On Monday, Boston Scientific Corp. faced its first federal trials in two courts over claims from women who say they were injured by the company’s transvaginal mesh devices.

One, in Charleston, West Virginia, involves allegations from four women concerning the company’s Obtryx vaginal sling device, used to treat stress urinary incontinence (SUI). The other, in Miami, concerns women implanted with the Pinnacle mesh device, which treats pelvic organ prolapse (POP).

Both trials began November 3.

Boston Scientific is one of six major vaginal mesh manufacturers being sued by thousands of women injured by surgical transvaginal mesh implants. Some of the injuries mentioned in the vaginal mesh lawsuits include: mesh erosion, organ perforation, nerve damage and painful intercourse.

Boston Scientific has been hit with more than 23,000 vaginal mesh lawsuits in U.S. state and federal courts over transvaginal mesh devices in the six years since concerns were first publicly raised. Federal cases against Boston Scientific and six other companies have been consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

Plaintiffs say the vaginal mesh implants were poorly designed, made from substandard material, and can lead to injuries ranging from infection and pain to bleeding and nerve damage. Boston Scientific has denied liability and said in statements that they believe transvaginal mesh is an important treatment option for stress urinary incontinence and pelvic organ prolapse.

While Judge Goodwin originally scheduled a series of single plaintiff bellwether trials, he canceled those plans and instead consolidated claims from multiple women into a single trial. While not unprecedented, it is unusual for personal injury lawsuits involving medical devices to proceed with more than one plaintiff at a time, given that individuals may have different medical histories and product experiences.

Transvaginal Mesh Complications

A significant number of the adverse events reported to the FDA regarding pelvic mesh implants are due to mesh erosion or contraction. Mesh erosion through the vaginal tissue can cause pain, bleeding and infection. In addition, most surgical mesh products are made of polypropylene, a material that can shrink after being implanted, causing serious side effects. In some cases, these transvaginal mesh complications can cause the pelvic organ prolapse or female stress urinary incontinence that the devices were used to treat to return.

Symptoms of transvaginal mesh failure include:

• Urinary incontinence
• Abdominal pain
• Pelvic pain
• Pain during sexual intercourse
• Bleeding

Thousands of vaginal mesh lawsuits claim that the injuries women are suffering from vaginal mesh implants are severe and debilitating and could have been avoided had people had the proper information. The edges of the mesh/sling cut through the skin after implantation causing infection and cutting into nearby structures, sometimes puncturing the bladder, bowel, and uterus.

Additionally, petroleum-based synthetic material is particularly capable of causing infection because the material itself is a “breeding ground” for bacteria.  Complications from these infections include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc.  Some of these infections spread through the whole body and lead to death.

Vaginal Mesh Litigation

Tens of thousands of vaginal mesh lawsuits have been filed in recent years, making transvaginal mesh one of the most sued-over medical devices in U.S. history.

The U.S. Food and Drug Administration in April said it was considering requiring the makers of products used to treat pelvic organ prolapse and stress urinary incontinence to submit additional safety data to remain on the market.