FDA Decision Expected on Risky Silicone Breast Implants

[Guest guest]

Thanks Beth ... may sanity prevail.

`````````````````

http://www.now.org/issues/health/implants/092706implants.htmlToxic Platinum Found in Women With Implants; FDA Decision Expected on Risky Silicone Breast Implants By Jan kson, 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 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. 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. 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. 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. 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 WrongdoingA 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

..

" All that is necessary for evil to triumph is that good people do nothing " ~ Edmund Burke

beth

taylor

WWW.BREASTIMPLANTSUPPORT.ORG

WWW.TOXICBREASTIMPLANTS.ORG