Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

Inclusion Criteria: * Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair. Perineal repair, vaginal hysterectomy and/or mid urethral sling procedures for incontinence may be performed concurrently. * Age \> or = 18 years. * Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent. Exclusion Criteria: * Additional surgical intervention for POP repair concurrent to the Gynecare Prolift+M procedure (e.g. paravaginal repair, sacrocolpopexy, colporrhaphy in a non-Gynecare Prolift+M treated compartment). * Previous repair of pelvic organ prolapse involving insertion of mesh. * Previous hysterectomy within 6 months of scheduled surgery. * Experimental drug or experimental medical device within 3 months prior to the planned procedure. * Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared. * Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery. * History of any pelvic radiation therapy. * History of chemotherapy within 6 months of the planned procedure. * Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma). * Current evaluation or treatment f…