| Ilena Rose 2006-09-28, 4:29 pm |
| http://www.now.org/issues/health/im...06implants.html
Toxic Platinum Found in Women With Implants; FDA Decision Expected on
Risky Silicone Breast Implants
By Jan Erickson, Government Relations Director
September 27, 2006
Despite our formal objections, NOW and other women's health advocates
are concerned that the Food and Drug Administration (FDA) will
nonetheless permit risky silicone gel breast implants, approving sales
of the devices while many critical safety questions remain unanswered.
Members of Congress have joined us in expressing concern about the
agency's recent actions regarding not only breast implants, but also
its inexcusable delay in approving Emergency Contraception (EC—Plan B)
for non-prescription sale—allowing it only for women 18 and older. In
their oversight role, some members of Congress are crafting
legislation to force the agency to make decisions based on science and
not on politics and corporate interests.
Rep. Rosa DeLauro (D-Conn,) introduced legislation on September 21
that would halt the breast implant approval process until the
manufacturers can demonstrate safety—meaning no rupture or leakage of
silicone into women's bodies. Rep. DeLauro's bill, The FDA Scientific
Fairness Act for Women, would also require an independent study of
toxic platinum salts in breast implants and would also establish a
scientific review panel to assess data on the use of emergency
contraception for women 17 and under.
Recently, the agency announced that it was requesting comments from
the public through October 9 concerning the results of a study that
found high levels of toxic platinum salts in the blood, urine, hair,
nails, sweat and breast milk of women exposed to silicone gel breast
implants. High levels of toxic platinum salts were also found in their
children, some of whom are now suffering from rare autoimmune
diseases.
"The finding of this toxic substance, if confirmed by other studies,
could help explain why so many thousands of women have become sick
after getting implants," said NOW President Kim Gandy. "And the
presence of platinum salts in the women's breast milk may finally
explain what is happening to some of the children born to women with
implants."
The study, published in the May issue of Analytical Chemistry, was
conducted by researchers Dr. Ernest Lykissa and Dr. Susan Maharaj, who
examined a relatively small group of women and found an oxidized form
of platinum, commonly called platinum salts, in their bodies. The
findings came under immediate criticism from implant manufacturers,
who said that the study was flawed because of the lack of an
inappropriate comparison sample of women without implants and because
the findings were inconsistent with company claims that the platinum
used in breast implants is a safe form, not the toxic platinum salts.
In an astonishing lapse of scientific ethics, the FDA placed on its
website a dismissive article about the Lykissa and Maharaj study on
platinum, relying heavily on a review by Dr. Michael Brook. Dr. Brook
is a paid consultant for Inamed Corp., one of the two manufacturers
seeking FDA approval for their silicone breast implants, and one of
several experts who was paid by the company to defend the safety of
silicone implants during FDA Advisory Panel meetings.
Concerns about the health effects of platinum and other substances
used in silicone implants were expressed by Dr. Lykissa and others at
a May, 2003 scientific symposium, sponsored by NOW Foundation.
Regardless of the specific findings of the Lykissa-Maharaj study, the
fact remains that there is a critical need for additional clinical
studies—independent of industry funding—on larger numbers of women and
their children. It is essential that children born to or breast-fed by
women with implants be examined.
Additionally, Dr. Daniel Schultz, director of the FDA's Center for
Devices and Radiological Health which reviews implant marketing
applications, wrote a letter to the National Research Center for Women
& Families, saying that he just didn't believe the results of the
study indicating the presence of toxic platinum salts. This shockingly
disinterested response is consistent with the FDA's past lack of
concern about implant safety.
Senate Investigation Sidesteps Accusations of Wrongdoing
A second important development concerns the disappointing outcome of a
Senate Health, Education, Labor and Pensions (HELP) Committee staff
investigation conducted at the request of NOW, National Research
Center for Women & Families, National Women's Health Network, and
other organizations. Asked to look into the lack of long-term safety
data on implants, and on the near absence of breast reconstruction
patients (following mastectomy) in the studies, poorly-designed core
studies and other issues, Senate investigators responded with a seven
page summary report.
Considering the alliance of the Senate Republican leadership with the
Bush administration, perhaps it is not surprising that the committee
misstated our questions and thus offered non-answers and partial
answers, and then sidestepped the rest of the questions completely.
They dodged our inquiry as to whether the Senate Committee was still
investigating allegations of criminal behavior by Mentor Corp., an
implant maker who is seeking marketing approval from the FDA. Mentor
has been accused by a series of company whistleblowers of falsifying
data submitted to the government, including understated rupture rates
for some implant models—a serious deception if true.
Breast implant makers and plastic surgeons are ratcheting up their
promotional campaigns, suggesting that there is an imminent approval
from the FDA. An obvious motivation on the part of the manufacturers
is to increase their companies' stock value. Recent business website
news articles say that implant makers expect to double their $350
million annual sales of implants once the silicone gel-filled implants
are available. That figure, combined with $669 million (2002) earned
by plastic surgeons for breast augmentation, would make implants a
billion dollar a year business—earned at the cost of thousands of
women's broken health.
Meanwhile, women with implants continue to find it nearly impossible
to find plastic surgeons who know how to safely evaluate and remove
leaking silicone implants, or to find doctors who know how to use MRIs
to determine whether an implant is ruptured. Women with implant
questions or problems can use the online health hotline offered by one
of NOW's coalition partners at http://www.breastimplantinfo.org.
~~~~~~~~~~~~
For latest breast implant news, studies and support groups, please
visit:
www.BreastImplantAwareness.org
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