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 5 of 5)

"I get calls from women who say, 'I have implants. Where do I pick up the money?'" says Sandy Finestone of the Women's Implant Information Center in Irvine, California. The center dis seminates information on implant safety. "You dangle $4 billion in front of them and it certainly gets their attention." Finestone has two polyurethane-coated implants that she makes clear will not be the subject of litigation.

Indeed, attorneys have not only ignored scientists, they've attacked them. After Mayo Clinic rheumatologist Sherine E. Gabriel published a study in NEJM in June 1994, a lawyer claiming to represent 2,000­3,000 implant recipients began filing legal demands against her. "The magnitude of the demands is staggering; the burden is staggering," she told TheNew York Times. "They want over 800 manuscripts from researchers that were here, they want hundreds of data bases, dozens of file cabinets and the entire medical records of all Olmsted County [Michigan] women, whether or not they were in the study."

Not surprisingly, Gabriel says the demands have "severely compromised" her ability to do research and made colleagues of hers back off from doing their own implant research, for fear their findings would also infuriate plaintiffs' lawyers. "Some," she says, "determined that the price in terms of their own research careers is too high to pay."

The widespread association of silicone implants with various illnesses is largely the result of unsophisticated reporting on the topic. "The media may be portraying a closer link between implants and autoimmune disease than is actually merited because younger women tend to be more prone to autoimmune disease than other groups," explains David Leffell, associate professor of dermatology at the Yale School of Medicine. But the real question, says Leffel, is whether women with silicone implants are getting these diseases at levels higher than expected. All signs point to no.

With silicone implants, the media have managed to make news as much as report it. Clearly, they have had a significant impact on public perceptions, which then fueled both litigation and contributed to the FDA moratorium. This in turn fueled more litigation.

Whatever role sheer confusionand ignorance of scientific data and principlesplayed on the part of the media, it is disturbing to realize that opportunities to present the other side were often ignored. In 1991, for instance, CBS reran the Connie Chung show that did so much to kick off the implant scare. But at the last minute, the network yanked a Dow Corning rebuttal to the program's charges. CBS didn't explain its decision. Apparently it felt its viewers would not benefit from an airing of both sides of the issue.

Unfortunately, the anti­silicone implant crusade has given women something very tangible to fear. Because of the negative publicity, as early as 1991 insurance companies were already denying or restricting medical coverage to women with implants. Now, because some doctors and lawyers have tied various illnesses to implants, women with implants who do eventually get any of those illnesses may find themselves without medical coverage. The founder of the Washington, D.C., chapter of the Y-ME National Breast Cancer Organization told a congressional panel, "In some instances, it is easier for a cancer patient to obtain insurance than one who has implants."

In early June, even before the NEJM connective-tissue disease study, Y-ME Executive Director Sharon Green wrote to Kessler asking him to "make a public statement regarding the most recent epidemiological studiesto stop the current frenzy." The only statement he issued that month was a response to the NEJM study saying yet more evidence was needed.

Emory's Connell says the FDA's actions and the legal profession's high-tech ambulance chas ing are "costing us not only what we [already] have but the chance for new and better products in the future. I think we're in a worse mess in American medicine than we've ever been in. Instead of leading the world, we're now a third-rate country in terms of our ability to develop new drugs and devices."

Indeed, J. Donald Hill, chairman of cardiovascular surgery at California Pacific Medical Center, worries that the anti-implant crusade will broaden into an attack against a wide variety of medical aids already on the market. The first device to go down the tubes may be the Norplant contraceptive, which after implantation into the arm releases a tiny amount of silicone into the system. While no suits have yet been filed, lawyers are encouraging women with the devices who have any sort of illness to contact them. Trial lawyer seminars are already being held, using some of the same instructors and same self-styled medical experts who torpedoed breast implants.

In a country so heavily dependent on science to improve the quality of our lives, to defend our shores, to feed our growing population, to prevent and cure illness, the resoundingly anti-scientific and successful crusade against silicone implants portends problems that right now cannot even be guessed.