Boston Scientific has been hit with more than 23,000 product liability lawsuits in U.S. state and federal courts over transvaginal mesh devices in the six years since concerns were first publicly raised over their potential to cause serious harm in women.

The latest allegations against the vaginal mesh manufacturer accuses the company of ignoring patient safety in order to rush its vaginal mesh implants to the market, sacrificing the safety of women who used them to bolster sagging pelvic muscles, a lawyer argued in the first federal trial of claims over the devices.

Boston Scientific officials ignored internal calls for more testing of their Pinnacle transvaginal mesh implant and hurried the device along to counter competitors’ products, Shelley Hutson, a lawyer for four women suing over the implants, told a Miami federal jury.

“We have four very different women,” Hutson told the jury in closing arguments of the first case to combine multiple claims over the Boston Scientific vaginal mesh implants. “They are the victims of the lack of testing and the lack of a safe product.”

Boston Scientific has faced three trials over the transvaginal mesh implants so far, all in state court. The first two, in Massachusetts, ended in wins for the company. The third, in Texas, resulted in a $73 million verdict for the plaintiff, which was later reduced to $34 million under a state damages cap.

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 transvaginal mesh products are made of polypropylene, a material that can shrink after being implanted, causing serious side effects and the Pelvic Organ Prolapse (POP) or female stress urinary incontinence (SUI) condition to return.

Symptoms of transvaginal mesh failure include:

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

The injuries that women report suffering vaginal mesh implants are severe and debilitating and could have been avoided had people had the proper information, according to claims raised in thousands of lawsuits. The edges of the mesh/vaginal sling can 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.

Transvaginal mesh has become 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 to submit additional safety data to remain on the market.

Transvaginal Mesh Lawsuits

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 in the vaginal mesh litigation generally allege the devices are defectively made from a substandard material, causing injuries ranging from bleeding and infection to nerve damage and pain during sex. Boston Scientific has denied liability and said in statements that it has made patient safety a top priority and stands by the devices as an important treatment option for women.