The Controversy Over Silicone-Gel Implants
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, the U.S. Food and Drug Administration (FDA) Advisory Council panel met to review the issues. On November 17, 2006, the FDA approved the marketing of silicone gel breast implants for breast reconstruction in women of all ages, and for breast augmentation in women aged 22 years and older. After reviewing the clinical trial data and other information, they concluded that the silicone gel implants are safe and effective. The FDA will require monitoring women in a large post-approval study following 10,000 women for 10 years after receiving breast implants. The FDA also plans to conduct focus groups, continue laboratory studies, and track each implant for updated product information.
After reviewing the clinical trial data and other information, the panel concluded that the silicone gel implants are safe and effective. The FDA will require monitoring women in a large post-approval study following 10,000 women for 10 years after receiving breast implants. The FDA also plans to conduct focus groups, continue laboratory studies, and track each implant for updated product information.
The panel has lifted the ban on silicone gel implants. However, here are some important factors that women should consider when deciding about implants:
- Breast implants do not last through a lifetime; a woman will likely need additional breast surgeries.
- Changes to the breast following breast implants are irreversible(permanent).
- Silicone gel implant rupture is usually asymptomatic(without symptoms).
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:
- 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 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(repeat) 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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This information is provided by the Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition. This document was last reviewed on: 11/16/2015...#8337