The Politics of Women's Health

Breast Implants

Silicone Breast Implants: No Safety Data Mean No Real Choices

Written by Judy Norsigian and Diana Zuckerman
November 2003

A split decision by an advisory panel to the Food and Drug Administration (FDA) recently recommended that restrictions be lifted and silicone gel breast implants be approved for the first time. The 9-6 closer-than-usual vote was orchestrated by the four plastic surgeons and two breast surgeons on the panel, who voted in lock-step for a product that would bring these doctors and their colleagues billions of dollars in future patient fees.

Most of the scientists and other doctors on the panel voted against approval. The toxicologist, epidemiologist, radiologist, statistician, dermatologist, and cancer surgeon bemoaned the lack of safety research for a product that has been sold for 40 years. 

They asked why the company seeking approval for silicone gel implants studied them for only 3 years, after selling the same implant since at least 1990. They pointed out that the main concern about breast implants is how to predict when an implant will leak, how to remove it safely before that happens, and what the health risks of that leakage are. They reminded us that these questions have never been answered.

Both of us have been in touch with hundreds of women with breast implants over the last dozen years. Together, we and our organizations have read every epidemiological study ever published on the topic, from start to finish. We’ve read the Institute of Medicine report on implants -- an often-quoted but rarely read tome that has been widely misquoted and misunderstood, so that thousands of teenagers and women are now sorely misinformed.
Marcia Angell and others have said that there is no conclusive proof that implants cause disease. That is true. So what is the problem? There are at least 4:

• #1: Silicone gel implants break and can leak to breasts, lungs, and lymph nodes

  We have spoken to dozens of women who describe the pain and deformity of having leaked silicone scraped from their own breast tissue or their chest wall. Others have told us of coughing up silicone from their lungs, or having nodules containing silicone on their faces, arms, breasts, and backs. Nipples dripping with silicone have been described by numerous clinicians as well as patients.

  According to research conducted by FDA scientists, all silicone gel implants will eventually break, most within 10 years, many without any obvious symptoms. When silicone leaks out of a broken implant, it can migrate to healthy breast tissue, the lungs, lymph nodes, and elsewhere where it is often impossible to remove. These leaks and the subsequent need for surgery are considered "local complications" rather than "diseases" but they show implants are not "safe" in the usual sense of the term, whether or not they cause disease.
  
  

• # 2: Long-term Safety Studies are Needed

  Research shows extremely high complication rates in the first three years. For example, 46% of breast cancer patients will have problems requiring additional surgery within three years. Long-term research is needed to study the health risks over 5 and 10 and 15 years, especially from leaking silicone. The FDA panel chair was "flabbergasted" that the company studied women who had implants for only two or three years, since FDA research shows that most silicone implants break after 10 years.

  Some argue that a 4-year-old Institute of Medicine report proves that implants are safe. Not true. The IOM report expressed strong safety concerns about "local complications" such as leaking implants. Although they were less concerned about implants causing diseases, their analysis was based on studies of women with implants for as briefly as a few months. Most diseases develop several years after an exposure, so longer studies are needed. After all, even chain smokers usually don’t develop lung cancer within 5 or 10 years.
  
  

• #3: Government Scientists have found links between implants and disease

  After the IOM report, the National Cancer Institute and the FDA completed studies on women who had implants for at least seven years. Among their disturbing findings: women with breast implants are more likely to die from brain cancer, lung cancer, or suicide compared to other plastic surgery patients, and women with leaking implants were more likely to have fibromyalgia and several other painful autoimmune diseases than women with intact implants.  Also, government-funded pathologists have found silicone from leaked implants in lymph nodes, lungs, and other organs.
  
  

• #4 Research is Needed on Implant Safety for Women of Color

  The safety of silicone breast implants is not the major health concern of women   of color, but those who are breast cancer patients frequently consider reconstruction with implants. Research shows that African Americans are more likely to get autoimmune diseases -- the major health concern for breast implants. And yet only six African American breast cancer patients were in the "core study" submitted by Inamed to prove implant safety to the FDA.  Research also shows that African Americans and Asian Americans are more likely to have excessive scarring, which is an important concern for cosmetic surgery, and could cause pain or deformity and interfere with mammograms for women with breast implants.

We reluctantly conclude that silicone gel implants cause pain and suffering for many women, while the long-term risks remain unstudied. The lack of research and difficulty with diagnosis has been used to unfairly discredit these women as well as the physicians trying to help them.  Unfortunately, recent, better-designed studies give new reasons for concern.

The "choice" to get breast implants is not a real choice, until we collect the much- needed data on long-term risks.  These risks are not remote “hypothetical” problems – as thousands of women have already made clear – and the FDA should require this long-overdue proof of safety before approving any silicone gel implants.

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