The U.S. Food and Drug Administration (FDA) posted meeting materials, including an executive summary and meeting information/logistics, for the March 25-26 public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee.
The committee will discuss and make recommendations about the benefits and risks of breast implants indicated for breast augmentation and reconstruction.
The FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person:
In addition, you may submit comments to the public docket through April 26, 2019.
This two-day public meeting will include presentations, recommendations, and discussion on the following topics:
- Breast implant associated anaplastic large cell lymphoma (BIA-ALCL);
- Systemic symptoms reported in patients receiving breast implants;
- Registries for breast implant surveillance;
- Magnetic resonance imaging (MRI) screening for silent rupture of silicone gel filled breast implants;
- Surgical mesh in breast procedures such as breast reconstruction and mastopexy;
- Real-world data and patient perspectives in regulatory decision making; and
- Best practices for informed consent discussions between patients and clinicians.
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