Statement of Sybil Niden Goldrich of the Command Trust Network on the

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Press Release

Source: Command Trust Network

Statement of Sybil Niden Goldrich of the Command Trust Network on theIntroduction of 'The FDA Scientific Fairness for Women Act'

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Thursday September 21, 5:32 pm ET

WASHINGTON, Sept. 21 /PRNewswire/ -- The following is a statement of Sybil Niden Goldrich of the Command Trust Network on the introduction of 'The FDA Scientific Fairness for Women Act': " The Command Trust Network and women from around the nation want to express our gratitude to Congresswoman DeLauro (CT-3) for her bold leadership to protect the health and well-being of American women by introducing the FDA Scientific Fairness for Women Act. Unfortunately, the FDA has time and again relegated the safety of women to the back burner and one only needs to read the news to see example after example, " said Sybil Niden Goldrich of The Command Trust Network. " The law is very clear: it is the responsibility of the FDA to establish the safety of a medical device BEFORE it is approved for general use, not to give approval and then simply hope for the best. This legislation would reinforce the need to establish safety before approval. Most important, it would require the FDA to determine the actual lifetime of silicone breast implants and ensure the safety of them for that period PRIOR to approval. We think this is an important step toward protecting the health and safety of American women and applaud Congresswoman DeLauro for introducing this important piece of legislation, " Goldrich concluded. Among other things, The FDA Scientific Fairness for Women Act would:

* Require that the safety of silicone breast implants to be demonstrated

for the life of the device and prior to approval;

* Hold FDA accountable for its actions if silicone breast implants are

approved by requiring the Secretary to report to Congress explaining

how the Secretary has complied with the requirements that the safety be

demonstrated for the life of the device;

* Require FDA to list potential members of Breast Implant Advisory

Committees with a short biography on the website, and would allow NO

exemptions for conflicts related to personal financial interests; and

* Require the FDA to provide for a study of the levels of platinum and

platinum salts in women with silicone breast implants, including

women's breast milk, and require them to convene and oversee the

creation of a panel of independent scientists to design the study.

Virtually all breast implants disintegrate in the body over time, according to independent studies. The largest-ever analysis of explantation showed that approximately half of silicone implants fail within 10 years and that three-quarter will rupture within 20.(1) The manufacturer's own data revealed that over half of cancer survivors and one in five cosmetic patients require additional surgery within 3 years of receiving breast implants.(2) In addition, a study conducted by the National Cancer Institute found that women with silicone implants had leukemia and cervical and brain cancers at twice the rate of women without implants.(3) (1) Marotta et al. Silicone gel breast implant failure and frequency of additional surgeries: analysis of 35 studies reporting examination of more than 8000 explants. Journal of Biomedical Materials Research, 1999; 48(3): 354-64. (2) FDA Summary Panel Memorandum, Mentor PMA Review Team, March 2, 2005; and FDA Summary Panel Memorandum, Inamed PMA Review Team, March 2, 2005. (3) Brinton et al. Cancer risk at sites other than the breast following augmentation mammoplasty. ls of Epidemiology, 2001; 11: 248-56.

Source: Command Trust Network