Endo Health Solutions Inc.’s American Medical Systems Inc. (AMS) just agreed to a $54.5 million settlement to resolve a number of lawsuits that were brought over its vaginal mesh implant devices.
The lawsuits involve allegations that the AMS vaginal mesh implants eroded in some patients, which left women incontinent and suffering from pain, according to Bloomberg News. In its Securities and Exchange Commission (SEC) filing, AMS officials stated that Endo agreed to the settlement and payment to resolve an unidentified number of lawsuits brought over its Perigee, Apogee, and Elevate vaginal mesh devices. Endo acquired AMS for $2.9 billion in 2011, according to Bloomberg News.
This settlement does not involve most of the 5,000 vaginal mesh lawsuits brought against AMS and which have been consolidated for pre-trial proceedings before a federal judge in West Virginia, according to Bloomberg News. The first of these federally filed AMS trials is scheduled for December, according to court documents.
Vaginal mesh devices were approved through a U.S. Food and Drug Administration fast-track route known as the 510(k) under which a formal clinical review for safety and efficacy is not required. The devices were approved for the treatment of stress urinary incontinence (SUI); surgery is meant to strengthen pelvic walls. Vaginal mesh is also approved for the surgical treatment of pelvic organ prolapse (POP) in which weakened pelvic muscles cause organs to slide out of place.
Thousands of women implanted with transvaginal mesh devices allege complications related to the devices’ defects. According to a prior FDA Safety Communication, the most commonly reported adverse events related to vaginal mesh devices include:
· Mesh erosion through the vagina (exposure, extrusion, protrusion)
· Pain
· Infection
· Bleeding
· Dyapareunia (pain during sexual intercourse)
· Organ perforation
· Repeat and increased urinary problems.
Perhaps the most devastating aspect associated with the alleged risk of erosion, which is when the mesh moves through the body’s tissues, is that the mesh can become embedded in inappropriate areas, which can lead to severe pain and the need for multiple surgeries to remove the device. Typically, erosion is often so significant and widespread that the mesh cannot ever be fully removed.
Endo officials indicated that lawsuits filed over the implants have grown from 2,900 in 2012 to about 5,100 earlier this year. Endo is one of four device makers facing about 29,000 lawsuits over allegations that their vaginal implant devices led to injuries and complications, which have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Device maker C.R. Bard Inc. is scheduled to face its first trial in this litigation next month, according to Bloomberg News.
In 2012, a California jury found C.R. Bard liable for $3.6 million in damages in a lawsuit brought by a woman who alleged her injuries were associated with its Avalta Plus vaginal mesh device. That case was the first Bard trial heard over its device.
According to Bloomberg News, an Atlantic City jury found Johnson & Johnson and its Ethicon unit must pay more than $11 million in damages—this also includes more than $3.3 million in punitive damages—to a woman over her allegations concerning injuries associated with the Gynecare Prolift implant. That lawsuit concluded earlier this year. Johnson & Johnson globally pulled four of its vaginal mesh device lines in 2012.
