Breast Implant Safety
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 breast reconstruction. However, the FDA is also expected to require manufacturers of these devices to submit safety and effectiveness information in the near future.
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:
- Silicone implants do not cause major disease
- Breast implants have improved
- Radiation doesn't harm implants and vice versa
- In general, silicone is safe
- Most problems with silicone implants are local
- Breast implants do not last forever
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.