Boston Scientific Corporation (NYSE: BSX) today issued the following statement from John Pedersen, Senior Vice President and President of the Company's Urology and Women's Health Division, following the conclusion of a two-day meeting of the U.S. Food and Drug Administration (FDA) Obstetrics & Gynecology Devices Advisory Committee. During the meeting, the Committee heard presentations on the safety, effectiveness and continued classification of surgical mesh as a Class II device to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women.
"Boston Scientific believes that mesh products are a valuable option for surgeons who treat women with pelvic floor disorders and stress urinary incontinence and that these products offer a safe and effective alternative to non-mesh treatment options. We will continue to work with the FDA and other members of the AdvaMed Working Group to reinforce the safety and effectiveness of these devices.
"Within Class II, FDA has the authority to implement Special Controls to ensure consistency in the evaluation of the safety and effectiveness of products through standardized requirements, including pre- and post-market clinical trials, and the adequacy of labeling information provided to both patients and physicians. We believe that the current 510(k) requirements for Class II devices are appropriate for surgical mesh devices intended to treat pelvic organ prolapse and stress urinary incontinence.
"As part of our commitment to manufacturing and marketing high quality and safe products, we look forward to our ongoing work with the FDA, physicians and others in our industry to ensure that accurate and complete information is provided to healthcare providers and their patients so they can make fully informed decisions regarding these treatment options.
"We appreciated the opportunity to present our perspective on this important issue and anticipate continued government and industry collaboration with respect to this important treatment option."
How gut bacteria regulate stress and sleep cycles