Faulty Jaw Implants

DANA HAWKINS / US News & World Report 29jul02

Scarred lives:
A faulty jaw implant was recalled years ago; thousands of patients found out too late

Barb Drexler never used to worry about her health. An athletic woman who played weekly softball, she knew she was in good shape. As a nurse, she believed in the power of medicine should problems arise. So, back in 1977 when she bit into an apple and her jaw locked, she wasn't terribly worried. Her doctor gave a name to her affliction: temporomandibular joint syndrome, or TMJ, a malfunctioning of the jaw that causes symptoms as mild as popping and as serious as disfigurement and severe difficulty opening and closing the mouth. After a few years of unsuccessful treatment, the doctor suggested a jaw joint implant.

Diagram from www.tmj.org

That was 21 years ago. Today, Drexler's once lovely face is a twisted tangle of scars. Her full cheeks have hardened; her deeply recessed chin is limp and boneless. A morphine pump implanted in her stomach controls the bolts of pain that convulse her face. Before the pump, she tried to commit suicide by cutting her wrists. "I would lie on the couch in so much pain," she says, "that I didn't know whether it was night or day." In a futile attempt to repair the damage inflicted by the device, she has endured 30 surgeries. At 53, Drexler can no longer work. She eats only soft food, walks with a cane, and is blind in one eye. She must often catheterize herself and sleeps with a mask connected to a whirring machine to make sure that she breathes through the night.

The failure of Drexler's surgery was a common outcome for thousands of patients who had the device known as a proplast Teflon joint implanted in their jaws in the 1970s and 1980s. The implants were used in an estimated 26,000 patients, mostly young women diagnosed with TMJ. But shortly after implantation, many of these devices began to shatter and erode, creating tumors that ate through bone and flesh to the brain. So in 1991, in a highly unusual move, the U.S. Food and Drug Administration banned the devices and advised surgeons to remove all the implants that had failed.

But the story doesn't end there. The crumbling of the jaw implants parallels the breakdown of a regulatory system that, rather than protecting patients, left them to suffer and, in dozens of cases, die. The FDA, a U.S. News investigation shows, failed to notify thousands of victims of the recall. Of 300 patients contacted by the magazine, only a handful ever received a recall notice. One victim was implanted with the device after it was pulled from the market. And just last month, surgeons removed devices from two patients who had been suffering from the implants for decades. "This is a case study in how both the government and the medical profession have abandoned patients," says Terrie Cowley, president of the TMJ Association.

Such apparent neglect illustrates the flaws in the FDA's recall process and the limits placed on the agency by laws that restrict the monitoring of medical devices. Unlike automobile recalls, device recalls are mostly voluntary. Doctors and hospitals are not required to report device failures to the FDA. Manufacturers must report failures, but they don't have to make their tracking systems public. And recalls are largely left to their discretion. "Could the TMJ disaster happen again today?" asks Stephen Milam, an oral surgeon who has treated over 300 implant patients. "In a heartbeat."

Botched recalls. It has been a busy time for medical recalls, many of them problematic. Last year, over 50 patients worldwide died after using dialysis machines equipped with a malfunctioning filter. The manufacturer, Baxter International, stopped distribution in September and announced a recall a month later, after two patients died in Texas. Additionally, two patients at Johns Hopkins Hospital died last year of infection after exposure to contaminated bronchoscopes. The scopes had been recalled by the manufacturer, Olympus America. Officials at Hopkins and several other hospitals say they did not receive the recall notice.

It's hard to say what did not go wrong with the jaw implant recall. Normally, it is up to the manufacturer to alert medical institutions, and at times, to collect existing devices. But in this case, the manufacturer, Houston-based Vitek Inc., went bankrupt, so the FDA stepped in. Elaine Crosby, then the agency's compliance officer in Dallas, says her office did everything possible to notify patients through their doctors. The FDA also issued a press release, but it was overshadowed by news of the Persian Gulf War. Congress later ordered the FDA to conduct a more effective public-information campaign, but the agency did not issue any further press releases. "In hindsight," says David Feigal, director of the FDA's Center for Devices and Radiological Health, "we could've tried to make this more of an issue."

Yet the law severely limits what the FDA can do. The agency seized Vitek's records, but they named only doctors and hospitals, not patients. Crosby says the agency tried to contact every institution and physician, but the law did not–and still doesn't–allow it to force doctors or hospitals to take action. "Some huge proponents of the device felt it wasn't necessary to notify their patients," says Crosby. Doctors argued that patients were hard to locate; patients contend that doctors were afraid of being sued. Whatever the case, implant victim Leslie Zatezalo of Pittsburgh says she never received a recall notice even though her surgeon managed to send her regular bills. And Darcy Holleman of Warner, N.H., received jaw implants six months after the recall. She had them removed last year in a 16-hour surgery to clean out Teflon debris and destroyed tissue and to reconstruct her jaw.

When a medical device malfunctions, doctors and hospitals are not required to notify the FDA. Unless a patient dies, physicians are simply asked to file a report on the problem–and most don't. At an annual conference of about 100 oral surgeons in Philadelphia, a speaker posed the question: "Who has removed a bad jaw implant?" Nearly every hand in the room shot up. But when the surgeon asked who had contacted the manufacturer or the FDA, all hands came down. Acknowledges Feigal: "We know there's tremendous underreporting."

Other recalls have gone more smoothly. Bjork-Shiley heart valves were recalled in 1990 because they were prone to break. The company paid $2.5 million for an exhaustive search of the 27,400 patients with the device and found nearly all of them. By contrast, no one tracked down jaw implant victims like Valerie Filoramo of Plainfield, Ill., who didn't learn until four years after the recall that the cause of her extreme fatigue and mysterious viruses was a tumor, caused by the implant, that had eaten a half-dollar-size hole in the base of her skull.

Injuries like these have convinced doctors that the jaw implants should never have been approved in the first place. And legal claims support their view. John Kent, the oral surgeon at Louisiana State University who helped develop and promote the product, allegedly ignored research that linked the devices to aggressive giant cell formation and extensive bone loss. Early on, he is said to have dismissed a damaging study of the effects of the implants on dogs and allegedly used his position on a professional board to try to squelch a study on monkeys, according to lawsuits filed in Louisiana. In 1984, Kent wrote to his partner, Vitek founder Charles Homsy, about a patient's "devastating results." Kent worried that the implants could lead to "a calamity of unbelievable proportions." All the while he continued to implant the devices, allegedly earning over a hundred thousand dollars in royalties.

Kent declined to comment. Homsy said he prefers not to discuss the past. "I'm at a time in my life when I want peace," he said. But when asked why his implants failed, he blames the patients. "If you've destroyed your own tissue by grinding your teeth, and are given a second chance with an implant, you have to protect it," he says.

Such sentiments no longer surprise implant victims, who feel they have been forsaken not only by the government but also by their doctors. Candy Van Loo of Rockaway Beach, Ore., who heard about the recall by chance on television, says it took four years to find a doctor who would see her. "They're very complicated patients," concedes Peter Quinn, an oral surgeon at the University of Pennsylvania Medical Center. "Surgeons like to fix things, and you can't always make them better." Doctors don't always get paid, either. Although many insurers covered surgeries to have the implants put in, few will pay for their removal or for periodically necessary surgeries to clean out debris. As a result, according to a survey by the TMJ Association, implant patients have each paid an average of $68,370 out of pocket for treatment.

Suicides. For some patients, the pain and financial pressure have proved too much. Stephen Harkins, a facial pain specialist in Tucson, says eight of his implant patients have committed suicide. Countless others have contemplated it. Donna Cunningham, 45, of Coin, Iowa, took a handful of sleeping pills in May before her husband found her. She has had 10 heart attacks, believed related to the implants, and her doctor had suggested amputating her legs to improve her heart function. "I get up every morning and thank God I'm alive," she said. "And by the end of the day I'm cussing him because I'm alive."

Experts say the FDA and the device industry could do far more to prevent future recall disasters, including creating an independent group to keep a detailed registry of patients. Robert Baier, a biomaterials professor at the State University of New York-Buffalo, says implant owners should take legal title to their devices, just as car owners do, and he believes reporting of device failures should be mandatory and enforced. Robbin McColley of Vancouver, Wash., whose implant was removed just last month, agrees. "A few years ago I got a recall notice on a 1982 pickup truck that I bought used," she says. "They're told they have to fix it, so they fix it."

Meanwhile, implant victims are mourning the most recent loss of one of their own. Dessa Hightower, 54, of Huntsville, Texas, suffered for years from painful growths on her spine, lungs, stomach, and face. "My medical history sounds like a sci-fi horror story," she told U.S. News shortly before she died on June 6. Since then, Barb Drexler has been examining her own life and wondering who's next. "When I look back over the past 20 years, I think: 'What happened to the time?' " she said. "I could've been helping people as a nurse. I would've been a good mom. So much of my life is lost."

• The TMJ Association