Jewish World Review Dec. 15, 2000 / 18 Kislev, 5761
http://www.jewishworldreview.com -- FOR NEARLY A DECADE, women with silicone breast implants have been buffeted by emotional and legal waves. Three new studies are out: Two are settling and the other roiling the waters. It is time to put the issue behind us.
The breast implant saga began a decade ago, when lawyers began targeting the industry. Food and Drug Administration head David Kessler ordered silicone implants off the market, despite acknowledging the absence of evidence backing the multiple charges against them.
Passions were inflamed by an active public relations campaign. The implant experience "shows how easy it is to manipulate the media to achieve policy goals and make a profit," explains a new report by the National Center for Public Policy.
A torrent of lawsuits followed, ruining the industry. Yet, there was never any evidence to justify them. Quite the contrary. Peer-reviewed studies from leading American hospitals and universities found no link between implants and cancer, autoimmune conditions or connective tissue diseases. Professional reviews at home and abroad reached the same conclusion.
Last year, the Institute of Medicine dismissed the case against implants. Some women with implants were sick but, reported the institute, it could "find no evidence that these women are sick because of their implants."
Now, researchers at the National Cancer Institute have released a study involving 13,500 women - one of the largest ever conducted - that "found no association between breast implants and the subsequent risk of breast cancer." Adding to its significance is the fact that the lead researcher had controversial links to the trial bar.
Although the case against major health risks seems conclusive, last year the IOM did report some local complications, such as ruptures. But, it indicated that the problem was modest, in contrast to another new study.
In a recent article in the American Journal of Roentgenology, a group of researchers concluded that 69 percent of women surveyed had at least one ruptured silicone gel implant.
Previous estimates ran less than 6 percent.
However, the work is of questionable value. Although it has been described in the press as an "FDA study," it does not represent official government research.
Several research flaws likely inflate rupture rates. For instance, the report defined ruptures more broadly than other, more common definitions, such as that advanced by the College of American Pathologists. The study also relied on the records of surgeons who had been plaintiffs' witnesses and, thus, had an incentive to overstate implant failure.
The report used MRIs, which even the authors note is an imperfect mechanism for detecting ruptures. To read the MRIs, the researchers employed a testing protocol which they acknowledge is followed by no other radiologist. The doctor who did the testing has also worked with implant plaintiffs' attorneys.
The research suffered from additional problems. Even the authors acknowledged that "we could not rule out all sources of bias." There is no guarantee that the women for whom records collected were representative. Moreover, some women - many of whom had their implants removed despite suffering no adverse symptoms - may have mistakenly reported rupture or leakage.
The data for this study was taken from the larger, newly released NCI study, which drew its subjects from Birmingham, Ala., where federal silicone implant litigation had been consolidated. That may have raised public awareness of the issue and inflated response rates by women who believed themselves to be at risk. Even the article's authors admitted that the litigation might have had some impact on the results.
Moreover, Institute of Medicine President Kenneth Shine worries that the NCI study's recruiting materials may have "encouraged women with symptoms and problems to enroll." And, fewer than one-third of the original eligible participants were ultimately surveyed.
In short, rather than offering dramatic breakthrough research, this study tells us little upon which we can safely rely.
The crusade against silicone breast implants is fading. Years of research have demonstrated that none of the most serious charges of harm are true.
Unfortunately, some more limited problems with implants remain. They were probably inevitable: No medical device lasts forever. But, there's no evidence of an epidemic. It is time to again treat silicone implants as other, normal health care
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