Boston Scientific released a statement to the press on June 3, announcing its plan to pay $1 million toward a study that is going to seek to prove the efficacy of vaginal mesh device implant surgery over traditional forms of surgery in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence.
The trial is called the SUPeR clinical trial, and is to be conducted by researchers at the Pelvic Floor Disorders Network (PFDN). For the study, researchers will analyze data collected from 180 female participants who are thinking of having surgery to treat their POP and who do not want to have any more children. Researchers will then give some of the women vaginal mesh implant surgery and others will receive hysterectomies. The vaginal mesh surgeries will be using Boston Scientific’s Uphold LITE Vaginal Support System.
The participants will then be monitored over a five-year period to decide the surgeries’ success rates, and the efficacy of the surgeries for comparison. The researchers will also weigh the costs of the surgeries and the complications. The study is expected to conclude in 2017.
“The data for this study will give physicians reliable evidence from a randomized trial on surgical treatment for women with uterine prolapse,” says Charles Nager, M.D., director of the Urogynecology and Reconstructive Pelvic Surgery Division at UC-San Diego School of Medicine. “That evidence will help inform clinicians as they make decisions in an effort to provide the best patient care possible.”
The FDA is in agreement with the dangers associated with vaginal mesh devices, which is probably why Boston Scientific is seeking this kind of study. On July 13, 2011 in a safety memo, the FDA issued a warning that stated that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” This information helps to add credence to the vaginal mesh lawsuit cases that are currently pending in the court system. So far, numerous lawsuits have been filed against manufacturers of vaginal mesh devices, including Boston Scientific.
