Recalled Pacemakers Injuries. Not until Cynthia Herrmann went to an oral surgeon this year after suffering what she thought was an infected tooth did she learn that jaw implants she had for nearly two decades were recalled in early 1991.
”I would have had them taken out sooner if I had known,” says Herrmann, 51, a loan collector, who believes a variety of illnesses she suffers can be linked to the implants, which were meant to ease the pain associated with discs in her jaws.
And Gary Murphree at age 44 has already had three pacemakers. Two were recalled. With the second recall in 2000, Murphree whose life depends on the device says he found out about the problem only by calling the manufacturer himself. ”I never got a notice, and my doctors claim they never did either,” says Murphree, vice president of an oil company in Jackson, Miss. The manufacturer says it notified Murphree’s doctor.
As Murphree and Herrmann learned, it can be easier to find out that your car has been recalled than your pacemaker. Or your artificial hip. Or other medical devices.
Millions of Americans sport some kind of implanted medical devic
Millions of Americans sport some kind of implanted medical device, be it a pacemaker, heart valve, artificial knee, breast implant or any of about 240 other types of products. Those numbers will grow as baby boomers age and more devices come on the market. Congress last week approved a controversial measure that is expected to speed medical device approval.
Yet only 12 of the most high-risk types of devices must be tracked by manufacturers under current law. Even for those, when a recall is issued, no one is required to directly notify patients.
”If you are the third owner of a used Chevy, and they discover something wrong with the brakes, you get a recall notice. You don’t get that with devices,” says Robert Baier, a professor of biomaterials at the University of Buffalo.
That’s because cars and their owners are registered and tracked. Most medical devices are not.
”We do it for automobiles. Why in the world would we not do it for medical devices?” says Minneapolis attorney Bruce Finzen, who brings personal injury suits against device makers. ”I’ve never gotten a good answer to that question.”
Data could also be used to raise early alerts about potential problems and report
For years, advocates have urged change, such as a national data bank that would keep track of patients. Such data could also be used to raise early alerts about potential problems and report on the long-term reliability of devices.
Several European countries track their implant patients. In the USA, data banks have been stymied by concerns about liability, patient privacy and cost.
It’s technically possible, although complicated.
Auto recalls rely on a system that tracks both drivers and automobiles, through licenses and registration. Drivers must update records when they move. When a particular model car is recalled, automakers can get the information about owners from those records.
A database of medical devices would require similar registry and updating. And patients may not want to participate.
People don’t want to be tracked, says FDA director
”People don’t want to be tracked,” says David Feigal, director of the Food and Drug Administration’s Center for Devices and Radiological Health.
”The interest in protecting patient privacy is pretty strong,” he says. ”It isn’t even something potentially embarrassing like penile or breast implants. Even people with heart valves or rods in their spines worry about being disadvantaged with insurance or employment (if their records were somehow made public).”
Two disastrous recalls
Currently, device manufacturers are required to keep track of which patients receive their devices for only 12 types of high-risk products, under a federal law passed in 1990 and modified in 1997. Among those tracked are pacemakers, heart valves, brain stimulators and abdominal aneurysm grafts.
No tracking requirement is made for all other implantable medical devices, but some manufacturers keep records of which doctors and hospitals purchased the devices.
Laws requiring tracking of devices were passed following two disastrous recalls
The laws requiring tracking of devices were passed following two disastrous recalls: One was an implant meant to replace a disc between the jaw bone and the skull for patients suffering jaw pain. It was sold by the Vitek company in the 1970s and 1980s and recalled in January 1991 after hundreds of reports of problems. The company went bankrupt, leaving the FDA to try to find patients.
The second was the Shiley heart valve, used on an estimated 40,000 people from 1979 to 1986. Shiley recalled them in 1986 after reports that the struts holding the valves in place could suddenly fracture. About 240 deaths were linked to the devices. Despite the recall effort, the company could confirm reaching only 61% of the valve recipients by November 1991, mainly because hospitals had not returned patient registration cards.
Currently, even for devices like pacemakers that are required to be tracked, only doctors are alerted of a recall or safety alert by the manufacturer, not patients.
”We as a manufacturer cannot practice medicine,” says Ron Stuedemann, director of technical and patient services at Medtronic, one of the nation’s largest makers of medical devices. ”Our job is to provide a stronger relationship between patients and physicians.”
Medtronic company spokeswoman Jessica Stoltenberg says it would be ”irresponsible and concerning to patients” to directly send them recall information.
Many recalls are quite complex and don’t affect every patient given a particular device
That’s because many recalls are quite complex and don’t affect every patient given a particular device, the manufacturers say.
”We want to put the people who can make medical decisions in charge,” says Stuedemann, who oversees a 50-person department that tracks the doctors of about 2 million patients who use one of Medtronic’s devices that require tracking.
That argument doesn’t convince some critics.
”It’s a myth in the medical community that if they started mailing information directly to patients, that they’re somehow interfering with the patient/doctor relationship,” argues Mark Burton, a lawyer at Hersh and Hersh in San Francisco, a firm that has brought lawsuits for patients injured by medical devices.
Patients like Murphree say they want a national database, even if it means sacrificing some medical record privacy.
”I would, because it may save my life someday,” says Murphree.
He takes issue with device makers’ assertion that directly notifying patients would cause them undue alarm.
”What I should be concerned about should be up to me, not someone sitting at a desk somewhere,” Murphree says. ”If I’m informed enough to have the device put in me, I ought to be informed enough to make any other decision once it’s implanted.”
Recalls not uncommon
More than 550 recalls affecting more than 2 million implants have been issued in the past decade, according to data collected by the FDA. William Maisel, an associate physician at Brigham and Women’s Hospital in Boston, found that 500,000 pacemakers and implantable defibrillators had advisories or recalls from 1990 to 2000.
Do patients find out about those recalls?
”The answer is, ‘Maybe” says Jeffrey Lerner, president of ECRI, a non-profit agency that investigates possible device problems and alerts its members, which are mainly hospitals.
While most doctors evaluate the need to tell their patients and bring in the ones who need to be told some do not, some lawyers and patients say.
”No one is accountable to patients; no one is responsible,” says Terrie Cowley, president of the TMJ Association, an advocacy group for patients with jaw implants.
Linda Parkin, 46, says she had a Vitek jaw implant that fell apart after seven years. It was replaced in 1990 with the same brand of device, although patient advocates say problems with the devices had been reported for years.
”(The surgeon) told me I was lucky to get the device because it was one of the last ones left,” says Parkin of Melbourne Beach, Fla. ”You can’t trust surgeons to tell you the truth.”
All recalls aren’t equal
Sometimes devices are recalled because a part is faulty, sometimes because an instruction manual is incorrect. New information that arises about surgical techniques can also result in a safety alert.
Still, just because a device is recalled or a safety alert is issued, it doesn’t mean it will fail, nor does it automatically mean the device must be replaced.
”There are many devices affected by recalls, but relatively few that actually malfunction,” says Maisel at Brigham and Women’s Hospital in Boston.
Doctors and patients need better information about recalls
Still, Maisel says, doctors and patients need better information about recalls, problems and the durability of devices information that would help build a true market in the device industry: ”Data regarding actual device malfunctions is poor. Simply allowing patients and physicians access to that data would provide a market force.”
Some suspect that a national data bank won’t happen unless manufacturers are required to participate.
”A lot of it is the manufacturers don’t want it to happen,” says Suzanne Parisian, a former chief medical officer with the FDA’s devices office and now a private consultant. ”Because then you would know which is the best hip (or other device). The less information that’s available, the more they like it.”
Not so, say manufacturers. They say a database or registry would be unlikely to collect the kind of information that would allow comparison between devices. Such information would need to include regular updates on patients’ medical conditions, for example.
”The FDA has a tremendous number of tools at its disposal right now in gathering data and assessing data to make sure we’re learning from mistakes,” says Janet Trunzo, vice president at Advanced Medical Technology Association, an industry trade group. ”It might sound good on paper, but from a public health standpoint, it would not add to the role the FDA plays right now.”
It’s easier to find out about car recalls than device alerts
She and other industry representatives take issue with the claim that it’s easier to find out about car recalls than device alerts. Peter Gove at St. Jude Medical says his company puts all the information about safety alerts on its Web site. Patients can call an 800 number to ask about their devices, he says. Gove says his company’s records show that Murphree’s doctors were notified of both pacemaker recalls.
Notifying patients directly, he says, would not serve anyone well, particularly because many alerts involve only a fraction of the devices made.
”If every time one of these low-level problems occur, we have to send letters to hundreds of 75-year-olds saying there might be a problem with less than 1% of these pacemakers I’m not sure that’s what we want to do.”