Rate and Severity of Adverse Events Following Trans Vaginal Mesh Repair Calls Safety into Question
FDA Executive Summary: Surgical Mesh for Treatment of Women
with Pelvic Organ Prolapse and Stress Urinary Incontinence:
A new report reveals that federal health regulators are considering tough new regulations for surgical mesh used to treat pelvic organ prolapse (POP), which has been linked to thousands of serious injuries and complications.
RECOMMENDATIONS FOR HEALTH CARE PROVIDERS
The FDA encourages health care providers to:
- Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
- Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
- Consider these factors before placing surgical mesh:
- Surgical mesh is a permanent implant that may make future surgical repair more challenging.
- A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
- Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
- Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
- Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
- Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
- Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.
- Continue to follow the recommendations provided in the 2008 PHN.
CONSIDERATION OF REGULATORY CHANGES
The FDA is considering regulatory changes that may improve our understanding of the safety and effectiveness of this device. Considerations include:
- A change in risk classification of mesh used for transvaginal POP repair from Class II to Class III, which would require manufacturers to submit premarket approval applications, including relevant clinical data for these devices.
- Clinical studies to address the risks and benefits of mesh used to treat POP and SUI.
- Expanded post-market monitoring of device performance
On September 8-9, 2011, the FDA will convene a meeting of the Obstetrics-Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss the safety and effectiveness of transvaginal placement of mesh for POP and SUI procedures.