Benzinga | Oct 28, 2021 03:56PM EDT

FDA Restricts Sale, Approves New Labeling Of Breast Implants

* The FDA is restricting the sale and distribution of breast implants over concerns about the risks of the devices, limiting the products to healthcare providers and facilities that provide information using the "Patient Decision Checklist."

* Patients must be given a chance to initial and sign the checklist. The physician implanting the device must also sign the checklist.

* The restrictions reflect the FDA's finding that measures are needed "to provide a reasonable assurance of the device's safety and effectiveness" given links between breast implants and a type of cancer.

* The second set of changes adopted by the FDA relate to the labeling of breast implants.

* FDA has asked manufacturers to add a boxed warning about the "significant risks" of breast implants and other information.

* FDA directed the request to AbbVie Inc's (NYSE:ABBV) Allergan, Johnson & Johnson's (NYSE:JNJ) brand Mentor, Ideal Implant Inc, and Sientra Inc (NASDAQ:SIEN).

* The labeling also includes updated silicone gel-filled breast implant rupture screening advice and a detailed list of materials used in the device. The FDA also provided an update on post-approval studies.

* The agency said studies run by Allergan, JNJ, and Sientra had made inadequate progress. Ideal Implant has made adequate progress in its study.

* The risk of developing BIA-ALCL is considered low, but the cancer is serious and can lead to death, FDA has said.