CONSUMER ALERT

From: Miami Herald, FL - 29 Dec 2002

DIATHERMY DANGER TO IMPLANT PATIENTS

Following the deaths of two patients, the FDA has issued a warning to physicians and other healthcare providers that patients with implanted deep brain stimulators (DBS) used to control tremors associated with Parkinson's and other diseases should not receive shortwave or microwave diathermy.

It also warns against diathermy for anyone with an implanted lead or implant containing a lead.

That includes cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators, spinal cord stimulators, and other nerve stimulators.

According to the FDA, one person died after diathermy following oral surgery, another after treatment of chronic scoliosis. In both cases, the interaction of the diathermy with the implant caused severe brain damage in the area where the lead electrodes were implanted.

Diathermy involves the passage of high frequency alternating current through body tissue. Three types of diathermy equipment are used by physicians, dentists, physical therapists, chiropractors, sports therapists, and others: radio frequency (shortwave) diathermy, microwave diathermy and ultrasound diathermy.

Shortwave and microwave diathermy, in both heating and nonheating modes, can result in serious injury or death to patients with implanted devices with leads, although ultrasound diathermy appears safe.

Laboratory testing has shown that patients with any implanted metallic lead are at risk of serious injury when exposed to shortwave or microwave diathermy therapy even if the implanted device is not turned on, and even if the lead is no longer connected to an implanted system.

The FDA also warns that leads are often left in the patient's body after the implant is removed.

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