FDA > CDRH > Breast Implants > Consumer Information > FDA Breast Implant Consumer Handbook - 2004

FDA Breast Implant Consumer Handbook - 2004

MEDWATCH

MedWatch is the FDA's program for reporting serious complications and problems with medical products, such as drugs and medical devices. MedWatch data include voluntary and mandatory (required) reports by consumers and others. MedWatch data are most useful as an early warning system when the hazards of a device are previously unknown. FDA also uses these data to follow trends with particular devices and look for signals that further follow-up could be needed.

If you have experienced one or more serious problems related to your breast implants, you may ask you healthcare provider (for example, nurse or doctor) to report the problem(s) to the manufacturer or to FDA. If you are participating in a study, you should report all problems to your doctor so that information will be included as part of the study data.

If you want more information, please visit the MedWatch website at http://www.fda.gov/medwatch or call 1-800-332-1088.

Updated June 8, 2004