Here are five things to know:
1. The TOPAS System is a medical device using implantable surgical mesh to treat female fecal incontinence after more conservative treatments have failed.
2. Because no medical device currently exists to treat this problem, ASTORA Women’s Health, the developers of the TOPAS System, was required to submit a premarket approval application, including a clinical trial to test the device’s efficacy and safety. While the trial achieved its primary endpoint, the FDA noted in briefing documents released ahead of the meeting that questions still remain about its safety.
3. Overall, 52 of 80 participants completing the TRANSFROM trial achieved a more than 50 percent reduction in the rate of female fecal incontinence episodes over a 12-month period compared to baseline. The device also achieved secondary endpoints, such as long-term effectiveness, a reduction in incontinent days, fecal incontinence episodes and symptom severity.
4. However, 72 of the 152 patients in all who received the implant reported adverse events related to the device. Of these, 45 percent reported pain, followed by 27 percent reporting infection and 12 percent reported new or worsening pelvic organ prolapse.
5. Panel members will not be asked to vote explicitly on whether the device should be approved, but the three voting questions on the agenda are whether they believe the product is safe, whether it’s effective and whether the benefits outweigh the risks.
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