A Split Decision on Breast Implants

Diana Zuckerman, PhD, National Center for Health Research, The Washington Times: October 26, 2003

Breast implants are back in the headlines, with two equally passionate sides to the story. Both claim the science is on their side. Who is right?

In a split decision on October 15, advisers to the Food and Drug Administration voted to recommend that silicone gel breast implants are safe enough to have the FDA ‘seal of approval.’

The 9-6 vote for approval was orchestrated by the six plastic surgeons and breast surgeons on the panel who voted in lock-step. In contrast, most of the other doctors and scientists voted against approving the implants, citing the lack of safety information. To add to the drama, a panel member who seemed ready to vote against approval mysteriously disappeared before the vote. And the panel chairman, who only votes when there is a tie, said he would have voted against and was flabbergasted by the lack of safety information.

The spin machines are already working overtime. Plastic surgeons and implant manufacturers (and the lobbying and PR firms they generously support) remind us that women like silicone gel breast implants. They tell us that there is “no scientific evidence” that breast implants cause disease and that it is time to make them widely available again. They often back up this statement with a 4-year old Institute of Medicine report, which they claim proves that implants are safe.

On the other side, patients testified about the pain and deformity of having leaked silicone scraped from their chest wall– a problem that is considered a “local complication” rather than a “health risk.” Their testimony is the heartbreaking illustration of the Institute of Medicine report’s concerns that breast implants can break, leaking silicone inside the body. Although the Institute concluded that research did not prove implants cause disease, their report was only a review of the research available four years ago, most of it of women with implants for just a few months or years.

Most diseases — lung cancer for example — take more than a few years to develop. Implants tend to break after eight years or more, and the health risks of leaking silicone implants aren’t known. When scientists from the National Cancer Institute and the FDA recently conducted several studies on women who had implants for at least seven years, their results were frightening: Women with breast implants were twice as likely to die from brain cancer, 3 times as likely to die from lung diseases, and 4 times as likely to commit suicide, compared to other plastic surgery patients. Women with leaking implants were more likely to have fibromyalgia and several other autoimmune diseases.

The FDA advisors who voted against approval included a toxicologist, epidemiologist, radiologist, statistician, dermatologist, and cancer surgeon. They understood diseases take time to develop, especially since breast implants tend to break after 10 years, not two years. Their vote against approval was based on their concerns about long-term safety, and their criticisms that the company didn’t bother to study women who had implants for more than three years.

There’s even a divided opinion among our government health officials about the safety of breast implants. At the very moment when the FDA is considering lifting restrictions on silicone gel implants, the Medicare program has successfully sued implant manufacturers for tens of millions of dollars. Why? Because the government claims that women who became sick from their silicone implants have cost Medicare a lot of money in medical care.

You might wonder why the FDA would consider making a product more available when scientists question their safety and when government experts believe that it has cost our already-strapped healthcare system millions of dollars. This is a health question where it doesn’t help to ask your doctor –but you might try the lobbyists on Washington’s K Street. The companies that were successfully sued for billions of dollars by breast implant patients — such as Dow Corning, 3M, and Bristol Myers Squibb — are among the most powerful companies in the country. Perhaps their lobbyists are more effective than the women with implants who are coping with leaking silicone in their bodies.

The FDA’s mission is to safeguard all of us when we eat, use medical products, or are vaccinated. The division of opinion among FDA advisers reflects a frequent split — between those who are selling a product or procedure and think it is safe based on personal clinical experience, and those who believe research is necessary to prove such safety

There is passion (often called hysteria when it’s the “other side”) and science on both sides of this issue. The short-term research shows most women with breast implants don’t get diseases in the first few years. But there is little long-term research, and those studies raises serious questions about leaking silicone, illness, and death related to implants. In the meantime, research also shows extremely high complication rates — including the need for repeated surgeries. The bottom line is: Will the FDA demand a company prove its product is safe before “approving” it, or decide a company can experiment on millions of women while we wait for research to be completed?

We’ll find out soon.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.