Urogynecologic Surgical Mesh Implants

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.

Surgical mesh can be used for urogynecologic procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI.

Based on an updated analysis of adverse events reported to the FDA and complications described in recent scientific literature, on July 13, 2011 an FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse was issued to inform the medical community and patients that:

1. serious complications associated with surgical mesh for transvaginal repair of POP are not rare
2. it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair

The FDA continues to evaluate the effects of using surgical mesh for treatment of urine leakage during moments of physical activity (stress urinary incontinence) and will provide updates on this webpage at a later date.

On this webpage, the FDA provides information about the use of surgical mesh placed transvaginally for the treatment of POP, recommendations for health care providers and women to help reduce risks, and steps to report problems to the FDA. The information provided on this webpage is not meant to replace a discussion with your health care provider.

 

UPDATE 01/04/2012:

• Based on assessment of Medical Device Reports (adverse event reports) submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III.

The FDA continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through:

• Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.
• Epidemiological research on safety and effectiveness of surgical mesh, as a part of our effort to better understand possible adverse events associated with surgical mesh for SUI and POP.
• Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events.
• Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.
• Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued:
• 88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and
• 11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.

The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. For information on the status of the 522 Postmarket Surveillance Studies and the FDA’s authority to order 522 studies, visit the 522 website.

The FDA will provide additional information to the public as it becomes available.