The first mesh device to treat fecal incontinence took a step closer to FDA's stringent PMA approval, winning the unanimous backing of the FDA's Gastroenterology-Urology Devices Panel on Feb. 25. The FDA is not obligated to follow the advice of its advisory panels, but typically it does.
The independent experts voted 8-0 that the Endo's ($ENDP) second-line Topas System demonstrated a reasonable assurance of safety and efficacy, and that its benefits outweighed its risks, meaning that they think it should be approved.
During the device's clinical trial, 105 of the 152 female patients (69%) who were implanted with the Topas 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.
Patients in the trial had failed conservative therapies like dietary modification, medication and pelvic floor muscle training, in line with its proposed second-line indication.
According to Medscape, some panel members expressed concerned that the trial was on the small side for a PMA device and had a single-arm design. The FDA wrote in its executive summary of Endo's application that it approved the trial in 2009 because it did not think there was an appropriate control treatment available.
Regarding safety, 50 of 115 participants (43.5%) reported pelvic pain at the 3-year follow-up. But the panel members said the risk was acceptable given the debilitating nature of fecal incontinence. "I would trade off pain to having to wear a diaper," Barbara Berney, a consumer representative on the panel, said, according to Medscape.
In addition, 13 of 115 of the women (11%) in the trial reported de novo or worsening pelvic organ prolapse at the 3-year follow-up, but the panelists said it probably occurred due to disease progression and not the Topas device or implantation procedure.
Perhaps the biggest safety concern among the panelists is the spectacular failure of vaginal mesh implants, which have drowned their makers in lawsuits (including Endo, though most are now settled) and injured thousands of women.
"When mesh implants were approved, everything looked great. Now look where we are," panelist Dr. Terrell Hicks said, according to MedScape, who is concerned about long-term safety issues that weren't captured by the trial, due to its duration.
Endo wrote in its executive summary of the PMA application that "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."
The Topas is implanted below the anorectum through two small incisions in the thigh and buttocks. It is believed to reduce fecal incontinence by providing anatomical support to the anorectum, thereby restoring the 90-degree angle between the axis of the rectum and the anal canal, according to FDA's executive summary.
Endo applied for approval of the Topas in April 2014, but FDA asked for more information, resetting its one-year clock for making a decision, MedScape reports. It is not available in any other country. A previous version of the device was 510(k)-cleared by the FDA for pelvic floor repair in 2007.
The Topas belongs to Endo's Astora Women's Health unit, which was previously named American Medical Systems, prior to Boston Scientific's ($BSX) acquisition of Endo's men's health devices for $1.6 billion in August 2015.