Hopes for Silicone Implants May Have Been Overinflated

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Jan. 9, 2007

Following the November 2006 approval of silicone gel breast implants by the FDA, ABC News consulted plastic surgeons nationally. Dr. Friedman was quoted extensively:

“Many women are excited by the lifting of restrictions on silicone gel, but many more remain concerned about the safety of silicone gel,” Friedman says. “After $3 billion of lawsuits and a 14-year federally-mandated moratorium, it is no surprise that silicone gel remains controversial. I think that we may be sending out mixed messages by putting in silicone gel implants in the 1980s, taking them out in the 1990s, and putting them in again in the 2000s.” He went on to say, ” I think that sales of silicone gel implants, while partly revived by the FDA approval, will continue to lag behind sales of saline implants for several years. There is certainly a role for silicone gel implants,” Friedman says. “However, there are definite disadvantages relative to saline.” He says that since silicone implants are pre-filled-unlike their saline counterparts, which are “pumped up” only once they are in the body-the surgeon must make a longer incision to put them in. He also voiced concern regarding the FDA’s proposed MRI surveillance of silicone gel implants: “Who will pay for this $1000-or-more test?” Friedman asks. “Certainly not the FDA, the implant manufacturers, the plastic surgeons or the patients’ insurance companies. Ultimately this expense will fall upon the patients, most of whom will simply decline to undergo MRI.”