Table 1.

The Five Components of Breast Implant Manufacturer Labeling

Components of Breast Implant Manufacturer Labeling
1. A “black box” warning regarding potential short-term, long-term, and life-threatening consequences associated with implant use.
2. A patient decision checklist to help confirm patient understanding of the benefits, aforementioned risks, and other information about the implant.
3. Updated recommendations about silicone gel-filled implant rupture-screening protocols.
4. A device description with a list of materials that compose the implant.
5. A patient device card to fulfil medical device tracking requirements.