As it faces legal troubles over pelvic mesh, Boston Scientific Corporation has set aside nearly a billion dollars to cover legal expenses.

Pelvic mesh, also called transvaginal mesh, a vaginal sling, or a bladder sling, is a surgical implant designed to help support tissues when their natural support structures are weakened or damaged. For example, pelvic mesh is often used to treat pelvic organ prolapse, a condition wherein the uterus falls out of place, usually after childbirth. However, pelvic mesh has come under regulatory and legal scrutiny over alleged side effects and practices.

Vaginal mesh lawsuits and medical surveillance have suggested that pelvic mesh may cause a host of serious medical problems. Allegedly, these problems include mesh erosion, a condition where pelvic mesh cuts into the very tissue it is intended to protect. Through friction, pelvic mesh can damage surrounding tissue and cause mesh pain. For this and several other serious problems, pelvic mesh has been recalled across five different makers of pelvic mesh, including Boston Scientific.

One issue that has come up in many of the pelvic mesh lawsuits is the fact that pelvic mesh was able to skip several phases of U.S. Food and Drug Administration (FDA) testing protocol. Under a program called 501(k) approval, a medical implant can skip parts of FDA testing if it is “substantially similar” to existing medical technology. In the case of pelvic mesh, it is derived from surgical mesh, a less specialized medical implant.

However, vaginal mesh lawsuits have alleged that pelvic mesh has problems not seen in more generalized surgical mesh, such as mesh erosion, mesh pain, and anchor point issues unique to the pelvis. Pelvic mesh lawsuits have alleged that pelvic mesh itself is inherently more dangerous than older alternatives.

Estimates put the number of pelvic mesh lawsuits facing Boston Scientific specicially at more than 20,000. Of these, 12,000 have been grouped together in a type of coordinated legal action called multidistrict litigation or MDL. In MDL, similar lawsuits are coordinated through the court system, functioning similar to a class action lawsuit.

To cope with this onslaught of pelvic lawsuits, Boston Scientific has added billions to their legal funds, though company officials have been reluctant to publicly state how much of this money is specifically for pelvic mesh lawsuits. Payouts for individual pelvic mesh lawsuits in the MDL could be in the millions.

The Pelvic Mesh MDL is In Re: Boston Scientific Corp. Pelvic Repair Systems Products Liability Litigation, MDL No. 2326, in the U.S. District Court for the Southern District of West Virginia.