On February 12, 2019, the FDA plans to convene an Advisory Committee Meeting to share the available evidence and seek expert opinion on the evaluation of the benefits and risks of trans-vaginal mesh devices for anterior pelvic organ prolapse. This will provide an opportunity for the FDA to hear directly from the public, including patients, about their experiences, and consider additional regulatory actions. The Advisory Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, risks and benefits of trans-vaginal mesh placed in the anterior vaginal compartment and to identify appropriate patient populations as well as physician training needed for these devices. The February 12th meeting will include a public session, and a private session for organizations to provide testimony.
AUGS has already submitted written testimony, which is publicly available here.
As your President, I will also provide a presentation based on the written testimony, during the private session. AUGS supports the FDA framework for assessing the benefits and risks of the trans-vaginal mesh procedures for anterior vaginal wall POP within different populations of women suffering from anterior vaginal POP. AUGS believes that women are best served when they have options from which to choose, and well-educated and experienced providers. This allows women to make personalized treatment decisions based on evidence. However, it is essential to define medical device safety and appropriate regulation of devices to ensure patient safety. We believe that registries, like AQUIRE, are the most appropriate means to this end. Expanding AQUIRE and using it to enhance patient and physician education are priorities for AUGS.