Boston Scientific Reaches First Settlement with Transvaginal Mesh Perosnal Injury Victims
Medical device manufacturer Boston Scientific reported on Tuesday, April 28th, that they had reached their first settlement in a wave of transvaginal mesh personal injury lawsuits.
In a regulatory filing, Boston Scientific stated that the company expected to pay $119 million to settle around 2,970 of the transvaginal mesh personal injury cases. The company also reported that it still faced around 25,000 personal injury cases involving transvaginal mesh defects and injuries. Boston Scientific lost its first two bellwether cases that went to trial in November.
The settlement agreement adds that Boston Scientific would admit no wrongdoing or fault involving its transvaginal mesh devices. The manufacturer is one of seven companies involved in personal injury cases alleging serious medical complications from the transvaginal mesh devices.
The first transvaginal mesh device was approved for use in humans in 1996; however, by 1999, the Gynecare Prolift was recalled due to defects in the design. Other companies used the FDA’s 510(k) approval process – which allows medical devices that are “substantially similar” to previously approved devices to get on a fast-track approval process – to push their transvaginal mesh devices through to the US market.
Transvaginal mesh was originally designed to treat women suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI). These plastic slings were inserted through the vagina to hold up organs. However, many women experienced organ perforation, continued incontinence and prolapse, bleeding, pain during intercourse, pain in the legs and decreased ability to walk, and infection, among other symptoms. In many cases, transvaginal mesh can grow into existing tissue, making removal difficult – leaving women suffering from continued side effects. The dangerous side effects of transvaginal mesh are so serious that the Scottish Health Board actually banned the devices from use.
Other transvaginal mesh manufacturers have entered settlement talks, and Endo Pharmaceuticals reached a settlement agreement with many of their multidistrict litigation’s plaintiffs last fall. Coloplast also offered several settlements to cover different plaintiffs in its transvaginal mesh MDL. Johnson & Johnson has not offered settlements for its transvaginal mesh personal injury cases, but the company was accused during one of its trials of destroying safety evidence that could have shown transvaginal mesh devices are not compatible with the human body.
After learning how many complaints and lawsuits involved transvaginal mesh devices, the FDA ordered TVM manufacturers like Johnson & Johnson and Boston Scientific to perform more in-depth safety studies of the devices. The FDA added last fall that it would investigate problems that could involve the 510(k) approval process.
The Strom Law Firm Defends Victims of Defective Devices Like Transvaginal Mesh
If you or a loved one has pelvic organ prolapse or stress urinary incontinence, have had a transvaginal mesh device implanted, and have since experienced detrimental complications, you may be entitled to transvaginal mesh personal injury compensation. The experienced lawyers at Strom Law, LLC can help. We offer free consultations, so please contact us today, and we can help get you on the road to recovery. 803.252.4800