Women with fecal incontinence (FI) may soon have another treatment option if they do not respond to conservative therapies, such as a dietary change, medications, or exercises.
The US Food and Drug Administration's (FDA's) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee voted unanimously to back approval of the TOPAS system (Astora Women's Health LLC).
The FDA usually follows the advice of its panels.
The synthetic mesh does not require a transvaginal approach. It is implanted using four small incisions in a procedure that takes less than 30 minutes. The goal is to place the mesh inferior to and about 2 cm from the anorectum, parallel with the puborectalis.
The panel said TOPAS was effective in reducing FI episodes by at least 50%. The committee voted 8-0 that the device was safe, although there was some concern that the small, single-arm study — in which the implants were placed by highly skilled surgeons — might not be an indicator of long-term safety or of use in a broader patient population.
"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," said Mark Talamini, MD, panel chairman and professor and chairman of surgery at Stony Brook University School of Medicine, in New York.
Transvaginal Mesh Haunts Panel
The specter of ongoing safety and litigation issues involving transvaginal mesh hung over the committee's discussion of TOPAS.
"When mesh implants were approved, everything looked great. Now look where we are," said panellist Terrell Hicks, MD, associate chairman of the Department of Colon and Rectal Surgery at the Ochsner Health System, in Jefferson Parish, Louisiana. Dr Hicks said he worried about safety problems arising in 5 or 10 years.
In January, after multiple safety alerts about the risk for severe pelvic pain, infection, painful intercourse, bleeding, organ perforation, and urinary problems with the use of previously approved products, the FDA reclassified transvaginal mesh for pelvic organ prolapse repair from a moderate-risk device (class II) to a high-risk device (class III) and gave manufacturers 30 months to prove safety and effectiveness.
Astora says it will limit performance of the TOPAS procedure initially to surgeons who have previously implanted the device or who are participating in a proposed postapproval study. The company also has developed a training program. To enter, physicians must be board certified in female pelvic medicine and reconstructive surgery or colon and rectal surgery; they must be currently treating patients who have FI; and they must have surgical experience implanting other FI devices or mesh in the pelvic floor. As part of the training, clinicians would be required to complete two proctored cases.
The committee members said the training was necessary but that it was difficult to say how many cases would indicate competency. Ashley Faulx, MD, a panelist and associate professor of medicine at Case Western Reserve University School of Medicine, in Cleveland, Ohio, said that quality of the completed proctored procedures was probably more important than the quantity.
Panel member Cheryl Iglesia, MD, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, in Washington, DC, agreed and called for a registry to follow surgeon and patient outcomes. "I don't want to stifle innovation," she said. "At the same time, there is potential for harm."
Majority Had Reduction in Episodes
In Astora's pivotal trial, TRANSFORM, 152 patients received a TOPAS implant. The trial was a prospective, single-arm, open-label study. The procedure was conducted by colorectal surgeons at eight US clinical sites and by urogynecologists at seven US centers.
Patients had to have failed at least two conservative therapies and had to have had FI for more than 6 months. Those who were pregnant or who were planning a future pregnancy were excluded, as were patients with a history of inflammatory bowel disease, chronic watery diarrhea, or a recent gastroenterologic or gynecologic repair. For almost 60% of the particiants, obstetric trauma was the etiology of their FI; in 41%, the cause was unknown.
Overall, 69% of the 152 patients who received the implant exerienced a reduction in FI episodes of 50% or more. The number of episodes dropped from a median of 18 per day at baseline to five at the last 36-month follow-up. Patients improved on six of the seven quality-of-life scales that were used.
Forty-four percent of the women in the study reported pelvic pain, and 11% had de novo or worsening pelvic prolapse, according to the FDA. But committee members said they thought most women would trade pain for a decrease in FI and that the prolapse might not be caused by TOPAS.
"I would trade off pain to having to wear a diaper," said Barbara Berney, a consumer representative on the panel.
"The bottom line is, this is a terribly debilitating disease, and women would trade an awful lot," agreed Susan Kalota, MD, a panel member who practices at Urological Associates of Southern Arizona. "Many people would trade some pain for continence," she said.
Committee member John Efron, MD, said, however, that patients might not be happy if they were still incontinent and experienced an increase in pain. The prolapse seen in the trial was "probably more a continuation of the overall disease process taking place," said Dr Efron, who holds the Mark M. Ravitch, MD, Endowed Professorship in Gastrointestinal Surgery at Johns Hopkins University, in Baltimore, Maryland.
The panel said that if TOPAS is approved, it should not be used in pregnant women and that women who are expecting to become pregnant in the future who receive an implant should be counseled to undergo cesarean delivery.
It is not clear when the TOPAS system might be approved. Astora applied for approval in April 2014, and by law, a decision should have been made by April 2015. But the FDA asked for additional data, which reset the clock on that decision, Benjamin Fisher, PhD, director of the FDA's Division of Reproductive, Gastro-Renal, and Urological Devices, told Medscape Medical News.
TOPAS is not available in any country, said Thomas Rasmussen, senior director of Astora’s clinical and regulatory affairs.
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Cite this: FDA Advisers Back Mesh for Fecal Incontinence - Medscape - Feb 26, 2016.