Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Language(s):
English
Format:
Text
Subject(s):
Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This 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 breast implants. 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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (19 pages)) : illustrations.
Illustrations:
Illustrations
NLM Unique ID:
9918232103006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918232103006676