A Confederacy of Boobs

How special interests, assorted ideologues, and a sensationalist press torpedoed breast im plantsand now threaten other medical devices

Michael Fumento from the October 1995 issue

(Page 3 of 5)

There's another, deeper irony in the whole polyurethane controversy, one the FDA obviously couldn't state: that a product designed to alleviate the only absolutely certain health problem clearly linked to implants was forced off the market because of worries over other unproven health effects.

Since silicone gel from implants is most commonly accused of causing autoimmune disease, or connective-tissue disease, it isn't surprising that a large number of studies on both animals and humans have looked for a link between silicone exposure and autoimmune/connective-tissue disease. When the British Department of Health undertook a review of these studies earlier this year, it found approximately 270 papers published after 1971 alone.

The animal studies, the department concluded, "provide no immunological reason for concern over the use of silicone gels in implants." The report went even further, however: "None of these studies demonstrated that the coexistence of connective-tissue disease with silicone breast implants is any more prevalent than would be expected by chance."

The largest study of connective-tissue disease to date appeared in the New England Journal of Medicine this past June. Conducted by the Harvard School of Public Health and the Brigham and Women's Hospital in Boston, the study looked for evidence of 41 types of connective-tissue disease among 87,501 nurses, of whom 1,183 had implants.

The results were unambiguous. The researchers found no "association between silicone breast implants and connective-tissue diseases, defined according to a variety of standardized criteria." Already anticipating the charge that they knew would be forthcoming from plaintiffs' lawyersthat silicone implants cause a special kind of autoimmune disease that doesn't show up with standardized criteriathe authors added, "or signs or symptoms of these diseases." In fact, they reported that women with silicone implants were significantly less likely to relate symptoms of these diseases or to complain of symptoms or signs of illness resembling connective-tissue disease.

For many health professionals, the NEJM study, added on top of all the others, was the final piece of proof needed. "I think we have enough data to end the moratorium," George E. Erlich, a Philadelphia rheumatologist and head of the FDA arthritis advisory committee, told TheNew York Times. Erlich emphasized he was speaking for himself and not the FDA committee, but he added that the International League of the Associations of Rheumatology also agreed unanimously there was no evidence linking implants to connective-tissue disease. And long before that, the American College of Rheumatology had already issued its own statement, saying, "There is no convincing evidence that these implants cause any generalized disease."

If the evidence against silicone implants is so weakand has always been sowhy have they inspired such commotion and fear? The chief reason has to do with the federal bureaucrat whose various power-grabbing machinations would embarrass a villain from Central Casting: David Kessler, commissioner of the FDA.

In December 1991, Kessler called together a panel of physicians, self-styled consumer repre sentatives, and the like to evaluate the evidence of potential harm caused by implants. The verdict of the panel, though by no means unanimous, was that the devices should remain on the market pend ing collection of further data from studies already underway.

That, however, did not please Kessler, who ordered FDA staffers to solicit case histories from doctors of implant recipients who later claimed to have suffered ills as a possible result. Since lawyers had already begun soliciting women with complaints and sending them on to specially chosen doctors, finding such case histories was probably not difficult. In any event, case histories reveal little because they don't allow for comparison groups. That's what the epidemiological studies were, but Kessler couldn't wait for them.

In January 1992, Kessler implemented the moratorium, citing the case studies as the reason (and glossing over the fact that he himself solicited them). The next month, he reconvened the panel to ply them with his new "evidence." The panel didn't budge and Kessler once again ignored its advice.

"We still saw no clear evidence of danger, though there were a number of unanswered ques tions," says Emory's Connell, who served as the chair of both panels. "We felt breast implants should stay available to women who, with informed consent, wanted to use them." Three and a half years after the first panel voted to recommend keeping the implants available, Connell says she would clearly do so again. "I think the difference is we could say it this time with a great deal more assurance."

"A whole new literature has been developed since that time," she explains. "We were operating on anecdotal evidence and case history. Now the evidence has been gathered by good people in well -designed studies so it's an entirely different situation."

So why did the FDA ban silicone implants despite the lack of evidence that they are harmful? Pressure came from repeated anecdotal reports in both print and television media. The moratorium that became a ban occurred after more than a year of intense media pressure, including Connie Chung's inflammatory show, which was repeated a year later.

Congressional pressure, in the form of the late Rep. Ted Weiss (D-N.Y.), also came down on the FDA. Weiss, who chaired the House committee with jurisdiction over the FDA, accused Dow Corning of possible misconduct in its effort to document the safety of silicone implants and called for both the Justice Department and the FDA to investigate the company. (This May, the Justice Department dropped the investigation for lack of evidence.) He also accused the FDA of dragging its feet over the polyurethane-implant issue.

To be sure, there was pressure to keep implants available, too. It came from the American Medical Association, implant makers, plastic surgeons, and breast-cancer groups. But this was not the sort of public pressure that can embarrass an agency, and the breast cancer groups' objections were dealt with by allowing continued use of silicone implants for breast reconstruction following mastectomy.