Health  
Risky Reconstruction
and Breast Cancer
By Elayne Clift

"I received my silicone implants following a double mastectomy. During the first year I experienced chest pain and headaches. By the eleventh year, a sonogram verified a silent rupture [of the implants]...I was diagnosed with several diseases,  including rheumatoid arthritis."

"I was told by my doctors I needed mastectomies, radiation therapy and breast implants. I trusted the doctors...I didn't know that safety studies of breast cancer survivors with implants had never been done before."

"When I was 22 years old, I had a bilateral mastectomy and I got silicone gel breast implants. My breasts started to get hard; the implants were replaced and the new implants also hardened. This continued for years. It's easy to call an implant 'new and improved' but you won't know if it is really better until it has been inside a woman's body for 10-15 years."

These testimonials appear in a new report - "Decisions in the Dark: The FDA, Breast Cancer Survivors, and Silicone Implants" - released in February 2006 by the National Research Centre for Women and Families (NRC), a non-profit research and education organization based in Washington DC.

The report reveals that breast cancer survivors who undergo reconstructive surgery using silicone implants have access to very little research-based information about the likely risks. It warns that industry-funded data shows that reconstructive surgery patients experience substantially more complications, ruptures and a greater need for additional corrective surgeries than women who receive implants for augmentation. The report also highlights research carried out  by the US Food and Drug Administration (FDA) showing that silicone implants interfere with mammography and may limit future breast cancer treatment options such as lumpectomy and sentinel node biopsy.

Among the more alarming findings in the report was the fact that a manufacturer of silicone implants had included only 80 mastectomy patients in a longitudinal safety study submitted to the FDA, although it had sold tens of thousands of silicone breast implants to mastectomy patients under condition that they participate in clinical trials. Another company did not include a single breast cancer patient in their long-term study.

Industry-funded research reveals that reconstruction patients experience two to three times as many complications and additional surgeries as augmentation patients. And while most ruptures (86 per cent) are 'silent' and can only be detected with MRIs (magnetic resonant imaging), medical societies representing plastic surgeons do not advise women with silicone implants to undergo MRIs. Further, silicone breast implants can limit treatment options for later breast cancer, a fact often withheld from patients during decision-making.

The NRC report also says that research has consistently indicated that reconstruction patients do not enjoy life more than women who opt not to have implants. It even says that there is evidence to suggest that implant patients may be more likely to commit suicide.

"For a woman to survive breast cancer and then find herself facing additional surgeries because of a poorly-tested product is terribly unfair," says Dr Diana Zuckerman, President of NRC and author of the report. "It is critical that implant manufacturers include breast cancer survivors in their research and that they carefully test for any adverse health impacts that occur over the lifetime of these devices."

"It is disturbing that the FDA would consider approving these devices despite the lack of data for breast cancer patients," adds Dr Susan Wood, former director of the FDA's Office of Women's Health.

More than 200,000 US women will be newly diagnosed with breast cancer this year, adding to the millions already living with the disease. According to the NRC report, although three out of four of these women will be eligible for lumpectomies (removal of the tumor and surrounding tissue only), about half of them will opt for mastectomy instead. Many of those women will choose some type of reconstructive surgery, often immediately after the mastectomy.

Silicone gel breast implants first became available in the 1960s but manufacturers were not required to conduct safety studies. Only in 1976 did the FDA begin to require that all medical devices, including breast implants, be regulated. However, breast implants were 'grandfathered' in, allowing them to continue to be sold without requiring safety studies. Breast cancer manufacturers were given until 1991 to conduct research and provide data to prove that their silicone gel implants were safe. However, when the studies were scrutinized by FDA scientists, not a single company was able to demonstrate the safety and efficacy of its products. The Compassionate Need Exemption of 1992 allowed implants to remain available on a limited basis. Not currently available to the general public, they are available to breast cancer survivors as 'investigational devices'. Since 1992, an estimated 70,000 women have been implanted with silicone, according to industry reports.

While the Compassionate Need Exemption is often described as a "clinical trial for breast cancer reconstruction patients", most women who received implants under the exemption never had breast cancer, according to the NRC report. "Instead, according to information provided by the FDA, in most cases a physician arranged for silicone implants when patients' previous saline or silicone breast implants were unsatisfactory, or for 'reconstruction' for women whose breasts were described as 'deformed' because they sagged from aging or breastfeeding."

Since 2000, several well-designed studies conducted by scientists at the National Cancer Institute have found that implanted women are at increased risk of dying from brain cancer, lung disease or suicide. FDA scientists have published several articles indicating a high rupture rate among women with silicone breast implants for at least six years, leakage outside the scar tissue among 21 per cent of women with implants for that long, and an increase in several autoimmune diseases among women with leaking implants. Unfortunately, none of these studies included any breast cancer reconstruction patients.

Nevertheless, in 2005, the FDA signaled its intention to possibly approve silicone implants, sending 'approvable letters' to two manufacturers if certain conditions could be met. At the time of the NRC report's release in 2006, those conditions had not been made public. More than a dozen public health organizations, researchers, physicians and non-profit organizations have petitioned the FDA to deny the companies' current applications for FDA approval because neither company had provided 'reasonable assurance' that its silicone implant products are safe.

According to the NRC: "In addition to silicone gel breast implants, breast cancer patients have the choice of saline breast implants or, in many cases, tissue transfer surgery. Clearly, women considering breast implants to replace a breast lost to cancer need to be fully informed of the long-term consequences of this choice before they make it."

April 2, 2006

(Elayne Clift is an academic and the author of several books on women's issues, health and perspectives.)    

By arrangement with Women's Feature Service 

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