The Cleveland Clinic

Breast Implant Safety

Over the past few years, much attention has been focused on the safety of silicone-gel-filled breast implants. Some women who have them have complained of chronic low-grade fever, fatigue and joint pain and have attributed these discomforts to their implants.

This raised concerns about a possible connection between silicone leaking into the body and the occurrence of connective-tissue and immune-related disorders such as scleroderma or rheumatoid arthritis.

To date, however, there is no convincing scientific evidence associating these implants with connective tissue disease.

Because of these and other concerns, a Food and Drug Administration (FDA) Advisory Council panel met to review the issues. On April 16, 1992, the FDA concluded its investigation. Although the panel did not find silicone-gel-filled implants to pose a health risk, it concluded that implant manufacturers had not provided adequate data to confirm the absolute safety of the devices.

The panel announced that silicone-gel-filled implants would continue to be available, but only if saline-filled implants are not an option. For this reason, most plastic surgeons are using saline-filled implants almost exclusively.

When silicone-gel implants are used, it is only under a strict set of criteria. Patients who have silicone-gel-filled devices implanted must agree to participate in a study designed to monitor their health for five years after surgery. These and other research studies are now underway to answer questions regarding the safety and long-term effects of these devices.