MANAGED CARE ALERT
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Breast cancer survivors making surgery decisions with limited information
Breast cancer survivors who undergo reconstructive surgery using silicone implants have access to very little research-based information about the likely risks, according to a report released by the National Research Center (NRC) for Women & Families.
Susan Wood, former director of the U.S. Food & Drug Administration's (FDA) Office of Women, was a speaker at a National Press Club Newsmakers' event where the report was released.
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Decisions in the Dark: The FDA, Breast Cancer Survivors, and Silicone Implants warns that industry-funded data indicates that reconstructive surgery patients experience substantially more complications, ruptures and a greater need for additional corrective surgeries than women who receive implants for augmentation purposes. The report also highlights FDA research showing that silicone implants interfere with mammography and may limit future breast cancer treatment options such as lumpectomy and sentinel node biopsy.
"For a woman to survive breast cancer and then find herself facing additional surgeries because of a poorly tested product is terribly unfair," said Diana Zuckerman, president of the National Research Center for Women & Families, and author of the report. "It's 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," said Susan Wood, former director of the FDA's Office of Women's Health.
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The report focuses on the lack of adequate short- or long-term clinical data being provided to the FDA by implant manufacturers for all breast cancer patients. However, those least represented in the current research are women of color, such as African American, Asian and Hispanic breast cancer patients.
"We have good reason to believe the medical experiences of these women differ from those of white patients," said Bettye Green, RN, president of African American Women in Touch and a breast cancer survivor and nationally- respected advocate who spoke at the event. "Women need better information about implants and their long-term safety and effectiveness so that they can make informed choices about the risks of reconstructive surgery."
Pam Noonan-Sarceni, a breast cancer survivor, said she would not have chosen silicone implants had she known years ago what she knows now. "I trusted my doctors when they told me the implants were safe and would last forever."
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