Breast Cancer Survivors Making Surgery Decisions With Limited Information

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Press Release Source: National Research Center (NRC)

for Women & Families

Breast Cancer Survivors Making Surgery Decisions With

Limited Information, Says New Report

Friday February 3, 8:53 am ET

Former Director of FDA Office on Women's Health Speaks

at Release of 'Decisions in the Dark'

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.

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.

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. 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.

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Source: National Research Center (NRC) for Women & Families