FDA Unable to Keep Dangerous Medical Devices Away From Public: Report

  • Written by: Staff Writers

A new report criticizes the FDA’s ability to keep dangerous and potentially defective medical devices out of the marketplace. 

The report, published last week in the British Medical Journal, indicates that the FDA is currently unable to protect the public from harmful medical devices because it lacks the manpower, the budget and the authority to do so. It also suggests that the FDA has been co-opted by medical device manufacturers, political forces and other special interests.

The analysis comes a little more than two weeks after the FDA rescinded approval of the Menaflex Collagen Scaffold knee replacement device. The agency admitted that the medical device was approved without being properly researched due to political pressure and the overly flexible requirements of a program designed to fast-track certain devices through the approval process.

It also comes just three months after DePuy Orthopaedics issued a recall for 93,000 artificial hips, which had failure rates of 12% and 13%. Many individuals who received one of the defective hips are pursuing a DePuy hip lawsuit, alleging that doctors were expressing concerns to DePuy about a higher-than-expected failure rate for the metal hip system before the recall. The implants have been found to shed metal particles into the bloodstream, which could lead to cobalt toxicity.

The new report, written by Jeanne Lenzer, a medical investigative journalist, and Shannon Brownlee, an instructor at Dartmouth Institute for Health Policy and Clinical Practice, focuses on gaps in the FDA’s post-approval surveillance process. They focused, in particular, on the vagus nerve stimulator (VNS) by Cyberonics, which is designed to treat epilepsy through electrical impulses to the vagus nerve, which is located in the neck. It is also approved to treat depression.

The researchers said that since its approval 13 years ago the FDA has received reports of 900 deaths of people using the device. However the FDA has yet to require the company to determine the cause of death of those people, which the researchers say means that nobody knows if the VNS was tied to their deaths or not. The VNS is currently in use by about 60,000 patients, and Cyberonics is looking to expand its approval for the device to the treatment of stroke, traumatic brain injury and obesity.

In the case of the Menaflex, as well as a number of other medical devices that have turned out to be controversial, the products were approved through the FDA’s 510(k) approval process.

The 510(k) program allows quick approval of new medical devices if their manufacturers can show that they are functionally equivalent to devices already on the market. However critics say that the standards of the program and the definition of “functionally equivalent” have strayed over time.

A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

As a result ofgrowing concerns, the FDA has proposed a more stringent application of the 510(k) process.

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  1. Dennis Reply

    954 VNS deaths listed in MAUDE (As of 10/20/10)

    102 of those deaths are classified as possible, probable, and definite SUDEP

    *SUDEP is estimated to be 1 per 100 for patients with symptomatic seizures and 1 per 1,000 for patients with idiopathic seizures.

    That shows you are at least 10 times more likely to die of SUDEP with a VNS than with out it.

    And let’s not forget about the 232 reports that do not mention a cause of death.

    How the hell can the FDA let Cyberonics get away with that? Read the reports for yourself if anyone doesn’t believe me. The MAUDE reports are easy enough to find on the FDA site. The FDA’s handling of the VNS is a real fine testament as to how they are protecting the welfare of the American public.


  2. Georgia Reply

    What is wrong with the FDA when they are our source of protection from companies who design and build appliances to be used in surgery for suffering patients. I’ve had a left knee replacement from Depuy since 2006 and it has been nothing but pain and suffering. You can’t go to another doctor for a second opinion because of the mal-practice insurance these doctors pay. I have read many articles of how they knew this appliance wasn’t working right from previous patients. I want someone in the FDA to step up to the plate and take the blame for this problem. There is too many people in the same shape I am in. When I seen the lawsuit on the t.v. and the internet, I called the number they had. They ask me how I found this number. Right then I knew they were trying to wiggle out of the responsibility.
    I feel like Johnson & Johnson paid off the lawyers and their firm to protect their company name.
    I read all the comments by the people who are in the same boat I am in and feel so sorry for them. I know what they are going through because I have and still am there with them.
    If you can’t do anything to help, then stop the surgery for knee replacement and stop the suffering.

  3. Thomas Reply

    My daughter had a Vns put in about 10 years ago. The DR put the wires on the say he wanted not the way the Cyberonics rep told him to he said it didn’t make a difference . The DR died so I can’t sue him but I sure would love to sue Cyberonics. It just about killed her , she stopes eating and was loosing weight rapidly. I shut it off and guess what she now eats fine. The problem now is that it can’t be removed so we can’t have MRI done only sonnagrams. They don’t work as well and is now putting her life in jeopardy again. This is a danger to you and your children be very careful.

  4. trish Reply

    I had the vns put in in 2010. my husband had to come home from Iraq for me to have the surgery because it was life threatening for me. for about 2 weeks now i have been having severe problems with it. I went to the hospital by ems twice within a week. The doctors gave me the run around and tried to blame the malfunction on me. cyberonics told me that if the device didnt stop my small seizures and reduce the effect of the grand mal then it was malfunctioning from the beginning. when i taped the magnet to it to turn it off, it burned me leaving a mark. luckily I took pictures of it. the dr is finally agreeing to take it out but I will still be left with part of the lead in for the rest of my life. not only that, but I was told that because I had a bleed on my brain, I shouldnt have had it put in. Nobody from cyberonics nor did the doctors tell us this!!! i filed a complaint with the FDA but of course i wont here back from them

  5. Mary Reply

    I think this is insane…I had nothing but trouble with my VNS implant and could find no answers from anybody. Cyberonics was wonderful until I had problems then suddenly they quit taking my calls and talking to me. I had to have it turned off…unfortunately things continued to be bad…hard time breathing, aspirate food, liquids, even my own saliva. I have a paralyzed vocal cord and had no voice for 9 months, today I have a voice but it isn’t very attractive.
    I do not understand not being able to sue for this, it has ruined my quality of life and will never get better. I think if we can’t sue Cyberonics, then maybe we can sue the FDA…they approved this wretched device…they should take responsibility for it. You can sue to bad food, bad medication, but not a medical device…I don’t get it.
    If you think it is bad in USA…you should look into what Cyberonics has done in other countries without any guidelines or FDA. I feel sorry for those people. I would like to sit in a room with the higher up’s from Cyberonics and they should be made to listen to all the people lives they destroyed. I want an apology from them.

  6. Donna Reply

    My son started having cluster seizures and drop seizures after having the VNS. Have not found a doctor that will order it to be removed. I did make them turn it off. My son suffers daily from all these drop seizures . I have no way to prove this was caused by the VNS . Does anyone know where I can go in Florida to get it removed he is 38 years old and mentally disabled ? Thank you Donna

  7. Joseph Reply

    I had my vns implanted in march of 2003. I had severe seizure activity before implantion. 9-12 grand mal seizures a week ,with numerous petit mals. When told about the vns ,I was excited that I could go back to having a normal life ,that seizures would no longer control me .Well life isn’t that easy. My seizure control is amazing ,2 grand mail seizures since implantation. Now I’m dealing with the side effects of this lovely device . unexplained heart attacks , severe headaches that are crippling , severe pain left side neck and ear area , and numerous other symptoms. Now I can’t work due to all of this . Just wish someone could help.

  8. arlene Reply

    I think vsn killed my sister, she had it for her epilepsy, it gave her cancer, are there others?

  9. craig Reply

    My wife had A VNS implant in Nov of 2006. It has never worked properly since day one . It has caused a number of side effects that are literally killing her her and Cyberonics will not as much as return a call. She no longer can speak ,severe pain,cannot sleep, asphyxiation , causing us trips to the ER,severe weight loss , wire wrapped around jugular, burning in chest. Its unbelievable that they can’t be held accountable

  10. John Reply

    Omg this is all really scary to read! My wife has had epilepsy since she was 5yrs old and we are now 40. She used to have a lot of peti mal siezures which would always cause her to fall asleep or sometimes fall down. After our teenage yrs the siezures became uncontrollable and really started to endanger her life. She couldn’t do anything, it was horrible, so around 2006 her Dr told us about the VNS. It sounded great and has actually worked great except for the fact that this second unit (first one was replaced due to the old battery dying after 7yrs) which is only a yr old, is now dying and malfunctioning when it should have lasted 7 or 8 yrs. I’m just praying that the new unit about to be installed works like it should, and that the battery lasts like it should!

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