When medical implants fail

"The industry's concern about the FDA in the last few years is that while they haven't changed their standards for review, reviews have become much slower and more inconsistent," Nexon said.

But Dr. Hauser cautions that speeding up an already ineffective approval process could be dangerous, because there's also inadequate follow-up after a device hits the market - something called post-market surveillance.

"In the United States, there is no definite requirement for post-market surveillance for defibrillators and heart valves, artificial hearts and so forth," he said. "There's no absolute requirement. In other words, you wait for problems to be reported to you rather than actively seeking out problems, and there's a big difference."

He says active reporting could have saved Joshua Oukrop. Remember, the GAO says the FDA received 26 reports during the three years before Oukrop's death.

"I suspect nobody read the report," Dr. Hauser said.

"FDA has got to know there's a problem here," said Axelrod.

"They do, and Congress knows they have a problem," Dr. Hauser said.

"So when you say there can be tens of thousands of people walking around with faulty devices, I mean, really, tens of thousands? It doesn't have to be, in your view?"

"No," Dr. Hauser said.

Last year, the Institutes of Medicine, an independent advisory group, issued a report stating that the FDA's current regulatory framework for most devices is so flawed it should be thrown out and replaced with a new system that "provides a reasonable assurance of safety and effectiveness."

Advamed's David Nexon says that even though in the last couple of years recalls of device models with problems that could cause serious injury or death have doubled, in his view, the numbers are still small.

The American people, Nexon said, "should be very confident that the FDA and the industry working together have an exemplary safety record. There are 50,000 different models and devices on the market right now. About 20 of those on average they find serious problems with. That's less than two-tenths of one percent."

Lee Oukrop asks, "Why did I have to be the 1 percent? Not wishing it on anybody else, but why does there have to be any? There shouldn't be any. There can't be. When it's that critical of a piece, there can't be that kind of problem with it."

When we finally heard back from the FDA - the agency refused our request for an on-camera interview, providing us instead with a lengthy statement, which said in part:

"The FDA weighs the benefits and risks of every medical device we review. ... We must balance risk with the careful evaluation of patient benefit - this helps promote public health."

Full FDA statement on medical device safety

Today, Lee Oukrop worries for his other son, Jacob, who inherited the same heart condition as Joshua - and has a defibrillator implanted inside him.

"I mean, I feel confident that it will save me if and when I ever do need it," Jacob said. "They have assured me that this device is a life-saving device and I just put my trust in what the doctors say."

But this isn't Jake's original device. As the luck of the one percent would have it, a part on Jake's defibrillator was faulty. Remember those smaller leads Dr. Hauser described? Jake was among the 268,000 patients who received that "shrunken up" version.

"There was a recall on some of the leads that go from the defibrillator to the heart," Lee Oukrop explained. "The leads were cracking and shorting, and then the defibrillator couldn't deliver a charge if it needed to."

After having that device inside him for nearly three years, it was replaced before Jake was harmed.

But 13 others died.

Lee Oukrop says Jake just had better luck than Joshua - and that's not nearly good enough.

"Somebody out there needs to be looking out for me, for us," said Lee. "We're not doctors, we're not scientists. Here it is six, seven years later, and you still see that stuff is getting through. Stuff is being recalled. And it's all stuff that the FDA should be looking at and they should be paying a little bit more closer attention to."

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[bryanstark]

Is this still going on today in 2012? My mother is having one implanted in Tampa, FL today and I am wondering if this is something our family should be concerned about or if this is primarily a story about these faulty devices having been implanted in the past. I will try and check back here for comments, but if you have any helpful updates or information, if you could email to [e-mail] I would really appreciate it! Thanks. Bryan

[In_Memory_of_Dad]

First I wanted to say that I love your program and my Sunday mornings just wouldn't be complete without it.
It was with great interest that I watched your segment on "When medical implants fail". My father had the St. Jude ICD implanted at Mercy Hospital in Pittsburgh, PA and began complaining of being "shocked" on the left side of his ribs. After 3 visits to the ER at the Ellwood City, PA Hospital and 3 visits to his Cardiology group, he was merely sent home with pain medications and without a diagnosis. It wasn't until a Physician's Assistant made the comment that she thought the lead wires had punctured his heart that the problem had been discovered - 10 days later. She was correct that the lead wires punctured his heart and were shorting-out at his ribs and that is a KNOWN potential complication of the surgery. He had a second surgery to correct the problem but ultimately contracted pneumonia and died.
As I worked at a medical device company for a few years I was aware of the FDA Medwatch program where you can report injury or death due to medical devices. I called the Pittsburgh hospital to see if they had reported the injury to my father and was told by their regulatory group that the reporting by them was VOLUNTARY. After research I found that neither the Doctors who performed the surgery or the hospital are REQUIRED to report such events. As a family member I have reported my father's case through the Medwatch program and he has now been counted.
In your story it was reported that the medical device had a 1% defect rate but it wasn't really stated that most injuries or deaths are NOT reported so therefore the statistics are inaccurate. I think the story could have been clearer about this and the viewers would have been better served by providing them with the information about the Medwatch reporting program. Even better would have been to ask a FDA official about WHY the reporting by Doctors and Hospitals is NOT REQUIRED.
In honor of my father I have started a Facebook Group called "Be Counted with FDA Medwatch" (still in construction) where information can be found and stories can be shared. It is my hope that with enough outrage the requirements will be changed so the statistics will be meaningful.

[papaknight]

Having been through a failed ICD (St Judes Medical), an intense cover-up campaign by St Judes (still ongoing) and a full packet of lies by every company representative concerned I now have a Medtronics unit that has saved my life several times. They did not hesitate to remove the fidelis lead that was called into question but I still have a piece of the st Judes Riata lead inside me as well as the newest recalled riata lead which i cannot get removed..yes you had better shop around and get educated before you have an ICD implanted and get a full report on paper every time your device is interrogted. Dont know aboout the others but St Jude Medical will not hesitate to alter your records to cover-up problems resulting in injury or death. kirby [e-mail]

[janea9]

Thank you CBS- the public needs to understand that they are not protected when it comes to most medical devices. FDA says it needs to make approvals of untested devices faster- but the public doesn't care about faster, it cares about safer. Industry cares about faster... and the FDA is the lapdog. Read injuries from surgical mesh at mesh medical device news desk. What is happening?

[janea9]

One of the worst offenders is Al Franken now a lawmaker from MN who carries water for medical device industry. Remember when he was funny on Sat Night Live and spoke out about Bill O'Reilley?

[FraudAlert]

CBS News April 1, 2012 - 6:56 AM

Re: Allen v. Guidant Civil No. 11-22 (DWF/AJB) for a copy of Judge Donovan Frank's Memorandum Opinion and Order March 14, 2012. See: http://www.sidley.com/files/upload/Allen%20decision.pdf

Non FDA approved Guidant defibrillators and pacemaker's were illegally introduced into interstate commerce using Guidant counterfeit FDA certifications on the changed post April 16, 2002 PRIZM 2DR 1861.

Guidant/Boston Scientific has been ongoing since August 19, 2005. I warned the Food and Drug Administration in writing seven separate times. I also filed a "Adverse Event Report" with the Food and Drug Administration on February 7, 2006. The fraud in my False Claims Act filing involves an additional 35,000 post April 16, 2002 devices not mentioned by Dr. Robert G. Hauser and to date, nothing has been done by the FDA and/or the GAO to recall these devices and/or make the patients aware of the danger. The financial theft that took place is in excess of $726,000,000 million dollars.

This post April 16, 2002 PRIZM 2 device subgroup had never been litigated prior to my False Claims Act filing date of July 23, 2008. I became the "original source" to the government February 7, 2006.

1. I acquired direct and independent information December 5, 2002 through mid 2004 with respect to knowledge of the defective post April 16, 2002 PRIZM 2 failing and non-FDA approved devices. I provided the first information to the managerial responsible Food and Drug Administration in writing February 7, 2006 and had a hand in, and indirectly caused, the first public disclosure on the post April 16, 2002 subgroup. The information I provided was released by the FDA (in part) out from under the dome of the government to the physicians, patients, hospitals and general public prior to my filing the FCA.
2. I provided the 27 pages of information on the post April 16, 2002 devices and the FDA released 1 paragraph with the true and false state of facts publicly disclosing for the first time the known dangerous and defective post April 16, 2002 device subgroup and fraud. The balance of the information was concealed by the FDA as confidential not to be released to the public under any circumstances.
3. The PRIZM 2 devices manufactured April 16, 2002 - October 5, 2007 subgroup were non FDA approved, adulterated, changed, misbranded, imported, investigational and experimental devices without human clinical testing and/or FDA certification for Veterans Administration and/or Medicare (CMS) reimbursement of Treasury dollars.
4. These devices had several major changes made without the required FDA Supplemental Pre Market Approvals including, but not limited to, the use of two experimental, first of their kind, increased viscosity and molecular weight polyimide silicones. Guidant also ran illegal non-FDA supervised human clinical trials on the public without toxicity or carcinogenic testing on the new polyimide adhesives. Serious injuries and deaths were caused as a direct result of these actions.
5. These post April 16, 2002 (35,000) devices were never FDA recalled. The illegal changes made affected the safety and effectiveness of the device. The post April 16, 2002 PRIZM 2 experimental devices were failing as a result of body fluid and blood leaching into the header connector assembly causing degradation, oversensing, needless storm shocking of up to 750 volts, battery depletion, capacitor shorting, additional heart damage and eventually caused the device to become ineffective as the degradation of the known defective polyimide progressed into disabling the device in several ways and in some cases including the electrical shorting as a result of the "root cause" known defective non FDA approved polyimide adhesive.
6. The information that was given to CBS that over 3 years there were approximately 26 "serious adverse event reports" on the pre April 16, 2002 Ventak Prizm 2DR 1861 model is not true or in the words of Mark Twain "there are three kinds of lies: lies, damned lies, and statistics." Guidant underreported the adverse events to the FDA, added misinformation, withheld information and the majority of the device failures went undetected as it is extremely rare for a post mortem autopsy or examination of the body to determine the cause of death. Daniel J. Schultz publicly stated in 2006 that the FDA had more productive uses for their time than to read adverse event reports. The fox (Guidant) was guarding the hen house.

If you are interested in bringing your information and questions to the light of day and getting the truth on this tragedy or you are a patient or know someone who was implanted with the Guidant Ventak Prizm 2DR 1861 defibrillator post April 16, 2002 please feel free to contact me at [e-mail]. All questions will be answered.

James F. Allen (Ventak Prizm 2DR 1861 post April 16, 2002 patient and victim.)

[britoeliz]

Have you ever heard of the device leaking? My dad has a bacteria infection that they can not figure out and think it could be coming from a leak in his ICD. I don't know what kind he has. Please let me know anything you know about this.

Thank you.

Elizabeth Brito

[trytobeinformed]

I used to work at a Biomedical Instrument Company. Companies are making new devices and re-designing equipment all the time. These companies hire the best and brightest engineers to design this equipment and the government can't compete in the job market with trying to understand the complexity of biomedical instrumentation. To have a goal to make each and every piece of equipment 100% safe is an unachievable and unrealistic expectation, especially, since everyone currently wants severe cuts in the Federal Budget. A 0.2 % failure rate is statistically and economically realistic, especially, if we want to keep medical cost down. These are devices that humans make and there will always be errors in designs. It is unfortunate that some people may experience negative consequences with some faulty equipment and devices. However, there is always some lawyer ready to take on class action lawsuit against any company. Everyone want new medical cures immediately and at a low cost with no downside risks. This is just not going to happen. All medical procedures have risks!

[wirewolfman]

I've read all of the above comments. You can say want you want about the FDA and it's failure to do it's job correctly and all of the other problems associated with the companies lack of response and oversight.

I just came back from my Cardiologists' (EP) office. Why? I found out last week that I have one of the leads on the recall list. I have a Medtronics CRT-D and one of the three leads I have is a 7000 series lead from St Jude. For now we discussed a more careful and more often monitoring of the leads' electrical tolerance's, both, with a new home monitor unit and adjustment of the units' alarm set points. My unit at it's current rate of use (device lifetime) has about another three years of battery life. If there is the slightest indication of a lead problem my Cardiologist said he will recommend an immediate replacement of the lead.

So, for three more years I'll have to live with a potentially ticking time bomb in my chest and just hope the unit will deliver a life saving jolt if needed. Or at least hope the device will give me an advance warning.

My Cardiologist is extremely upset over this news from the FDA and St Jude. He mention the report given by Dr. Hauser and has, like Dr Hauser, fought for better reporting and monitoring on both the devices and the leads.

I have to take this all in and for now just go with the flow. Or maybe my next Google search will be for good attorney.

Just in case my children wish to file a wrongful death lawsuit.

[jmdldp]

Can you tell me where I can find the recall report. I have St Jude 7120-Q leads. My (EP) has said nothing about a recall. I want to make sure if I have faulty leads that I can remedy the problem.
My E-mail address is [e-mail]
Thank you so much.
Worried and Scared,
Johnny Ray

[papaknight]

I was told the same thing as you.."we are watching your lead and you need not worry" but worry I did. Luckily I ws in th ehospita; whem it happened and was revived but not before suffering a hopixic episode and brain damage. Shortly after i coded and my ICD failed to fire I was told the battery was dead, and then the lead was fractured and then the unit had fired 5 times but failed to revive me. These were all lies and we can prove them so. There is no safe way to test the defibrillator or to know if it will fire when needed until it is nedded. Replacement is the only to be assured it will not be the cause of your death. I currently have a lawsuit in federal court that isin the discovery stage in which we will prove these allegations if we can obtain funding to keep the suit alive. Sorry to hear about your problem but beieve this your life isin your hands and the device manufacturer cares naught about your situation. Good Luck. [e-mail]

[papaknight]

The first inkling you have that there may be a problem may well be when your heart stops and the device fails to "shock" you or when the lead causes an ICD storm any you get 50 shocks 30 seconds apart. Both happened to me. St judes Medical has campaigned to the point that they have made up patient records trying to say the unit did fire. Luckily, I was in a hospital elevator when my heart stopped. Ask you EP if he can verify that your "high voltage lead" is functioning and get printed copies of all data interrogated from your unit. Health care personnel are handcuffed by the manufacturers tech reps and their most practiced lies. Want proof just ask me ([e-mail]) too late for me but I hope to be able to save someone else from this horrific experience. Best of luck to you and yours Kirby Knight

[PHansel]

This case and others underscore the need for continued reforms to how the FDA approves and monitors the drugs and medical devices we use. And yet, pharmaceutical and medical device companies are lobbying Congress to roll back protections. A new report found that they spent more than $700 million in lobbying in the last three years: http://blog.ucsusa.org/money-talks-and-what-its-saying-may-harm-the-fda.

[animator411]

I wish they would have mentioned what the heart condition was. I think it is important to the story for others who may have the same condition.

[Herne42]

The U.S. government still classifies Marijuana as a class one drug (like heroin)....The F.D.A. once claimed agent orange and asbestos were safe.

(apparently the F.D.A.or D.E.A. hire anyone!)

It is BS that ANY product can get approval, when a politician is taking large sums of "donations" from that company.... (happens ALL THE TIME). Those politicians should be tried under charges of terrorism and treason. (WE NEED LAWS TO PROTECT US FORM THIS)

Something is wrong. Politicians need to answer some questions, and many SHOULD go to jail... in my opinion.

[retm-w]

Not just the politicians, these device and drug makers CEO's should get some serious jail time, instead of a little fine.