Keeping track of patients and their implants

On the evening of Aug. 27, Lincoln Bryant, a Presbyterian minister in Kingston, Ont., was watching the news. A report came on that left him stunned: DePuy Orthopaedics Inc., a U.S. company, had announced a global recall of two implants used in hip replacement surgery. Bryant, 53, suffers from hip dysplasia, an instability in the joint. In January 2008, after years of managing the pain, he had hip resurfacing surgery, a type of hip replacement that preserves more bone. Since then, the pain has gotten worse; he can’t be on his feet more than a few hours at a time. “I didn’t know what I had in my body,” he says, but he suspected it might be a DePuy implant.

The next day, feeling increasingly worried, he phoned his surgeon, but was unable to reach him, playing phone tag with a secretary for a few days. (Kingston General Hospital, where Bryant says he had the surgery done, couldn’t confirm details of his story for privacy reasons.) His situation was complicated: unrelated to the recall, in January he’d filed a complaint against his surgeon with the College of Physicians and Surgeons of Ontario (CPSO), which regulates doctors in the province, and was awaiting his hearing.

A few days later, Bryant still hadn’t managed to get in touch with his surgeon, and “started digging around in my patient records,” paying $35 to get copies of his notes. These confirmed he had a recalled DePuy unit in his body, he says.

On Aug. 26, just one day before Bryant had learned of it, DePuy, a subsidiary of Johnson & Johnson, announced a voluntary recall of the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System (Bryant had the latter). New data had shown that, within five years, about one in eight patients needed a revision surgery after suffering a variety of symptoms—including pain, swelling and problems walking—which could be caused by problems like the implant loosening, or bone fracture. Not everyone would need to have the implant taken out, DePuy said, but they suggested patients should contact their surgeons, who might order testing, like X-rays, or blood tests to look for microscopic metal particles floating around the hip.

It’s fairly unusual for a hip implant to be recalled. Even so, in 2008, orthopaedics manufacturer Stryker Corp. voluntarily recalled the Trident PSL and Hemispherical Acetabular Cups that were constructed at its plant in Cork, Ireland; that same year, Zimmer Inc., another manufacturer, temporarily suspended sale and marketing of its Durom Cup in the U.S. so it could train doctors how to better implant it. All three companies—Stryker, Zimmer and DePuy—now face lawsuits. Merchant Law Group, a firm with offices across Canada, has filed class action lawsuits in different provinces on behalf of patients who say they’ve been injured by hip implants from these companies. (Patients in the U.S. have filed class action lawsuits against DePuy as well.)

When a car gets recalled, manufacturers contact owners and “tell them there’s something they need to fix,” says Dr. Nizar Mahomed, an orthopaedic surgeon at Toronto Western Hospital. (He’s never been involved in a medical recall, and didn’t use the DePuy products.) “Unfortunately, in the medical device sector, there is no standard registration process.” Other jurisdictions, like England and Australia, methodically track artificial joints; the U.S. is launching its own registry, hoping to capture over 90 per cent of hip and knee implants by 2015. Not only do these databases provide early warning signs of implants that might not be producing the best results; they can be incredibly useful in a recall. In Australia, hospitals can contact the registry and get the names of patients affected.

Canada has a voluntary registry—the Canadian Joint Replacement Registry (CJRR)—but a relatively low number of doctors participate, so it tracks only about half of all knee and hip replacements here. Dr. Robert Bourne is a professor of orthopaedic surgery at the University of Western Ontario, and co-chairman of the CJRR. When asked if we’re doing a good job tracking joint replacements in Canada, he replies: “No, in a word.”

About 1,300 Canadians were implanted with the ASR hip systems, which became available here in 2006, according to Health Canada, the federal agency that regulates medical devices. As for how many people went in to see their doctors after the recall, neither Health Canada—nor anybody else contacted by Maclean’s—could say for sure. When there’s a recall, manufacturers tell hospitals, who inform patients; manufacturers also submit a report to Health Canada, including the number of affected devices and distribution lists. But Health Canada only monitors notification “at the health care facility level, not the patient level,” it said in an email to Maclean’s, and suggested following up with the manufacturer, DePuy—who said, in their own emailed statement, that they don’t keep the names of individual patients, either. (Neither Health Canada nor DePuy would provide a spokesperson for an interview.)

As for whether anybody is actually following up to make sure every patient is informed of a recall, again, nobody contacted by Maclean’s could say. Health Canada is “not aware of a body that performs this function,” said its emailed response, adding that if a patient had a complaint about a specific doctor or hospital, that would be a provincial matter. The CPSO is responsible for doctors in Ontario, and at Bryant’s complaint hearing in September, he says he raised the issue. (He’s awaiting their final report.) The CPSO wouldn’t comment on Bryant’s complaint, but a spokesperson noted in an email that it isn’t involved in regulating medical device recalls, and that it has never received a complaint against a physician about how a recall was handled, as far as its investigators could remember.

As the number of Canadians living with implanted medical devices continues to rise, tracking them has never been more critical. Almost 29,000 had a hip replacement in 2007-08, up from 23,600 four years before, according to the Canadian Institute for Health Information (CIHI). That same year, about 19,620 were implanted with a pacemaker. A large number of implants are related to orthopaedic or cardiac procedures, says Eric Sacks of the ECRI Institute, a U.S. non-profit that researches patient care, but other devices (like bone cement and screws) are increasingly common, too. As they become more sophisticated, and more scrutinized, the number of recalls is going up: there’s been a tenfold increase in the past decade, he says.

Trying to untangle the details of the DePuy recall as it affected one patient—Lincoln Bryant—resembles a game of he-said-she-said. DePuy says information packets were sent to all affected Canadian hospitals on Aug. 25. But Kingston General Hospital (KGH) said in an email that it didn’t get official notification about the recall until Oct. 7, and began informing patients immediately after that. Bryant says that, “after hounding them mercilessly,” he got in touch with KGH in mid-October, and got an appointment for Nov. 4—10 weeks after he first learned of the recall.

“I think my surgeon is a good man, and this is an unfortunate set of circumstances,” Bryant says. Still, “one of the most difficult things for a patient is a period of uncertainty. I have found it very stressful from the night I heard about the recall.”

Patient stress is a huge concern when a recall is announced—and it’s a reason some members of the medical community feel that, when it comes to these devices, we should abandon the word “recall” entirely. “Our whole community has campaigned vigorously to get the name changed,” says Dr. David Birnie, director of arrhythmia service at the University of Ottawa Heart Institute. He prefers the term “advisory notice,” as do others. “When a car is recalled, the faulty part is taken out. But when it’s an implanted device, we don’t replace them all,” he says. “We contact the patient, and [weigh] the risks and benefits.” When doctors help patients manage that anxiety, they seem to do well.

In 2008, Birnie co-authored a study on patients with a cardioverter defibrillator (which controls irregular heartbeats) under advisory notice due to “rapid battery depletion.” Affected patients were contacted immediately. They and their relatives were invited to one-hour lectures, with the opportunity to ask questions; after that, each patient visited with a doctor privately to discuss having the device changed (as well as the risks involved), or regular testing with a self-applied magnet. Of the 241 patients implanted with the device, nine were recommended to have the generator changed, and only one insisted on a change due to severe anxiety. Otherwise, the study found no sign of increased long-term psychological problems in patients with the device under the advisory notice, compared to those with implants that weren’t.

Medical device recalls are “an area that’s not particularly well-regulated,” Birnie says. As a result, patients in different parts of the country could sometimes receive different care. To fix this, the Canadian Heart Rhythm Society developed its own system to respond to advisory notices for cardiac implants. Now, the process begins with a conference call between members of the CHRS’s device advisory committee (Birnie is a member) and manufacturers; the CHRS then issues recommendations for its doctors. It’s created a more consistent response, but it’s “entirely physician-led,” and based on “altruism,” says Dr. Andrew Krahn, CHRS president, who proposed creating the committee. (Doctors aren’t forced to comply, but recommendations are public, so they do.) When asked if Canada should have a national registry for medical device implants, Krahn responds, “absolutely.”

DePuy’s recall was sparked by new data from the National Joint Registry (NJR) of England and Wales, the biggest of its kind in the world, which showed that more patients were having revision surgeries than expected. The NJR wasn’t the first to identify a problem. The Australian National Joint Registry flagged the ASR hip resurfacing system as early as 2007, says Dr. Stephen Graves, its director. Both ASR devices were recalled in Australia in December 2009, nearly a year before the company’s wider recall. Back in England, “it wasn’t showing as an outlier,” says Elaine Young, NJR project lead, but after the Australian action, “we checked very closely, and at that point, it was indicating a concern to us.” The English NJR notified the government, “and the rest is history,” Young says.

When determining whether a device is faulty, the Australian and English registries have the advantage of huge statistical databases to draw from. Last month, the English NJR (launched in 2003) added its one-millionth record, and “the bigger the database, the better your results,” Young says.

Participation is voluntary in England and Wales, but around 90 per cent of surgeons comply, and soon it will be all but mandatory: doctors will have to participate in a clinical audit as part of a medical revalidation process which, for orthopaedic surgeons, will be the NJR. In Australia, “we have 100 per cent compliance,” Graves says. Their system is voluntary, too, but “there are a lot of carrots.” Surgeons can access their own data on the Web, “so they can sit there in the evening, have a look and see how their hip and knee replacements are going from the point of view of how many have been revised,” he says. Hospitals have all the electronic records of patients with joint replacements accessible in one place and, in the event of a recall, “can contact the registry and ask who’s been affected.” And government and manufacturers get better oversight of these products.

In the U.S., the new American Joint Replacement Registry (AJRR) aims to capture over 90 per cent of knee and hip implants, according to Dr. David Lewallen, chair of the AJRR’s board of directors. Participation, which is voluntary, “will be viewed as a quality measure,” he says. “It’s a win-win-win situation,” he says, for patients especially. The first country to launch a national registry was Sweden, which started tracking knees in 1975, hips in 1979. “It was a tool for continuous improvement,” Bourne says. As a result of meticulously tracking implants, “Sweden boasts the lowest redo rates in the world.” Revision rates for patients over 65 with total hip replacements can vary globally from six to 18 per cent, Bourne says. Sweden has the lowest, with six per cent; in Canada, it’s 11 per cent.

The Canadian Joint Replacement Registry, run by CIHI, was launched in 2001. It’s proven useful on some matters, like highlighting the growing demand for hip replacement surgery; but only about 70 per cent of orthopaedic surgeons participate.

The relatively low participation rate is hard to explain. Our registry is voluntary, and requires patient consent—but confidentiality issues have been worked out in other countries, and other registries are voluntary too, so that can’t be the whole problem. “We’ve been meeting with people for over 15 years,” Bourne says. “Many governments and health ministers have come and gone.”

On Nov. 4, Bryant went to his appointment. The orthopaedic surgeon—a different one from before—examined his hip, which continues to give him trouble, and ordered that he have blood tests done, as well as a CT scan. “There is relief to know that I will know whether or not the joint needs to be replaced again,” he says. “I also feel significant frustration I had to work this hard,” spending two months “pushing buttons, making calls, and waiting.” On Nov. 22, he finally got an official letter in the mail from his original surgeon’s office, he says, informing him of the recall.

Bryant wonders about others who might find themselves in a similar position after a medical recall—and might even fall through the cracks. “I’m quite capable of pursuing these issues. But I’m not sure a lot of people are. And, as a minister, that concerns me,” Bryant says. “What about the people who don’t even know if they’re at risk?”