In November 2006, the FDA allowed silicone impants back on the market. In June 2011, the FDA released a follow-up statement on the clinical and scientific information for the use of silicone gel-filled implants. This report reiterates the safety of silicone implants for breast augmentation and breast reconstruction.
A brief summary of the FDA’s findings:
. When used as labeled, silicone implants are reasonably safe and effective.
. No association is evident between silicone implants and connective tissue disease, breast cancer or reproductive problems.
. Breast implants are not a permanent lifetime device and will have to be replaced. “Between 20 to 40 percent of augmentation patients and 40 to 70 percent of reconstructive patients had reoperations during the first 8 to 10 years after they received their implants”.
. An MRI is recommended for detecting silicone implant ruptures.
