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.

Saline-filled implants are still available without restriction for reconstruction. However, the FDA is also expected to require manufacturers of these devices to submit safety and effectiveness information in the near future.

Another Safety Report

The U.S. Department of Health and Human Services commissioned the Institute of Medicine to conduct an independent review of all past and ongoing scientific research regarding the safety of silicone breast implants. It is the most comprehensive and current information available on the safety of silicone implants.

Following are the most prominent points of the report which was released in 1999:

Positive Findings

  • Silicone implants do not cause major disease
  • Breast implants have improved
  • Radiation doesn't harm implants and vice versa
  • In general, silicone is safe

Negative Findings

Conclusions:

  • There is no evidence that silicone implants are responsible for any major disease.
  • There is no increase in either primary or recurrent breast cancer in women who have breast implants.
  • Many women have local problems such as contracture (scarring around the implant), rupture or implant removal. Implants don't last forever. This recent independent study has given surgeons and patients more confidence in using silicone gel implants for breast reconstruction.

If you have questions about the safety of implants, talk to your plastic surgeon.

Reviewed by the doctors at The Cleveland Clinic, Department of Plastic Surgery.
Edited by Charlotte E. Grayson , MD, Sept. 2003.

Portions of this page © The Cleveland Clinic 2000-2003.



Last Editorial Review: 1/31/2005 7:05:54 AM




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