Boston Scientific ($BSX) is teaming up with the Pelvic Floor Disorders Network to study whether its Uphold LITE transvaginal mesh beats out traditional surgery in women with uterine prolapse.
The company is providing a $1 million research and education grant to PLDN to fund a study of 180 patients with uterine prolapse, testing whether Boston Scientific's uterine-preserving mesh improves women's outcomes compared to vaginal hysterectomy.
After the initial implantation, investigators will evaluate patients every 6 months, collecting data on surgical success, patient safety, cost-effectiveness, quality of life and body image for up to 5 years, the company said. Boston Scientific expects to have results in hand by 2017, and the randomized trial will help clinicians make treatment decisions for the roughly 28 million U.S. women who suffer from pelvic floor disorders, the company said.
Uterine prolapse occurs when the tissues in the pelvic floor can no longer support the uterus, leading to a painful and dangerous sagging of the organ. Uphold LITE is used in pelvic floor reconstruction, inserted through a small incision to reinforce failing muscle tissue.
Boston Scientific bills its latest Uphold device as designed to reduce the possibility of erosion, likely an effort to differentiate it from the vaginal meshes that spurred thousands of patient lawsuits, with plaintiffs claiming serious injury in exchange for little clinical benefit. About 100,000 patients have sued over similar products from Boston Scientific, Johnson & Johnson ($JNJ) and C.R. Bard ($BCR), claiming the companies marketed dangerous devices while knowing of the risks.
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