Transvaginal mesh device maker, C.R. Bard Inc. has agreed to settle litigation involving a woman’s claims that its device caused her injury.
The case is the second federal trial of lawsuits brought over the devices and was scheduled to begin in West Virginia, according to Bloomberg News. Attorneys for the woman just advised a judge in Charleston, West Virginia, that her claims had been settled over allegations that C.R. Bard’s Avaulta device caused her pain and forced her to have to undergo six surgeries. Settlement terms were not released and C.R. Bard spokesman, Scott Lowry, said that the accord covered just the claims in this one case and was not part of a larger pending group of thousands of cases, Bloomberg News reported.
The settlement followed last week’s award, also in West Virginia, in which C.R. Bard was ordered to pay the plaintiff $2 million in damages, according to Bloomberg News. “This is a large, complex litigation and Bard will consider each case based on the facts and merits,” Lowry said in an emailed statement to Bloomberg News. “We will continue to vigorously defend against all other lawsuits involving Avaulta.”
C.R. Bard faces more than 8,000 claims over the Avaulta device, which is tied to allegations of organ damage and painful sexual intercourse when the devices erode. Johnson & Johnson, Endo Health Solutions Inc., and Boston Scientific Corp.—other device makers that manufacture transvaginal mesh devices—face similar claims that the devices, which are threaded in place through incisions made in the vagina, shrink, causing serious injuries, according to Bloomberg News.
The implant cases brought against C.R. Bard and other device makers, have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial proceedings. Court dockets indicated that two other trials are set for October, Bloomberg News reported.
Thousands of women were recipients of transvaginal mesh devices, which have come under intense scrutiny as many women who were implanted with these devices are reporting complications allegedly related to their defects. Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. The devices are meant to help correct these conditions by providing additional strength to the pelvic walls.
The vaginal mesh devices were approved through a U.S. Food and Drug Administration (FDA) expidited process known as the 510(k), under which a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for transvaginal mesh and other controversial devices, the process has drawn increasing criticism.
The FDA has stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful when compared to alternative methods for treating POP. The FDA also recently reported that the most common complications associated with transvaginal mesh may include:
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems