The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding specific patient labeling measures. FDA’s proposed guidance provides recommendations for the form and content for certain labeling information for saline and silicone gel-filled breast implants, including:
- Boxed warnings
- Patient decision checklist
- Materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants
- Silicone gel-filled breast implant rupture screening recommendations
- Patient device card
Black box warning for breast implants
The draft comes on the heels of the General and Plastic Surgery Devices Advisory Panel meeting in March 2019, which discussed the long-term benefits and risks of breast implants for achieving breast augmentation and reconstruction.
The recommendation that breast implants carry a “boxed” warning, also known as a “black box warning” includes warnings that
- Breast implants are not considered lifetime devices
- The chance of developing complications increases over time
- Some complications will require more surgery
- Breast implants have been associated with the risk of developing a specific type of cancer BIA-ALCL and may be associated with systemic symptoms
The black box is the strongest form of warning for FDA-regulated products and evidences FDA’s view that there are potentially serious risks of breast implants. In light of the very extensive and sweeping proposed patient labeling, which does not distinguish between risks of specific types of implants and appears to actively discourage reconstruction after breast cancer, there is no doubt that the device industry and healthcare providers will offer comments to FDA. This draft guidance will be open for public comments for 60 days, through December 23, 2019.
This alert does not purport to be a substitute for advice of counsel on specific matters.
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