, and Stress Urinary Incontinence (SUI) is a condition of bladder leakage. Transvaginal mesh implants are used to correct symptoms of both POP and SUI. The failures and side-effects of the devices can lead to devastating injuries, some of which require surgical repair, and can include bowel problems, dyspareunia, erosion, extrusion, fistula, infection, neuromuscular problems, organ perforation, pain, recurrence, scarring, and urinary problems.
In July 2011, the Federal Drug Administration (FDA) issued a public safety update regarding complications of transvaginal mesh for treatment of prolapse, stating that mesh repairs are no more effective than non-mesh repairs for treating prolapse. In September 2012, the FDA stated it was considering reclassifying transvaginal mesh as a high-risk device and ordered post-market studies from several manufacturers.
Several different Multi District Litigations (MDL) are pending against several defendants in the United States District Court for the Southern District of West Virginia against the Honorable Judge Goodwin as well as in several state court venues