Implant Tests Cashing in on Junk Science

By Michael Fumento

February 27, 1996
Copyright 1996 Michael Fumento

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"Government Warns on Breast Implants," ran the title of a recent AP story. The title was misleading. The issue wasn’t breast implants but tests claiming to show that such implants may have caused harm. And this is a real shame because behind that false headline lies a story about one of the greatest health hoaxes of the decade and of how junk science permeates the courtroom.

The brief article itself was accurate as far as it went. It informed readers that the Food and Drug Administration has warned doctors against using unapproved tests to detect antibodies to silicone leaking into the body from ruptured breast implants or to detect illness that silicone may have caused. Antibodies are a defense response the body produces to the introduction of a foreign substance.

The article failed to point out that these very tests have played a key role in trials against silicone implant manufacturers which sometimes return verdicts measured in millions of dollars. Their existence no doubt played a part in the manufacturers’ consenting to a $4.2 billion dollar settlement, the largest personal injury settlement in history.

The article also didn’t say that these tests are essentially a scam — worthless except that, yes, they can pull in verdicts of millions of dollars.

The tests generally claim to work by one of three methods: detecting chemicals given off by the silicone implant; finding antibodies created by the body in reaction to the silicone; or detecting antibodies created in reaction to the body’s own proteins that have been somehow modified by the implant.

Part of the problem with any silicone-detecting test is that we’re all continually exposed to silicone from a number of sources, including puddings, cake mixes, antacids, and lipstick. Diabetics are exposed to relatively high levels of silicone as well, through repeated injections. Indeed, the very pouch that contains the silicone gel of a breast implant is itself made of a form of silicone.

Because of this, the British Department of Health stated in a 1995 report: "The fact that anti-silicone antibodies have been detected both in silicone implant recipients and, at a lower titre [level], in people who had not received medical silicones, raises doubts about their significance." The report went on to exonerate silicone implants of the charges against them:

Yet, the scam-artist inventors of these tests have enjoyed great success pushing their traveling medicine show.

Consider the case of Dr. Nir Kossovsky of the UCLA, an inventor of one of the types of tests the FDA warned against. Kossovsky is one of the best-known critics of silicone implants, has testified at the FDA hearings that resulted in the essential ban on silicone breast implants, and is a regular expert witness for plaintiffs in implant- related trials.

Kossovsky developed what he called Detecsil, for "detect silicone." "The Detecsil test confirms whether or not an individual has developed an immune response to silicone-associated proteins," declared an advertisement. As such, it could be useful in showing whether women with autoimmune disease (in which the body’s immune system turns on itself) got that illness from silicone.

In legal depositions supporting his expert witness testimony, Kossovsky cited tests from the famed Scripps Clinic and Research Foundation in La Jolla, California as corroborating his own. In fact, Scripps researchers found the antibodies of autoimmune disease victims were the same regardless of whether they had silicone implants or not. All the test found was that there was a higher level of antibodies in anybody with autoimmune disease, exactly what one would expect.

Scripps has repeatedly to disavowed Kossovsky’s statements. Indeed, a Scripps researcher was on record as saying, "To my knowledge, there is no test that can predict or indicate any specific immune response to silicone," which is what the test must do to prove adverse health effects.

Even before this latest public FDA warning, Kossovsky had been warned by the Agency to quit using his test. But the damage has been done. The test has played a crucial role in numerous implant trials, including ones with verdicts of $7 million, $25 million, and an incredible $40 million.

Then consider the case of another company making claims for a test able to detect silicone antibodies in women with autoimmune disease. It was developed by Emerald Biomedical Services of Woodlands, Texas. Dr. Noel Rose of Johns Hopkins University in Baltimore, one of the most prominent researchers in the field, contacted Emerald to see if he could confirm their findings.

Originally he did, but later he found the same positive reactions in women without silicone implants. He informed Emerald the test appeared useless, and Emerald sent Rose a letter telling him in politest terms to go play in the traffic.

Nonetheless Emerald persisted in sending out information packets to potential clients boasting that Rose had validated their study — until being warned to desist by Johns Hopkins lawyers. In that same packet, Emerald offered their services as an expert plaintiffs’ witness and bragged about the large settlements their test and testimony had helped win.

At last Kossovsky and Emerald have been put in their place. But not before their tests terrified countless numbers of women and wreaked havoc in a major sector of American industry.

It’s always been a false cliche that crime doesn’t pay. It does, and so does its close relative, junk science.


Read Michael Fumento’s additional work on breast implants and on the FDA.