Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Doctors and their patients with recalled Medtronic defibrillators implanted in their chests may soon be faced with making difficult decisions about whether to undergo life-threatening surgery to remove the faulty heart devices to prevent possibly fatal events, according to the New York Times.

Medtronic recalled the defibrillators in 2007 after five deaths occurred in patients who had the devices implanted in them. It was discovered that the Sprint Fidelis leads, or cables that connected to the devices, had fractured causing the defibrillators to unnecessarily shock patients or fail to work all together. Since the recall, Medtronic has increased the number of fatalities linked to the devices to 13.

About 150,000 Americans still have the defibrillators. Medtronic advises patients to discuss with their doctors whether the benefits of removal outweigh the risk, adding that it should be done only as a last resort. Removing the cables can be dangerous. Four patients have already died during the device removal process. Some experts fear that that number will climb if patients don’t seek out skilled doctors at medical centers to perform the extractions.

Finding credible medical centers may also present challenges. Data on the number or the success rates of lead extractions is generally not available to the public.

For those who do choose to have extractions, Medtronic is supplying replacement leads. However, the $15,000 to $20,000 cost of the surgery to remove and implant the new leads is falling on the shoulders of private insurers or Medicare.

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