On September 8-9, 2011 the FDA held a meeting of the Obstetrics & Gynecology Devices Advisory Committee to debate the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
As a brief introduction, pelvic organ prolapse is a common condition that occurs when the tissue and muscles of a woman’s pelvic floor deteriorate and no longer support her pelvic organs. This deterioration results in the drop (prolapse) of pelvic organs from their normal position. Stress urinary incontinence is the unintentional discharge of urine prompted by a physical movement or activity – such as coughing, sneezing or heavy lifting – that puts pressure (stress) on the bladder. Read our article on the dangers of vaginal mesh to learn more about what conditions the devices treat. Vaginal mesh is a medical device inserted through a vaginal incision to repair the weakened or damaged tissues in women with POP or SUI.
The panel was asked to provide input on the risks and benefits of surgical mesh used for POP repair based on the published literature and adverse event data from the FDA’s (MAUDE) database. The panel also weighed in on the FDA’s proposed premarket and postmarket regulatory strategies for surgical mesh indicated for POP repair, including reclassification into Class III (premarket approval) and postmarket surveillance studies.
The panel considered the risks and benefits of surgical mesh to treat SUI. The FDA sought the panel’s input on the need for additional clinical studies (premarket and/or postmarket) on all or a subset of surgical mesh indicated to treat SUI based on data from the published literature and the MAUDE database.
The panel was asked to consider whether 522 studies are needed for cleared mini-slings, all cleared surgical mesh indicated for SUI, or not needed for these devices. If the panel believes 522 studies are needed for all or just a subset of these products, the panel will be asked to discuss the type of clinical study that should be required, with consideration to patient selection, controls, randomization, outcome measures, concomitant surgeries, follow up duration, etc.
Boston Scientific Corporation 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 the meeting.
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.”