Last week, we posted on the recent FDA Obstetrics & Gynecology Devices Panel Advisory Committee hearings that centered on the use of transvaginal surgical mesh to correct Pelvic Organ Prolapse (POP). The second day of the advisory committee hearings focused on the use of surgical mesh for the surgical management of female Stress Urinary Incontinence (SUI), with differing recommendations from those regarding POP.
At the open public hearings, presenters ranged from patients to advocacy groups to clinicians. The presentations themselves also ranged widely from adverse event reporting to a broader review of clinical data.
Surgical mesh manufacturers also presented at the second day of hearings. The industry association AdvaMed advocated on the safety and effectiveness of what are known as suburethral slings to correct SUI. They do not believe that mandatory clinical studies are needed for the products currently being marketed. There are studies underway for products that have new features and they argued that this is sufficient. They also took the position that Class II special controls are adequate.