> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Breast Implant Labeling Guidance
- URL: https://www.fdaweb.com/breast-implant-labeling-guidance/
- Published: 2020-09-29T12:00:00.000Z
- Updated: 2026-09-14T16:30:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147759

FDA has published a guidance, *Breast Implants—Certain Labeling Recommendations to Improve Patient Communication*, with recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication?ref=fdaweb.com) says the agency is issuing it to help ensure that a patient receives and understands the benefits and risks of the 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 breast implants,” FDA says. “These 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.”