Our Opinion on FDA's Approval of Silicone Gel Breast Implants
On November 17th, after nearly a decade and a half, the U.S. Food and Drug Administration finally lifted the ban on silicone gel breast implants, as reported far and wide in most mainstream media--including The Washington Post and The New York Times.
This news should be cause for celebration for women who desire the natural appearance that silicone gel provides. It's also liberating for all women, whether augmentation or reconstruction (for example, following breast tumor removal) candidates, who deserve improved options in technology promised by reawakened incentives for innovation in this category of medical devices.
As you can read in news accounts, organizations that oppose the FDA's decision continue to drum up the same old charges, offering no legitimate scientific evidence of serious harm to women, relying instead on anecdotal accounts intended to scare women. Further, some so-called public interest groups that decry silicone gel's approval as a victory for greedy corporations are themselves all too familiar with the greedy business of keeping the implants controversy stirred up to fatten the wallets of trial lawyers, as well as their own. Most unfortunately, caught in the middle have been truly ill women who have been misled to believe their illness was due to implants, when in reality the nature is unproven or unknown, obscured by anti-technology interests and emotion.
Years of studies, including a comprehensive review by the prestigious Institute of Medicine of the National Academies, to publications in peer-review literature such as The New England Journal of Medicine (accompanied by an editorial by Dr. Marcia Angell, no friend to the health care industry, by the way) have demonstrated repeatedly that zero evidence exists to associate silicone gel implants and serious disease in women with any greater frequency than diseases occurring in a similar population of women without implants.
Finally, take a look at the following Web sites and decide for yourself which organization relies on legitimate evidence and puts it forth in evaluating whether implants should be available to women.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html
http://www.citizen.org/pressroom/release.cfm?ID=2320
Some lawyers and organizations that want to prevent women from evaluating the risks and benefits of newer technology breast implants aren't happy with FDA's decision. But we're not aware that any of the millions in fees collected in previous years by driving Dow Corning and Bristol-Myers Squibb out of the business was ever invested in conducting legitimate medical research to prove that silicone gel implants are dangerous or even pose an unacceptable risk.
Spectrum Science Communications is proud to have served the medical device industry on the breast implants issue in the past. Valid medical research won the day for women this Friday, and this firm helped promote quality science over a period of years.
It may be time for "citizens" organizations interested in furthering public health to focus on banning tobacco, where there's harm - and science - aplenty.
John J. Seng
