Dr. Zuckerman on Press Conference / Breast Cancer & Implants

[Guest guest]

We released our new report at a National Press Club Newsmaker event

today. The press release is below and the report is at

http://www.center4research.org/pdf/ImplantReport2006.pdf. Thanks so

much to breast cancer/implant survivors Lynda Roth and Pam Noonan-

Saraceni for coming to DC to speak at our press event. We were also

joined by Dr. Wood, Bettye Green of African American Women in

Touch, Pamela Bridgewater of Our Bodies Ourselves, and Pearson

of National Women's Health Network.

Our next step is to share the report and recommendations with

Members of Congress. We'd love the help of those of you who are

willing to write to your Senators and Congressional representative.

Best wishes,

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 "

(Washington, D.C.) – Breast cancer survivors who undergo

reconstructive surgery with silicone implants have access to very

little research-based safety information about the likely risks,

according to a report released today by the National Research Center

for Women & Families. Dr. Wood, former director of the U.S.

Food and Drug Administration's 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 condition that

they participate in clinical trials, implant manufacturer Inamed

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 the intended population, " said

Dr. Wood, former director of the FDA's Office of Women's

Health.

The report focuses on the lack of adequate short-term 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-Saraceni, 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 for Women & Families 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.