If I Experience a Problem, Should I Report It?

Frequently Asked Questions: Breast Augmentation & Breast Implants

If you believe that you have experienced a serious problem(s) related to your breast implants, you should have your health professional report the problem(s) to the FDA. You are encouraged to report any adverse events through their health professionals. Although reporting by physicians or other health professionals is preferred, women may also report any serious problem directly through the MedWatch voluntary reporting system. An adverse event is serious and should be reported when it results in an initial or prolonged hospitalization, disability, congenital anomaly, or medical or surgical intervention.

To report, use MedWatch form 3500, which may be obtained through the FDA's website at http://www.fda.gov/medwatch/. You may also call 1-888-463-INFOFDA (1-888-463-6332) from 10:00 a.m. 4:00 p.m. Eastern Time, Monday through Friday, to receive an additional FDA MedWatch package.

Keep a copy of the MedWatch form completed by your doctor for your records.