As the Food and Drug Administration (FDA) considers approval of silicone breast implants, the National Organization for Women (NOW) convened a panel of doctors and experts yesterday to talk about the possible long-term effects of the controversial product. “We believe that the FDA is rushing to approve silicone gel implants, and we’re very concerned about the health consequences for American women,” Kim Gandy, president of NOW told the Washington Post.
Banned in 1992 after numerous lawsuits found that the implants had caused a wide range of illnesses, silicone was replaced on the market by saline – which has been approved by the FDA. However, after studies came out in 2000 that claimed silicone did not cause the illnesses, several silicone-producing companies submitted applications to the FDA. Rulings are expected before the year’s end.
Gandy and the experts on yesterday’s panel noted that the studies cited in 2000 relied on data that reflected two years worth of effects. Meanwhile, long-term effects, of 10 years or more, were not studied – even though research conducted by the FDA has found that the “median silicone gel-filled breast implant age at rupture was in the range of 10 years,” according to NOW. “Two years of data is not going to give you any valid information so that women will know what’s going on in their bodies,” Gandy said as reported by Reuters. The panel concluded that the FDA should delay approval of silicone implants until they have studied the long-term effects. “If the FDA approves silicone gel implants now, women will assume they are safe since they have the FDA seal of approval,” Gandy told the Post. “They won’t think about risks and benefits – they’ll just assume FDA approval of something like this means they’re safe. But the science is still inconclusive and the concerns remain.”
The popularity of breast implants has grown rapidly over the past decade – more than 300,000 women received implants of all types last year compared to 32,000 women in 1992, according to the American Society of Plastic and Reconstructive Surgeons.