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About Breast Implants’ Safety
Requirements
Breast implants are medical devices
implanted under the breast tissue or chest muscle to increase
breast size (augmentation) or to replace breast tissue that has
been removed due to cancer or trauma or that has failed to develop
properly due to a severe breast abnormality (reconstruction). They
are also used in revision surgeries, which seek to correct or
improve the result of an original surgery.
There are two types of breast
implants approved for sale in the United States: saline-filled and
silicone gel-filled. Both types have a silicone outer shell. They
vary in size, shell thickness, shell surface texture, and shape
(contour).
On October 27, 2021, the FDA took
several actions to strengthen breast implant risk communication
and help those who are considering breast implants make informed
decisions. These actions include orders restricting the sale and
distribution of breast implants to help ensure that patients
considering breast implants are provided with adequate risk
information so that they can make fully informed decisions. These
FDA requirements are described in detail at FDA Strengthens Safety
Requirements and Updates Study Results for Breast Implants. In
addition, the FDA regularly updates information on the status of
breast implant manufacturers’ post-approval studies, at
Post-Approval Studies (PAS) Database.
The U.S. Food and Drug
Administration has taken several actions to strengthen breast
implant risk communication and help those who are considering
breast implants make informed decisions.
( Ref :
https://www.fda.gov/medical-devices/implants-andprosthetics/breast-implants
).
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