The Role of FDA on Breast Implants – Watchdog or Grandma?

Diana Zuckerman, PhD, National Center for Health Research, Knight Ridder Newswire: May 2000

When the FDA approved saline-filled silicone breast implants last week, it admitted that implants have a tendency to break and cause health problems, and urged women to consider the risks carefully before making a decision. If you thought FDA was supposed to be a watchdog and think that this sounds more like a helpful grandma, you’ve got the picture exactly right.

The FDA’s decision comes weeks after the plastic surgeons gleefully announced that the number of women getting breast implants has doubled in the last two years. In 1999, almost 200,000 women got breast implants, all of them made with silicone bags, most of them filled with saline. None of the breast implants sold to these women had ever been approved by the FDA as safe and effective. But in November, for the first time, implant manufacturers had to provide research data to the FDA to prove that their saline implants were safe.

The manufacturers’ studies, analyzed by FDA scientists, showed that between 73 percent and 84 percent of the breast cancer patients who tried saline implants had complications within three or four years. Those complications included additional surgery, broken implants, breasts that were as hard as a rock, excruciating pain and serious infections. These are not the kinds of problems that a breast cancer patient needs, and a product that causes these problems would not usually be called “safe.”

The bad news doesn’t end there. The complication rate for healthy women who wanted larger breasts was lower, but still was as high as 60 percent for some of the most popular saline implants. Even worse, the FDA was told by experts that breast implants interfere with mammograms, and can hide cancerous tumors, even when experts use more expensive, special techniques. FDA was told that of the almost 2 million women who already have breast implants, one in every eight will get breast cancer, and 20,000 to 40,000 of these women will have a potentially deadly delay in their diagnosis because of their implants.

The FDA decided that, despite those risks, women should have a right to choose implants if they want them. The FDA does not want them to be sold to girls under 18, but they know that they can’t stop that from happening. Apparently, the FDA believes that doctors can be persuaded to provide accurate information about the risks, especially if given an attractive government brochure that provides that information.

Would any woman put a breast implant in her body if she realized that it would break after a few years, could grow bacteria or fungus inside, and might cause her breast to get hard and painful? Would she be reluctant if she knew that each additional surgery would mean that she would lose some of her own breast tissue and she would get new scars where the implants are inserted and removed? What would a young, healthy woman think if she were told that breast implants stretch her own breasts so out of shape that they will never look as good again if she needs to remove the implants? My guess is that she would run out of the plastic surgeon’s office and never come back, but if I’m right, the plastic surgeons will soon learn that providing accurate information to patients is not in their best interest.

I have no doubt that women are smart enough to make good choices if they have good information, but I have some doubts that they will ever get the information they need. Most have already heard, from the media or their doctors, that breast implants are safe. They haven’t seen the fine print, which specifies that the widely publicized studies of breast implants did not measure potentially expensive and devastating “local complications” such as broken implants, repeated surgeries, or breasts that are very hard and painful.

Most patients trust their doctors and believe what they are told. Most doctors rely on information that is conveniently and persuasively provided by the manufacturers, or possibly their local media. You don’t need to be a rocket scientist to know that FDA approval will increase the popularity of implants, and not necessarily increase information about the risks.

Perhaps most distressing, now that the FDA has approved saline implants, the manufacturers have no incentive to improve their implants, because they couldn’t sell a new and improved implant unless they go through a lengthy and expensive approval process. So, even though everyone might agree that it would be better to have safer breast implants available, it is unlikely that any manufacturers will have the incentive to develop them.

A watchdog prevents dangerous products from being sold to the public. A helpful grandmother provides information and advice, and tells the individual to make a decision and live with it. Teen-agers and adults make decisions all the time, but we rely on watchdogs to eliminate risky medical products because the stakes are so high. Once a woman has a breast implant in her body, her body is changed forever, and removal is expensive.

FDA has decided that it’s up to us to determine what is safe. Let the consumer beware.

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