Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Monday, August 17, 2015

Sacrificial lambs! U.S. Senate: AMEND 21st Century Cures Act


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    • A caller to Jack Pattie's radio show recently asked a disturbing question: Are patients guinea pigs for medical devices?
    I responded that medical devices are often poorly tested and if I received a faulty one, guinea pig would be the mildest term I would use.
    In fact, we are not even guinea pigs, we are sacrificial lambs for corporate profits.
    When a guinea pig is used in an experiment, data are collected to improve the product. Not so with medical devices. There is little effective post-market monitoring of these devices.
    Just look at the morcellation debacle. A device intended to grind tissue into little pieces, thus allowing hysterectomies to be performed through a small incision, was found after 20 years of use to be spreading cancer. High failure rates are being reported for metal-on-metal-hip implants which can even cause metal poisoning; retrograde medical endoscopes can spread untreatable bacteria. Safety problems are being reported for vaginal mesh, used in reconstructive surgery, and the Sprint Fidelis heart defibrillator.
    These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers.
    That's right, untold numbers. No one in the United States is effectively watching what happens to these devices after they are implanted in patients. The safety feedback loop, which helps spur device improvement and safeguards patients, is all but lacking.
    The problems with metal-on-metal hip implants were first systematically detected in England, which has an effective reporting registry.
    Problems with retrograde medical endoscopes spreading untreatable bacteria were known in Europe two years before the United States, and morcellators posed an unacceptable risk of spreading cancer for many years before anyone noticed.
    Some have stated it is not practical to test all medical devices. This may be true, but I want any device implanted in me to be thoroughly tested.
    The U.S. House of Representatives passed the 21st Century Cures Act but instead of strengthening medical device oversight, the House weakened the requirements for testing even further.
    What are patients to do?
    First, remember that for many implants the benefits are overestimated and the risks underestimated. Before any implant procedure patients should at least ask:
    ■ What is the implant's failure rate?
    ■ How does the tissue react around the implant?
    ■ If the implant fails can it be taken out?
    I was faced with a decision once to have metal cervical joints placed at multiple levels in my neck. I asked the above three questions. The first two were not known and the answer to the third was no. I chose to have the "old-fashioned" cervical fusion.
    Some would think that a device that has long been in use would be safe. But, as exemplified by the morcellator, which was first marketed in 1994, if no one monitors for problems they may be perpetuated indefinitely. Out of sight, out of mind.
    Next, patients should check the MRSA and C. Difficile rates at their hospital, available on Hospital Compare (https://www.medicare.gov/hospitalcompare/).
    If you are having a hip or knee implant or a lumbar or cervical spine fusion, check for your surgeon's complication rates on ProPublica's Surgeon Scorecare website(https://projects.propublica.org/surgeons/).
    Finally, remember nothing lasts forever and all man-made devices can fail, so keep your follow-up appointments.
    For those with chrome-cobalt metal hip implants, consider having blood cobalt levels tested to screen for dangerous, and sometimes life-threatening, heavy metal poisoning. Your doctor may tell you there is not good literature to support the testing. But remember few are looking for or monitoring problems.
    Dr. Stephen Tower just reported in the Journal of Patient Safety 25 cases of cobalt poisoning from hip implants. Until the true incidence is known, play it safe and get tested.
    According to a report from Johns Hopkins published in the Journal of Patient Safety, over half of all medical hospital inpatients had an implant. It is more likely than not that you are or will be an implant recipient.
    Almost everyone has a stake in health-care policy regarding implants.
    We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices.
    Dr. Kevin Kavanagh of Somerset is board chairman of Health Watch USA.



    My comment:  I trained 9/2010 at FDA/CDRH as a Patient Representative.  In 2008 my brother was implanted with a Tornier elbow that was designed by the Mayo Clinic surgeon that performed the implant.  The elbow failed(pain and loss of function) and was 'revised' by removing two of the components . . . yet it was not reported to the FDA as an adverse event.  Multidistrict lawsuits (MDL's) for metal-on-metal hips(100,000) and pelvic surgical mesh(75,000) have begun to prompt anemic settlements for the PREVENTABLY, severely and permanently harmed patients.  Implanted elbows are rare (@4,000 annually) and can be considered an 'orphan' device and lawyers have little incentive to bring a lawsuit.  The surgeon is not legally required to report an AE (adverse event) unless there is a fatality and the FDA does not investigate anyway.  If patients knew the catastrophic downside and actual patient outcome statistics on implants they would demand the medical device implant industry provide a product warranty on permanent implants.  Marketing statements should align with patient outcomes.  The 21st Century Cures Act is an affront to public health and all the SACRIFICIAL LAMBS that Dr. Kavanagh refers to.  

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