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« on: July 09, 2014, 03:35:49 PM »

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.

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

https://www.center4research.org/medical-devices-can-kill/

Cardiac arrest reports
http://www.vnsmessageboard.com/index.php/topic,3832.0.html
« Last Edit: July 30, 2018, 10:41:26 AM by dennis100 » Logged
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« Reply #1 on: July 10, 2014, 08:49:20 AM »

Shock Factor: Cyberonics Link To Death, Injury Reports
Apr. 16, 2014 2:36 PM ET | 4 comments | About: Cyberonics, Inc. (CYBX)

Summary

  • The FDA reporting system shows over 10,000 deaths and injuries were reported as "adverse events" that may be linked to the company's medical device.
  • Plagued by Medicare’s decision to deny coverage of its anti-depression device multiple times; the door to the depression space has slammed shut on Cyberonics.
  • A false claims complaint filed against Cyberonics poses significant risk if the government takes it further, as we believe it should.
  • Exciting, new treatments – even non-invasive ones - threaten the VNS position.
  • Difficult-to-treat epilepsy patient base is small. Demand for VNS replacement units is declining.


By Sonya Colberg, Senior Investigative Reporter

Judy Bowling could easily complete the night shift at a New York medical clinic, drive the 20-mile commute back home, yank off her favorite green scrubs and grab a few hours of sleep. After school, the single mom and her young daughter would often jump in the car so the child could spend the night with Ms. Bowling's parents, giving the two some cherished "girl time" during the drive.

But life changed radically after Ms. Bowling had a "VNS" (vagus nerve stimulation) device by Houston, Texas-based Cyberonics (CYBX) implanted inches above her heart to try to control her epileptic seizures with tiny electric shocks transmitted to the brain.

She is one of thousands of patients who have been implanted with the device that Dr. Peter Barglow terms, "completely worthless."

"I'd never dream of subjecting anyone to that sort of nonsense," said Dr. Barglow, an MD with more than five decades in the psychiatry field, now handling a busy practice in Berkeley, Calif. After extensive examination of the issue and VNS studies, he said he considers any association with VNS irrational.

In Ms. Bowling's case, the seizures became worse, and she quickly spiraled downward both physically and mentally.

Ms. Bowling's experience is one of more than 9,000 Cyberonics-linked injury reports submitted to the US Food and Drug Administration from 1998 to this month. The manufacturer is mandated to investigate the reports to determine links to its medical implant.

In fact, more than 1,980 Cyberonics-linked death reports were uncovered in our investigation.

These "adverse events" resulted from the device made and touted by a company staggering beneath two extensive FDA warning letters and targeted by a US Senate investigation over effectiveness and safety concerns springing from its FDA approval process. And the heat's still on in the form of a false claims lawsuit that we believe the government should move forward.

Losing it: In the institution

Ms. Bowling had to fold up her scrubs and place her 10-year-old daughter under the temporary care of her parents. With that pocket watch-sized VNS device still pulsing in her body, Ms. Bowling then found herself shuffled from psychiatric hospital to psychiatric hospital. Often she arrived as a screaming, writhing ball of fury, bound in a five-point restraint from which she says she learned to escape.

"It was a nightmare," she said with a nervous laugh. "Like something you see on TV."

By then, her mother had already told Judy's big sister, Nancy Bowling, that she felt certain the personality changes were caused by the VNS device. She investigated and became convinced the problem was indeed that device shooting tiny electric shocks into her sister's brain.

Judy Bowling settled into what would become her final, five-month stay at a psychiatric hospital. In New York's Rockland Psychiatric Center - an institution she now remembers fondly - the normally mild, disciplined then-45-year-old woman manipulated and fought for her place in the inmate pecking order.

One day, an 18-year-old inmate made fun of the way she looked in the throes of a seizure. Ms. Bowling stood up to her and the teenager threw a punch. Ms. Bowling flew into the toughie who had been known to enjoy a good street fight now and then. Fists flew. Feet kicked. Hands grabbed.

The street fighter grabbed a chunk of Ms. Bowling's glossy blond locks. And another. And, while keeping her own hair out of Ms. Bowling's reach, yet another handful.

"She pulled out half my hair!" said Ms. Bowling, now 50.

Nancy Bowling insisted that the neurologist (who has not responded to TheStreetSweeper's request for comment) authorize removal of the VNS device that the family suspected caused Judy Bowling's uncharacteristic behavior.

But he was reluctant because he thought it didn't cause her problems. In fact, February 2009 documentation shows it took a congressman's interest to convince the neurologist to authorize removal of the device.

At that point, Judy Bowling's surgeon immediately removed the VNS device.

Beating "the devil": Medical literature describes VNS link to psychotic behavior

Medical literature contains cases that point toward a link between VNS and the onset or worsening of psychosis.

A hospital admitted a 38-year-old epileptic patient claiming he was the devil. He had tried to cut his own throat because he believed he heard the voice of God urging him to kill himself.

The VNS inside him pumped out a few seconds' electrical charges every five minutes, according to his doctors' medical report.

Just three months earlier, doctors had surgically implanted the device. He'd had mental issues previously that he'd overcome but after surgery his mental state hit the boiling point. Psych ward doctors tried anti-psychotic drugs over five months to try to break his psychotic state. To no avail.

Desperate doctors combed the medical literature and found 11 published cases of VNS inducing or aggravating psychosis. On their suggestion, the neurologist repeatedly reduced the VNS pulse rate, a simple procedure using a computer.

"The improvement in his condition following each reduction in VNS pulse intensity was swift and dramatic," doctors wrote.

"Only adjusting the VNS pulse intensity brought relief," they reported.

His improvement was so startling, doctors signed papers authorizing the patient to move to a halfway house to begin his transition back into society.

FDA's bizarre approval sets device free in the marketplace

We've found the Cyberonics reports describe more than 10,000 deaths, injuries and equipment malfunctions. These are "adverse event reports" filed in the FDA's "MAUDE" online reporting system. These reports represent events that may be linked to VNS as well as some that occurred in VNS patients with other medical issues that make establishing a VNS link more difficult. Anyone knowledgeable about an adverse event, from doctors and medical facilities to patients and family members, may file a report here.

An FDA spokeswoman said in an email that the medical device reports are just one of several post-market data sources.

"As such, the FDA evaluates each situation on a case-by-case basis, considering a variety of factors to determine whether additional analysis or action may be needed for a particular device," she said.

So how did the device get FDA approval?

The VNS first got approval in 1997 for use in difficult cases of epilepsy. Then the FDA went into a bizarre - and secretive - application process to approve the use of VNS for treatment-resistant depression or TRD.

The FDA's head honcho then responsible for approvals, Dr. Daniel Shultz, made an astonishing decision to override an entire FDA panel and sign the company's application - personally.

He approved the application despite objections of more than 20 FDA scientists, doctors and managers, according to a report filed in the Congressional Record. He acknowledged to staffers that the public would be unaware of this.

Reports of death after death and injury after injury among VNS epileptic patients poured in, TheStreetSweeper found, even as the company sought the depression-use application.

Death reports reached 115. Injury reports hit 181 and malfunction reports reached 458 during that time.

During that time, the FDA also socked the company with an official warning letter in December 2004 that listed 30-odd serious allegations - including failure to fully investigate adverse events - uncovered during the agency's two-month inspection of Cyberonics. The company took months to address the issues to get the FDA to close the file just three months before Dr. Schultz stunned the FDA team with his decision.

FDA reviewers: Like an "experimental project;" "disturbed"

The FDA panel reviewed Cyberonics' application materials for 15 long months. They focused on Cyberonics' clinical studies on depression (TRD) and determined they did not show the device was safe or effective.

One reviewer said in an email: "I am disturbed that VNS might actually get an approval for ''TRD''. In my opinion, they do not have adequate data and I don't understand how this can move forward."

Another wrote: "As an MD interested in science, it seems to me that such an approval would be akin to approving an experimental product."

Cyberonics increased its lobbying effort, in the midst of all this, to mount the company's record high in 2005 of nearly half-a-million-dollars.

Meanwhile, the FDA rumblings reached the ears of Sen. Charles Grassley and Sen. Max Baucus, who commanded an investigation into the FDA's decision.

Though the FDA team recommended again and again that the device not be approved for treating depression, the Senate staff report states that "at every stage of the review, the team was instructed by the FDA official, who ultimately made the decision to approve the device, to proceed with the next stage of pre-market review."

Patients and doctors were kept in the dark about the scientific dissension or that Cyberonics' short-term study "failed to reach, or even come close to reaching, statistical significance with respect to its primary endpoint (of efficacy)."

The FDA team requested that the company strengthen its weak study results by conducting a new randomized, controlled study prior to approval, according to the report. Cyberonics refused to conduct that study pre-approval.

The investigative report and the senators harshly criticized the whole mess. On Aug. 10, 2005, Dr. Schultz resigned by "mutual consent" with the FDA commissioner. He later found a job with a consulting firm serving companies regulated by the FDA.

But Cyberonics already had what it wanted. On July 15, 2005, the company walked away with FDA's approval letter in its back pocket.

Another risk: Medicare/Medicaid approval fails - again

Insurance giant Blue Cross Blue Shield hit the warning bell shortly after the FDA approval with an ominous comment that "overall, the evidence supporting efficacy of VNS is not strong." Over the years, insurers tended to pay in some depression cases but generally refused because of the safety and effectiveness questions.

Insurance often isn't covering VNS treatment now, according to Dr. Robert Dolgoff, director of the Berkeley Therapy Institute in California.

Cyberonics chief executive Daniel Moore mentioned this very issue during the last earnings call. Mr. Moore, who replaced the embattled CEO in charge during the application fiasco, partially blamed weakness in the last month of the quarter on "an unusually large number of changes in insurance coverage."

Cyberonics has tried numerous times to get the ever-important Medicare/Medicaid reimbursement for VNS for depression.

But time and again, Medicare/Medicaid has said, "No," and it seems doubtful Cyberonics will secure coverage for depression use, effectively shutting itself out of its most promising market. After the May 2007 Medicare denial, Cyberonics filings say it ceased marketing VNS for depression in all markets.

The stock price crumpled by 10 percent last May on the most recent news that federal administrators once again said, "No," to Medicare reimbursement costs for depression.

The Centers for Medicare and Medicaid Services (CMS) pays for about 25 percent of the implants, the company's filings state. The cost for implant surgery and programming the device runs about $25,000.

The company didn't respond to TheStreetSweeper's request for comment. Investors may find other viewpoints on Cyberonics here.

Risk: Options, options and more options for difficult epilepsy and depression cases

"Write this down, 'TMS,'" said Dr. Dolgoff.

TMS or transcranial magnetic stimulation is probably the hottest, new FDA-approved treatment for depression. Dr. Oz featured this nerve-stimulating therapy on his show, showing a doctor using a painless magnet inside a helmet-like device on an audience member. The magnet - pinging like a subdued woodpecker - stimulates the part of the brain responsible for depression. Therapy takes about 35 minutes, five days a week for three to six weeks until depression disappears.

Results have been so encouraging that Dr. Dolgoff said his clinic now recommends TMS first for patients with depression.

This private company's non-invasive therapy - a far cry from Cyberonics' surgical implant - is among the potential risks listed in the company's Securities and Exchange Commission filings.

Cyberonics also faces stiff competition from $58-billion Medtronic (MDT), the giant that parlayed its Deep Brain Stimulation therapy beyond the Parkinson's field into the refractory epilepsy field with FDA approval.

Mountain View, Calif.-area private company NeuroPace's therapy just last November got FDA approval for difficult-to-treat epilepsy and is in early commercialization. This newcomer's RNS device sends an electric pulse through thin wires precisely located at the one or two spots in the brain where seizures start.

"We don't look at VNS from a competitive perspective. We really look at the need to grow the overall field," said NeuroPace chief executive Frank Fischer.

A NeuroPace study found seizures dropped 37.9 percent in patients implanted with live RNS wires. For comparison, a Cyberonics' study found seizures dropped just 28 percent with the highest level of VNS. The low stimulation VNS group saw 15 percent - or 2 percent less relief - than RNS subjects who received absolutely no stimulation from their RNS wires.

"Both of us, ourselves and Cyberonics, are going to benefit by virtue of the therapy becoming available. Because it gives the community something to think about, to discuss, to get excited about and then doctors refer their patients. That's what's not been going on in recent years," said Mr. Fischer.

Since the therapy addresses difficult or refractory epilepsy, this poses some issues. Cyberonics claims about 70,000 patients in this comparatively small category of about 400,000 that seems unlikely to suddenly grow. In fact, only six more US units were sold last quarter than the same quarter the year before.

So replacement units would be especially important to sales growth. Unfortunately, Cyberonics is seeing a decline in replacement devices. They fell by 9 percent last quarter compared with prior year, or 1,047.

Cyberonics' SEC filings also include Neurotech, CerebralRX and St. Jude Medical among the arm's-length list of companies aiming for depression and epilepsy patients.

Signals? Insiders selling

Cyberonics insiders tip their hands about the level of confidence they have in their own company when they sell its stock like crazy. That's all they've done in the past year.

In the last month alone, CEO Moore has sold more than his peers, peeling off over 11,000 of his direct and indirectly owned shares. He now owns little more than 191,000 shares of his company. Under his automatic trading plan over the last two months, he's cut down his direct and indirect ownership by nearly 11 percent - not a good sign for investors.

Conclusion

Judy Bowling, now free of the VNS device, still struggles with some memory problems and depression, along with lost confidence.

"I lost my life over this. I lost it," she said, her voice quivering. "I've been so traumatized that I won't be able to go back to work as a nurse."

Like other families, the Bowling family is not suing Cyberonics because a 2008 US Supreme Court decision allows manufacturers to avoid being sued in state court if their medical devices have been approved by the FDA.

Ms. Bowling and her daughter now get more girl time together, and Ms. Bowling is making plans to become a counselor. She wants to go back to the New York state psychiatric hospital, Rockland. But this time, she hopes to gain respect for her counseling. Instead of her left hook.

The company behind the VNS device, we believe, faces its own challenges that pose significant risk to investors.

TheStreetSweeper would love to see better treatments for epilepsy and depression patients. But not this device. And not this company.

Disclosure: The owners of TheStreetSweeper hold a short position in CYBX and stand to profit on any future declines in the stock price.

As a matter of policy, TheStreetSweeper prohibits members of its editorial team from taking financial positions in the companies that they cover. To contact Sonya Colberg, the author of this story, please send an email to scolberg@thestreetsweeper.org.

http://seekingalpha.com/article/2145123-shock-factor-cyberonics-link-to-death-injury-reports


Mental health reports
http://www.vnsmessageboard.com/index.php/topic,3837.0.html

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