Medical Debate Over Implants Has a Dark Side : Science: Regardless of results, researchers studying the safety of silicone gel implants have been targets of harassment.
Bernard M. Patten, a Houston neurologist, was relaxing at home one evening last fall when he heard a noise outside the front door.
“I heard a thump, and I thought someone was delivering the New York Times closer to the house for a change,” he said. “But it wasn’t a paper, it was a dead rabbit.”
Patten says there was no mistaking the message behind the rabbit--which had been decapitated. The Baylor College of Medicine professor says he has been the victim of constant harassment since publishing a research paper last year that found a possible link between silicone gel breast implants and unusual chest pain in women. His laboratory at a Houston hospital was broken into, he says, and documents were stolen from his university office.
Police have no suspects. But Patten says the cloak-and-dagger goings-on are part of an unseemly behind-the-scenes backdrop to the impassioned debate over breast-implant safety. Scientists stand accused of allowing money to skew their research results. Attorneys on all sides trade accusations of harassment.
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The skirmishes are evidence of disagreement over some fundamental questions: Do breast implants really pose a medical risk, as hundreds of thousands of implant recipients and their attorneys contend? Or have the dangers been overblown by plaintiffs’ attorneys in pursuit of million-dollar damage awards, as implant suppliers and their attorneys contend?
Whatever the case, implant manufacturers and suppliers have agreed to ante up $4.23 billion to settle personal-injury claims--a sum that appears to fall seriously short of the demand from implant recipients.
The corporations have said they agreed to the massive settlement to shield themselves from the potentially crippling effect of further lawsuits. But the suits came in a flood anyway, prompting Dow Corning, once the biggest maker of implants, to seek federal Bankruptcy Court protection Monday in Michigan.
The corporate defendants say the weight of scientific evidence on implant safety tilts the debate in their favor. More than six major studies have found no statistically significant link between implants and certain diseases that recipients have associated with their use.
The U.S. Food and Drug Administration took silicone implants off the market in 1992. The agency said manufacturers had failed to supply sufficient data to demonstrate that the devices are safe.
Dr. Bruce Burlington, director of the FDA’s Center for Devices and Radiological Health, said Tuesday that the FDA is continuing to review research data, in part because studies so far have not examined large enough groups of women. “All the studies have weaknesses and limitations,” he said. “But we think the studies we’ve seen to date are reassuring for most women with implants.”
Still, he said, “even a few hundred women with scleroderma, which is a life-threatening [skin] disease, is a serious problem,” he said.
One of the most influential studies to find no evidence of a link between implants and disease was conducted by researchers at the Mayo Clinic in Rochester, Minn., who examined the medical records of all residents of Olmstead County, Minn., from 1964 to 1991. The study, published last year, found that 749 women with implants did not have a greater number of medical problems than the county’s population as a whole.
One criticism, however, of such epidemiological studies is that they have looked only at the well-established connective tissue diseases, such as systemic lupus or scleroderma, that are among the maladies being claimed by women with implants.
Some researchers believe women with implants are suffering from a new group of rheumatic problems characterized by chronic fatigue, dysfunction in thought processes, rashes and other maladies--things that medical experts call “atypical connective-tissue disease.”
According to these researchers, the scientists who have found no connection between implants and disease have been looking for the wrong things.
“If you’re looking for a disease called peach and you run across cherry, you are going to report ‘no peach seen,’ ” Patten said.
So far, “Juries seem to pay more attention” to physicians who have treated injured women than they do to epidemiological studies, said Ernest H. Hornsby, a Alabama trial lawyer who won a $6 million verdict on behalf of Brenda Toole, even though her injuries “did not fit into any neat diagnostic category.”
Hornsby said Toole’s doctors testified that her condition--a variation of lupus--was caused by implants after ruling out other possible diagnoses. Jurors were told that Toole’s implants had ruptured and that she had a total of six operations which left her severely scarred.
Indeed, other researchers say the high rupture rates for implants should be the focus of more analysis and attention. The failure rate ranges from about 25% overall to about 50% for women who have had the devices for more than 10 years, according to Dr. Norman Anderson, associate professor of medicine at Johns Hopkins Medical School in Baltimore.
“The women are stuck with scarring, chronic inflammation and pain,” Anderson said. “This needs to be dealt with, but it has been ignored in the chasing after the esoterica.”
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Of course, it’s one thing to have a scientific disagreement. It’s another to begin hurling about decapitated bunnies. Medical experts who have published research on both sides of the debate say they have faced harassment both at work and home.
The authors of the Mayo Clinic study say plaintiffs’ attorneys accused them of bias because the research was partly financed by the educational arm of the American Society of Plastic and Reconstructive Surgeons--a group that has been outspoken in their contention that implants to not pose health risks. Organizations representing plastic surgeons have been outspoken in their contention that implants do not pose health risks. But the Mayo Clinic researchers have insisted that the plastic surgeons’ support did not taint their study.
“It’s unfortunate that the legal issues have made it so difficult to do good science,” said Dr. Nir Kissovsky, a UCLA pathologist who has been a medical expert for implant recipients. “I think both sides of the legal issue have bastardized the scientific community. Just as the defense side has bought off investigators, the plaintiffs’ bar has supported a lot of less-than-credible experts.
Kissovsky, who has conducted research on implants and says he is “absolutely convinced that silicone causes disease in humans,” says he has received threatening letters and phone calls about his research.
“I’ve had funny-looking people with dark sunglasses hanging out in front of my office door with subpoenas, and I’ve had everything I’ve ever worked on subpoenaed,” he said. “They’ve even subpoenaed my students.”
