Transvaginal mesh lawsuits are on the rise and a continuing legal issue for Boston Scientific, Mass Device reports. In their most recent 10-k report, the company said that there is an ever-increasing interest in lawsuits over their pelvic mesh devices. As of late last month, there were at least 18,000 lawsuits, including 8 reported class actions, in the United States. There were 1,700 cases pending in one Minnesota state court alone. Pelvic mesh cases have also been filed in Canada, where there are over 10 lawsuits, including 3 class actions. Boston Scientific is accused of fraud, failure to warn and other offenses. Plaintiffs claim that the company was aware of the risks but made no effort to inform the public.
The devices have also led to numerous lawsuits for other manufacturers. C.R. Bard, Endo Health Solutions, Cook Medical and Johnson & Johnson’s Ethicon are also being sued over their mesh devices. In August, C.R. Bard was ordered to pay $2 million to the plaintiff at the conclusion of its first bellwether trial.
Transvaginal mesh products are supposed to treat pelvic organ prolapse and stress urinary incontinence, conditions that become more common after childbirth. They are supposed to provide extra strength and support to the pelvic walls in order combat weakening of the pelvic muscles. According to many women, however, they do more harm than good. Plaintiffs allege that the devices have led to painful, sometimes life-changing problem, including cases where the mesh erodes into their tissue and causing internal damage, bleeding, painful sex, and other debilitating problems.
Transvaginal mesh devices were approved through 510(k), meaning that they were not clinically tested before being sold and implanted in thousands of women. This route allows companies to circumvent testing if they can argue that the device is “substantially equivalent” to a previously approved device, referred to as “predicate”.
According to the U.S. Food and Drug Administration (FDA), the following complications are more frequently associated with transvaginal mesh:
- Dyspareunia (pain during sexual intercourse)
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Organ perforation
- Urinary problems
The agency has warned that complications associated with the devices are “not rare”, and noted that transvaginal mesh may present more risks compared to other methods.