According to the Wall Street Journal health blog, as described in the New York Times, Medtronic had been accused of allegedly paying kickbacks to physicians who used their medical devices in surgery. Beyond that allegation, is the well-known fact that manufacturers of drugs and medical devices routinely issue honorariums to doctors and surgeons for speaking to their colleagues on behalf of the entities that are paying them. Many doctors accept speaking engagements and honorariums as a means to supplement their income, and the practice is perfectly legal.
Rather than revoking that right, the US Senate is pushing for full disclosure as to the payments that pharmaceutical and medical device manufacturers make to doctors via a 'physician payment sunshine act.'Health advocates wonder if the same disclosure would benefit recipients of medical devices, if there was a way of knowing where their medical device was manufactured and where the various parts and components of that medical device were sourced.
It's a fair question, given the increasingly globalized economy and the rise in failure rates of medical devices. Medtronic, at the moment, is still stinging from the failure of its Sprint Fidelis defibrillator leads, which are prone to fracture. A recent study suggested that the failure rate is worse than first thought, although Medtronic disputes those findings.
A lead serves as the lifeline to the heart for an implanted defibrillator. When a lead fractures, effective and precise communication between the device and the heart is compromised, resulting in either the failure of the defibrillator to deliver life-saving impulses to a failing heart when needed, or the generation of excessive electric shocks needlessly. Both events can have devastating consequences.
There have been other medical device failures. The Kugel Mesh hernia patch failed when a memory ring, inserted in a collapsed state through a catheter and expanded inside the body to hold a piece of hernia repair mesh in place, was found to separate at the welds and introduce sharp edges to soft tissue and vital organs.
The Zimmer Durom Cup hip replacement system has also been in the news over the past year, when prosthetic devices have been found to fail within a relatively short period in some patients.
Can we assume that all of these, and similar medical devices are manufactured in the US? Or are they assembled in some far away land, where workers labor for much less than they would earn doing a comparable task on US soil?
Are they, indeed assembled in the US from parts sourced from other countries?
With the possible exception of places like Japan, Germany and Switzerland, which are renowned for excellence in the manufacture of automobiles and electronics, developing countries that are emerging as newfound industrial nations are getting more and more work from US companies, due to the cheap labor available.
A chat with a plumber the other day yielded the observation that the quality of many American-made plumbing appliances went immediately south when the jobs did, too. Suddenly implements were failing and water began leaking where leaks never used to be. Quality dropped, in terms of both materials and workmanship.
Companies made more money. However, all homeowners had to show for it, were more leaks.
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Medical devices, like medical drugs, are not add-ons that can be easily unbolted and put back on if there is a problem. They are ingested, or implanted—and all too often removing a medical device, or revisionist surgery to correct a faulty devise comes at huge risk. With both drug and medical devices, the damage is done once they're inside of you and all too often once the damage is done, it's too late.
We can joke about vacuum cleaners not being made like they used to. But if and when the same can be said about something deep inside of you, that statement takes on a significantly different meaning.