Chemist Gets Fired After Calling Breast Implant Unsafe

OTTAWA—Research chemist J.J.B. Pierre Blais joined the health protection branch of Canada’s Department of National Health and Welfare in 1976 in the midst of a productive career in the federal science bureaucracy. He had spent seven years at the National Research Council, and looked forward to many more satisfying years with his new agency. For a while it was just that. An expert in the biocompatibility of implant materials, Blais has worked on projects that have led to amendme

By | September 4, 1989

OTTAWA—Research chemist J.J.B. Pierre Blais joined the health protection branch of Canada’s Department of National Health and Welfare in 1976 in the midst of a productive career in the federal science bureaucracy. He had spent seven years at the National Research Council, and looked forward to many more satisfying years with his new agency.

For a while it was just that. An expert in the biocompatibility of implant materials, Blais has worked on projects that have led to amendments in Canada’s Medical Devices Regulations and served as section head within the department. “He’s a brilliant scientist who is always searching for the truth,” says one of his superiors, Agit Das Gupta. Blais also built a reputation as an innovative and productive investigator, with some 180 published articles, book chapters, patents, and monographs.

But six weeks ago Blais, at the age of 49, was fired from his job. And he blames that same bureaucracy that had employed him for 20 years for trying to stifle his scientific criticism of a product that he and others believe is unsafe.

That product is a polyurethane-coated breast implant known as Même. Blais first became interested in it in 1979, and the more he learned about M~me, the more concerned he became about its potential harmful effects on the women who had received it as part of reconstructive or cosmetic surgery.

Blais is not the only scientist to hold such views. All silicone gel-filled breast implants are unsafe, says Douglas Teisch of the Health Research Group, a Washington, D.C.-based consumer advisory body, and polyurethane-covered types are “a particularly noxious” variety. Laval University’s Robert Guidoin, whose laboratory of experimental surgery conducts research on breast, heart, and cardiovascular implant designs, believes the implant should be removed from the Canadian market. And the U.S. Food and Drug Administration last spring warned the parent company of the current manufacturer of the implant that the manufacturer has failed to report at least 11 prosthesis failures that probably caused serious injuries.

Spokesmen for Canada’s Department of Health and Welfare refuse to comment on any details of the Blais case, noting that his dismissal is being appealed by the labor union to which Blais belongs, the Professional Institute of the Public Service. Blais says he was persuaded by the institute to lodge the appeal, which is not expected to be heard for several months, “in order to protect the professional and scientific reputation of the department.” The department,. which carries out a range of scientific, regulatory, and social welfare functions, has some 9,000 employees and oversees expenditures of $36 billion.

Another government scientist, who is also a former executive for the union’s scientific research group, says that Blais “has enormous backbone, considerable personal and technical integrity, and a conscience.” Citing a stream of budget cuts and previous cases in which the advice of government scientists on various health issues was ignored, the scientist called Blais’ dismissal “another blow to the morale of the scientific community in the Canadian public service” and “a sign of general malaise” in the government.

The events that led to Blais’ firing go back a decade, when he first learned about the implant. By 1985 Blais had collected a spate of journal articles that cited difficulties stemming from its use. The following year other medical product manufacturers started to complain to the health minister about the practices of the product’s Canadian distributor, Real Laperriere Inc., of Montreal, (The U.S. distributor is Surgitek Medical Inc., of Racine, Wis., a subsidiary of Bristol Myers Pharmaceuticals. Since January, the manufacturer has been Surgitek’s Aesthetec Division of Paso Robles, Calif.)

Soon surgeons began to ask Blais to identify material from implants removed from patients. In November 1988, the Canadian health minister received a letter asking him if he would agree to have Blais appear as an expert witness in a lawsuit involving the prosthesis. It was at that point, Blais says, that the government lowered the boom on him.

“I was ordered not to commumcate with anyone connected with this type of implant,” he says. “I was given no reason. It was the first time I had seen such a thing happen.” Blais says that he has been told that the department fought subpoenas from the court requesting that he tes tify. “They initiated a series of procedures that blocked or reduced the probability I would be compelled to appear,” he says. Although the government’s attempts failed, Blais has yet to testify because the trial has been postponed.

By this time, Blais had written a number of memos asking for further investigation of the implant and calling for a voluntary halt to its sale until the work was completed. He believes thatthose memos made him a target of on-the-job harassment. At first Blais was bewildered by the logistical roadblocks thrown in his way, but eventually he was told that his professional activities were being restricted for purposes of “policy coordination.”

Finally, on July 17 Blais received a letter of dismissal, citing his official “misconduct.” He was accused of leaking confidential information on the Même implant to the press, contrary to departmental regulations, and of having failed to return all his laboratory samples and files. Given only a few hours to clean out his desk, he was escorted from his office.

Weeks later, Blais is still trying to figure out why. He admits to having become increasingly convinced that the Même implant was unsafe, and he’s made no secret of his views within the department. But, he declares;,, I am not a whistle-blower. I have never gone public with this type of information. I’ve always held [to] the confidentiality of the department—in fact more so, perhaps, than I should have in retrospect, because many situations involve the public good. I remained within the terms of reference given to me by the department, but I fought tooth arid nail within the department to get this stuff off the market.”

What apparently caused the health and welfare department to clamp down on Blais were reports earlier this year in the Montreal Gazette that quoted his confidential memos. Says Blais, “It was a time when much of this information [about the implant] was already surfacing in different ways, and because the department is very small and there’s only a few plastic specialists, everyone inferred that [the person responsible for the leaks] was me. I’d published before on this subject for the scientific literature. I’d given lectures and so on.”

Blais says that the government is wrong in its assumption. “The department leaks like a sieve,” he says. And he says that he wouldn’t be surprised if the leaks continued.

In the meantime, Blais is still reeling from the shock of being fired. “It’s one of the most distressing episodes in my career,”he says. “It’s not just that I have been dismissed. I fought within the department to have the product at least sidetracked until we knew more about it, but they refused to withdraw it.”

He says that many scientists have called him and the union to express their support for his appeal. “They feel,” he says, “that the whole integray of the scientific arm of the public service is at stake.”

David Spurgeon is a freelance science writer based in Ottawa.

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