Should the Cyberonics VNS Implant Device be Recalled by the FDA?
by Chad Points cdp@denenapoints.com
Board Certified Personal Injury Trial Lawyer, One of Founding Partners, Denena & Points, PC
4/20/2014
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The Houston medical implant injury lawyers at Denena and Points believe that a look at the available literature on the device would probably lead you to say, “Yes.” Actually, your look at the data would more likely lead you to wonder why the device was ever approved at all.
The Cyberonics Vagus Nerve Stimulator (VNS) device is a surgically-implanted apparatus comprising a generator and wires ending in leads coiled around the Vagus nerve in the throat. The device generates periodic electrical pulses to stimulate the nerve. The frequency of the pulses can be adjusted using a computer.
The original purpose of the device was to provide treatment for patients with epileptic seizures that had not responded to other forms of therapy. Cyberonics itself warned against implanting the device in patients less than 12 years of age, but “off label” implants in these younger patients are apparently common. However, when complications, injuries, or deaths occur in these young patients receiving off-label implantation of the VNS device, the adverse effect gets chalked up to user error.
Our Houston medical implant injury lawyers emphasize that any surgical implantation procedure involves risk. The VNS device, due to its implantation in the throat near the carotid artery and jugular vein and the main juncture of the body’s central nervous system into the brain, entails especially high risks. And complications involving nerve damage, vascular damage, and damage to the larynx have been frequently reported.
Furthermore, many physicians say the device is useless, perhaps even actively harmful, and there is insufficient data to indicate that it’s effective for its intended uses. Significantly, Medicaid/Medicare consistently refuses to pay for VNS implant procedures, and insurers generally are reluctant to foot the massive bill for a device that has not been proven effective and is linked to thousands of injuries and deaths.
The federal MAUDE database, a data aggregation system for reporting adverse events linked to medical devices, shows more than 10,000 deaths, injuries, and malfunctions linked to Cyberonics’ VNS device. Many of those reports are vague, making it hard to pin down the precise cause of death or injury. And many of the deaths are classified as SUDEP, sudden, unexplained death in epilepsy. Between May and December 2004 alone, 500 adverse events occurred. And the year 2002 lists 1,414 adverse events.
Cyberonics’ own website details the high risks from malfunctions of the implant. “Device malfunction could cause painful stimulation or direct current stimulation. Either event could cause nerve damage. Patients should be instructed to use the Magnet to stop stimulation if they suspect a malfunction, and then to contact their physician immediately for further evaluation.” Other possible adverse effects include vascular damage, onset of sleep apnea, damage to the larynx, increased frequency of seizures, and SUDEP. Are any of these possible effects worth the risk for a device that has not been proven effective? Studies conducted by Cyberonics that show a reduction in seizure frequency generally indicate that real reductions only kick in after two or three years of using the device. And our Houston medical implant injury lawyers point out that some studies show little difference in seizure frequency compared to patients receiving other, or no, treatments. Continue to Part 2 to learn about the dangerous effects of the VNS device when used on patients with TRD, treatment-resistant depression.
http://www.denenapoints.com/blog/should-the-cyberonics-vns-implant-be-recalled-by-the-fda-.cfm
Ongoing Problems with Cyberonics Implantable Vagus Nerve Stimulator
by Tony Denena amd@denenapoints.com
Board Certified Personal Injury Trial Lawyer, One of Founding Partners, Denena & Points, PC
4/20/2014
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Continued from Part 1. The Houston medical device injury attorneys at Denena and Points report that the FDA’s own teams of scientists recommended against approving Cyberonics’ VNS device to treat depression. Yet Cyberonics won that approval in a way that resulted in Congressional scrutiny, and its website still lists instructions and warnings regarding implantation of the device into depression patients. That open description of potentially dangerous use of the product to treat TRD could be construed by patients desperate for relief as evidence that the device is effective for such treatment.
Yet medical literature provides case studies linking implantation of the VNS device to the onset of or worsening of psychosis in patients. In effect, treatable depression becomes dangerous psychosis requiring institutional confinement.
FDA approval of the device for such use was somewhat irregular, if not downright shady. The VNS device received its initial approval for use in treatment-resistant epilepsy patients in 1997. Dr. Daniel Schultz, then in charge of the FDA approval process, personally signed off on the approval of Cyberonics’ VNS device for use in TRD (treatment-resistant depression) after an entire FDA panel of physicians, managers, and scientists recommended against the approval. Our Houston medical device injury attorneys note that Schultz later resigned from the FDA by mutual consent with the FDA Commissioner.
Even while Dr. Schultz was going against the FDA panel to approve the device, reports of injuries, deaths, and malfunctions linked to it were mounting. And the FDA itself, perhaps in an example of the left hand not knowing what the right hand was up to, saddled Cyberonics with one of its serious warning letters, often the prelude to a recall. But a true recall has yet to emerge against the VNS device. The letter contained more than 30 serious allegations against Cyberonics and its VNS device. Cyberonics addressed the issues over the course of many months, getting the FDA to close the file on the warning shortly before Dr. Schultz issued his approval.
The FDA panel of scientists, physicians and managers had taken more than a year, 15 months actually, in reviewing Cyberonics’ application to use the Vagus Nerve Stimulator to treat depression. The reviewers found that the company simply didn’t have enough data to support such use of the device. And what data there was did not support the thesis that the device was effective against TRD. One reviewer wrote that approving the application would be like “approving an experimental product.” Our Houston medical device injury attorneys emphasize that the FDA teams repeatedly recommended against approving the device for use in TRD patients, yet those recommendations repeatedly got overridden by FDA officials.
Further adverse events resulted in another FDA warning letter to the company, as well as the Senate investigation relating to safety, efficacy, and the startlingly irregular approval process, as well as a false claims lawsuit. But the product still has not been recalled from the market. After a Class II recall in 2011, the FDA approved a “redesign” that put the VNS device back in play. We note that aClass II recall only suggests a minor danger, despite the ongoing reports of injuries and deaths linked to the product. It is a Class I recall that alerts the public to the danger of death and serious injury. And a Class I recall would seem more appropriate for the Cyberonics VNS device given the more than 10,000 adverse event reports linked to its implantation.
The Houston medical device injury attorneys at Denena and Points wonder just how many more deaths, injuries, and malfunctions will be needed before safety regulators, responsible for ensuring the public’s health and safety recognize the dangers posed by this device and remove it from the marketplace. Click the link to read about the 2011 Cyberonics Class II recall.
Class 2 Device Recall VNS Therapy Aspire HC Generator and VNS
Class 2 Recall
VNS Therapy Aspire HC Generator and VNS
Date Posted
November 18, 2011
Recall Status1
Terminated on August 20, 2012
Recall Number
Z-0210-2012
Recall Event ID
59818
Premarket Approval
PMA Number
P970003
Product Classification
Stimulator, Autonomic Nerve, Implanted For Epilepsy - Product Code LYJ
Product
VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression.
Code Information
Model 105, VNS Therapy AspireHC Generator
Recalling Firm/
Manufacturer
Cyberonics, Inc
100 Cyberonics Blvd
Houston, Texas 77058-2069
For Additional Information Contact
Brian Olin, Ph.D.
281-228-7323 Ext. 223
Manufacturer Reason
for Recall
The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action
Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011. A Field Safety Alert was delivered on 09/19/2011 to implanting facilities. Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied. Cyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of: Lack or loss of efficacy Pain, inflammation, swelling/edema in the neck area; and/or Patient perception of stimulation or muscle twitching in the area surrounding the implant. Cyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring. Physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com. For questions regarding this recall call 281-228-7323.
Quantity in Commerce
340 units
Distribution
Worldwide Distribution - USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.
Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database
PMAs with Product Code = LYJ and Applicant = CYBERONICS, INC.
Page Last Updated: 07/24/2014
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COMMENT:
07/25/2014
Dear Messieurs Chad and Denena,
It is only just recently that I came upon your essays relating to VNS Therapy to which I would like to take this opportunity to briefly comment and respond to distortions.
By way of background I am a very long-time support person and health care advocate/activist of more than 50 years to my spouse who formerly suffered for some 36 years with MDD (Major Depressive Disorder) with 9 suicide attempts notched in her medical history. I am also a former board member, president and facilitator of a local chapter of DBSA and a Florida State appointment as a Guardian Advocate.
The first point I would like to address is your statement and seeming confusion:
“Furthermore, many physicians say the device is useless, perhaps even actively harmful, and there is insufficient data to indicate that it’s effective for its intended uses. Significantly, Medicaid/Medicare consistently refuses to pay for VNS implant procedures, and insurers generally are reluctant to foot the massive bill for a device that has not been proven effective and is linked to thousands of injuries and deaths.”
Contrary to your statements and misunderstandings, from my research and readings, I find physicians and more current study results both for epilepsy and depression acknowledging the benefits and safety of the therapy for some of the most difficult to treat patients. Apparently you are confusing Medicaid/Medicare payment policies when applied to depression as to those for epilepsy patients. Epilepsy patients are receiving medical health insurance coverage.
On the other hand in a decision rendered May 4, 2007 CMS (Centers for Medicare and Medicaid Services) has denied health insurance coverage for the depression indication and the private insurers followed suit. Thereby and for the first time placing a group of patients with implanted medical devices in a “Catch-22” with health insurance but being denied the coverage.
In a more recent decision of June 3, 2014, U.S. Administrative Law Judge, Troy Smith has ruled that a depression patient implanted prior to the May 4, 2007 CMS decision is entitled to Medicare/Medicaid health insurance coverage:
http://www.vnstherapy-herb.blogspot.com/2014/07/us-administrative-law-judge-sides-with.html
Which in my opinion this decision should then set precedence for all the volunteer study subjects and depression patients implanted prior to the May 4, 2007 decision wanting to continue the therapy that may need legal assistance especially when confronting the private insurance carriers as well as Medicare/Medicaid.
I shall also point out to you through my efforts and advocacy CMS has agreed and arranged an informal procedure and staff to help the Medicare/Medicaid depression patients obtain care and replacement coverage.
http://www.vnstherapy-herb.blogspot.com/2014/07/important-information.html
Furthermore I can easily debate with you and shoot holes in many of your premises and statements but my efforts are more importantly directed to helping my spouse and others maintain wellness and long-term stability contrary to your presentation. My spouse has been almost continuously depression free for the past 14 years which I and her physician attribute to VNS Therapy.
Where you folks as a law firm can be beneficial and possibly obtain cases is helping to represent those study subjects and depression patients who were negligently, egregiously, immorally and stupidly etc. denied care and replacement by not being grandfathered into the 2007 thereby placing them in a “Catch-22” situation and who wish to continue the therapy and are still trying to obtain coverage from their existing health insurance carriers.
Should you have any interest in possible referrals or would care to discuss this matter further, please contact me.
Sincerely,
Herb
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
(954) 349-8733
You guys are scaring the heck out of me. My daughter had an Aspire 105 installed in her 9/11/15. This is for seizures. Is it safe? Should it be turned on? Should it be taken out?
ReplyDeleteAny information in appreciated.
Sincerely,
Douglas Barbian
Denver, Colorado
Hi Doug,
ReplyDeleteI sent you under separate cover a private e-mail.
Herb