Breast implants: Silicone headlines gloss over the real risks

Silicone breast implants are designed to get attention. But it’s almost never a good thing when they show up in headlines.

A new FDA report on silicone implants is a mixed bag for the millions of women who are currently living with them. On the plus side, the FDA says there’s no evidence that the implants can cause lupus or fibromyalgia or other diseases that have worried implant users for many years. But those sacks of silicone aren’t foolproof, either.

The agency estimates that 20% to 40% of women who receive the implants for simple breast enhancement will need another operation within eight to 10 years because of pain, infection, scarring, shrinking, unsightliness or other complications. For women who received implants under more serious circumstances — such as reconstructive surgery following a mastectomy — the chances of a follow-up operation are more like 40% to 70%. As is so often the case with medical devices and procedures, it’s not the big, scary outcomes that are the biggest threat. It’s the mundane stuff that could get you in the end.

News reports — along with thousands of lawsuits — in the early 1990s helped spread widespread fears that implants were like squishy time bombs. The concerns gained so much momentum that the FDA took the implants off the market in 1992, although they were still available for some women who were in clinical trials or who had ruptured bags that needed to be replaced.

The FDA approved two brands of implants — the Natrelle from Allergan and MemoryGel from Mentor — in 2006.

Now, five years and more than a million operations later, the risks have come into clearer focus. As manufacturers have long claimed, silicone itself seems to be essentially harmless, even if the bag breaks or leaks. An article in the journal Seminars of Immunopathology published in May summed up the situation: Those claims that implants could cause fibromyalgia, rheumatoid arthritis, lupus or other diseases appear to have been driven by lawsuits, not science.

The agency reported earlier this year that some women with silicone implants had developed anaplastic large cell lymphoma (ALCL), a very rare type of cancer. The agency is still investigating to see if the implants had anything to do with the disease, but the risk appears to be tiny. According to a recent Mayo Clinic report, only three in 100 million women are diagnosed with ALCL of the breast each year. Even if it turns out that silicone implants triple or quadruple or a hundred-ple that risk— and nobody’s saying that they do — the chances that any particular woman will get ALCL is still vanishingly small.

The FDA says that any woman considering breast implants should have a clear understanding of the risks. The real risks, that is.