Approvable Letter Issued for Incontinence Implants
Uroplasty, Inc., of Minnetonka, Minn., announced that it has received an approvable letter from the FDA following the agency's scientific review of the safety and efficacy of Macroplastique Implants for female stress urinary incontinence.
The letter determined that Uroplasty's application for the implants is approvable subject to auditing of manufacturing facilities, methods and controls, and compliance with quality standards.
Macroplastique is a soft-tissue, injectable bulking agent. When injected by a physician into the periurethral tissues, the added “bulk” allows the urethra to close more effectively and prevents urine leakage.