A study by American Medical Systems (AMS), a unit of Endo Health Solutions ($ENDP), showed that the company's fecal incontinence implant product reduced by half the number of weekly bowel leakage incidents in nearly 70% of the female participants.
The study, called TRANSFORM, involved 152 women at an average age of 59 who met the criteria. It was conducted over a 12-month period in 14 locations in the U.S. The participants were implanted with the company's TOPAS System, a permanent mesh implant that helps maintain anatomic support of the pelvic floor muscles, the company said in a release.
Nearly one in 5 women in the U.S. over the age of 45 experience accidental bowel leakage, and about 11 million women in the country over age 20 have dealt with ABL, the company said. It is the second leading reason for nursing home placement among the elderly.
"These new findings suggest that TOPAS has the potential to be a safe, effective and minimally invasive approach to managing ABL in women where more conservative measures have failed," Dee Fenner, a professor of obstetrics and gynecology at the University of Michigan and a primary investigator in the study, said in a statement.
TOPAS is an investigational device that hasn't been approved by the FDA.
In 2013, researchers in Finland and the Netherlands showed that fecal transplants were vastly more effective than a standard antibiotic therapy in treating patients with diarrhea linked with C. difficile. In that study, transplants successfully treated 15 of 16 patients, or 94% of those who received them, compared with success rates of 31%, or 4 of 13 patients, on vancomycin alone, or 3 of 13 patients (23%) who got vancomycin with lavage therapy.
Last month, the Wall Street Journal reported that Endo was looking to put the Minnetonka, MN-based AMS unit up for sale. Endo announced in May it would pay $830 million to settle 20,000 lawsuits stemming from AMS vaginal mesh-related cases. The settlement, the company said, would resolve a "substantial majority" of those lawsuits.
- see the release