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Federal health regulators are advising anyone who has received a St. Jude Riata or Riata ST defibrillator lead to get an x-ray or other imaging exam due to concerns that the insulation may fail. In addition, the manufacturer is also being required to conduct additional studies to evaluate the risk of St. Jude defibrillator lead problems that may exist with several different models of the small wires.
The FDA issued a safety communication on the St. Jude Riata defibrillator lead recall on August 16, with new recommendations for patients who received one of the recalled products.
St. Jude stopped selling Riata leads in 2010 and issued several warnings about the risk of premature insulation failure, where the small wires may poke through the insulation. The FDA classified the company’s actions as a recall last November.
The guidelines come in response to continuing concerns facing thousands of patients who still have the leads implanted, not knowing whether the leads should be explanted and whether it is safe to have them removed.
St. Jude Riata Leads Failing Within A Few Years
Implantable cardioverter defibrillator (ICD) leads are designed to monitor a patient’s heart rhythms and provide a life-saving electrical shock if necessary. While the average ICD lead should last at least 10 years, the FDA warns that the St. Jude Riata failures appear to be occurring after only about four years.
The Riata and Riata ST leads were recalled amid reports that the conductors were poking through the insulation, resulting in an exposed wire inside the body. This could result in unnecessary shocks or failure of the device to deliver a life-saving jolt when needed.
The recall set off a firestorm of debate in medical journals between St. Jude and independent researchers who differed on how dangerous the exposed leads were and how many deaths or severe injuries could be attributed to the Riata lead problems. In the interim, it was unclear whether doctors should remove the leads or let them stay implanted.
After the St. Jude Riata leads were introduced in 2002, there were more than 227,000 of the small wires implanted in patients worldwide. Reports suggest that there are still approximately 79,000 of the leads active in patients in the United States.
FDA Calls for Monitoring, New Clinical Trials
According to the new guidelines, the FDA recommends that health care professionals closely monitor patients who have the recalled leads and make sure the patients know that their leads have been known to have problems.
The agency recommended patients get a two-view chest x-ray or fluoroscopy to check the condition of the leads and suggested that they have an exam to check for any electrical abnormalities. The FDA also recommended that doctors consider remote monitoring for patients with the Riata leads in order to quickly catch electrical problems.
St. Jude Medical has also been ordered by the FDA to conduct a battery of new clinical studies to help the agency truly assess the problem. The medical device manufacturer will have to conduct a three-year postmarket surveillance study to look at the risks of premature insulation failure on not only the Riata and Riata ST ICD leads, but also the QuickFlex, QuickSite, Riata ST Optim and Durata leads as well.
A growing number of individuals throughout the United States are currently pursuing a St. Jude Riata lead lawsuit, after their leads failed due to the insulation problems. The complaints allege that St. Jude Medical failed to adequately research their product before marketing the defectively designed lead.