--Gynecologic Surgical Mesh
In another important action, we’re announcing today that the FDA will convene an advisory committee meeting on February 12, 2019 to discuss the safety and effectiveness of surgical mesh intended for transvaginal pelvic organ prolapse (POP) repair. Two years ago, we took action to strengthen our regulation of mesh by issuing an order to upclassify surgical mesh for transvaginal POP repair. FDA required manufacturers to submit premarket approval (PMA) applications and obtain approval in order to remain on the market. As a result, manufacturers ceased their marketing of surgical mesh intended for the highest risk indication, transvaginal posterior POP repair. Only three surgical mesh products intended for transvaginal repair of anterior compartment prolapse remain on the market while the FDA evaluates the data submitted in their PMAs.
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The advisory committee meeting will seek expert opinion regarding the available evidence of the benefits and risks of mesh for transvaginal POP repair and provide an opportunity for the FDA to hear directly from the public, including patients, about their experiences, and consider additional regulatory actions.
Next Steps
Ensuring the safety of medical devices on an ongoing basis requires a multi-layered effort. One element of this system is a vigilant post-market surveillance system for quick identification and evaluation of new or increased safety concerns. Robust oversight of safety also requires, timely public communication about safety issues and effective interventions to address concerns. The FDA also must foster innovation that spurs the development of safer, more effective technologies and assures timely patient access.
Doing all of these things, and more, will enable us to improve the safety, health and quality of life of patients and enable decision-making based on the best available evidence about medical devices.
We look forward to providing updates soon about our progress in these other areas. This includes seeking new authority for faster and more efficient imposition of post-market safety mitigations and efforts to further assure the safety and effectiveness of devices reviewed under the 510(k) process. We believe all of these steps will continue to strengthen our policies and processes in order to best protect patients.
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