Electronic Medical Implants - Promises & Perils

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15 Dec 2004 14:04:14 -0000

 

Electronic Medical Implants - Promises & Perils

press-release

 

 

 

The Institute of Science in Society Science Society

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press-release ISIS Director m.w.ho

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ISIS Press Release 15/12/04

 

Electronic Medical Implants - Promises & Perils

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Dr Mae-Wan Ho reports

 

The sources for this report are posted on ISIS member's

website http://www.i-sis.org.uk/full/EMIPAPFull.php. Details

here http://www.i-sis.org.uk/membership.php

 

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 "

(http://www.i-sis.org.uk/matrix.php).

 

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 http://www.i-sis.org.uk/isisnews/sis23.php).

 

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.

 

 

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