Science in Society Archive

Electronic Medical Implants - Promises & Perils

Dr. Mae-Wan Ho reports

Electronic medical implants have been in development since the 1950s with the first cardiac pacemakers. They have since expanded to include defibrillators for the heart, neurostimulators for the nervous system, including those implanted into the brain, drug delivery infusion pumps and cochlear implants to assist hearing.

The latest implants - brain computer interface devices to help the paralysed regain control and communication, and electronic tags for instant medical records retrieval - are raising many additional ethical and social concerns (see "The new body & mind control", this series). As populations in the industrialized world are getting older and sicker, an increasing demand for such prosthetic devices is forecast.

According to a financial consulting firm, the worldwide market for electronic medical implants is estimated to reach $9.68 billion in 2004, and growth will continue at a compound rate of 14% to reach approximately $18.65 billion in 2009. The basis for this forecast is unknown, as the firm demands thousands of dollars to download their complete report. Judging from previous forecasts about the biotechnology market, which is wide of the mark, this present forecast should be taken with a large grain of salt. Unfortunately, our governments have probably bought expensive advice from financial consulting firms like these, when they should have listened to groups like ISIS, which provide much more reliable advice free of charge.

The United States currently accounts for approximately 72% of this market. And the forecast by the consulting firm is that cardiovascular devices will continue to lead with over 80% of total market revenues, but that the approval of devices, such as neurostimulators for additional indications, including depression and Alzheimer's disease, will contribute substantially to market growth. Again, this advice is probably not up-to-date, as it has not taken into the account the rapidly developing brain computer interface devices as described in "Get ready for matrix" (this series).

What the consulting firm does not tell you is that, according to the Good Housekeeping magazine, more than 2 million implants have been recalled over the past 10 years, with heart devices the most common. Some of the faults listed in the FDA archives include software malfunction (perhaps they got their science wrong and came up with a bad model?), software/hardware incompatibility, leaky pumps, incorrect dosage or stimulation power, failure of electrical or mechanical components, battery malfunction, incorrect assembly, generator malfunction, errors of measurement, fractures, faulty circuit boards. In addition, sterility is a big problem. A recent study linked Staphylococcus aureus bacteremia (staph infection in the blood) with implanted heart devices.

Even when correctly implanted, the devices can cause problems from exposures to electromagnetic fields. The FDA received reports in 2002 of patients with implanted deep brain stimulators dying after receiving diathermy therapy (the generation of heat in tissue by electric currents from radio frequency and microwaves for medical or surgical purposes). One patient had diathermy after oral surgery, the other had diathermy for treating chronic scoliosis. In both cases, the treatment interacted with the implanted device, causing severe brain damage in the area where the lead electrodes were implanted.

Laboratory tests showed that patients with any implanted metallic lead are at risk of serious injury when exposed to radio frequency or microwave diathermy therapy. This is true even if the implanted device is not turned on, and even if the lead is no longer connected to an implanted system. It also raises questions as to whether these implants might make subjects particularly vulnerable to using mobile phones and other electrical devices (see "Mobile phones and brain damage", SiS 23).

Although the Food and Drug Administration is responsible for licensing and recalling the devices, no one is legally required to notify patients if there's a problem with a medical implant.

"People think that if a product is FDA approved, it's safe. But there' no medical device that's not capable of failing in some way," Dr. David Feigal, head of the FDA Center for Devices and Radiological Health, was reported to have said. Injuryboard.com, a website sponsored by a network of law firms, says that between 1990 and 2000, the rate of recalls and safety alerts relating to popular heart rhythm devices, pacemakers, and defibrillators, dramatically increased. During the period, the Food & Drug Administration issued over 50 advisories, approximately 3 each month. Furthermore, since 1990, use of various heart devices has increased 49%.

The economic costs associated with device recalls totalled nearly $1 billion over the past decade. These costs include only hospitals stays, device replacement, and doctor's fees; and not the cost of pain, suffering, and loss of life.

Article first published 15/12/04



Sources

  1. Electronic Medical Implants Market Report June 2004 Navigant Consulting, Inc. http://www.mindbranch.com/page/catalog/product/2e6a73703f636f64653d523335392d3030363626706172746e65723d30.html
  2. December 20, 2002
    http://www.injuryboard.com/view.cfm/Article=1867
  3. FDA Archives mdi Consultants, Inc http://www.mdiconsultants.com/Section_NI/FDA_Recalls/recallarchive3.htm
  4. Good Housekeeping http://magazines.ivillage.com/goodhousekeeping/ghtv/articles/0,,284608_607667-4,00.html

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