FDA backs Endo’s Topas mesh to treat fecal incontinence

The FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee this week voted unanimously to back approval of Endo Health Solutions (NSDQ:ENDP) subsidiary Astora Women’s Health’s Topas mesh designed to treat fecal incontinence.

The synthetic mesh does not require a transvaginal approach, according to a Medscape report, but is implanted using 4 small incisions in a procedure that takes less than 30 minutes.

“The safety issues are addressed within the confines of the study, but specific panel members have concerns about the applicability more generally…and over longer periods of time,” panel chairman Dr. Mark Talamini said, according to Medscape.

The panel said the device is effective at reducing fecal incontinence episodes by at least 50%.

Past issues with the safety of transvaginal mesh devices affected the panel’s judgement and discussion of the Topas system.

In January the FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review.

The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through its pre-market approval process for transvaginal POP procedures. The moves do not apply to mesh used in other indications, including stress urinary incontinence and abdominal POP repair, the FDA said.

Astora said it will limit Topas procedures to surgeons who have previously implanted the device or those who are participating in a proposed postapproval study, and said it is developing a training program for the devices.

The committee said training would be necessary but it would be difficult to judge how many cases it takes to reach a competent level. The board called for a registry to follow surgeons and patient outcomes with the Topas mesh.

The company said it is still not clear when the Topas sytem will be approved.

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