Endo Health to Pay $55 Million to Settle Some Vaginal Mesh LawsuitsJun 21, 2013
A unit of device maker Endo Health Solutions Inc. has agreed to a $54.5 million settlement to resolve lawsuits related to its vaginal mesh implant devices.
Lawsuits allege that Endo’s vaginal mesh implants eroded in some patients, leaving the women incontinent and suffering from pain, according to Bloomberg News. In a Securities and Exchange Commission (SEC) filing, Endo’s American Medical Systems Inc. (AMS) officials stated that Endo has agreed to the settlement to resolve an unidentified number of lawsuits brought over its Perigee, Apogee, and Elevate vaginal mesh implants.
The settlement does not impact most of the 5,000 vaginal mesh lawsuits against AMS that have been consolidated into a multidistrict litigation (MDL) before a federal judge in West Virginia, according to Bloomberg News. Court documents indicate that the first of these federally filed AMS trials is scheduled for December.
Transvaginal mesh devices are approved for the treatment of stress urinary incontinence (SUI). In this surgery, the vaginal mesh is implanted to strengthen the walls of the pelvic. The devices are also approved for the surgical treatment of pelvic organ prolapse (POP), in which weakened pelvic muscles cause organs to slide out of place.
Vaginal mesh devices were approved through a U.S. Food and Drug Administration (FDA) fast-track route known as the 510(k). Under the 510(k), a formal clinical review for safety and efficacy is not required. This has been used to gain clearance for transvaginal mesh and other controversial devices, and has drawn increasing criticism due to links between these devices and injuries and other complications.
Thousands of women were implanted with transvaginal mesh devices. Now, many who were implanted with these devices are reporting complications allegedly 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)
- Dyapareunia (pain during sexual intercourse)
- Organ perforation
- Repeat and increased urinary problems.
Perhaps the most traumatic injury associated with erosion occurs when the mesh moves through the body’s tissues, becoming embedded anywhere – and leading to severe pain and the need for multiple surgeries to remove the device. Sadly, erosion is often so significant and widespread that the mesh cannot ever be fully removed.
According to Endo officials, lawsuits filed over the implants have grown from 2,900 in 2012 to about 5,100 earlier this year. Endo acquired AMS for $2.9 billion in 2011, according to Bloomberg News. Endo is just one of four device makers facing some 29,000 suits over allegations that their vaginal implant devices led to injuries. The cases have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. In fact, device maker C.R. Bard Inc., is scheduled to face its first trial in this litigation earlier next month, according to Bloomberg News.
In 2012, a California jury found C.R. Bard liable for $3.6 million in damages due to a woman’s injuries associated with the company’s Avaltas vaginal mesh device. That was the first Bard trial over the device.
Also, according to Bloomberg News, an Atlantic City jury found Johnson & Johnson and its Ethicon unit must pay more than $11 million in damages—which includes more than $3.3 million in punitive damages—to a woman over allegations of injuries associated with the Gynecare Prolift implant. That suit concluded earlier this year. Meanwhile, Johnson & Johnson pulled four of its vaginal mesh device lines off the market globally in 2012, in the face of mounting injury reports and litigation.