|
FDA Strengthens Breast Implant Safety Requirements and Updates Study Results
Today, the U.S. Food and Drug Administration (FDA) took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.
First, the FDA issued 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.
Second, the FDA approved new labeling for all legally marketed breast implants that includes:
- Boxed warning.
- Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
- Updated silicone gel-filled breast implant rupture screening recommendations.
- Device description with a list of specific materials in the device.
- Patient device card.
The FDA expects manufacturers to post the updated device labeling to their websites within the next 30 days.
Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies.
Questions?
If you have questions about this final guidance, contact the Division of Industry and Consumer Education.
|
