Breast Implants – Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 29, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, General & Plastic Surgery , Labeling
Status: Final

Breast Implants – Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and Food and Drug Administration Staff

This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. FDA is issuing this guidance to help ensure that a patient receives and understands the benefits and risks of these devices. The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of these devices. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of breast implants that uniquely pertain to individual patients.

Download the Guidance Document