Despite FDA's recent approval (November 2006) of silicone breast implants, there still are considerable risks that women must consider before walking into the operating room. The FDA approval stipulates that the manufacturers inform women that the implants are not lifetime devices and that most recipients will need at least one additional surgery to replace or remove their implants. In addition, women also will need to receive magnetic resonance imaging every two to three years to ensure the implants are not leaking.

The medical community does not have a clear picture of how many women have become sick due to a leaking implant. Silicone that leaks into the lymph nodes poses greater risks than leaking saline. Requiring silicone manufacturers to conduct a study on the implants long-term effects after the approval is the greatest indicator that the FDA has proceeded too quickly. Women considering the implants need to be fully aware of the lack of data showing these implants are safe.