Endo International PLC announced in early August that it will set aside a massive $775 million fund to end “virtually all known” US claims over problematic mesh devices. The number of women having filed a mesh lawsuit against Endo and its subsidiary, Astora Women’s Health – formerly known as AMS Women’s Health – totals about 22,000 in the US.
“We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known US mesh product liability claims,” Endo CEO Paul Campanelli said in a statement. “While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities.”
Transvaginal mesh has proven to be a scourge for countless women requiring treatment for conditions common in middle-aged women who have borne children. Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) occur when internal organs begin to sag, and droop. Historically, surgeons at one time fashioned slings derived from a patient’s own tissue to shore things up and give women relief from the symptoms of POP and SUI. However, the invasive surgery required resulted in substantial blood loss, risk of infection and long periods of convalescence.
The advent of transvaginal mesh, rolled into a tube and deployed laparoscopically, was originally viewed as a vast improvement over more traditional forms of invasive surgery. However, in recent years there have been scores of adverse event reports asserting transvaginal mesh has shifted, or become intertwined with internal organs. There have been numerous reports of mesh protruding through, and into the vagina, causing pain and suffering for both the woman and her partner.
2014 turned out to be a watershed year for both Endo in particular and the mesh industry overall. That was the year when the US Food and Drug Administration (FDA) announced the issuance of two proposed orders that would result in the re-classification of transvaginal mesh as high-risk, and would require manufacturers to obtain premarket approvals from the federal regulator.
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Five months after that, Endo announced it had reached settlements resolving “a substantial majority” of transvaginal mesh lawsuits in the AMS litigation file.
Combined with the 2014 settlement, this most recent announcement of a US $775 million fund equates to a US $1.6 billion hit overall for the Dublin-based manufacturer.
In March of last year, Endo announced it was winding down Astora Women’s Health.
Under terms of the most recent agreements, Endo will begin issuing installment payments in Q4 of 2017 and expects those payments to continue for two years, until the end of 2019.