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Endo Stops Making AMS Transvaginal Mesh

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Eden Prarie, MNEndo International is closing its Astora Women’s Health device unit, the company that sells the now-defunct American Medical Systems (AMS) transvaginal mesh implants for stress urinary incontinence (SUI) or pelvic organ prolapse (POP). Endo, which bought AMS in 2011 for $2.9 billion, said it is shutting down transvaginal mesh production due to soaring legal costs and settlement payouts awarded by juries to injured women in the United States.

By closing Astora on March 31 rather than selling it, Endo said it will be able to reduce its potential product liability related to about 46,000 transvaginal mesh lawsuits claiming severe adverse events from its meshes to treat POP and vaginal slings for SUI, according to the Star Tribune (March 3, 2016).

Coincidentally, Astora announced it was shutting down on February 29, four days after an FDA advisory panel recommended approval of Topas, a new surgical mesh device for treatment of fecal incontinence in women that Endo was going to sell through Astora.

Endo and the Johnson & Johnson-owned firm Ethicon are the two biggest suppliers of mesh devices: There are approximately 140,000 transvaginal mesh lawsuits filed in the United States alone. About this time last year, Endo (AMS) had $1.3 billion in a mesh product liability fund and was actively negotiating settlements.

Experts predict that Endo may set a precedence by stopping the production of transvaginal mesh. US attorney Adam Slater, who was instrumental in banning transvaginal mesh in Scotland and lead trial counsel in the first pelvic mesh trial against Ethicon, told the Scotland Daily Record (March 13, 2016) that “Endo’s decision to stop marketing pelvic mesh was inevitable. In my opinion, all manufacturers will eventually stop selling these insidious devices proven incompatible with permanent implantation in the female pelvis.”

Despite juries awarding a number of transvaginal mesh plaintiffs large settlements, Astora still stands behind the safety and effectiveness of its AMS transvaginal mesh products for POP and SUI.

“At Endo, patient health is our number one priority,” Endo spokeswoman Heather Zoumas Lubeski said in an e-mail to the Star Tribune. “As such, we have decided to expedite this closure, so that the patients and physicians who may be considering an Astora device for an upcoming surgery will have the opportunity to assess alternative treatment options as soon as possible.”

Elaine Holmes, a spokesperson for Scottish Mesh Survivors, said: “We’re delighted Endo are stopping production and yearn for the day all mesh firms follow suit.”

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