After two years of consideration, the FDA has restricted the sale of breast implants to healthcare providers that use an FDA-approved patient-decision checklist to discuss the benefits and risks of the implants with patients.
This is the second time the FDA has required the use of a checklist before implanting a medical device and another example of the FDA’s increasing interest in broader disclosure in medical-device labeling.
FDA Requires ‘Patient-Decision Checklists’ for Breast Implants: What Could This Mean for Industry?
