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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 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 a treatment option. For
this reason, most plastic surgeons are using saline-filled implants almost
exclusively.
If 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 implant 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.
1999 Institute of Medicine (IOM) Report
The
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.
What the IOM committee found –
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 implants are local.
- Breast implants do not last forever.
1999 IOM study 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.
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