Fw: Regush/Blais

August 18, 2009

More information on breast implants...love...Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Sent: Thursday, March 27, 2003 10:12 AM

Subject: Regush/Blais

Saturday Night Magazine April 1991

HEALTH AND WELFARE'S NATIONAL DISGRACE

In the past two decades medical devices - from heart valves, infant incubators, and dialysis machines, to tampons and surgical gloves - have killed, mutilated, electrocuted, blinded, burned, and injured hundreds, if not thousands, of Canadians. And if you think the federal government's watchdog agency is serious about policing them, you probably believe in the tooth fairy.

By Regush

Dr. Pierre Blais is a wiry, cerebral Montreal-born physical chemist with a solid international reputation for his work on the properties and behaviour of the various plastics, metals, gels, rubbers, and synthetics being used ever more widely to repair or enhance the human body. In 1976, when he was in his mid-thirties, Blais left the National Research Council to join the newly created Bureau of Medical Devices, a subdivision of a subdivision of the Health Protection Branch within the department of national health and welfare. It had been set up in the wake of the Dalkon Shield furore to protect the public's interest in the thitherto unregulated field of medical materials and equipment (as distinct from medicines and drugs). Passionate, rigorous, and hard-working, Blais soon became a bureau star. The founding director, Agit Das Gupta, calls him "the most brilliant scientist who ever worked for me." One part of Blais's job was to identify and track developments in the medical-device field. Though the bureau was chronically underfunded and the staff hard-pressed, Blais kept himself informed by wide reading and by tapping into his own network of biomaterials scientists, either by telephone or at conferences. In the mid-1980s, he picked up some promotional literature from a colleague about a breast implant called the Même, which appeared to be making a dash in the marketplace, in both the U.S. and Canada. Most breast implants are made of silicone gel. The Même had an added feature: a polyurethane foam coating. Breast implants are prone to harden, even to get rock hard, because scar tissue generated by an immune-system reaction surrounds them, forming an envelope which then contracts. The promotion for the Même suggested that the foam coating acted to keep the implant soft in the body. Curious about the new feature, Blais decided to keep a watching brief.

From April, 1983, onwards, breast implants had belonged on the bureau's high-risk list: a category of medical devices not allowed to enter the Canadian market until the bureau had cleared them for safety and effectiveness. But the provision was not made retroactive and, since a number of Mêmes had been sold directly from the United States to Canadian plastic surgeons before 1983, this particular brand had escaped formal prior review.

By 1986 Blais had developed serious misgivings. Monitoring the medical literature had turned up several reports of the foam's breaking up and becoming tangled with the patient's own tissue. Other published studies described difficulties encountered in removing the implants, in the wake of infection, without excising interlaced breast-tissue or else leaving behind crumbs of the rotting foam. In an article prepared that year for a U.S. professional journal, Blais drew these reports together and raised questions about the foam's apparent tendency to decompose. A version of the article appeared in a Canadian journal Transplantation/ Implantation Today, in September, 1988.

By early 1989, the matter had become more urgent. Blais learned that the foam had originally been developed for industrial applications - in carburetors, air conditioners, furniture upholstery, carpet-shampoo equipment, and the like - and was never intended for medical use. A succession of manufacturers of the Même had been buying the foam from jobbers, without questioning its chemical composition.

Meanwhile, experiments conducted by a biochemist named Batich at the University of Florida had demonstrated that a chemical called 2,4-Toluene diamine was a by-product when the foam was decomposed under very harsh conditions. Toluene diamine causes liver cancer in animals and is a suspected carcinogen in humans. Industrial workers who handle the chemical are strongly advised to wear protective clothing. While the Florida tests by no means proved that the same process could occur in the body, Blais was well aware of scientific concerns that reactive biological substances such as enzymes and immune-system cells could break down implant materials to release their constituent chemicals. At the very least it seemed irresponsible to use an industrial foam when more chemically stable foams were available.

Before and after: the Même breast implant showed "an apparent tendency to decompose." By this time, about 12,000 Canadian women had been implanted with the Même, at an average cost of $2,500 for the operation. Among them, Blais knew of several who had already suffered problems such as infections, but his real fear was for the implant's unknown long-term potential to cause mischief. He and other bureau scientists formed the strong opinion that the Même in its existing form should be withdrawn from use. At a special meeting on January 6, 1989, all seven of the bureau scientists including Blais and his immediate boss, Irwin Hinberg, recommended that the bureau ask the Même's manufacturer, by now Surgitek of Racine, Wisconsin, voluntarily to remove the implant from the market until its safety could be documented.

A fortnight later, and a rung or two higher on the bureaucratic ladder, a meeting of senior bureau managers decided differently. One might suppose that the first instinct of a federal agency whose mandate is to protect the public would be to carry out its scientists' recommendation and get the suspect product out of circulation unless and until it can be proved harmless. (The bureau even has the power to impound outright and without warning any device it deems dangerous, or dangerously unequal to its advertised function.) One might further suppose that the agency would feel obliged to alert the public, along with the medical profession, to Its scientists' very serious concerns. Instead, and on the instruction of a departmental assistant deputy minister, Albert Listen, the meeting decided it had inadequate information on which to make a regulatory decision and opted imply to invite Surgitek to submit its safety data. This left the Même still on the market and the public to all intents in the dark.

Pierre Blais is not a born bureaucrat. A former staffer in the health department's media-relations office once referred to him as "that guy who runs off at the mouth." (Under gentle prodding, the government flack shifted ground a little and explained: "Well, he's the only person here who feels he has to tell everyone everything.") Accordingly, having concluded that the Même was unfit for human implantation, Blais saw it as his obligation to keep arguing the case until the bureau got the news out and the product withdrawn. He thus set in motion an instructive sequence of events.

On January 27, 1989, Blais fired off a strong recommendation to his superiors that the Même be removed from the market. He was asked for his supporting evidence so, on February 20, he submitted a sheaf of documentation to his boss, Hinberg, along with a vigorously phrased appraisal of the Même, in which he referred scornfully to its foam covering as "a general purpose industrial foam" and went on to question rhetorically whether any expert on this type of material "would consider, recommend, or sanction the use of such a foam coating on a device intended to be implanted permanently in a disease-prone area such as the female breast." In the normal course, Blais's appraisal would have become part of the bureau's permanent records - available for internal reference and also subject to public requisition under the Access to Information laws.

Hinberg's boss, , got a copy of the report and judged Blais's comments so intemperate and sweeping - so lacking in what would later be called the "rudiments of interaction within the department'' - that he did some heavy editing. On March 3, Hinberg returned 's edited version to Blais, ordering him to accept the changes. Though Blais complied on March 6, he wrote Hinberg that, "in my opinion, the content of the original documents is significantly altered.'' On March 9, Hinberg ordered Blais in writing to destroy his original memo and report, as well as his March 6 response.

On March 29, Hinberg's order to Blais was reported in a story in The Gazette in Montreal, along with details of the memos exchanged among Blais, Hinberg, and . The Gazette had been tracking recent rumblings about the breast implant but, predictably, this story unleashed a media flurry about the Même all across Canada - as well as a call from an opposition health critic demanding an RCMP investigation of the document alterations. Instead, the bureau ordered an internal investigation, to be conducted by a senior manager in the health department, Roy Hickman.

Four months later, on July 17, 1989, Pierre Blais was fired. The three-page letter Hickman handed him that afternoon was signed by assistant deputy minister Listen and specified not Blais's standing or performance as a scientist but his "unsuitability for employment in the Public Service." The letter itemized the grounds for dismissal: several acts of insubordination including acquiring tissue samples through unorthodox channels, publishing an article about the Même "unbeknownst to management," and keeping his original report and the ensuing documents in his files in breach of Hinberg's order to deep-six them. And a worse charge: "on the balance of probability," he had leaked copies of the documents to the media.

As a result of the unfavourable publicity attending that leak, the letter of dismissal reminded Blais, the bureau had been put to the trouble and "substantial" expense of commissioning an independent report on the Même to clear the air.

This was true. In April, on the heels of the press uproar, Surgitek had complied with the bureau's request to make its case for the Même. The company's basic position was -- as it remains -- that the product is safe. But its data were, by bureau standards, incomplete and inadequate. (Ten months later, holes in the submission still remained to be filled.) So the bureau had gone outside for a study. Its author was a Montreal plastic surgeon, Carolyn Kerrigan, who had herself implanted Mêmes in some of her patients. She took seven weeks to review the literature, after which her findings were presented at a press conference held by the health department. Effectively, the bureau had adopted an official position.

Though Kerrigan had been at pains to cite the absence of controlled experimental studies to corroborate the generally favourable clinical reports, this position was, according to the letter signed by Listen and handed to Blais, that Kerrigan's review had "unequivocally established that the Même Breast Implant Prosthesis is safe."

Blais read the letter without comment, shook Hickman's hand, thanked him noncommittally, and was escorted out of the building by a guard.

Canadians are on the whole trusting consumers. When it comes to goods and services with obvious health implications - infant incubators, for example, or breast implants - it's likely that most members of the public have assumed all along the existence of fairly sophisticated systems of official assessment and regulation.

The truth is that, as recently as twenty years ago, both implants and incubators fell into a product category - medical equipment and devices - for which only the sketchiest rules existed. Under the Food and Drugs Act of 1954, they were lumped in with "therapeutics" and, since the law said the government had to prove a therapeutic was harmful to health before sales could be stopped - and since the government had no enforcement agency focused on medical devices, nor a master list of what devices were out there - the field was going unpoliced. Unlike makers of drugs, medical-device manufacturers were not even required to register their products with the federal government.

Starting in the early 1970s, however, pressure began to build from Canadian doctors who were concerned about the lack of quality control. As it happened, incubators were one of their worries: above a certain threshold, the oxygen concentrations in the enclosed incubator atmosphere could damage eyesight in newborns. The doctors asked the government to begin assessing devices before they were marketed, and to create and enforce manufacturing standards.

on was then head of the Health Protection Branch (HPB) of the health department; he freely admitted the medical-devices area had been neglected and, beginning in 1973, the department started revamping its approach. Its first move was to amend the Food and Drugs Act so that the onus of proving medical-device safety was on manufacturers.

The department's next major move, a year later, was the creation of the Bureau of Medical Devices. It came in the wake of congressional hearings south of the border that had focused on the Dalkon Shield, a widely used intrauterine contraceptive device. The IUD had been billed by its manufacturer in 1969 as a breakthrough in birth control. U.S. government investigators now blamed it for miscarriages, permanent sterility, many cases of pelvic infection, and several deaths.

Its mission thus underscored, the new Canadian agency might have been expected to enjoy a high level of government commitment. Instead, right from the beginning it seemed a bit of a changeling. For no compelling reason, it was positioned - five levels down on the health department's organizational chart - as an add-on to the Environmental Health Directorate. The department's choice to head the new bureau seemed almost as arbitrary. Agit Das Gupta was the acting head of the Radiation Protection Bureau and his expertise was in radiation. He seems to have been chosen partly because he had made a modest contribution to a federal task force that was examining the safety of hospital equipment, some of which involved the use of radiation. He had no particular interest in medical devices as such. When he received a memo from a health-department manager asking him to appear at an interview for the job of heading the new bureau, he wrote back no thanks. The next memo ordered him to appear. When he complied, the third memo congratulated him on winning the position. As fate would have it, he was a sterling choice.

Das Gupta was no slouch. He had begun his physics career in India, where he was born in 1921. In 1960, after advanced studies in physics at McMaster University in Hamilton, he had joined the federal radiation programme. His track record there was first-rate: he is credited with the creation of most of the federal safety programmes and the regulations for x-ray and gamma-ray equipment.

Only weeks into his new job Das Gupta realized he was going to have to fight hard for funds and staff. The Environmental Health Directorate itself was competing for money and recognition with other environmental programmes operated by the departments of environment, labour, and agriculture. And within the directorate, the new agency was in instant rivalry with the existing bureaus, radiation protection and chemical hazards. "We were definitely not a priority,'' Das Gupta says. He was given cramped offices in the directorate building in Tunney's Pasture, a start-up staff of four, and a mandate to develop a series of regulations that would provide the bureau with some teeth in its task of policing medical devices. As well, he was to oversee the registration by manufacturers of all medical-device products available for sale in Canada.

With a staff that increased to about fifteen by 1976, Das Gupta developed the regulations that were issued that year as an amendment to the Food and Drugs Act. According to the new Medical Devices Regulations, a medical device was any article, contrivance, machine, or piece of equipment used for the diagnosis, treatment, or prevention of a disease, for correcting or altering human body functions, or for contraception. The definition encompassed a dizzying array of products - from tongue depressors, bandages, and dental wax to pacemakers; from condoms, syringes, and contact lenses to paediatric cribs and anaesthesia equipment; from artificial lungs and heart valves to surgical gloves. The regulations required that a manufacturer or vendor of such products register what was being sold with the department, adequately label the product, and have available in Canada test data, other evidence of the product's safety and efficacy, and files on its safety record.

As the manufacturers complied and the bureau's catalogue of devices swelled, it became obvious that some categories were a good deal higher-risk than others. It was decided that new products in these categories should be kept off the market until they passed a strict safety review. Before they were cleared for sale, their manufacturers would have to provide the bureau with detailed manufacturing data, quality-assurance information, and the results of animal and human studies. The first products to come under these strict premarketing requirements were intrauterine devices and pacemakers. Intraocular lenses, prolonged-wear contact lenses, and tampons were added in a year or two.

As for devices already on the market, while no formal system of registering complaints or problems existed in those early years, a growing number of health professionals took to alerting the bureau about their concerns. Bureau staffers also encouraged problem-reporting in lectures to medical bodies.

Still, as Das Gupta put it, "We were only scratching the surface. It became more and more obvious to us just how much was required to bring the regulation of medical devices in line with, say, the government programme to regulate prescription drugs."

By 1980, Das Gupta's staff had grown to about thirty, but the number was still laughably short of being a match for the bureau's mandate. Medical technology was making breathtaking advances; the sale of medical devices had become a major international growth industry. But Das Gupta was having trouble finding the money even to print warning bulletins to health professionals about defects and device-failures the bureau had identified.

Pierre Blais remembers his first years at the bureau under Das Gupta as some of the best a scientist could have. "There was not much money, but there was direction and motivation, and it was an exciting place to work," he says. "Staffers even worked on weekends. The place felt something like a university."

Besides trading data and know-how with colleagues outside the bureau, Blais often got around budget shortfalls by making use of non-government laboratories and hospitals on his own time and at his own expense. To take an early example, in association with Guidoin, a biochemist at Laval University, he was part of the team that discovered the actual process by which the Dalkon Shield could infect long-term users: together with U.S. researchers, they determined that the attached string used for removing the IUD developed cracks in which bacteria built up. Once the string became saturated, it released an explosion of bacteria, which led to infection. The bureau warned Canadian women to have the IUD removed even if it seemed to be causing no immediate problems.

The pace at which Blais and his colleagues drove themselves was fuelled by their growing sense of the size, complexity, and urgency of the task they had embarked on. Most troubling was the fact that crucial hospital equipment was subject to no independent safety assessment. "Working at the bureau sometimes made you feel hospitals were minefields," Blais says. Some examples: in 1981 a hospital in Winnipeg reported the death of a boy whose blood was, in effect, cooked when the temperature of a blood-warming device rose out of control. In 1983, at a Toronto hospital, another boy was crushed to death by his electric bed. He was pinned between stationary and moving parts of the frame when a poorly designed switch on the bed was triggered accidentally. In 1984, an eighty-five-year-old woman at a Montreal hospital was burned when the machine assisting her lungs with a steady flow of oxygen exploded one morning. The fire leapt to the curtains surrounding her bed. Badly scorched, she caught pneumonia and died nine days later. All the bureau could do was issue a warning to hospitals about this type of machine, if improperly assembled.

Experiences with faulty equipment at major hospitals - among them Vancouver General, Edmonton's University Hospital, Hamilton's McMaster Medical Centre, Toronto General, and Montreal's Royal - suggested that foreign medical-device manufacturers, who controlled about eighty per cent of sales in Canada, were flooding this market with sub-par equipment, some of it U.S. rejects. Biomedical engineers and hospital equipment managers would find, for example, that a particular piece of electrical equipment was prone to current leakages, or had ground wires that could easily be broken. It was not unusual to return as much as twenty per cent of device shipments.

But often the potential for accident or crucial malfunction showed up only with use. In the early 1980s, hospitals started reporting problems with anaesthesia breathing circuits that disconnected. Their cone-and-socket connectors were intentionally designed to join easily, with a push and a twist, and to separate with a pull, but most had no locking mechanisms. In one tragic case, at Vancouver General Hospital, the tube supplying the gas mixture pulled free during an operation, and the patient had a heart attack.

Hospitals began reporting problems with anaesthesis breathing circuits that uncoupled.

In 1983, a man undergoing kidney dialysis died at Toronto Western Hospital because of contaminated tubing. Testifying at the inquest in Toronto, Blais brought along samples. The supposedly "sterile" tubing meant to clean the patient's blood of impurities had proved to contain paint chips, soot, slivers of wood, and copper traces. "We found out too late that the tubing was made in a slop shop with chronically poor staff-management relations," Blais said.

Like anaesthesia equipment, kidney dialysis equipment could be put on the market without any prior safety evaluation or the filing of any manufacturing details. (For that matter, manufacturing standards hadn't even been established.) The bureau was well aware of the gap. The problem was its lack of staff.

If Blais was occasionally daunted by the dimensions of the mandate, he was constantly incensed at the workings of the public service. As a small agency within a directorate that was itself a sub-division of a branch of a huge government department, the bureau was subject to sudden programme cuts, staff raiding, and frequent orders to shift offices and laboratory space. When good staff left for promotions elsewhere, obstacles appeared in the path of hiring replacements. "Here was Das Gupta fighting for laboratory, office, and storage space, more and better-qualified staff, new laboratory equipment," says Blais, "and the upper echelons kept bottlenecking."

Emmanuel Somers, then head of the Environmental Health Directorate and thus Das Gupta's boss, dismisses him in retrospect as "a typical government manager: never satisfied with the attention and resources he was receiving." For his part, Das Gupta likes to point out that he was never your typical public servant - in his words, someone who keeps his mouth shut, obeys orders, and never makes waves. Das Gupta made waves.

Concern had been building for several years among bureau scientists about the number and variety of new medical implants coming into use. Intraocular lenses and pacemakers were specifically subject to prior assessment, but other body-part replacements were not, though they included cardiac defibrillators, infusion pumps, prosthetic limbs, orthopaedic joints, neurological shunts, implants related to reconstructive and cosmetic surgery, and heart valves. In 1980, Pierre Blais had testified at two inquests into deaths due to heart-valve difficulties; in 1982 he testified at two more. As well, the range of intraocular lenses was widening. Das Gupta determined to sell the idea to his bosses that, at the very least, the premarket review process had to encompass all medical devices that were implanted in the body for more than thirty days. But there was going to be one major hitch. He would need about thirty more people - some to conduct laboratory evaluation of implants, the majority to review and process what would surely be an avalanche of applications to market new implants.

Seeing Emmanuel Somers as the major obstacle to his planned expansion, Das Gupta waited until late 1982, when Somers was dispatched to Geneva for six months to promote environmental issues in the World Health Organization bureaucracy. In his absence, Das Gupta presented his case directly to the federal Treasury Board. He was given a go-ahead.

"The bad news was that when Somers got back, all kinds of staffing games suddenly began to be played," Das Gupta said. The recruits were translated into person-years, which were deployed throughout the directorate. Das Gupta effectively ended with not many more than a dozen of the thirty staffers he needed. A number of them were fresh out of school and untrained. "I went over Somers's head to protest to the assistant deputy health minister," Das Gupta recalls, "but it wasn't considered a nice thing to do, and it fell on deaf ears."

In April, 1983, the premarket review requirements for all new implants came into force. As Das Gupta had expected, manufacturers swamped the bureau: more than 500 applications arrived that first year. Each application had to be read, assessed, and, if necessary, investigated in the laboratory or the literature by bureau specialists. The untrained newcomers scarcely lightened the load.

By the end of March, 1985, the backlog of undealt-with files had reached 122. The figure is recorded in the minutes of the bureau's annual meeting with medical-device manufacturers. The same meeting produced some other daunting statistics. The bureau was trying to police a $2-billion business. (Hospitals were the main customers.) At that point it had catalogued more than 300,000 medical devices on the Canadian market. The registrations came from 6,595 manufacturers, of whom only 471 were Canadian.

When a problem with a device had a serious enough potential to cause death, the bureau got the word out by means of a bulletin referred to as an "Alert." An Alert was an urgent warning to hospitals and health professionals; but it was also - given its instant potential to damp a manufacturer's sales - a loaded weapon. There was tension from the beginning between the bureau's public-safety mandate and the very Canadian tendency to treat loaded weapons with extreme caution. Before Das Gupta could issue an Alert, he had first to make his case to Emmanuel Somers and seek his permission. If persuaded, Somers would in turn seek approval from his boss, the directorate's assistant deputy health minister. Even then, the Alert could be issued only with the manufacturer's approval, and after the wording had been worked out with him. This kept the bureau out of lawsuits and other nastiness, but, it could be argued, short-changed the public. The Bjork-Shiley heart-valve episode is a case in point.

Back in the 1960s valve patients were few, their life expectancies short, and the mechanical lifetimes of heart valves almost irrelevant. But the 1970s had brought much better valves, with lifetimes in the range of twenty to thirty years. Surgeons had also developed better implantation techniques and the procedure was becoming routine. As long as clotting didn't develop in the valve, it was assumed that patients could live without problems. Clots could clog the mechanisms or, if released into the bloodstream, cause strokes.

The heart valve known as the 60-degree Convexo-Concave (C-C) was manufactured by Shiley Inc. of Irvine, California, a unit of the pharmaceutical giant Pfizer Inc. It was marketed on claims that it reduced the risk of blood clots and became the popular medical choice. Its mechanical lifetime was taken for granted: surgeons believed it could last indefinitely. The C-C was introduced in 1976 and various models were available in Canada for several years prior to the 1983 premarket regulations. The C-C thus never came under the mandatory bureau safety checks.

But as early as the beginning of 1980, Pierre Blais had reason to believe the C-C seriously flawed. Two Calgary women fitted with C-Cs died that year and the Alberta government asked Blais to conduct post-mortem examinations of the valves. His finding was that unless the device was precisely positioned, heart tissue could get caught in its mechanism, and the valve would jam.

A welded strut was the C-C heart valve's weak point: if it broke, the heart stopped.

In a memo to his boss on July 24, Blais wrote: "I feel that this new valve is conceptually faulty and, in addition, is transparently recognizable as such." For another defect had become apparent. Blais's network of pathologists in the U.S., Canada, and Europe had been sending him samples of C-C valves removed during autopsies. Although it wasn't clear whether any of the valves he was sent had been the specific cause of death, each had the potential to be so. The valve's disc opened and closed to control the flow of blood circulating through the heart. Two metal struts held the disc in place. One strut was cast as part of the valve ring. The other was welded. Blais reasoned that the welded strut was weakened and unpredictable at either of the two welds, and could eventually break under repeated stress as it opened and shut with each heartbeat. The very process of welding weakened the metal. If a strut broke, the valve would fail because the disc would float free and the heart would stop pumping.

In 1982 Blais was called on to do two more post-mortem studies of heart valves - this time by the Saskatchewan government. In both cases, they were C-C valves and they had broken at the welded strut.

The bureau issued its first Alert on heart valves that August. It was a compendium of fractures, flaws, and imperfections that had been detected in various makes of heart valves. The best-selling C-C with its structural defect was not singled out. In December of that year, another Alert warned of difficulties in surgically implanting various heart valves. Again, the C-C was not made a special issue.

In Blais's opinion, the Alerts were long overdue and should both have focused on the C-C. "They mixed the C-C fractures in with other heart valves and other valve problems, and this lessened the urgency of the warnings," he said. Nonetheless, in both cases the manufacturer could scarcely claim his attention had not been drawn to the problems.

Two more years passed. The scientific evidence mounted that the C-C valve was poorly made and a potential killer. Besides the jamming problem, about 200 C-C valves worldwide had been reported broken, including several in Canada.

On September 20, 1984, Blais fired off another memo emphasizing the urgency of taking some action on the C-C. In due course, Das Gupta got the necessary permissions, but, by the time the wording had been worked out with the manufacturer, the Alert issued by the bureau made no mention of the welding problem and focused mainly on ways to implant the C-C more effectively.

In 1986, Shiley Inc. stopped making the C-C. It had begun marketing a new product with the main support structure manufactured in one piece, using a more modern method.

On October 2, 1987, the bureau finally issued a specific Alert advising hospitals against the implantation of any and all welded C-C valves. By this time, the bureau was aware of seven Canadian deaths associated with the C-C. Throughout the country, somewhere between 1,300 and 2,000 had been implanted. But, in Blais's opinion, it was unlikely that more than a hundred or so were still on hospital shelves.

Agit Das Gupta wasn't a quitter. After the collapse of his staffing campaign, he switched his efforts to bolstering the bureau's information function. On average, Canadian health professionals were sending the bureau about 350 reports each year of various problems with medical devices. It greatly disturbed Das Gupta that these reports probably represented only a tiny fraction of the defects that were actually being encountered and the failures that were occurring. This in turn minimized the flow of potentially life-saving and injury-preventing information to other hospitals. But how to encourage and systematize problem-reporting?

In 1983, Das Gupta asked the Canadian Medical Association to sponsor a programme. His thought was that doctors might communicate more readily and comfortably with their own organization. The bureau would pay the costs.

Although it took the CMA two years to assess the feasibility of the project, in 1985 it accepted a $74,000 one-year contract with the bureau and established a twenty-four-hour, toll-free, bilingual hot line. Then it mailed information on the programme to its 38,000 member doctors, as well as to 1,500 hospitals, several Canadian medical publications, and more than 200 societies.

The mail campaign brought a promising flurry of mailed and telephoned reports. Forwarded by the association, they accounted for fifteen to twenty per cent of total reports to the bureau that year. In addition, reports directly to the bureau suggested a heightened general awareness; they totalled 522, a hike of almost 200 from the previous year.

But the bureau's collaboration with the doctors ended abruptly after only a year. The Conservatives had come to power in the fall of 1984 and Mulroney had campaigned on a platform of slashing government expenditure and returning power to the private sector. Both promises had reverberations within the bureau. In 1986, just before the contract was scheduled to expire, the health department informed the CMA that an internal spending-restraint programme was now in force and the contract wouldn't be renewed.

Das Gupta wasn't around to mourn the death of his initiative. A few months earlier - and soon after returning from sick leave owing to a heart ailment - he had been told that the radiation protection and medical devices bureaus would merge. The director of the radiation programme, Dr. Ernest Letourneau, would take over as head of both operations. Das Gupta was invited to stay on as a sort of special adviser. Instead, he retired.

The merger of radiation and medical devices in April, 1986, rang in another phase of the bureau's history. In 1985 Albert Listen, the health department's newly appointed assistant deputy minister and head of the Health Protection Branch, had spoken enthusiastically of government's retreat from "the big-stick mentality" in the health protection field. Though he admitted publicly, later the same year, that the bureau was seen as too soft on manufacturers, he talked cooperation and "voluntary compliance."

So did Letourneau. In an article for a British trade magazine, co-authored with a bureau manager, the new head of the Bureau of Radiation and Medical Devices commented on the imperceptible, positive shift in the Bureau's relationships with regulated industry." In the same article he argued that the melding and reorganization of the bureaus would lead to "a more logical distribution of staff expertise and consolidation of the administration of the Bureau's various regulatory mandates."

In practice, "consolidation of the administration" meant more red tape. Nowhere was this as evident as in the processing and handling of problem reports.

When Das Gupta was running the bureau, he had held weekly meetings to review the reports, assign priorities, and investigate any delays in responding to urgent problems. With his departure, the weekly meetings gave way to a new system emphasizing forms and formal correspondence. Each report lodged with the bureau was entered on a long form, computerized, analysed, and summarized. A draft letter to a manufacturer now required signatures from senior management. "It made about as much sense as putting emergency ambulance dispatch messages in sea-bottles," says Blais. Typically, a hospital might report that a particular breathing tube had a tendency to disconnect after several hours of use. A senior manager would sign the letter notifying the manufacturer of the problem report. The manufacturer might then raise some technical issue in a reply to the senior manager who would then request a more detailed written briefing from his underling. The underling in turn would have to consult the initiator of the report at the originating hospital because no one at the bureau had investigated the problem in the first place. The paper shuffling could go on for months.

At the same time, the warning system underwent changes. Under Das Gupta, the information letter and the Alert had been the principal means of keeping the Canadian health profession informed. Under Letourneau, the bureau launched a new initiative: a regular news digest entitled Surveillance.

First published in July, 1987, Surveillance provided a broad view of medical device problems culled from the reporting system and staff research: deaths linked to patient-restraint vests and hospital beds; warnings about the potentially lethal rhythms that could be triggered in the heart by electrical equipment used in physiotherapy and sports medicine; news about surgical lasers, electrosurgical units, and other electrically powered instruments that had ignited surgical drapes or wearing apparel. It drew instant applause from health professionals: some 200 readers wrote in to say "Thanks" and to offer input. But the digest was dropped in November, 1988 - apparently for budgetary reasons - after only four issues.

At first, only pacemakers and IUDs had to undergo mandatory premarket safety checks.

In the meantime the Alerts had fallen into disuse. The Das Gupta years had produced some eighty Alerts. Between August, l988, and the beginning of January, 1990, not one was issued, though hospitals reported more than 300 medical-device problems ranging from faulty pacemakers and malfunctions of disconnect alarms in lung ventilators to actual disconnection of valve flaps in resuscitators. In all, only eight Alerts have appeared since the end of 1987.

Nor has the bureau been signally active elsewhere. Consider, for example, its file on materials used in eye surgery. At least 100,000 Canadians every year have cataracts removed, artificial lenses implanted, or retinas or corneas repaired. To facilitate these operations, surgeons use various gels and fluids to lubricate or irrigate the eye. Reports in the bureau's file indicate that scores of patients have suffered side effects such as inflammation, corneal tissue changes, and even loss of sight associated with the use of these materials. Nonetheless, to date, their manufacturers are required only to notify the bureau that they are available for sale in Canada, putting their federal regulation on a par with that of bandages and tongue depressors.

Intraocular lenses - along with tampons - were early on the bureau's high-risk list. The bureau's file on ophthalmic materials is at least half an inch thick. In 1986, for example, Pierre Biron, a professor of pharmacology at the University of Montreal, complained to the health department about the lack of follow-up safety checks on eye products; this was after injected fluids were linked to corneal damage in four Montreal patients.

That November, a push was got under way to make such materials subject to safety and efficacy checks. A document dated June, 1987, shows that Blais helped to prepare a proposal. But a document dated September 6, 1987, rejects the proposal because of insufficient manpower and suggests that it be replaced by a call for industry to follow a set of guidelines for manufacturers.

Meanwhile, even some quarters of the industry had been expressing concern.

In July, 1987, Geoff Holland, a vice president at Pharmacia (Canada) Inc., a Montreal-area company that imports materials for the eye, wrote a letter to Jake Epp all but begging the health minister to take concrete action. "It seems to be becoming more urgent as there are now an increasing variety of relatively unregulated products appearing on the market," Holland wrote. He was concerned then - as he is now - that doctors face pressures to use cheaper and possibly hazardous brands of gels and fluids in eye surgery because of budget squeezes at their hospitals.

Another document in the file, dated July 8, 1988, proposes a series of marketing guidelines that would, in effect, force companies to disclose more information about their products and keep better records of manufacturing practices and quality control. As of March, 1991, there had been no regulatory move.

Asked about the inaction, Eva Callary, acting head of the bureau's clinical advisory division, replied: "There have been delays. . .but I am not sure why."

Canadian experts in biomedical technologies are increasingly worried about the bureau's inadequacies. "Products such as artificial organs and replacements for natural tissues are becoming more sophisticated and more in demand as the population ages," says Dennis at the University of Toronto's Centre for Biomaterials, adding that underfunding has denied the bureau both the research capability and the scientific firepower to keep pace with new designs and materials.

Laszlo, a biomedical engineer at the University of British Columbia and a member of the bureau's scientific advisory committee, agrees: "The interpretation of complaints about medical devices requires considerable expertise and the bureau is badly lacking in that regard. It has a very small staff with little hands-on hospital experience."

Other critics are less charitable. One Vancouver scientist simply writes off the bureau as "a national disgrace."

Germain Houle has been associated with the bureau through much of its lifetime: as head of the Canadian Anaesthetists' Society, he agreed to join a start-up scientific advisory committee at the time of the bureau's creation in 1974 and he is now the committee's head. A grey-haired, energetic fifty-seven-year-old, he had decided to specialize in anaesthesiology after witnessing an anaesthesia-related death while he was in general practice near Hawkesbury, Ontario; a very similar motivation has kept him involved in the bureau's fluctuating fortunes.

It was hoped that the advisory committee would become the bureau's eyes and ears in the medical community, and take an active role in planning regulatory strategy. In the beginning it did. Day-long meetings with bureau staff were held twice a year. The committee's recommendations were taken seriously - as, for example, when the committee asked the bureau to inform all health professionals, not just the chief executive officers of hospitals, about device-related problems. The bureau's move on the recommendation helped to encourage more problem-reporting from hospitals.

By 1987, though, meetings had been cut down to an annual two-day affair, with little communication in between. The bureau said it was pinched for cash.

In 1988, when the committee suggested that its members should be receiving their own copies of all bureau bulletins, Houle was told he'd be supplied with one and could make his own copies. He began to think the committee was getting the bum's rush. "The bureau has not taken us very seriously for several years now," he complained.

The October, 1989, meeting brought more signals. For one thing, the bureau scheduled it in a dank conference room in the basement of the Claxton building at Tunney's Pasture. "It was a terrible place," Houle says. "Worse still, the bureau put us up in a very poor hotel. Most of the members were quite upset." But the same meeting brought something much more disconcerting: a casual report by an official of the bureau about its findings on medical and surgical gloves. The bureau had been given $50,000 by the Federal Centre for AIDS for the purpose of subcontracting a research firm to assess the quality of the gloves. There were special worries that glove failure could expose health professionals to the Hepatitis B virus, and to the human immunodeficiency virus that is widely believed to be the cause of AIDS.

More than half of the brands of surgical gloves had defects - but doctors weren't warned.

The bureau, it now seemed, had been informed by its outside researchers five months before the advisory-committee meeting that more than half of fifteen brands of latex gloves had failed tests and did not meet proposed standards. Every second pair of one popular brand had holes. Worse, the holes were not easily detectable. But no, said the official, so far the bureau had not alerted doctors or the hospital community.

"We all stared at him," Houle said. "We were absolutely amazed. They didn't tell anybody all those months. It didn't seem to even occur to these people that health professionals should be warned."

Rather than send out an Alert on the defective gloves, the bureau had opted to try to persuade manufacturers to shape up. But it wasn't until April, six months after the advisory committee had met, that the health department sent a notice to companies setting out manufacturing guidelines for medical gloves.

Margaret Catley-Carlson, Health and Welfare Canada's deputy minister, is an attractive and energetic forty-eight-year-old. She leans with engaging candour towards the visitor to her huge corner office in Tunney's Pasture and says she isn't too keen on Alerts. They're old hat, she says. A product of bygone days when consumer crusades were in fashion, the days when much of government's regulatory machinery was put into place, when it was assumed that the private sector, in pursuit of the bottom line, would often cut corners. And so it was a time when public servants could cut their careers on being a thorn in the side of industry. "People got their kudos, their jollies, their bureaucratic pre-eminence," Catley-Carlson remarks, "by what embarrassment they could generate." In the old system, "you judged your efficiency by how many Alerts you had."

But the world has moved on. Better now, she says, to work hard to encourage industry to monitor itself, harness its cooperation in meeting standards set by government, and have faith it will comply After all, isn't it in industry's best interest to do good? "We're moving to a monitoring and post-audit approach rather than a pre-emptive strike approach," Catley-Carlson says.

The new thinking applies to all areas of government, she says. "Most regulatory regimes in the government are in a state of flux."

So people who champion the old approach - the obsolete approach - are going to be very disappointed and disaffected. "They find discomfort in the fact that what was used previously - either in the form of Alerts or public notices - are no longer being used."

What shape, then, will the new relationship between government and industry take, specifically in the case of the Bureau of Radiation and Medical Devices? How will it actually work?

Catley-Carlson defers to Albert Liston, who, as administrator of the Health Protection Branch, is the orchestrator of the New Thinking. He speaks of going through an examination of regulatory programmes, adding that much of the focus so far is on finding better communications procedures in the Environmental Health Directorate. A consultant has been hired to advise on ways to create smoother relations between the bureau and its advisory committee and to respond more effectively to reports of medical-device malfunctions. Perhaps more bureau communications will find their way into industry publications, Liston suggests. "Change is being brought about," he says.

And indeed, a few months later - on February 11 of this year - the department announced its intention of appointing a committee, with representatives from the industry, the health-care professions, and consumer groups, to conduct a comprehensive review of its medical-devices programme. The committee's mandate will be to arrive at recommendations that, according to Liston, "will help guide the Department over the next decade."

One important bit of old business, however, will accompany the bureau's reinvention - the Même breast implant.

Catley-Carlson says: "It's going to be a hot file for a very long time."

No kidding.

Firing Pierre Blais in July, 1989, didn't mean he would cry uncle. He filed a grievance against the health department for unlawful dismissal, was reinstated several months later, and then reached an agreement to leave.

Told in due course of the projected review committee he was unimpressed. In his view, nothing less than the Canadian counterpart of a U.S. congressional hearing - the sort that, for example, put the finger on the Dalkon Shield - would produce significant change. "Let's face it," he said. "You need a lot of political will to do a good house-cleaning."

Blais had quit the bureau but he had not quit the Meme: rather, he had begun laboratory research on it with his friend and sometime research associate Guidoin, who is head of the Laboratory of Experimental Surgery at Laval University in Quebec City.

By the spring of 1990, Guidoin, Blais, and five other researchers from Laval had hard evidence that, even under laboratory conditions much milder than those reported by Batich at the University of Florida, the Même's foam released the carcinogen toluene diamine in significant quantities. The Laval tests also showed the Même's foam was saturated with silicone oils and other impurities.

At long last, the bureau stopped relying on an outside - plastic surgeon's - review of a scanty literature, got busy on its own tests, and by the end of the summer had verified the Laval and Florida conclusions to the extent that it found toluene diamine to be detectable in the implant's foam. But Blais's former boss, Irwin Hinberg, dismissed the amounts of toluene diamine as "insignificant." Nor, he said, could data be extrapolated to what happens in the bodies of Même users.

This pretty well coincides with the manufacturer's position. Surgitek was understandably upset by the Batich findings in 1988, and by subsequent pressure from the U.S. media and consumer groups, and began a belated scramble to find out what might actually be happening in the bodies of Même users. Late in 1989 the company commissioned its own electron-microscope study of ten explanted Mêmes. As a result, in sequential "Dear Doctor" letters sent to plastic surgeons last December and this February, Surgitek claimed that the foam's "basic" cellular structure, while invaded by breast tissue, had been found to remain "intact" for as much as nine years; that, while the foam undoubtedly underwent "slow biodegradation via hydrolytic reaction," a chemical reaction seemed to act to halt the process, thus limiting the release of toluene diamine to an amount "so small that scientific risk assessment studies show that the risk of cancer under such conditions is less than one in several million." Both letters stressed: "Risks of 1:1 million are considered to be insignificant." Both letters also stressed the Même's track record of staying soft in the body, as promised, and producing satisfied customers. The company continues to use the same industrial foam in the Même, though it claims to have developed a better cleaning process. It is facing a number of lawsuits in the U.S.

So is Shiley Inc. Finally admitting the risks linked with the discontinued C-C heart valve - though still stoutly maintaining that the benefits had outweighed them - Shiley contracted with Medic Alert, the international patient registry, and last December announced a sweeping and expensive programme of locating and warning the 21,000 U.S. and 2,000-odd Canadian living recipients of the C-C. The company acknowledged that, along with a congressional subcommittee hearing and pressure from a consumer advocacy group in Washington, its involvement in litigation over the valve had played "an important role" in prompting the move. Significantly, Shiley Inc. did not mention moral suasion or regulatory action from any official agency either in the U.S. - where heart valves, like breast implants, come under a bureau of Reagan's and Bush's FDA - or in Canada.

The bureau of medical devices' turbulent history raises difficult questions including, obviously, ones about acceptable levels of risk weighed against benefits, and about the correct saw-off between public safety and fairness to particular manufacturers. But it also raises the question of whether a watchdog agency that raises false expectations while it grievously under performs isn't worse than no agency at all. It's worth noting that, in the two decades of the bureau's existence, hundreds, if not thousands, of Canadians have been killed, mutilated, electrocuted, burned, blinded, and injured by medical devices.

| Premium Subscription || Site Philosophy | Columnists | Special Features | Health | Science | Environment || Media | Arts | RFW Store | Free Newsletter | Links | Home | E-mail |

November 11, 2009

This is a vey interesting article...love to all...Lea

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~`````