Defibrillators, stents, artificial hips-medical devices that should save lives can maim or even kill.
The ambulance crew gave the hospital staff at Corpus Christi Medical Center a fast rundown. Dennis Fegan, 48, had passed out at his home about 30 minutes earlier. Luckily, his parents were visiting, and they called for an ambulance after he fell from a dining chair to the floor. Then Fegan woke up, just as suddenly as he had collapsed. Three minutes later, he passed out again for less than a minute; then he came to. By the time the medics arrived, Fegan’s parents had watched their son lose and regain consciousness at least eight times.
Fegan, a former oil rig worker and firefighter, fell unconscious yet again in the ER. This time he was hooked up to a heart monitor, and the emergency staff could see clearly what was happening: His heart had stopped. Fegan was flatlining at three-minute intervals, for 30 seconds each time.
His doctors soon realized that Fegan’s repeated bouts of near death and resurrection coincided precisely with brief electrical jolts coming from a small device that had been implanted under his collarbone six years earlier to control his severe epilepsy. The Vagus Nerve Stimulation, or VNS, device sends electrical impulses to the vagus nerve, which controls many crucial body functions. Fegan’s neurologist raced to the ER to turn off the device-and Fegan’s heart began beating normally again.
That was four years ago, and while Fegan’s heart has been doing fine, he worries that the VNS device could be harming other patients. His concern may be justified. In the 13 years since the device has been on the market, the U.S. Food and Drug Administration (FDA) has received reports of more than 900 deaths among people implanted with it. It’s impossible to know whether any of those deaths are due to the device; its manufacturer, Cyberonics, says studies show it’s safe. Still, some of the life-threatening incidents reported to the FDA are eerily similar to what happened to Fegan. Even more disturbing, problems with medical devices extend far beyond any single gadget, says Dr. William H. Maisel, MD, director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center, in Boston. Our system, say Dr. Maisel and other experts, doesn’t adequately protect us from medical devices that can harm or kill.
Everyone is vulnerable. Though Fegan was being treated for the relatively rare condition of epilepsy, people have stumbled into disaster when they got a hip replacement, for instance, or had “better safe than sorry” treatment to prevent stroke, or asked for a fix for urinary incontinence. The FDA received more than 150,000 “adverse event reports” in 2007, and the true number of problems is almost certainly far higher. At one point, a government study found that less than 1 percent of device problems occurring in hospitals made their way into FDA files, and “the more serious the problem with a device, the less likely it was to be reported.” Things have improved since then-but, experts say, not nearly enough.
How did we get to a point where we can’t trust the equipment doctors use for-and in-our bodies? The FDA is both underfunded and too cozy with the device industry, say many critics, including some who work in the agency. In 2008 and 2009, a group of scientists and physicians wrote to members of Congress, charging that senior FDA officials had “ignored serious safety and effectiveness concerns of FDA experts” and had “ordered, intimidated, and coerced” them to change their decisions and approve devices. But that’s not the worst of it. In 2009, a study by Congress’s Government Accountability Office found that the safety and efficacy of many of the riskiest devices on the market have never been proved. Says Diana Zuckerman, PhD, president of the National Research Center for Women & Families, a group that analyzes research on medical products, “The FDA’s oversight of these products is broken.” […]
7 Stay-Safe Questions
Jeffrey C. Lerner, PhD, makes his living tracking the safety of medical procedures, drugs, and devices-he is president of the nonprofit ECRI Institute, which works with the World Health Organization and federal agencies to improve patient care. If you’re considering a device, here are the questions he says you should ask.
1. Are there nonsurgical ways to treat my condition?
2. Have any cases of serious harm associated with this device been reported to the FDA?
3. How many procedures have you performed using this device? (If it’s only a handful, consider finding a more experienced surgeon, unless one will supervise your doctor.)
4. How long has this device been in use? Like the latest cell phone, a new device may be a little buggy. If you have a choice, go with one that’s been on the market for several years.
5. What percentage of patients nationally have to go back into surgery to correct a problem with this device? What percentage of your patients each year have to go back into surgery to fix a problem with this device? (If your surgeon can’t or won’t answer, consider it a red flag.)
6. If there’s a problem with the device-or if it’s recalled-how does the manufacturer notify you? How do you notify me?
7. What are the danger signs that something is going wrong with my device?
E-mail or call Senator Chuck Grassley (R-IA), a longtime FDA gadfly, and urge him to support a mandatory registry for implanted devices.
Take Extra Care!
Any implanted device carries risks, but some are more prone to problems than others. The following are in wide use-and either the type of device or some brands within the category have been linked to particularly serious, even life-threatening, complications.
Carotid artery stents are implanted to keep the neck’s major vessel unobstructed, in hopes of preventing a stroke. But recent studies have shown that stents are roughly twice as likely to cause a stroke or heart attack as a Roto-Rooter-style surgery. (In some cases, treatment with drugs and changes in diet and behavior can be superior to either.)
Pedicle screws are used in spinal fusion surgery to stabilize the vertebrae. But studies comparing back surgery with and without pedicle screws found that patients who got the device were more likely than others to need more surgery, suffer more blood loss, and experience other complications.
Artificial spinal disks replace damaged or ruptured spinal disks between the vertebrae. But artificial disks can put enormous pressure on the spine, causing fractures in the vertebrae and leaving patients in pain.
Surgical mesh is used to repair hernias and treat gynecological conditions such as urinary incontinence and prolapsed uterus. Though many people flourish with it, studies show that mesh can result in nerve damage, incontinence, bleeding, infection, and intestinal obstruction.