Implant issue giving good science day in court

By David K. Martin
Copyright 1998 Houston Chronicle
September 6, 1998

Science finally appears to have trumped emotion in the bizarre lawyer-driven controversy about the safety of silicone gel breast implants.

A prestigious panel of British physicians and scientists, formed last year to review all of the voluminous research on the issue, now states "risks to patients associated with the use of silicone gel breast implants are no greater than for other implants."

The British conclusion, of course, coincides with the findings of more than 20 studies by respected medical and academic institutions in the United States, Canada and several of the most advanced nations of Western Europe.

But the panel's inherent fairness and its dogged thoroughness ought to be the final episode in a class-action soap opera that has threatened to halt production of such vital silicone-based medical devices as pacemakers, brain shunts, hip and knee replacements.

Former Food and Drug Administration Commissioner David Kessler played into the lawyers' hands in 1992 when he banned breast implants filled with silicone gel - not because of evidence they were dangerous, but because manufacturers had not proved their safety.

Kessler, the new dean of the Yale Medical School, now concedes his ban may have been an overreaction. His order, which overruled the recommendations of an FDA science panel, unduly frightened many of the estimated 1 million to 2.2 million American women with breast implants.

Plaintiffs' lawyers eventually recruited several hundred thousand women for class-action lawsuits. The lawyers involved pocketed millions, while most of their women clients received pittances. Worse, tens of thousands - most at the urging of plaintiffs' attorneys - went back under the knife to have their implants removed and ended up, unnecessarily, with permanently disfigured bodies.

But Kessler's decree did have some healthy effects as well. The FDA mandated that studies be done to determine if silicone gel breast implants did, indeed, cause the bevy of auto-immune and connective-tissue diseases cited by the plaintiffs' attorneys.

As the results began rolling in - from prestigious institutions like Harvard, Johns Hopkins and the Mayo Clinic - it quickly became clear the plaintiffs' bar was trading in what can only be described as "junk science."

Losing badly in the United States, the plaintiffs' attorneys last year decided to open a "second front" in Great Britain.

They signed Fenton Communications, the left-wing Washington, D.C., public relations firm best known for promoting the Alar apple scare and Nicaragua's Marxist Sandinistas, to a multimillion-dollar contract.

Fenton, in turn, pumped funding into a foundering group of breast-implant survivors called Command Trust and sent some of those women and one of their "referral" doctors off on a media blitz of England and Scotland.

Relying heavily on Britain's sensational tabloids and talk-TV programs, they were able to generate high-voltage publicity. The Labor Party's newly appointed minister for health, Baroness Jay, saw one of the programs, became concerned and quickly ordered a new safety review of silicone breast implants.

The review went forward even though the British Ministry of Health already had conducted two studies on silicone breast implants and declared them safe on both occasions. The latest review also exonerated silicone implants.

The third time should be the final coffin nail in laying this issue to a merciful rest. Science clearly has triumphed, but the only real winners are a handful of plaintiffs' lawyers who have stuffed their pockets with fistfuls of dollars.

The biggest losers, unfortunately, are the women who have been gulled by the plaintiffs' lawyers. Many went to great expense to have their implants removed - most often unnecessarily.

Others had real but curable illnesses that went undiagnosed because they believed their lawyer's spiel that implants were to blame. And breast cancer victims who underwent mastectomies were prevented from restoring their figures - and their psyches - by Kessler's ill-advised ban.

One hopeful sign emerges from the wreckage, however. The nation's mainstream science and health reporters now have a much better understanding of the difference between good science and "junk science."

And so, apparently, does our judicial system. A panel of blue-ribbon scientists appointed by federal Judge Samuel Pointer of Birmingham is expected this fall to recommend that similar panels be set up to review the credentials of experts testifying in trials involving complex scientific issues.

"Expert witnesses" who turn out to be obvious quacks will be banished from the courtroom - in effect, leveling the playing field for "team truth." This development may well be the most important legacy of the silicone breast implant saga.

Martin, a former Associated Press writer and Rocky Mountain News editor, frequently writes about legal and regulatory affairs as an independent journalist based in Washington, D.C.

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