Diana Zuckerman, PhD, National Center for Health Research, Detroit Free Press: December 1, 1999
Every autumn, newspapers and magazines and the Internet are filled with helpful information aimed at increasing our awareness of breast cancer.
The goal is to improve early detection, and it works. Nevertheless, the sad truth is that many of the 175,000 women who will be diagnosed with breast cancer next year will not have all the information they need to get the treatment that is best for them.
This year, 6,500 Michigan women will have been diagnosed with breast cancer — more than 43 other states. They are beginning a terrifying journey, one that will involve making life-changing decisions. For many, these decisions will be based on inaccurate and misleading information rather than “informed consent.”
Medical experts are finding, for example, that many women are not told about the excellent safety record of lumpectomy — the removal of the cancer and the tissue around it. This procedure is less traumatic for many women than losing an entire breast, but many women are never told about that option. Older women, poor women, and women in the Midwest and South are especially likely to have unnecessary mastectomies.
Michigan is one of the few states that requires that newly diagnosed breast cancer patients receive information about lumpectomies. Unfortunately, research indicates that this law has had limited success — after an initial increase in lumpectomies, there was a return to the old surgical habits. Recent increases in lumpectomies are apparently due to slowly changing habits, rather than legal requirements.
Meanwhile, many mastectomy patients choose breast reconstruction, but this too provides options rather than objective information. Reconstruction using the woman’s own tissue is increasingly popular, but there are very few studies evaluating the safety of the various procedures.
Even more shocking, the Federal Drug Administration has never approved any kind of breast implants as safe and effective, even though implants have been sold since the 1960s. The saline implants that have become increasingly popular in recent years have not been evaluated in any major studies.
Two weeks ago, the manufacturers of saline implants were required to submit safety studies to the FDA for the first time. Which manufacturers submitted safety studies and what do those studies indicate? None of that information is public, and it will be months before any of these studies are available to patients or doctors. Even then, since the manufacturers’ economic well-being depends on the conclusions, it would be difficult to consider these studies objective.
Members of Congress from Detroit and elsewhere have worked hard to increase funding for government research on breast cancer, and yet our government has never funded a single study of the safety of breast implants for mastectomy patients. It’s difficult to believe, but former officials at the National Institutes of Health decided it was too complicated and expensive to study what happens to breast cancer patients who get breast implants.
When Congress required the National Cancer Institute to study the safety of breast implants, NIH ignored its plea to include mastectomy patients. It’s crazy but true: When the government’s study is published in the next few months, it will not include even one mastectomy patient.
McGhan Corp., a breast implant manufacturer, recently conducted a five-year study of mastectomy patients. It showed terrible problems: One out of four of the women need additional implant surgery within a year, and one out of four had their implants removed within two years.
The study results were provided to the Institute of Medicine for their expert panel’s recent review, but perhaps because it was unpublished, those experts didn’t think these problems were important enough to mention in their widely publicized report. As a result of this omission and others like it, the headlines gave implants a clean bill of health instead of warnings for mastectomy patients.
“It was hard enough losing my breast to cancer — I was devastated to lose it again when the implant failed” is a comment I have heard from many cancer survivors, whether they tried silicone or saline breast implants.
Even worse are the stories from cancer patients who describe terrible pain, infections that wouldn’t go away, and sores or lesions on their breasts, back or arms. When these terrible side-effects were duly noted by their doctors and reported to the manufacturers or the FDA, they were referred to as merely “local complications.”
Meanwhile, breast cancer patients and their doctors read the headlines about the safety of breast implants, and assume that implants are safe for mastectomy patients. They are not warned about the lack of research on mastectomy patients, or told that the few existing studies indicate the need for multiple surgeries, many of which are unsuccessful.
Tuesday’s $3.2-billion settlement by Dow Corning Corp. represents a bittersweet compensation victory for the 170,000 women who claimed injury from their silicone breast implants. But for those women who chose implants after being diagnosed with breast cancer, better information about the risks of implants and alternatives to mastectomies could have enabled them to avoid the heartache of additional health problems and a lawsuit.
Public support for medical research has probably never been higher. Awareness campaigns are working. But isn’t it time we spent more of those resources to make breast cancer patients aware of the safe alternatives to mastectomy and to develop the safest possible reconstruction options for women who truly need them?