Breast Implant Risks Must Be Better Detailed To Patients, FDA Orders
The Food and Drug Administration finalized new regulations that include "black box" warnings on implant packaging and that plastic surgeons must run patients through a checklist of possible complications, including scarring, pain, rupture and a rare form of cancer.
The New York Times:
Patients Must Be Warned Of Breast Implant Risks, F.D.A. Says
Federal regulators on Wednesday placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery. Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue. (Rabin, 10 /27)
AP:
FDA Sets Stronger Safety Warnings For Breast Implants
In the biggest shift, plastic surgeons and other health professionals who work with the implants must give their patients a checklist detailing possible side effects, such as scarring, pain, rupture and even a rare form of cancer. The checklist also explains that breast implants often require repeat surgeries and they should not be considered lifelong devices. The doctors must sign the document and confirm that the recipient was given an opportunity to review it before surgery. Companies that sell implants to doctors who don’t comply could face fines and other penalties from regulators. The rules begin to take effect in 30 days. (Perrone, 10/27)
CNN:
FDA Adds Boxed Warning To Breast Implants
After hearing testimony in 2019 from women who said their doctors did not adequately warn them about the potential health complications of breast implants, the FDA said it decided to restrict the sale of breast implants to only health care providers who offer patients a standardized checklist that explains the risks. The changes require doctors to walk patients through these potential problems and to give the patient an opportunity to sign off on the checklist to show they were properly informed about the risks to their health. The older the implants are, the more health risks they pose, and those risks could require additional surgery. (Christensen, 10/27)
