Breast Cancer Survivors Making Surgery Decisions With Limited Information, Says New Report

Former Director of FDA Office on Women's Health Speaks at

Release of 'Decisions in the Dark'



03 Feb, 2006, 00:00 ET from National Research Center (NRC) for Women & Families

    WASHINGTON, Feb. 3 /PRNewswire/ -- 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.
 
 

SOURCE National Research Center (NRC) for Women & Families
    WASHINGTON, Feb. 3 /PRNewswire/ -- 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.
 
 SOURCE  National Research Center (NRC) for Women & Families