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March 24, 2019  
HEART NEWS: Feature Story

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  • Guidant and Implant Industry Under Fire

    Guidant and Implant Industry Under Fire


    July 05, 2005

    By: Jean Johnson for Heart1

    Americans used to make sci fi jokes about bionic men from Mars. As the 21st century unfolds, though, thousands of people are going bionic with anatomical structures or physiological processes that are replaced or enhanced by electronic or mechanical components.

    Take Action
    Living with an implanted heart device:

    1. Take all medications prescribed by your doctor.

    2. Follow your doctor’s instructions regarding diet and physical activities.

    3. Avoid pressure to the area where your device was inserted.

    4. Continue to participate in your normal activities. If you feel tired, rest.

    5. Contact your doctor if: you have difficulty breathing, your legs and ankles swell, you feel dizzy or if you experience any other unusual symptoms.

    Read Guidant’s letter to patients here
    or a general notice on the recall here

    Essentially modern medicine has really come to the forefront in this area and helped people achieve quality of life they could not enjoy otherwise. Yet, when the mechanisms folks rely on let them down, problems ensue.

    Case in point, the recent recall of 38,000 faulty cardiac defibrillators by the manufacturer, Guidant Corporation, along with the pledge that the company will cover the cost of a new defibrillator if a physician and patient decide a replacement is needed for certain previously-implanted models in question.

    It all started last March after the death of a 21-year-old college student who had Guidant’s Ventak Prizm 2 Model 1861 implanted in 2001 to protect against a genetic heart defect. Joshua Oukrop from Grand Rapids, Michigan, a handsome, healthy looking young man with wavy blonde hair and every hope for a full life, died on a bicycling trip after the device short-circuited and his heart went into sudden arrest.

    Now, after four months of investigation by the U.S. Food and Drug Administration that revealed a second death and at least 45 failures of the devices, Guidant is voluntarily recalling 50,000 of the faulty defibrillators.

    A defibrillator sends an electrical shock to an arrhythmic heart to restore normal activity. Failures occur when short circuits develop and needed jolts go undelivered. Computer memory problems in the devices can also interfere with the successful response of the mechanism.

    Guidant admits to discovering the electrical problems in early 2002 and made production corrections by April and November of that year. The company did not, though, divulge either the initial problems or the subsequent changes to physicians. More, Guidant continued to sell the older defective units from its inventory. So, even as Guidant was manufacturing the improved versions, physicians and hospitals remained in the dark and continued implanting the questionable defibrillators in patients.

    Each device sells for about $25,000 and typically has to be replaced every five to six years after batteries wear out. After problems came to light, Guidant initially resisted replacing faulty defibrillators currently implanted in patients, maintaining that they were safe despite the electrical problem. Further the company took refuge behind its warranty that pays only half on replacements older than three years that have problems.

    But after an outside medical consultant to the company, Eric Prystowsky M.D. of Indianapolis went on record saying Guidant should cover full costs, the corporation changed its posture and complied. Thousands of cardiac patients must now consult with cardiologists on surgery.

    As The New York Times recently noted, “It’s easier to get data on a car than on a medical device.” Cardiac defibrillators, hip and knee replacements – name your bionic part. The problem is there seems to be no Consumer Reports to serve as a guide, so patients have to trust all will be well.

    While NYT writer Barry Meier notes that all the government would have to do is gather data – like make and model of the device – from Medicare patients, “Congress effectively bars this information from being collected.”

    “Frankly, we have little information on which one of these devices perform better than others,” said Robert Haralson III M.D., of the American Academy of Orthopaedic Surgeons.

    Cardiologist at Abbott Northwestern Hospital in Minneapolis, Robert Hauser M.D., put it more bluntly: “We are flying blind.”

    Some physicians tend to use brands of implants they trained on in school. Others operate more subjectively, sometimes relying only on product performance reviews compiled by the manufacturers themselves.

    “Public reporting of malfunctions and malfunction rates would force industry to improve their safety,” said William Maisel M.D. a cardiologist at Brigham and Women’s Hospital in Boston.

    That said, Meier wrote, “Under little known FDA requirements, however, makers of pacemakers and defibrillators must report highly detailed product performance data to the agency once a year. But most physicians do not know that the agency collects the data because the FDA has chosen not to make it public.”

    Despite the controversy, in 2005 Medicare expanded its coverage of patients who could potentially need defibrillator implants by a third, or 500,000 people. While the government forms request detailed information about the patient, the two blanks that would help resolve current problems by providing some public accountability – one for the make of the device and the other for the model number – are still missing from the application pages.

    That 21-year-old Joshua Oukrop is also missing underscores what the issue means in terms of our well-being. Indeed, a state-of-the-art medical system is only as good as its patients perceive it to be. And when it starts sending the message that stock prices are more important to than patient welfare, Americans start asking some deservedly hard questions.

    Last updated: 05-Jul-05

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