Cosmetic Procedures: 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 (autoimmune) disorders such as scleroderma or rheumatoid arthritis.

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 or more 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.

Conflicting Evidence

In 1999, the Department of Health and Human Services commissioned the Institute of Medicine (IOM) to conduct an independent review of all past and ongoing scientific research regarding the safety of silicone breast implants.

Following are the most prominent points of the report:

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

• Most problems with silicone implants are local
• Breast implants do not last forever

Since the 1999 IOM report, there have been other studies published with conflicting results.

A 2001 NCI study reported that women who had breast implants (both saline- and silicone-filled) were two to three times as likely to die of brain cancer and three times as likely to die of lung cancer, compared to other plastic surgery patients.

However, a follow-up study of this report showed that the excess risk of death from brain cancer in patients with breast implants was not as high as previously believed. The researchers also showed the rates of death from this cancer may not be significantly different than in other plastic surgery patients.

And that same year, FDA scientists published a study with findings of more autoimmune disease among women with leaking breast implants compared to women with intact breast implants.

More recently reported, in 2004, scientists at the National Cancer Institute (NCI) found an increase in reported connective-tissue diseases among those with breast implants, but also found that many of the women made errors in their self-reported diagnoses. They concluded that this area needed further study.

Talk To Your Doctor

While the topic of breast implants remains controversial, both types (saline- and silicone-filled) are still currently available. 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.