Fair Hearing for Breast Implants?

A Food and Drug Administration advisory panel is again preparing to review the science concerning the safety of silicone breast implants (search).

Though the scientific data will, once again, point to the safety of silicone implants, it’s not clear that the science alone will drive the panel’s decision.

In October 2003, an FDA advisory panel had voted to approve silicone breast implants, but trial lawyer-backed activists succeeded in creating a circus of the process. In 2004, the FDA decided to delay approval of silicone breast implants pending the collection of more safety data. The new data are in and, to no one’s surprise, silicone implants once again appear to be safe.

In an October 2004 study in the American Journal of Epidemiology, National Cancer Institute researchers detected no conclusive evidence that silicone implants caused connective tissue disorders (search) -- the allegation that ignited the silicone scare 20 years ago.

Researchers reported in a December 2004 study published in Breast Cancer Research that mastectomy patients with silicone breast implants had similar, if not slightly less, sickness and death than mastectomy (search) patients with other types of breast implants. National Cancer Institute-funded researchers reported in the Journal of the American Medical Association in January 2004 that, while breast implants may slightly lower the sensitivity of mammography, “there is no evidence that this results in more advanced disease at diagnosis compared with women without augmentation.”

All the new data reaffirm a 1999 report from the National Academy of Sciences’ Institute of Medicine concluding that available medical and scientific evidence does not associate SBIs with cancer and other systemic diseases. But as is often the case where activists and personal injury lawyers are involved, having the science on your side isn’t always enough.

Consider, for example, the October 2004 National Cancer Institute study. Although the study reported no credible link between silicone breast implants and disease, the spin the anti-implant activists are placing on this study is to demand larger and even longer-term research. The anti-implant activists seemingly would like to propagate the notion that science is incapable of establishing that the implants are safe -- a position entirely consistent with anti-implant crusader Sybil Niden Goldrich (search) who once asserted on PBS’ television show Frontline, “The science? The devil with science. It doesn’t matter anymore.”

Goldrich’s group, Command Trust Network (search), circulated a memo to congressional staffers in October 2004, claiming that in the January 2004 mammography study, “researchers have found that breast implants can result in undetected cancer.”

This, of course, flies in the face of the actual study result indicating that women with silicone implants are not disadvantaged in terms of breast cancer diagnoses. Now, in the weeks leading up to the FDA advisory panel meeting, opponents seem to be stepping up efforts to mischaracterize the science on silicone implants.

Last week, the National Organization of Women, National Women’s Health Network, National Research Center for Women and Families, and the National Council of Women’s Organizations began circulating a letter to get senators to oppose the FDA advisory committee’s endorsement of silicone breast implants and any forthcoming FDA approval.

Trying to exploit the Vioxx (search) controversy, the letter shrieks in bold italics, “It is imperative to tell the [FDA] Commissioner that silicone breast implants should not be approved for general use until there is evidence that they are safe for long-term use.”

The letter, however, fails to mention that the study subjects in the October 2004 study were followed for over 12 years, on average.

“Barely one year after rejecting silicone breast implants, the FDA is again considering an application to approve these same devices,” claims the letter.

But the FDA never rejected silicone breast implants. The agency simply requested more long-term safety data. The October 2004 study’s average 12-year follow-up among more than 7,000 women would seem to fill the bill -- as do several other epidemiologic studies with maximum follow-up times ranging from 23 years to 30 years. The claim that there aren’t long-term data supporting the safety of SBIs is flat-out wrong.

I’m not surprised by the distortions in the letter pushed by NOW and the other groups -- NOW is known to have had ties to personal injury lawyers involved in the multi-billion dollar breast implant litigation.

A final concern for women who want the option of silicone breast implants is the chairman slated to head the FDA advisory committee, Michael Choti. Not only did Dr. Choti vote against implants in the October 2003 meeting, he has since authored an article entitled, “Against Approving the Use of Silicone Implants” in the Fall 2003/Winter 2004 issue of the journal for the American Society of Breast Disease that fully chronicles his personal slants and prejudices.

As the panel chairman will run the meeting and set the tone, it would seem that someone less biased than Dr. Choti should be entrusted with this key position.

Anti-implant activists and their trial lawyer allies don’t want silicone breast implants back on the market as FDA approval would essentially expose the 20-year campaign against implants as being based on junk science. The desperate activists and lawyers will, it seems, say and do anything to avoid that outcome.

Steven Milloy publishes JunkScience.com and CSRwatch.com, is adjunct scholar at the Cato Institute, and is the author of Junk Science Judo: Self-defense Against Health Scares and Scams (Cato Institute, 2001).

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