FDA: Silicone Safe But Not Permanent

The U.S. Food and Drug Administration today said studies suggest there is no known link associating cancer and silicone gel breast implants, however implants should not be considered permanent.

"The (studies) confirm that silicone gel-filled breast implants are safe and effective when used as intended," the FDA news release said. "Women should fully understand the risks prior to considering (them) for breast reconstruction or augmentation ..."

The FDA proclaimed that breast implants "are not lifetime devices" and 1 in 5 who had augmentation surgery will need them removed within 10 years and 1 in 2 who received breast reconstruction surgery will need the implants removed.


The FDA said the most frequently occurring complications stem from "hardening of the area around the implant," which requires either additional surgery or removal. However, the FDA emphatically said silicone implants do not cause cancer, even though more studies are needed.

"Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis," according to the press release. "However, in order to rule out these and other rare complications, studies would need to enroll mroe omen and be longer than those conducted thus far."

The FDA approved silicone implants for women in 2006, for women over the age of 22, after banning the practice for the previous 14 years. Each year in the U.S., over 300,000 women opt for silicone gel-filled enhancement.

Click HERE for more information from the FDA about breast implants. www.fda.gov/breastimplants