Zdrowie i gospodarka · 29.09.2020
Breast Implants-Certain Labeling Recommendations To Improve Patient Communication; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Breast Implants-- Certain Labeling Recommendations to Improve Patient Communication." 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 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.