Implanting needed science
Editorial
Copyright 1998 Cleveland Plain Dealer
December 15, 1998
A panel of respected medical experts has made it official: There is
"no association between breast implants and any of the definite connective
tissue diseases ... or the other autoimmune-rheumatic conditions" for which the manufacturers have been blamed. Nor is there
"evidence that silicone breast implants precipitate novel immune responses or
induce systemic
inflammation."
The results of this study, commissioned by a federal judge overseeing a
multibillion-dollar class-action suit against silicone maker Dow Corning, come
a bit late for the company. The cost of defending that suit, and some 7,000
individual personal-injury suits,
forced a $3.2 billion bankruptcy settlement offering from $12,000 to $300,000
to women who have attributed various illnesses to their implants. Implants can
cause localized problems, but not the myriad ills that have been claimed.
That settlement process will continue, but the panel's findings should give
pause to plaintiff's attorneys, who literally have scared up prospective
claimants and witnesses
"expert" at exaggerating the risk, to juries that have awarded ridiculously high
verdicts on the basis of feelings rather than facts, and to the federal Food
and Drug
Administration.
The FDA's new top administrator, Dr. Jane Henney, was co-chairwoman of the task
force on breast implants that six years ago fueled near-panic among women who
had had implants and women who were contemplating them. Until implants are
proved
"safe," the agency decided, it would
deny implants for enhancement but allow them for reconstruction. That was more
a political and value judgment than a scientific one. No medical device is safe
for everybody, and an unrealistic expectation of safety coupled with a
company's realistic expectation of whopping damage awards as a
result, ends up denying people medical devices that could vastly improve their
lives.
The report of these four impartial scientists should have some welcome impact
beyond the breast-implant issue. The judge who commissioned it has been widely
and rightly hailed for trying to sort fearful fiction from fact.
"The implications of the
report," wrote Marcia Angell, executive editor of the New England Journal of Medicine,
"will reach beyond the breast-implant controversy. Courts trying technical cases
have become a hotbed of
junk science, and the inconsistent and capricious jury verdicts that result often have more
to do with the theatrical talents of the lawyers and
expert witnesses than with the facts."
Ongoing studies may unearth more facts about breast implants. But the
scientific verdict just in should ease women's minds and the assault on implant
makers.
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