[Research] Vagal Nerve Stimulation

[dennis100]

Why the FDA Can’t Protect the Public
Medical device makers often fail to properly conduct safety studies and the US Food and Drug Administration provides scant oversight.

By
Shannon Brownlee,
New America Foundation

and Jeanne Lenzer, medical investigative journalist

November 2010 | BMJ


In 1997, the US Food and Drug Administration's neurological devices panel met to consider approval of a vagus nerve stimulator (VNS). The manufacturer, Cyberonics, said it could prevent or reduce seizures in patients with partial onset epilepsy who did not respond to drug treatment. The device consists of a generator the size of a matchbox that is implanted under the skin below the patient's clavicle. Lead wires from the generator are tunnelled up to the patient's neck and wrapped around the left vagus nerve at the carotid sheath, where it delivers electrical impulses to the nerve lasting about 30 seconds every 3-5 minutes.


Getting approval

Representatives from Cyberonics offered no definitive explanation during the FDA meeting of how the device stopped or reduced seizures, but they had three studies, E03, E04, and E05, to show its safety and efficacy.

Two of the studies, E03 and E05, involved 313 patients with treatment resistant partial seizures randomised to high or low dose stimulation. The low stimulation arm was intended to avoid the problem of an unblinded placebo arm because all patients would be implanted and told they were receiving stimulation. The studies did not include a medical treatment arm for comparison, leaving unanswered the question of whether either treatment arm was superior to existing care.

Researchers reported that 25% of patients in the high stimulation arms of the trials achieved the primary end point: a 50% reduction in seizure frequency from baseline. However, 20% of patients in the high stimulation arm had more seizures.1


Concerns about safety

The safety of the device hinged on the cause of death among 17 patients of the 1000 implanted with the device worldwide. The device had been approved in Europe and Australia before approval in the US. The most common cause of death among young epileptics is sudden unexpected death from epilepsy (SUDEP), a poorly understood complication that is thought to be related to cardiac or respiratory arrest that sometimes occurs shortly after a seizure. SUDEP is reported most often among younger patients and those with poorly controlled seizures.2 3 The company told FDA panellists that the deaths were from SUDEP or other causes unrelated to its product.1 However, one panellist, Steven Piantadosi, professor of oncology and biostatistics and a clinical trial methodologist at Johns Hopkins, expressed concerns, saying, "I'm still a little worried about the death rates that we are seeing."

In the data provided by Cyberonics, patients implanted with the device had a SUDEP rate of 7.3/1000. Dr Piantadosi asked, "Should we be concerned by that?"

In response to Dr Piantadosi's questions, Ann Costello, an FDA reviewer, cited one epidemiological study that showed an even higher SUDEP rate, 9.3/1000, among treatment resistant patients about to have brain surgery to treat their severe seizures.4 W Allen Hauser, a member of Cyberonics' scientific advisory board, also responded to Dr Piantadosi's concerns, saying, "I don't think that the sudden death is an issue specific to the device. It's a specific issue in terms of people with bad epilepsy."


Conditions of approval

Dr Piantadosi continued to express concern about the SUDEP rate, but the advisory panel nonetheless voted unanimously to approve the vagus nerve stimulator for patients with treatment resistant partial seizures. The FDA made the approval conditional: Cyberonics would have to conduct a post-approval study to examine the safety of the device and it would have to report promptly all serious adverse reactions to the agency.5

In the 13 years since the device was approved in the US, more than 900 deaths have been reported to the FDA, and it is still not clear what impact, if any, the device has had on patient mortality. Although Cyberonics conducted post-approval studies, none of the studies submitted to the FDA included mortality data. The FDA did not specifically require Cyberonics to submit mortality data as part of the follow up study, merely to "characterize morbidity and mortality." According to a spokesman for Cyberonics, the company did collect mortality data from the Social Security Death Index, but they have not published the results and they declined to show the data to the BMJ. The FDA told the BMJ that it has not requested further studies concerning mortality.


Problems with post-approval surveillance

The FDA's failure to request and rigorously monitor mortality data related to the VNS is but one example of the gap in post-approval surveillance of medical devices. Most devices and drugs on the market are supported by studies that are underpowered to detect rare but potentially life threatening events that can kill tens of thousands of people if the drug or device is widely used.6 The impracticality of conducting large scale clinical trials before approval for every drug and device places a burden on post-approval surveillance.

This burden is especially important for devices because they are less likely than drugs to be supported by clinical studies before use. Less than one third of devices approved under FDA's premarket approval process had been evaluated in a randomised study, according to a review of 78 high risk cardiovascular devices approved by the FDA from 2000 to 2007.7 Just 5% were supported by two or more blinded, randomised studies. Most of the outcomes measured, according to the FDA study, were surrogate markers.

To monitor safety of devices, the FDA relies on reports of harms associated with devices once they have been approved. According to the agency, the most "comprehensive source of information about the safety and effectiveness" of devices as they are used in everyday circumstances is its Manufacturer and User Facility Device Experience (MAUDE) database.8 However, the data contained in the database does not constitute a comprehensive record of the numbers of adverse events or exposures, and thus can only pick up "signals" of possible safety problems that could be used to trigger more definitive investigation (box). Of course, these signals can be picked up only if someone is monitoring the data. An FDA taskforce on device regulation concluded in August, however, that "challenges" in "current data sources . . . make it difficult to . . . effectively obtain complete information about the risks and benefits of regulated products."9

 

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The problem with MAUDE

Although reports of adverse events associated with medical devices doubled from 2003 to 2007,8 the MAUDE database remains an imperfect tool.6 10 Several factors can contribute to under-reporting, including the voluntary nature of the reports; fear of litigation by surgeons and others in a position to report the event; and failure by patients and healthcare providers to connect new medical problems with a device.11 Even when device related adverse events do make it into FDA's databases, 39% are reported late.8 A review by the BMJ of deaths among vagus nerve stimulator patients listed in the FDA's database shows that some deaths weren't reported until several years after the patient died.

Perhaps the most serious flaw in the MAUDE database is the fact that manufacturers—not the FDA or any other independent body—can decide whether the device is connected with a negative outcome. Manufacturers are not required to report deaths or serious adverse events if they decide that the events were unrelated to the device.12

The FDA's ability to detect potentially unsafe devices is further hampered by the fact that many post-approval studies required as a condition of the device's approval are not conducted or conducted so poorly as to be meaningless. In 2005, the FDA evaluated the quality of post-approval studies. Susan Gardner, director of the Office of Surveillance and Biometrics at the Centers for Device and Radiological Health, which oversees approval and safety of devices, told an FDA advisory panel that 45 of the 127 premarket approvals granted between 1998 and 2000 had orders requiring post-approval surveillance or studies. But more than one fifth of the studies, she said, couldn't be evaluated for quality because there was no record at the FDA showing they had ever even been conducted.13 FDA has since automated its records but many companies continue to submit data deemed "inadequate" by the agency, while other studies remain unreported.


Warning signs

So what does the MAUDE database tell us about the vagus nerve stimulator? Most MAUDE death reports, which are mainly written by manufacturers, contain descriptions so brief that no definitive cause of death can be inferred. Despite the paucity of information available (narratives are often just a sentence or two in length), the device is often exonerated. For example, one death associated with the VNS was reported to be from SUDEP on the basis of a "visual autopsy." Marcia Angell, a pathologist and former editor in chief of the New England Journal of Medicine, says that without an actual autopsy it is impossible to determine whether it was SUDEP or some other factor, including potentially the device itself, that caused the patient's death, and even then causality could remain uncertain.

Some narrative descriptions, however, are clear enough that further investigation of the device would seem warranted. For example, on 4 December 2008, a patient with a vagus nerve stimulator was admitted to hospital after an abrupt increase in seizures and was found to have "severe asystolia" coincident with vagus nerve stimulation. The device was disabled and the asystole ceased. The database has more than a dozen reports in which the device's activity seems to be associated with asystole.

The database also contains reports of what could conceivably be downstream effects of asystole and bradycardia, such as increased "seizures," new onset drop attacks, and fainting—which in turn could be responsible for some instances in which patients were reported to have died in a fall, by drowning, or in a road crash.

Another case that ostensibly should have prompted further investigation by the FDA, was that of 48 year old Dennis Fegan. According to medical records obtained by the BMJ with Mr Fegan's permission, he woke up in pain at 2 am on 2 July 2006, only to pass out. After regaining consciousness, Mr Fegan, who had a 14 year history of partial complex seizures, passed out several more times. He thought he was having an unusually bad run of seizures. When an ambulance crew arrived, they witnessed Fegan having a seizure and administered intravenous diazepam. Once he was at the hospital and connected to a cardiac monitor, an apparent cause of his seizures emerged; at 3 minute intervals, his heart stopped for 30 seconds—synchronous with the firing of his vagus nerve stimulator. As soon as the device was disabled, the asystole ceased. His neurologist, a consulting cardiologist, and the treating emergency physician concluded that the device was the likely cause of his asystole.


Denominators, study bias, and failure to report

The FDA cautions that the MAUDE database "is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices."14 Its purpose is to allow FDA analysts and others to pick up "signals" of harm that can trigger further investigation. Any investigation would need to evaluate the numerator (number of adverse events) and the denominator (number of exposures), but this information is routinely absent.

In the case of the vagus nerve stimulator the denominator depends not only on the number of patients implanted with the device but also on how many devices are still functioning. Cyberonics reports that by 10 March 2010, they had received registrations for 57 284 patients worldwide implanted with the device, yet it acknowledges that it is impossible to know how many patients have had their devices deactivated because it has no way to collect these data. The combination of possible under-reporting of adverse events (the numerator) and possible over-reporting of the number of active devices (the denominator) could mean that the rate of deaths among device users is higher than is apparent. The more than 900 deaths among relatively young people (most of those with implants are 15 to 44 years old) 3 did not trigger a request for further investigation.

And what of the post-approval study, known as XE05, ordered by the FDA as a condition of approval? A spokeswoman for the FDA cited XE05 as part of the evidence that "supported the long term safety and effectiveness of the device." Cyberonics confirmed that only 50 patients were enrolled in the open label study and deaths were not recorded. When asked how such a small study that didn't include mortality data could show the device's "long term safety," Cyberonics replied that "the purpose of that study wasn't to look at SUDEP or mortality rates" but to evaluate other long term safety issues.

The FDA gave the BMJ references to five additional post-approval studies as evidence of the device's safety. Yet the five studies do not establish that the device wasn't responsible for deaths because none of them included mortality data. The largest study consisted of 4743 patients in the company's outcome registry. The other studies evaluated subsets of registry patients. Cyberonics acknowledged that "mortality was not an endpoint collected as part of the Epilepsy Patient Outcomes Registry."15

In 2005, the FDA approved the vagus nerve stimulator for the treatment of depression, despite the unanimous recommendation against approval by its own scientists. The FDA experts were concerned, in part, about the device's safety. Nicholas Stine, who was then a research associate at Public Citizen, a public interest group, wrote to the agency, urging that the device should not be approved for treating depression. He and his coauthor, Peter Lurie, now adviser to FDA's assistant commissioner for policy, said that "numerous reports" of worsening depression, suicides, and sudden deaths during clinical trials of vagus nerve stimulation "had not been adequately investigated," and that the manufacturer "had not demonstrated long term safety of the device."16 However, Cyberonics told the BMJ: "The FDA concluded that Cyberonics provided 'reasonable assurance of safety and effectiveness' of VNS therapy for the treatment of depression based on valid scientific evidence. There is no evidence linking VNS therapy to worsening depression, suicides, or sudden deaths."

The company has also suggested that the stimulator might have a role in treating obesity, stroke, traumatic brain injury, and other conditions, and has previously taken out patents for these potential therapies.17


Potential solutions

The gaps in post-approval monitoring of the vagus nerve stimulator are emblematic of the FDA's surveillance of all devices. Many of the problems have relatively easy fixes. Although the MAUDE database is flawed, it can still serve its purpose if qualitative signals are detected and trigger better analysis and quantification of a potential safety issue. Manufacturers could be required to regularly submit denominator data, which could be facilitated by requiring companies to provide a website link that patients or their surgeons could use to report whether the device is disabled or removed. An independent review panel could be appointed to decide whether adverse outcomes could be excluded from reporting. And, as the FDA has suggested, mechanisms to limit widespread uptake of new devices could be put in place so that fewer patients are harmed if it ultimately turns out that newly approved devices are flawed.

http://www.newamerica.net/publications/articles/2011/why_the_fda_can_t_protect_the_public_42817

 

[dennis100]

Medical Devices That Can Kill
Defibrillators, stents, artificial hips—medical devices that should save lives can maim or even kill.

By
Shannon Brownlee,
New America Foundation

and Jeanne Lenzer

August 23, 2010 | Reader's Digest



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."

This sorry situation might finally be about to change: Even the FDA itself now says it needs help, and Congress is expected to take up the matter soon. But don't breathe a sigh of relief yet. Previous efforts at reform have ended up going nowhere. What follows, then, is a call to action: why you should care about the obscure topic of device regulation, what needs to happen, and how you can make your opinion heard.

In March 2005, 21-year-old Joshua Oukrop was mountain biking with his girlfriend in Moab, Utah, when he complained of fatigue. Seconds later, he collapsed to the ground, dead. Oukrop had a genetic heart condition and had gotten a defibrillator to control it. But it short-circuited, and when his heart started to beat irregularly, the device failed to deliver a shock. Oukrop's doctor says Guidant, the company that made the defibrillator, later told him that it had known of the defect for three years. Yet the company didn't alert physicians to the malfunction until May 2005, after the New York Times started investigating Oukrop's death.

No one expects the FDA to check the tendency of tongue depressors to warp or the seaworthiness of bedpans. But devices that shock our hearts or perform other critical tasks—so-called Class III devices—are supposed to be tested to see that they're safe. A quirk in the law, though, allows many Class III devices to skate through. Call it the "me too" loophole: All a company has to do is claim its device is similar to another of its products that went through safety testing or that it's "substantially equivalent" to a device that's been on the market for years.

"It's so easy to go through that process," says Thomas McGarity, JD, a professor of law at the University of Texas at Austin. "Quite frankly, there's flat-out abuse." In fact, a Class III device is more likely to get a me-too approval than to go through more rigorous scrutiny. But not all those fast-tracked devices are truly similar to the older product—and sometimes the difference is deadly.

Take the Sprint Fidelis, the subject of a 2007 recall. The Fidelis is a wire, called a lead, that was used for certain implantable heart defibrillators—it's the piece that transmits the electrical shock from the defibrillator to the heart. It was approved in 2004 after its manufacturer, Medtronic, said it was a simple modification of a lead that had gone through FDA review. But there was a crucial difference: The Sprint Fidelis was thinner, to help surgeons thread it through blood vessels. By December 2005, the company had already received 30 reports that the wire had fractured, leading some patients to receive unnecessary and painful shocks.

Medtronic didn't inform surgeons who might be using the device. But two Minneapolis cardiologists, Robert G. Hauser and Adrian K. Almquist, were tracking their patients' results in a database—and they noticed troubling problems. "We had one patient who got 55 shocks," says Dr. Hauser. "And a shock is a major event."

In February 2007, Drs. Hauser and Almquist confronted Medtronic executives with the pattern they'd seen. A month later, the company sent a warning letter to physicians.

By October, when Medtronic recalled the device, at least 13 people were dead, possibly because of the faulty lead or from surgery to remove it. More than 268,000 others faced a terrible choice: They could undergo a possibly fatal operation to have the wires removed, or take the risk that their defibrillator would fire unnecessarily or fail when their lives depended on it. (Medtronic has since instructed doctors on how to reprogram its defibrillators to send an alert that the lead is having problems.)

"We believe we acted responsibly," says David Steinhaus, MD, medical director of Medtronic's cardiac rhythm division. "When it appeared to be an issue, we pulled the Sprint Fidelis from the marketplace, and we informed physicians the whole way."

Dr. Hauser takes a different view. "The Sprint Fidelis should never have been approved without human safety data," he says.

Lana Keeton lives in pain because of a different hole in the regulatory safety net. In 2001, she was scheduled for a hysterectomy because fibroids—benign tumors in her uterus—were causing bleeding and cramping. A few days before the surgery, she mentioned to her surgeon that she leaked a small amount of urine when she coughed or sneezed. No problem, the doctor said; he could fix that at the same time. To do so, he'd use a sling made out of synthetic mesh to support her bladder. What the doctor did not tell Keeton (and probably did not know himself) was that the mesh he planned to use had been approved thanks to its similarity to an older product, Boston Scientific's ProtoGen—which was recalled in 1999.

Synthetic surgical mesh is used in thousands of surgeries each year to patch holes in the abdominal wall during a hernia repair, for example, or prop up sagging organs like the uterus or bladder. But it turns out that something about mesh can make it a hospitable environment for germs. Three days after Keeton's operation, she was rushed to the hospital with a life-threatening infection known as necrotizing fasciitis—flesh-eating bacteria.

Keeton needed emergency surgery to cut away infected tissue. She spent 16 harrowing days in the hospital and was bed-bound for another three months. Then, after her wound had closed, the mesh began eroding through the wall of her bladder like a grater through cheese. "The pain was so bad that it woke me up even when I was on a morphine drip," says Keeton, who has had 16 surgeries and procedures to repair the damage. Unable to work and facing a mountain of medical bills, she lost her home and was forced to declare bankruptcy. "Nobody should have to go through what I've had to," she says.

 

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In 2008, the FDA issued an advisory: It had received more than 1,000 reports of infection, erosion, and other problems involving many brands of mesh. But the agency's action came years later than it should have, according to Diana Zuckerman. When ProtoGen mesh was recalled in 1999, Zuckerman says, the agency should have investigated all mesh products based on it, and doctors and patients should have been informed.

The consequences of the FDA's silence have been devastating. Published studies have reported problems that include bowel perforation, bleeding, and even death. Granted, those complications are rare. But, says Donald Ostergard, MD, past president of the American Urogynecologic Society, the FDA approval process for mesh "is inadequate to protect the public from what I consider to be a public health hazard."

Says Zuckerman, "You have all these women who started out with a relatively small problem with stress incontinence when they exercised or sneezed, and now they can't work, can't sit, can't have sex. When mesh goes bad, it's a disaster."



In an ideal world, manufacturers, hospitals, and doctors would quickly report any injury or death that might be linked to a device, and the FDA would act when it saw a worrisome pattern. But that's not how it works in the real world. Physicians frequently fail to let manufacturers know about problems. What's more, when a patient is harmed, the company gets to decide whether its product is responsible. Not our fault? Then no report necessary.

Reports also may not appear in the FDA database, known as MAUDE (for Manufacturer and User Facility Device Experience), until long after a disturbing incident. For example, the database included no manufacturer's report about Dennis Fegan's episode of cardiac arrest until last year, even though Cyberonics, the maker of the VNS device, says it faxed a report to the FDA soon after it occurred. (In an internal document, Cyberonics suggests that a medicine Fegan was taking might have contributed to his heart problem. His medical records from the time of the attack, obtained by Reader's Digest with his permission, blame the device.)

Cyberonics says the VNS device is safe and effective, and in 2005, the FDA approved its use for another condition, treatment-resistant depression. That approval came over the strong objections of more than 20 FDA scientists and management staff.

Clearly, an overhaul is needed, say watchdog groups and government officials alike. But reform requires a balancing act, says Scott Gottlieb, MD, the deputy commissioner at the FDA until 2007: It's important that the new system continue to encourage innovation and allow manufacturers to quickly respond to feedback from surgeons. Tightening regulation too much could slow the pace of medical advances to a crawl.

But even Dr. Gottlieb agrees that the FDA needs a better system for tracking devices once they are on the market. Reform-minded experts have called for a national registry for the riskiest implantable devices. Just as every vehicle on the road bears an identification number, every device would have its own ID, perhaps in the form of a barcode; surgeons would register each device they implant, along with anonymous information about the patient. If the patient is harmed or dies, or needs more surgery to fix a problem caused by the device, the surgeon would be required to log that information into the registry too.

"If I get notified that my car or my child's car seat has a defect, why can't a person with a device implanted find out quickly and automatically when there's a problem?" says Dr. Maisel, of the Medical Device Safety Institute.

Short of a registry, experts want to:
•Require all cases in which a patient is seriously hurt by a Class III device to be reported to the FDA, not just those that the company decides are due to its product.

•Create an independent panel to routinely monitor the MAUDE data-base—and give the panel access to company data when there appears to be a problem with a device.

•Stop payments, often called kickbacks, from device makers to physicians and hospitals in exchange for using the company's device.

Some of these reforms may require legislation and will certainly take money. The Project on Government Oversight recommends doubling the FDA's current budget for device regulation by 2012. In the meantime, patients can protect themselves by questioning their doctors before consenting to being implanted with a device.

For Dennis Fegan, changes like mandatory reporting and the appointment of an independent panel can't come soon enough. His brush with death has left him worried.

"I can't help but wonder," he says. "How many patients with the VNS device went through the exact same thing I did and never lived to tell about it?"

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?

Speak Up!

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.



Copyright 2010, Reader's Digest

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