Heart Health
Attorney
(866) 735-1102 Ext 415
In my previous posting I discussed the concerns relating to Guidant Defibrillators.
A new study suggests that for some patients with implanted heart defibrillators that have been recalled by the manufacturer, replacing the device might be riskier than leaving it in.
This study by Canadian researchers reported a higher rate of surgical complications in patients who had potentially faulty defibrillators replaced
"Six percent of 533 patients who decided to have their recalled defibrillator replaced over a 12-month period suffered major complications, including two deaths." This is the first study of the risk of major complications from replacement surgery. That is important information for patients and doctors faced with the decision of whether to leave a possibly defective device in the body or to replace it
Defibrillators are surgically placed under the skin in the upper chest and can be as small as a half dollar. They sense potentially deadly irregular heartbeat and send electrical impulses to bring the heart back to normal.
Surgery to replace a defibrillator is frequently performed with a local anesthetic and sedation and takes an hour or less and patients return home the same day.
2,915 patients (all who had received letters recalling the implanted devices were tracked by 17 Canadian hospitals in 2004-05. 18 percent elected surgery to replace the defective device. 31 patients required follow-up operations as the result of Infection, bruising or bleeding. Two patients died.
"The Heart Rhythm Society plans to release draft recommendations on pacemakers and implantable defibrillators which will include guidelines to assist physician's respond to recalls.
Cost of implantable defibrillators runs in between $30,000 and $40,000. In cases involving recall, the manufacturers provide replacements at no cost. However, insurance companies pay for surgery and related expenses which can be thousands of dollars.
Doctors and patients often decide to leave a potentially faulty device in place after weight the details of the recall and the patient's health. Some patients may decide they cannot risk a device failure, and may go ahead with replacement surgery.
article