Endo International announced Sept. 30 that it has reached a master settlement agreement to resolve nearly all vaginal mesh lawsuits filed against its American Medical Systems (AMS) subsidiary. The company expects to fund payments for the AMS vaginal mesh settlements in 2014, 2015, 2016 and 2017, which will total approximately $1.6 billion.

Earlier this year, the company announced its plans to pay $830 million to resolve more than 22,000 AMS vaginal mesh lawsuits filed by women claiming to have been injured by Endo and AMS’ transvaginal mesh and bladder sling products. Endo acquired AMS in 2011. Products implicated in the transvaginal mesh lawsuits – marketed as a treatment for pelvic organ prolapse and after hysterectomies — included the AMS Pedigree, AMS Apogee, and AMS Elevate implants.

In 2013, Endo disclosed that the company had already settled an unspecified number of cases to the tune of $54 million.

The final cost for the Endo vaginal mesh litigation is estimated to be $1.6 billion, according to a statement released by AMS.

Despite agreeing to settle the cases, Endo has not admitted liability or fault.  It did agree to educate both doctors and patients about the risks and benefits of transvaginal mesh products as well as continue with clinical trials investigating the safety of the devices for women who suffer pelvic organ prolapse or stress urinary incontinence.

In the news release, Endo’s president and chief executive officer, Rajiv De Silva, said that the company was “pleased to resolve substantially all of the remaining U.S. vaginal mesh litigation claims facing our AMS business.

“These settlements will allow us to continue to invest in the growth of our business segments and pursue accretive M&A opportunities. We believe that these settlements will also allow the AMS business to continue its return to growth and enhance focus on the operations and profitability of this leading medical device franchise.”

Vaginal Mesh Complications “Severe”

Patients who underwent transvaginal mesh surgery have reported experiencing myriad complications, including bleeding, pelvic pain, painful intercourse, urinary problems, multiple occurrences of pelvic organ prolapse, vaginal scarring, perforated bladder, perforated bowel or perforated blood vessels, device erosion, infection and organ injury.

Endo and AMS are not the only companies facing transvaginal mesh litigation. Nearly 50,000 lawsuits – a combination of complaints filed in state and federal court — had been filed as of April.

Defendants in those cases include C.R. Bard, Boston Scientific, Coloplast and Johnson & Johnson, the latter of which a Texas jury found should pay $1.2 million to a woman injured by its TVT-O mesh sling.

Last spring, Coloplast settled about 400 claims by agreeing to pay $16 million in vaginal mesh lawsuit settlements. Each woman in those cases would receive $40,000.