Thousands of patients are facing a tough dilemna. They were implanted with defective Medtronic Sprint Fidelis leads which have now been recalled. Surgery to replace the defective leads is risky. At least four patients have died during the extraction procedure. But what if the patient chooses not to remove the leads? Then they face potentially fatal rhythm if the leads have cracked and fail to provide life-saving jolts to their heart.
Even the manufacturer Medtonic has recommended any patient who opts for the removal surgery to only do so by a highly skilled physician at a hospital experienced with the procedure. The problem is that such hospitals are few and far between. Even experienced surgeons at well-regarded hospitals consider the removal procedure challenging. Apparently even Medtronic finds it hard to locate the very hospitals it suggests patients use. They only recently agreed to provide the FDA with a list of 10 experienced centers but do not plan to make the list public.
And wh0 bears the $15,000 to $20,000 cost of the removing the defective leads? Not Medtronic. They will only provide free replacement leads but the patient’s Medicare or private insurer must pick up the surgery costs.
So once again the public gets the shaft and the manufacturer of defective medical products count their profits.
Richard J. Arsenault, 2011
