Hopes for Silicone Implants May Have Been Over-Inflated
Women Still Cautious Despite FDA Ruling
Jan. 10, 2007 — -- When the Food and Drug Administration lifted the 14-year moratorium on silicone breast implants in mid-November, many believed that the move would have women rushing to their plastic surgeons for these once-forbidden enhancements.
However, some prominent plastic surgeons say the reaction remains tepid.
"In my own practice, I have not seen people necessarily swinging one way over the other," says Dr. Darrick Antell, an official spokesperson for the American Society of Plastic Surgeons and a surgeon in private practice in New York City.
"Most women in my practice remain skeptical of the FDA approval of silicone gel and continue to choose saline implants," says Dr. Ronald Friedman, director of the West Plano Plastic Surgery Center in Plano, Tex.
The reason, Antell and Friedman say, is that many women remain wary of silicone implants, despite the FDA's exoneration of the devices months ago.
"I think that with regard to silicone implants, while it is nice to know that science has put everything to rest, people still have reservations," Antell says.
"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."
For 14 years, an FDA-issued moratorium on silicone breast implants for cosmetic use drastically limited their use in the United States. The moratorium was adopted after thousands of women complained that silicone from leaky or burst implants made them seriously ill.
Since then, however, the implants largely have been cleared of concerns that they might cause serious or chronic illnesses such as cancer or lupus.
And though critics said that the FDA had not fully examined all of the facts surrounding the dangers of silicone, the FDA revoked the moratorium, making silicone implants available to women over the age of 21, as well as all breast reconstruction and revision patients.