FDA Advisory Committee recommends Topas system to treat fecal incontinence- Astora Womens Health/Endo
The FDA's Gastroenterology-Urology Devices Panel unanimously recommended the Topas System from Astora Womens Health, for the treatment of fecal incontinence.This device is a permanent implant consisting of a non-bioabsorbable mesh device, to be placed parallel to the puborectalis muscle and below to the anorectum. The device is intended to treat women with fecal incontinence who have failed more conservative therapies.
The Topas system's unique anatomical placement does not require transvaginal incision, or any incision or modifications to the pelvic floor muscle, and thus has a different safety profile than transvaginal mesh devices that are implanted in a different anatomical location to treat different disease states and which have been a spectacular failure.
Comment: During the device's clinical trial, 105 of the 152 female patients (69%) who were implanted with the Topas system experienced at least a 50% reduction in episodes of fecal incontinence. The median number of incidents per day fell from 18 per day to 5 per day as of the 36-month follow-up.
Comment:Currently, there are no legally marketed mesh devices for the treatment of fecal incontinence.
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