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 today by the National Research Center (NRC) for Women & Families. Dr. Susan Wood, former director of the U.S. Food and Drug Administration’s (FDA) Office of Women, was a speaker at a National Press Club Newsmakers’ event where the report was released.
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.
The report reveals that:
* After selling silicone breast implants to tens of thousands of mastectomy patients in the last 5 years, under the conditions that they participate in clinical trials, implant manufacturer Implant included only 80 mastectomy patients in their longitudinal safety study submitted to the FDA, and Mentor Corporation included 0 breast cancer patients in their only long-term study;
* Industry-funded research reveals that reconstruction patients experience two to three times as many complications and additional surgeries as augmentation patients;
* Most ruptures (86 percent) are “silent” and can only be detected with MRIs, yet Inamed included less than 30 women in their sample of breast cancer patients undergoing MRIs to determine rupture rates, and the medical societies for plastic surgeons do not advise women to undergo MRIs.
* Research consistently indicates that reconstruction patients are not enjoying life more than mastectomy patients without reconstruction, and there is evidence they may be more likely to commit suicide; and
* Breast implants can limit treatment options for later breast cancer.
“For a woman to survive breast cancer and then find herself facing additional surgeries because of a poorly tested product is terribly unfair,” said Dr. 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 Dr. Susan Wood, former director of the FDA’s Office of Women’s Health.
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.”
The report was released at a National Press Club Newsmaker event today, sponsored by the National Research Center (NRC) for Women & Families. NRC is a nonpartisan, nonprofit research and education organization that works to improve policies and programs that affect the health and safety of women, children and families.