medical devices

Medical devices are far more common than you might imagine. One American in ten has an implanted defibrillator, pacemaker, artificial hip or knee joint, surgical mesh or other device. How rigorously are such devices tested before they can be used?

How Does the FDA Regulate Medical Devices?

You would imagine that the Food and Drug Administration would be even more careful in its oversight of devices than it is with drugs. However, that would be a false assumption. The FDA does not require the same level of testing for medical devices.

Scandals about joint replacements, surgical mesh and birth control devices such as the Essure have not captured public concern. That’s largely because patients are told that the latest and greatest equipment is better and safer. Unfortunately, we often lack the research data to support that claim.

The Dangers of Medical Devices:

Learn how the FDA has stumbled on its approval of devices that we wear or carry within our bodies. What should we know about the danger within us?

This Week’s Guests:

Jeanne Lenzer is an award-winning medical investigative journalist and former Knight Science Journalism fellow. She is a longtime contributor to the The BMJ (formerly, the British Medical Journal), and her articles, reviews and commentary have appeared in the New York Times, Smithsonian,  the Atlantic, The New Republic, Discover, Slate, Mother Jones and many other outlets. She is the author of  The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.
The photograph of Ms. Lenzer is by A. M. La Hanko.

Diana Zuckerman, PhD, is
 President of the National Center for Health Research.

Websites are: www.center4research.org  and   www.stopcancerfund.org

Listen to the Podcast:

The podcast of this program will be available the Monday after the broadcast date. The show can be streamed online from this site and podcasts can be downloaded for free. CDs may be purchased at any time after broadcast for $9.99.

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  1. Lucy
    Arkansas
    Reply

    What about dental implants? Is titanium really inert? Im Told it actually encourages bone growth in the jaw that might deteriorate otherwise without teeth there. How long has this been done? Is it regulated?

  2. Lauren
    Orlando
    Reply

    This is classic 180 degree medicine – where we are not being told the rest of the story! You only get full circle when the ‘rest of the story’ occurs. My husband just had all the knee hardware he had implanted removed due to an infection that got in through a new cut on his foot. His leg doubled in size and was hot and bright red within 12 hours… the pain was excruciating and we did not know why because he’d had his knee replaced 8 years prior with no other issue.

    He had emergency surgery to remove all the hardware, a hospital stay of 3 weeks (he is only 62 and in great shape) and will spend 3 months in a wheelchair with a “spacer” full leg extension followed by a second surgery.

    The part they do not tell those with implants of any kind, is that infections go to the metal and stay! The only way to get rid of the infection is to totally remove the implant and start over again. The infection can even come from a urinary tract infection!

    The doctors told us ‘this only happens 1 % of the time’, yet 3 others in the hospital had the same thing the week we were there and I surveyed the doctor’s office on our next visit and there were another 4 patients with the same issue.

    We need to be told the whole story, not just half.

    • Kristin
      Arizona
      Reply

      Thank you for the detailed description of what happened to your husband. I have had both knees replaced and, so far, have had nothing but good luck with them. My surgeon warned me about the dangers of infections, and I’m pretty good about cleaning wounds, but after reading about what happened to your husband, I will be MUCH more careful! I don’t know if it makes any difference, but my artificial knees are covered with ceramic because I am highly allergic to the tiny amount of nickel in the titanium knees. Perhaps the ceramic knees are less likely to attract infection.

    • Colleen O
      Texas
      Reply

      So many things that we don’t hear anything about until AFTER the surgery.

      I am so sorry that I ever had knee replacement surgery. Not one pain free day since then, four years ago.

  3. marian
    Reply

    another issue is when catheters are left in too long after surgery-my late husband was sent to rehab with he catheter in place over 3 wks–then came home with it still in place with help from a urologist and months of self cauterization-he eventually was able to resume normal urnation
    we were later told that lengthy caherization can lead to total loss of normal urine function

  4. SandraLee
    Virginia
    Reply

    This was a most interesting program and I plan to listen to it again on my Kindle. I was shocked by so much of what I heard. I have had 3 hip replacements; my left one in 2002 was revised 11/28/17. It was disturbing to see that measurements were often (mostly?) taken in the supine position. Should be standing up so the distinction between leg lengths can be measured. I can tell the difference myself. Thanks for this program. My son just had a stent put in a month ago. This is scary.

  5. Anke
    Hillsborough, NC
    Reply

    Good show. I would welcome a further conversation about how implants are planned for, sized, positioned, because these also affect the lifespan of a joint replacement. In reference to hip replacements, my observation is that there are multiple techniques presently used by surgeons to plan implant size and placement.

    When an implant is incorrectly placed, so much can go wrong and will contribute to the components breaking down: leg length discrepancy, faulty proprioception, SI joint damage, balance and stability issues. I believe that much of this could be avoided with better preoperative planning and imaging, at the very least with some standing xrays to get a clearer picture of the gravitational center of the hip joint in weight-bearing stance.

    It is unfortunate that this is not a part of the current standards of care for hip replacements; as it stands now, supine imaging of the pelvis alone fulfills standards of care, although it does not give a clear picture of a patient’s natural posterior/anterior pelvic tilt, can easily give misleading information based on how the patient is positioned on the table (incorrect femoral neck length/angle, for instance), and – most importantly – does not clearly establish that all-important c.o.g. needed to place the acetabular cup correctly.

    In my quest to understand the thr planning process, I came across several commercials for “few clicks” thr planning software, based on the same supine images, or gender specific implant placement “rules.” This makes me so sad, because it further removes the surgeon from the necessary understanding of a patient’s geometry.

    Thank you for reading. As you can tell, I am not very happy with my hip replacement.

    • Lauren
      Orlando
      Reply

      Excellent response and what we all need to learn – my husband’s knee replacement (he is a tall guy and former athlete) threw off his back which led to back surgery – which also did not go well. Math matters and seems to not be taken into consideration. His doctor is a knee specialist, went to Stanford, and still this was never discussed.

      • Kristin
        AZ
        Reply

        I have had both knees replaced, one at a time. Because I was quite bow-legged, and the knee surgeon straightened my legs by positioning my knees correctly, I was in excruciating pain from sciatica BETWEEN the first knee and the second. After the second knee was done, and both legs were straight, the sciatica was reduced tremendously. I wonder if your husband’s leg angle was changed when his knee was replaced, and that tweaked his back. I’m sorry he is having to go through this.

  6. Wayne
    Rockledge, FL
    Reply

    After having a partial hip replacement about a year and half ago my recommendation is to have a total hip replacement instead. I also recommend having the replacement done by an orthopedist who specializes in hips and knees.

  7. Christine
    Wisconsin
    Reply

    I have four medical devices, both hips, shoulder & Loop Recorder since 11/14. Was scheduled for knee repl. C-Reactive Protein before repl. of 1.5 and after to 1.2. Recently diagnosed with late Lyme disease. Being treated with CBD oil – inflammation 1.2 went to 0.6. Still high but made a huge difference in pain. Stage 1 Modic changes in spine. Can I eliminate inflammation? Does Lyme disease cause inflammation?

  8. Tim V
    NC
    Reply

    I could not agree more with Ms. Lenzer’s comments. As a patient facilitator and manager for more than 10 years in spine surgery with Prof. Dr. Rudolf Bertagnoli, I have seen many devices come and go in spine surgery. Many of them have FDA approval, only later to be taken off the market for poor long-term performance.

    While some of this can be attributed to poor surgeries and patient abuse, many had fundamental design flaws. Following the drug model the FDA focuses on outcomes, not design.

  9. Kate
    Reply

    “Medical devices” even include cataracts!

  10. Chris
    Maple Grove, MN
    Reply

    I have been in contact with the People’s Pharmacy in the past regarding topics like this. I was NOT aware that the testing seems to be so lax on medical devices. The FDA should be just as strict with testing of devices as with medications to make them as safe as possible for the public. But even approved medications can later be found to have problems and sometime manufacturers were aware of the risks and did not warn the public. That’s when law firms like my client become involved.

    As you mention above, “…joint replacements, surgical mesh and birth control devices such as the Essure…” have resulted in much pain and suffering. It would be nice if the companies would step up and compensate those who have been harmed, but most corporations need to have lawyers make them do the right thing after a considerable battle.

    Hiring a law firm to represent you in this situation is a personal choice and one that should be made after doing considerable research. Since most law firms only receive payment from the compensation award there is little to no risk to take that option. I encourage anyone who feels they have been harmed as a direct result of a medical device to seek representation. If we did not have these kinds of law suits to get the attention of manufacturers, lord knows how much worse the product track record would be.

  11. Jean
    Reply

    My right hip replacement was in 1992 and the people who made the prosthesis did not sterilize the cup properly. Bacteria grew in it and caused me to have osteolitis (holes in the bone). I needed two revisions before it was able to hold. The rod in the leg was fine, just the cup and ball had to be replaced.

    Had I known about it sooner, I could have had a case, but because I didn’t know what the problem was, it was too late when I looked into it. Then I fell and cracked my left femur.

    Screws were inserted at UNC. They were not put in properly and after lots of pain, my original surgeon at Rex in Raleigh did a total hip replacement on the left hip. That was in 2007, and both hips are fine. I’m 91, so don’t want any more surgeries.

  12. CC
    TEXAS
    Reply

    One device that is seldom discussed is penal implants, used after prostate surgery to stop or minimize incontinence and often impotence. They do work… but less and less as time goes by. But, I’m referring to an old one, implanted back in 1994. Perhaps they have improved greatly.

    A major problem is that once implanted, they can not, never, ever be removed. And, if the person with the implant happens to develop any type of dementia, eventually they forget how they work. The worst is that trained or not, patient care personnel doesn’t like to help leading to a bladder that isn’t emptied and then to IYD’s and finally, renal failure. I just had this happen to someone very close.

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