Few, if any, are comfortable with the thought of a Guidant guiding the beat of their heart.
Boston Scientific now owns the company, after paying U.S. $27 billion for Guidant about a year ago. But it was under the Guidant Corp. banner that a worldwide recall was launched of nine models of the Guidant Pacemaker implant. That was in July of 2005. In June of last year, three more models of the device used to regulate a patient's heartbeat were recalled - and Boston Scientific is facing a litany of lawsuits over the failure of devices manufactured between 1997 and 2000.There have been similar problems with the Guidant line of defibrillators.
The first sign of trouble came in 2002, when a Guidant defibrillator was found to have faulty wiring. Guidant Corp. undertook steps to correct the problem on subsequent models and no action was taken. It wasn't until a 48-year-old Texas woman died, that things began to heat up. In this case, the woman was notified that her device was on the recall list - but on the advice of Guidant Corp and her electro physiologist, she elected not to have the unit replaced.
Seventeen days later, she was dead.
Allegations have emerged in civil suits that Guidant Corp may have known about problems with their products, but failed to alert patients and the medical community. A letter, drafted by the company to address those concerns, was never sent. A 'product update', with much softer language, was distributed instead. It's been suggested that Guidant Corp. knew about potential problems three years before the recall, which has encompassed 50,000 units.
The mere fact that the recall was identified as a Class 1 recall, the most onerous of three classifications, speaks to the seriousness of the issue, and the likelihood of malfunction.
At issue is the relationship between a seal that allows moisture to seep into the unit under certain conditions, and the internal electrical circuitry, which governs impulses to the heart. Defective units have been known to deliver more intervention than is required, or not enough.
That was the case with a 21-year-old student in 2005. His Guidant defibrillator experienced a short circuit and failed to deliver an impulse to the heart at a critical time. It could have saved the young man's life.
A 14 month-old infant also died, after a Guidant pacemaker failed.
Boston Scientific, which now controls Guidant Corp, has promised to replace all defective units. Unclear, however, is whether or not that offer includes the costs of surgery, and time lost for recovery.
It appears, however, that patients are taking the matter to heart. As of November last year, there were well over 600 pending lawsuits. One lawyer is predicting there may be as many as 5000 before all is said and done.
According to the American Heart Association, 197,000 heartbeat-regulating devices are implanted into American patients every year. Between 1990 and 2002, a staggering 2.5 million devices were implanted, of which 8,834 had to be removed when they malfunctioned.
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A recalled device is no guarantee that it is failing, and may not prove defective. Not until the device is removed, can it be reasonably determined if the device has the potential for trouble. Making the decision to replace a potentially defective device is a roll of the dice - and with the high costs of surgery and recovery, an expensive roll at that.Recalled Guidant units are:
• Insignia and Nexus pacemakers
• Contak Renewal TR and TR 2 cardiac resynchronization pacemakers
• Ventak Prizm 2, Vitality, and Vitality 2 ICDs (implantable cardioverter defibrillators)
• PULSAR® MAX Models 1170, 1171, 1270
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
• DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
• MERIDIAN® Models 0476, 0976, 1176, 1276
• PULSAR MAX II Models 1180, 1181, 1280
• DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
• CONTAK TR® Model 1241
• VIRTUS PLUS® II* Models 1380, 1480
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
