Silicone breast implants are back

Silicone breast implants banned in the U.S. in 1992 because of safety concerns are back. The U.S. Food and Drug Administration (FDA) on November 17, 2006, approved the marketing of silicone gel-filled breast implants made by two firms, Santa Barbara-based Mentor, and Irvine, Calif.-based Allergan for breast reconstruction in women regardless of age, and for cosmetic breast augmentation only in those 22 years and older.

According to the FDA, it took the decision based on a painstaking review of each firm’s clinical (core) and preclinical studies, of studies by autonomous scientific organizations, and discussions of advisory panels of external experts that examined numerous public complaints. It also inspected each company’s manufacturing facilities to ensure compliance with its Good Manufacturing Practices.

The FDA noted some of the complications reported in the core studies, namely, hardening of the periphery of the implant, breast pain, change in nipple sensation, implant rupture and the need for further surgery, but affirmed most women’s satisfaction with their implants. Nonetheless, the agency still wants each firm to follow up about 40,000 women that received breast implants for 10 years among other conditions, to ensure the implants continue to be safe and effective in the long term.

The follow up will collect information on rates of connective tissue disease, although the FDA observed that studies that examined if silicone gel-filled breast implants has links with connective tissue disease or cancer, including a report by the Institute of Medicine, did not reveal convincing evidence for such links. Other information that FDA wants collected include rates of local complications and of neurological disease, potential effects on offspring and on reproduction and lactation, cancer, rupture, and suicide rates, possible interference with mammography, and MRI compliance.

Many women who have had mastectomy as part of breast cancer treatment request breast implants, although there are also many who loathe the implants, some because of unpleasant personal experiences they or individuals they know had with them. Safety concerns remain rife, in particular those by some who question the long-term integrity of the implants, if they would rupture, how long before they did, and the potential health effects of leaks by the silicone to other parts of the body.

It is uncertain whether the rigorous approval process and the stringent follow up conditions, and other measures such as requiring women who have received these breast implants to have magnetic resonance imaging done every two to three years to make certain the implants are not leaking, would appease the skeptics. These issues point no doubt to the need for the release by relevant agencies and organizations of information on these implants to the public, and urgently too.


Please visit www.fda.gov/cdrh/breastimplants for more information.