When The Subject is Breast Implants, How Much Information is Enough?

Diana Zuckerman, PhD, National Center for Health Research, Knight Ridder newswire: July 1999

Breast implants have been incorrectly given something resembling a “clean bill of health” by the media, in response to a recent Institute of Medicine report. The report was not a new study, but it was based on more than 3,000 articles and book chapters. So, how dare I suggest that this isn’t enough information to conclude that breast implants don’t cause serious diseases?

Neither the report’s spokespersons nor the media reports mentioned that the controversial conclusions regarding autoimmune disease were based on only 17 epidemiological studies, almost all of which were conducted with funding from implant manufacturers or plastic surgeons. Certainly, both have overwhelming financial motives to support research designed to “prove” that implants are safe.

Despite the attention that everyone knew would be focused on autoimmune diseases, the report said very little about the well-established shortcomings of those 17 studies. In fact, the scientists who wrote those studies were more critical of their own results than this report was. The 400-page report devoted only 8 pages to the topic of epidemiological studies of autoimmune diseases, and those primarily described the studies, rather than carefully analyzing their strengths and weaknesses.

Most scientists would agree with the report’s conclusion that the available studies do not provide convincing evidence that implants cause autoimmune disease. But, there is a proverb in medical science that “If you haven’t proven a product is harmful, that doesn’t mean you have proved it is safe.” Some of the diseases studied, such as scleroderma, are extremely rare, striking one in several hundred thousand women. Many diseases also take many years to develop. We can’t draw conclusions about long-term safety regarding rare diseases based on studies of a few thousand women, especially when many had implants for only a few months or a few years.

Although it received much less attention, the report also pointed out that breast implants break, usually after 5-10 years, and that the silicone gel can spill into the body. These ruptures can result in silicone dripping from the nipples or terrible pain, and certainly require surgery. In addition to those serious problems, many of the women who are seriously ill believe their problems started when their implants broke. It would certainly make sense to study those women to see if they are more likely to have autoimmune or other diseases, but that has never been done.

The report was limited by the existing published research, but more information will be available in the coming year. A study of more than 13,000 implant patients, who had implants for a relatively long period of time, is being completed by the National Cancer Institute. In addition, government researchers will analyze medical information about implant patients who received payments based on a court-approved diagnosis of scleroderma. Until a few weeks ago, the implant manufacturers had successfully blocked access to that information, making such research impossible. If the large number of women involved are proven to have scleroderma, which is very rare, that would convince any reasonable person that implants can cause serious illness.

The Institute of Medicine report’s results are consistent with today’s conventional wisdom that breast implants are safe. But let’s remember that the conventional wisdom used to be that cigarettes were safe and that Agent Orange did not harm Vietnam vets. And sometimes erroneous conventional wisdom has been based on the views of the same kind of “blue ribbon panels” and university scientists as the current “wisdom” on breast implants.

When will we have enough information to conclude whether implants are truly safe? The number of studies is not as important as their quality. When well-designed research has studied larger numbers of patients who have had implants for a longer period of time, then we will have the answers that so many women are waiting for.

Diana Zuckerman, PhD is president of the National Center for Health Research.

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