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Press Release Source: Command Trust Network

Comments of Sybil Goldrich, Executive Director of the Command Trust
Network, on the FDA's 'Approvable Letter' to Inamed on Silicone Gel
Breast Implants
Wednesday September 21, 5:33 pm ET

WASHINGTON, Sept. 21 /PRNewswire/ -- The following is a statement by
Sybil Goldrich, Executive Director of the Command Trust Network:
"The FDA has once again shown it is more concerned about industry
profit than women's health. The Inamed approvable letter ignores the
recommendations of an FDA advisory panel, as well as the agency's own
staff scientists.

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"This is one more indication that Dr. Crawford and the agency's
political appointees have shown that the facts mean little to them.
They would rather bow to corporate interests than protect the public.
No wonder Dr. Susan Wood resigned her position has head of the Office
of Women's Health.

"At least Congress is concerned about breast implant safety. The FDA
must delay any final decision until an ongoing Congressional
investigation has thoroughly evaluated this flawed approval process.
No one agrees more than the women in the U.S. Senate -- nine women
senators recently signed a letter indicating their frustration with
the FDA on this and related issues.

"The FDA should not turn its back on almost 15 years of demanding safe
implant choices for women. If silicone breast implants are approved
after all of the FDA's other blunders this year, Crawford will have
shown that the FDA is the 'FEMA' of health care."

SYBIL'S BIO: Sybil Goldrich was the first woman to speak out about
problems with silicone gel breast implant when she published her story
in Ms. Magazine in 1988. Her subsequent activism led to restrictions
on the sale of the devices in 1992. Goldrich had four separate sets of
implants after mastectomy. Later surgery found silicone in her liver,
uterus and ovaries.

BACKGROUND: The U.S. Food and Drug Administration (FDA) today issued
an "approvable letter" to Inamed Corporation for their application to
lift restrictions on the sale of silicone gel-filled breast implants.
This is one of several intermediate steps in the FDA review process of
new products.

The letter comes after an advisory panel voted against approving
Inamed's application in April of this year. During the panel, FDA
scientists expressed grave concerns over the short-term data and lack
of meaningful long-term data presented by both companies. Several
clinical trial participants testified that they had been unable to
report their health problems.

Virtually all breast implants fall apart 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- quarters will rupture within 20[1].
The manufacturers' 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].

Last year more than 330,000 women got cosmetic breast implant surgery
and about 35,000 women had reconstruction after mastectomy. This
number has more than tripled since 1997.

The sale of silicone gel breast implants was restricted in 1992 to
women who needed them for medical reasons such as augmentation after
mastectomy or to replace a broken implant. The devices have been
available for augmentation since the late 1990s. Saline breast
implants -- a silicone shell filled with saltwater solution -- are
widely available.

[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. Annals of Epidemiology, 2001; 11:
248-56.

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Source: Command Trust Network