Breast Implant Myths

February 24, 1999 • Commentary

Liability law was once dominated by individual cases — a car wreck, a slip‐​and‐​fall, a doctor’s error. By the 1990s, however, class actions and mass torts became the norm. In many instances liability law became completely divorced from traditional notions of fault.

Such as been the case with silicone breast implants. Over the last decade, women have filed hundreds of thousands of claims alleging that implants caused a variety of ills. The industry imploded; Dow Corning was forced into bankruptcy, and [in December] proposed a $3.2 billion settlement package to resolve pending lawsuits.

Yet the scientific case against silicone implants has finally, and completely, collapsed.

Silicone implants became popular three decades ago. Although implants occasionally ruptured, causing local discomfort and disfigurement, there was no evidence that they caused more serious illnesses.

Of course, the trial bar is horrified by the prospect of disappearing fees. Suzanne Turner, a spokeswoman for plaintiff attorneys, called the report’s conclusion — that implants don’t cause harm — “terrible news for women.”

Of course, some women with implants got sick. But Dr. Marcia Angell, executive editor of the New England Journal of Medicine and author of Science on Trial, explains: “by coincidence alone” thousands of women “will have both breast implants and an immune disorder.” The relevant question is whether implants caused the illness.

But instead of waiting for an answer, the politically‐​minded Food and Drug Administration Commissioner, David Kessler, pulled implants off of the market in 1992. Trial attorneys invested heavily in what for them would be a highly profitable business venture.

Defendants won most of the cases, but never mind. Huge litigation expenses combined with the threat of massive judgments encouraged companies to settle. For instance, Baxter International, Bristol‐​Myers Squibb, and 3M Corp. offered women up to $100,000 each in a set of lawsuits consolidated under U.S. District Court Judge Samuel Pointer.

At the behest of the plaintiff attorneys, Judge Pointer formed a four member expert panel in 1996 to assess the scientific evidence on implants. Recently, it concluded: “No association was evident between breast implants and any of the individual connective tissue diseases, all definite connective diseases combined, or the other autoimmune/​rheumatic conditions.”

Not that this finding surprised anyone. A succession of peer‐​reviewed studies from researchers at such diverse institutions as Harvard University, Johns Hopkins University, the Mayo Clinic, and the University of Michigan had previously exonerated implants.

Nor is this only the opinion of American professionals. Earlier this year the European Committee on Quality Assurance and Medical Devices in Plastic Surgery, which included experts from Israel and South Africa, concluded that implants do not cause auto‐​immune or connective tissue diseases, and that “there is no scientific evidence that such things as silicone allergy, silicone intoxication, atypical disease, or a ‘new silicone disease’ exist.”

Similarly, the British government’s Independent Review Group reported that it could find “no histopathological or conclusive immunological evidence” and “no epidemiological evidence” of implant‐​caused diseases. Nor did it discern any “good evidence” of such conditions as silicone poisoning.

This succession of research is about as conclusive as one could imagine. Dr. Elizabeth Connell, who chaired two FDA hearings on implants, observes: The Pointer Panel report “might not be the end of it, but it will be extremely helpful in putting the controversy to rest.”

Of course, the trial bar is horrified by the prospect of disappearing fees. Suzanne Turner, a spokeswoman for plaintiff attorneys, called the report’s conclusion — that implants don’t cause harm — “terrible news for women.”

The trial lawyers certainly aren’t ready to surrender. Sybil Niden Goldrich of the Command Trust Network, which represents implant plaintiffs, complains of a “research gap.” Thus, she argues, “We need reliable government scientists to find trustworthy answers as to why thousands of women are sick.”

However, one senses that she believes there is a “research gap” only because no reliable study demonstrates a link between implants and illness. Were such evidence to surface, the plaintiff bar would almost certainly lose interest in more studies.

Calls for government research should be treated especially skeptically since it is easily politicized. In areas like the environment, for instance, scientists have long known that certain perspectives are far more likely to receive public funding.

The National Cancer Institute is already embarked upon a scientific review that some observers fear may be tainted by the influence of the trial bar. Moreover, a major congressional proponent of new federal research is Sen. Barbara Boxer, whose son‐​in‐​law, Hugh Rodham (a brother of the First Lady) is a trial lawyer.

The evidence is overwhelming — objective, peer‐​reviewed, epidemiological studies find that silicone breast implants do not cause disease. Unfortunately, this growing consensus cannot repair the damage wreaked by a decade’s worth of misguided litigation. Unless policymakers reform the legal process, however, the trial bar will soon be launching new mass torts based on junk science.

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