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Endo Unit Shutdown Could Strand Incontinence Treatment Praised By FDA Panel

Endo International plans to shutter its Astora Women's Health business unit – formerly part of American Medical Systems – this month due to ongoing legal concerns tied to the company’s vaginal mesh products. What’s unclear is what this means for the company’s investigational fecal incontinence treatment, which received unanimous support from an FDA advisory panel just days before the shutdown was announced.

Astora Women's Health's TOPAS treatment for fecal incontinence seemed headed to market after FDA’s Gastroenterology and Urology Devices Panel unanimously recommended approval on Feb. 25. (See Also see "TOPAS Fecal Incontinence Device Gets Unanimous Support For Approval At FDA Panel" - Medtech Insight, 26 February, 2016..) The mesh implant would be the first device of its kind to treat the difficult and socially isolating condition, which some estimates say affects up to 22% of women older than 60 (See Also see "Medtech Solutions For The "Other" Incontinence" - Medtech Insight, 20 October, 2015.).

But during an earnings call held just four days after the panel vote, Astora parent company Endo International PLC announced a decision to pull the plug on the Astora...

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