FDA panel supports approval of Topas mesh implant for fecal incontinence in women

The FDA’s Gastroenterology and Urology Devices Panel unanimously voted that the Topas System for the treatment of women with fecal incontinence has reasonable assurance of safety and efficacy.

The Topas System (Astora Women’s Health/Endo) is a minimally invasive, permanent mesh implant designed to “restore and maintain anatomic support of the pelvic floor muscles” in women with fecal incontinence who have failed conservative therapy such as dietary changes, anti-diarrheal medications or bulking agents, and pelvic floor muscle training, according to a press release.

After deliberations at its February 25 meeting, the FDA Panel voted 8 to 0 that there is reasonable assurance that the device is effective and safe for the proposed indications, and that the benefits outweigh the risks for patients who meet criteria.

A total of 152 women were implanted with the device in the Topas premarket approval study. The primary endpoint was treatment response at 12 months in at least half of participants, with treatment response defined as at least a 50% reduction in the number of fecal incontinence episodes in a 14-day bowel diary from baseline. Secondary endpoints included long-term efficacy (up to 60 months), improved quality of life, and reductions in incontinent days, urge fecal incontinence episodes and symptom severity.

At 12 months, 69.1% of patients were responders, and the median number of fecal incontinence episodes remained decreased at 12, 24 and 36 months. There were 677 adverse events, 17% of which were related to the device or procedure; the most common were pain and incision site infection. Eight treatment-related serious adverse events also occurred.

The FDA panel agreed that the primary and secondary outcomes supported the efficacy of the device, and that the safety profile was “adequately characterized.” The panel discussed adverse events including pain, infection, pelvic organ prolapse and urinary incontinence, as well as “the need for adequate training; they recommended that the use of this device should be limited to surgeons who have an adequate understanding of the anatomy of the pelvic region,” according to the FDA’s summary of the meeting.

The panel also recommended that labeling should exclude pregnant women and discourage vaginal birth, but not include an age restriction. Moreover, they recommended that patients enrolled in the investigational device exemption should be evaluated up to 5 years, and that a new enrollment postapproval study is needed. The need for a comparator group in this study, assessment of the device’s long-term location, systematic investigation of erosions into surrounding tissues, and more patients with diverse racial backgrounds in the postapproval study were also discussed.

Astora plans to follow participants in the premarket approval study through 60 months, and will update the FDA on safety and performance data annually until the study’s completion in 2017. The company has also designed a physician training program, and is in the process of designing a new postmarket study. – by Adam Leitenberger

References:

HHS. Brief Summary of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting – February 25, 2016. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM488397.pdf. Accessed March 2, 2016.

FDA. TOPAS Treatment for Fecal Incontinence PMA P140006 Sponsor Executive Summary for the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM487215.pdf. Accessed March 2, 2016.