Endo International has announced that it will close its Astora Women’s Health device unit and will cease the production and marketing of American Medical Systems (AMS) transvaginal mesh implants, as of March 31, 2016
The closure is seen in large part as an effort by Endo to reduce the company’s fallout from rising legal costs and large settlements paid to injured women through product liability lawsuits filed against the company. Endo and Johnson & Johnson subsidiary Ethicon are the two largest suppliers of mesh devices in the U.S.
Experts see Endo’s decision as a possible reaction to the new U.S. Food and Drug Administration (FDA) rules that require transvaginal mesh manufacturers to submit new safety and effectiveness data on pelvic organ prolapse (POP) surgeries by the summer of 2018, according to a Minneapolis Star Tribune report. Companies like Endo are electing to stop selling the devices in lieu of going through a lengthy regulatory process required by the FDA.
Problems With Pelvic Mesh
The FDA has been evaluating the safety of pelvic mesh implants since 2008, and issued its first public health notification that same year. In 2011, the agency reclassified some mesh devices to Class III, the highest-risk category, and ordered manufacturers to study the use of transvaginal mesh the following year. Although hundreds of women have asked for a nationwide recall of the devices, the FDA has not yet instituted an outright ban on the sale of transvaginal mesh.
An estimated 140,000 transvaginal mesh lawsuits – 46,0000 against Endo International alone – have been filed by women who claim that they experienced severe adverse effects from the devices, which were implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). About 59,000 of the mesh lawsuits have been consolidated into multidistrict litigation (MDL) in federal court in West Virginia, making up the largest group of ongoing MDL cases related to health care.