Transvaginal Mesh

Transvaginal mesh is a net-like implant, usually made of polypropylene, placed through an incision in the vagina to support weakened pelvic tissue. It has been used for two conditions: pelvic organ prolapse, where organs drop into the vagina, and stress urinary incontinence, where a narrow mesh "sling" supports the urethra.

Reported complications include mesh eroding through the vaginal wall, chronic pelvic pain, pain during sex, infection, bleeding, organ perforation, and urinary problems. Some women needed several surgeries, and mesh can be difficult or impossible to remove completely. These injuries led to large numbers of product liability lawsuits against several mesh manufacturers.

On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling and distributing those products in the United States. The FDA found that the manufacturers, Boston Scientific and Coloplast, had not demonstrated a reasonable assurance of safety and effectiveness, the standard that has applied since the agency reclassified these devices as class III (high risk) in 2016. The order did not cover mesh slings for stress urinary incontinence or mesh placed through the abdomen.

People with newly discovered complications may still have options depending on their state's deadlines, which often run from when the injury was discovered. Your operative report names the product. See our guides on multidistrict litigation and class actions versus mass torts, and our related hernia mesh lawsuit page.