Dangers of Silicone Breast Implants
For more than a decade, the potential dangers of silicon breast implants have raised serious concern among plastic surgeons and their patients. Various studies found that when the gel-filled implants ruptured or leaked, they caused severe health complications such as autoimmune diseases. Then in 1992, the U. S. Food and Drug Administration made the decision to temporarily ban silicone breast implants from the market until the safety of the devices could be confirmed.
For the last 14 years, a number of long-term clinical trials have been conducted to determine the dangers of silicone breast implants. In November 2006, the FDA announced that the devices are safe and re-approved them for use in women over 22 years of age. The implants are indicated for use in cosmetic enhancement, revision surgery, or reconstruction surgery.
Reported Risks of Silicone Implants
While the FDA has confirmed the safety of silicone implants, many remain skeptical. The reported dangers include a number of serious health conditions including:
- Degeneration of the breast tissue
- Necrosis (the formation of dead breast tissue)
- Hematoma (collection of blood in the body)
- Toxic shock syndrome
- Autoimmune diseases
- Breast cancer
Conditions of the FDA's Approval
While there are still concerns about the dangers of silicone breast implants, the FDA has performed an extensive review of all preclinical and clinical data of the risks associated with rupture or leakage and found no evidence that the devices cause autoimmune disease or cancer. However, as part of the approval, the FDA has outlined a number of conditions that implant manufacturers must meet to ensure the safety of silicone breast implants, including:
- Continue a core study of the dangers of silicone breast implants for 10 years
- Conduct a large, 10-year post-approval study involving 40,000 patients
- Continue lab research to determine causes of device failure
- Conduct an independent, focused study of the approved labeling
- Track every implant in case of updated safety information
Furthermore, the FDA urges all patients with silicone breast implants to receive frequent mammograms to identify "silent" leaks or ruptures and also to ensure immediate breast cancer diagnosis, since implants may make it more difficult to detect the disease.