| Ilena Rose 2005-07-28, 10:54 pm |
| Comments of Sybil Goldrich, Executive Director of the Command Trust
Network on the FDA's 'Approvable Letter' to Mentor on Silicone Gel
Breast Implants
Thursday July 28, 7:33 pm ET
WASHINGTON, July 28 /PRNewswire/ -- The following is being released by
the Command Trust Network:
STATEMENT: "The battle is not over on silicone breast implants -- FDA
can still do the right thing. We hope that Crawford's first act as
commissioner will not be one of 'sales before safety.' He should not
stamp 'guinea pig' on the foreheads of hundreds of thousands of women.
As FDA staff scientists have said repeatedly, the safety data are
insufficient to show safety -- at best. At worst, the research has
been manipulated.
The absurd number of post-market approval conditions recommended at
panel cannot protect women from a defective product, especially since
the agency itself has made clear it is unable to enforce these
conditions.
If the FDA chooses to lift restrictions, Crawford will completely
reverse the standards for safety and data on breast implants of nearly
twenty years. Eighteen months ago, then-FDA Commissioner Mark
McClellan established a clear set of guidelines and required the
companies to meet them if they wanted FDA approval. Today, Dr.
Crawford has proposed lowering this standard. If the devices are
ultimately approved, Crawford will have abandoned any rational basis
for FDA's decision making and further underscored the necessity of
radical reform at the agency."
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 Mentor Corporation for their application for
silicone gel-filled breast implants that outlines a number of
conditions which the company must meet for full approval of the
devices. While this does not mean that Mentor may now market the
devices without restriction, it is one of several intermediate steps
in the FDA review process of new products. Inamed, another implant
manufacturer that is seeking approval for its silicone breast implant,
has not yet received indication of approval.
The letter comes after an advisory panel issued a split decision in
April of this year, recommending Inamed's application be denied and
Mentor's be approved. 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 to
the companies. In May, The New York Times reported that former Mentor
employees swore under oath that they had been required to suppress
information about breast implant problems.
The unusual number of post-approval conditions reflected the panel's
discomfort with the safety data on the devices. In addition to a
patient registry and required doctor training, the majority of
conditions focused on improving and continuing the research for 10
years. They also required an independent annual data review and
reconvening of the FDA panel in five years to analyze the data.
However, an FDA report released this March showed that the agency has
no power to enforce post-approval conditions and that the majority of
companies fail to meet them.
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 -- for augmentation after
mastectomy, for example, or to replace a broken implant. The devices
have been available for augmentation since the late 1990s in clinical
trials. 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
www.CommandTrustNetwork.org
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