The Return of Silicone Breast Implants

The Food and Drug Administration announced its approval of silicone breast implants late Friday afternoon, a timing ploy favored by officials who hope to minimize attention to controversial actions. Although critics attacked the decision as a threat to women's health, the agency made a reasonable call that will allow women, in consultation with their surgeons, to make their own judgments. The silicone implants are widely thought to be more natural and softer than the saline implants that now dominate the market.

The silicone implants were largely banned in 1992 because the manufacturers could not prove they were safe and effective after health concerns arose. A barrage of lawsuits drove the main manufacturer into bankruptcy and led to payments worth billions of dollars to women who said they were harmed. But over the years a series of assessments concluded that the main fears were overblown. The implants did not appear to cause such major diseases as cancer, rheumatoid arthritis, immunological diseases or neurological problems.

That does not mean they are risk free. In approving the silicone implants made by two companies, the F.D.A. said simply that it had "reasonable assurance" that the devices were safe and effective, not ironclad proof. It approved the devices for cosmetic breast augmentation in women age 22 and older and for breast reconstruction in women of all ages whose breasts have been disfigured or removed for medical reasons. But it heaped on enough caveats to give women ample reason to pause before leaping into cosmetic breast surgery.

The devices are prone to rupture, contract or cause pain and inflammation in the breast as time goes on. One study found that 69 percent of the recipients experienced a rupture, and almost a quarter of the women who received one manufacturer's implant for cosmetic reasons had to have it removed within the first four years. The F.D.A. recommends that women have regular M.R.I. screenings to detect whether their implant has ruptured, imposing a lifetime cost that can exceed the thousands of dollars spent on the initial surgery.

The agency will require the manufacturers to track 80,000 patients for a decade to make sure no health concerns arise. Unfortunately, it has a poor track record in forcing companies to complete post-marketing studies. It will need to be vigilant in keeping the implant makers honest.

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