Silicone breast implants famously went, ahem, bust in the 1990s. Women sued the manufacturers, claiming the products ruptured, leaked and caused diseases like connective-tissue disorder. In 1992 the Food and Drug Administration (FDA) banned them—except in reconstructive cases—until clinical studies were done, leaving most implant-seeking women in the U.S. with only one option: saline (although saline results in smaller scars, silicone feels more natural). Now silicone is back. The FDA found no link between silicone implants and systemic disease and approved them for general use last November. The question on many women’s minds is, silicone or saline? Says Alan Engler, M.D., a New York plastic surgeon: “The concerns about silicone are not medically valid.”
The former editor of the New England Journal of Medicine, Marcia Angell, wrote a book in 1996 to that effect, Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case. Most important, today’s silicone implants are made of a cohesive gel that’s less prone to leaking. These aren’t the implants of twenty years ago.” Still, the debate continues, and there are conflicting conclusions about the risks of silicone leaking and migrating to neighboring organs. The FDA recommends MRI screenings every two or three years to check for ruptures and also advises replacement of ruptured implants.
Expect further data down the road: manufacturers will be conducting a ten-year study that tracks 40,000 women who’ve received implants.