Implant Critic Converts Government Crusade Into Business

A chemist who was fired by the Canadian health department after criticizing the Mime breast implant now consults on the issue OTTAWA--For J.J.B. Pierre Blais, doing good science has also turned out to be good for business. Two years after the Canadian chemist was fired from his country's health department in 1989 after his repeated attempts to have the MÆme breast implant removed from the market (The Scientist, September 4, 1989, page 7; also see accompanying story), Blais is running a burgeoning consulting practice built on advising physicians whose worried patients want their implants removed. Blais never abandoned his campaign against the implant, which is coated with a material that laboratory tests have shown can degrade into a substance that causes cancer in laboratory animals. Last month his views gained support from the United States Food and Drug Administration, which has advised physicians to stop doing implantation surgery using the MÆme implant until the agency has completed a study of potential health risks of the polyurethane foam that coats the silicone pouch. The manufacturer and marketer, Surgitek of Racine, Wis., has also voluntarily suspended all shipments of its implants. Pierre Blais began working on medical devices in 1976 for the Canadian government, and it was in 1979 that he first became interested in the MÆme implant. The more he learned about it, the more he became concerned about its potential harmful effects. By the mid-1980s, he had encountered scientific evidence of the difficulties stemming from its use, including complications during its removal, and his reputation as an authority on the subject was growing. In 1988 he was asked to appear as an expert witness in a suit involving the prosthesis, but his superiors within the government told him to keep his concerns to himself, and he never testified. By this time, Blais had begun a volley of internal memos calling for a voluntary halt to the sale of the implants until the government could fully investigate their safety. In July 1989 he received a letter of dismissal, citing official "misconduct," and within a few hours he was escorted from his office. He was accused of leaking confidential information on the implant to the press, contrary to departmental regulations, and of having failed to return his laboratory samples and files. The letter apparently referred to a series of articles in the Montreal Gazette that quoted his memos, but Blais emphatically denies that he was the source of the leaks. --D.S. Since leaving the government, Blais has formed a one-man consulting firm here that specializes in providing advice to doctors on the hazards of a variety of medical devices. And he reports that the firm, Innoval Ltd., which he operates out of his home, is inundated with calls from physicians who want advice on removing the implants. "We're suffering from case overload," says Blais, who successfully appealed his dismissal and was reinstated, but then resigned from his government position of investigator at the end of 1989. "The breast prosthesis furor has gradually been coming to a crescendo for about six or seven months," he notes, "with almost two to three new requests a week to deal with patients in trouble with those devices. The surgeons don't know where to go [for advice]." Government investigators estimate that more than 2 million women in the U.S. alone have received breast implants, about 80 percent of them for cosmetic purposes. About 70,000 women have been given implants covered with the polyurethane foam manufactured by Surgitek. There is no evidence that these women face a higher risk of cancer, says the FDA, but Blais says that the implant lasts only a few years and often bursts, making it more difficult to remove. The greatest risk, he says, is that if the patient contracts cancer for whatever reason, "the prognosis is much worse than if she bore a conventional prosthesis." Blais says that he receives requests for information on hazards associated with the removal of other breast implants, "but that this one [Meme] makes up a pretty good chunk of the problem." Although he is not a surgeon, Blais has expertise in the biocom- patibility of implant materials, especially polymers. And he has assisted and been involved in specialized surgery. As a consultant, his work involves contract design of high-risk medical products, primarily implants but also drug-delivery systems. In recent months, Blais has focused much of his attention on trying to help surgeons determine if they can remove the implants safely. To deal with such requests, he consults with experts in radiology, surgery, and medicine who have evaluated a patient. They then pool their data, analyze them, and provide an opinion on how that patient's problem can be dealt with. Blais also provides analysis of retrieved implant samples collected for monitoring reports that companies must file with the FDA. The 51-year-old Blais sees a relationship between his current work and what he wanted to do when he joined the Canadian government's Health Protection Branch in 1976. In his years with the government, Blais developed a reputation as an innovative and productive investigator and helped to reform parts of his country's system of regulating medical devices. But eventually, his concerns about the material in the Meme breast implant forced him to say things that angered his superiors. Even so, he says he always tried to work within proper channels. Blais insists that he is not a "whistle-blower" because he upheld the department's confidentiality standards by not leaking internal memos and other critical assessments of the implants. E.G. Letourneu, director of the radiation and medical devices branch of Canada's Department of Health and Welfare, declined to comment on the specific reasons for Blais's dismissal and reinstatement, citing the country's Privacy Act. Blais says he finally left when it became clear that he could not sway the department's official views on the subject. He feared that, sooner or later, he would be asked to sign documents approving a product he felt was dangerous and that, when the facts became widely known, would be removed from the market, he says. "At that point, I would have been badly injured professionally," Blais says. "This was my main consideration in leaving the department voluntarily after I was discharged." Blais also objects to his portrayal by the media as a somewhat quixotic individual on a lonely crusade. For him, the reason for his behavior was straightforward. "I was basically balancing short-term interests against long-term career prospects," he says. In his new career, Blais finds himself extending the work he did with the Health Protection Branch, but with "much more freedom to provide the service to physicians, something I was not able to do before." In addition, he says his independence allows him to talk more easily with various government officials: "I have broader access to coworkers, including those at the FDA, which was not truly available to me before." Blais acknowledges that his business is, so far, hardly a lucrative operation. But he predicts that soon he will be earning enough to match his government salary, and that the prospects for continued growth are bright. Although he is pleased that much more is known about the potential health hazards of the implants since he began investigating the problem, Blais believes that U.S. government agencies will eventually disclose significantly more information on the subject. "Only a very small part was made public," he says about the investigations by U.S. agencies. "Up to now, the FDA has said that the basis for withdrawing the implant was the risk of cancer. But the actual scientific and administrative reasons for the removal have not been made public. "And when they do, they will shake the confidence of quite a number of people who have been involved in this area, including physicians. They'll find they are as much a victim as the patients." David Spurgeon is a freelance science writer in Mont Tremblant, Quebec.

Implant Critic Converts Government Crusade Into Business

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