Transvaginal mesh devices have been the focus of thousands of lawsuits and mounting serious injury reports with allegations of severe and debilitating pain and other adverse health reactions.
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 cleared through a U.S. Food and Drug Administration (FDA) expedited 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
One woman described her pain to Denver CBS4 saying, “The pain is so bad that I sometimes go to sleep crying. The pain is so bad that I stay up until 5:00 a.m. trying to let the pain just go away,” adding, “I have no life. I can’t do anything without being in pain.” The woman’s husband described how the pain following his wife’s transvaginal mesh surgery has impacted their lives. “You know, it’s been two years I’ve seen her in pain, and it’s just … there’s just times I go into the room and I almost cry because when I see her in pain. It’s really destroyed our lives.”
In just one example of transvaginal mesh litigation, the second federal trial of lawsuits brought over the C.R. Bard transvaginal mesh device was recently settled. The lawsuit was scheduled to begin in West Virginia 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 a prior award, also in West Virginia, in which C.R. Bard was ordered to pay the plaintiff $2 million in damages, according to Bloomberg News. 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.