Even though few patients - about 120 across the country - have had St. Jude's newest artificial heart-related component implanted since it was released in early 2013, this latest recall of a mass-market heart implant part has patients around the country on edge.
This recall involves a particular type of "patch" used to close an opening between the two upper chambers of the heart associated with particular types of heart conditions and physiological anomalies. The device is known as the Amplatzer TorqVue FX Delivery System, and apparently has the potential to fracture after implantation. Doctors are being asked to remove the components from their inventory and use older-model parts instead, since those have a different design.
It is entirely possible that the latest recall might not be getting national attention but for the high-profile recall of another heart device implant piece in recent years, particularly the heart defibrillator leads manufactured by St. Jude medical and sold under the trade name Riata.
Riata defibrillator leads
St. Jude Medical first recalled the Riata defibrillator wires in November 2011 after evidence showed that the leads were malfunctioning in some patients. The U.S. Food and Drug Administration (FDA), the federal agency tasked with ensuring the safety of medical devices across the country classified the initial Riata lead recall as a "Class One" recall, the most serious type. The FDA has required St. Jude to study the safety of already-implanted lead wires since 2008, and is requiring a stepped-up inquiry into potential dangers through 2015.
The medical-device defect that became apparent in the St. Jude leads is that the wires can cut through their surrounding silicon insulation, after which the electrical shocks may not be delivered at the right times to hearts, or may not be produced at all, a potentially fatal malfunction. The problem has been dubbed "inside-out abrasion."
According to The Wall Street Journal, which did an in-depth article on the recall in October 2012, the problem had been showing up in patients as far back as late 2005. Some critics say the manufacturer should have publicized the problem earlier. Apparently, some doctors and some company representatives originally thought the wire failures were isolated events.
The article reports that about 80,000 people in the U.S. still have the recalled leads implanted in their bodies, and that St. Jude released a study in July 2012 that found about one-fifth of Riata patients' X-rays revealed the presence of the wire abrasion problem.
Dangerous and costly
Surgery to replace a defective heart implant component can be dangerous and very expensive. The product's warranty and insurance may cover some costs, but patients are still incurring additional personal expenses like travel and lodging in their quests for appropriate medical follow up, sometimes under the care of doctors with more experience in surgical lead removal. Reportedly, St. Jude Medical is sometimes agreeing to cover a portion of these added expenses on a case-by-case basis.
If you or a family member is concerned about or has been harmed by a dangerous implanted defibrillator lead - or any other faulty medical device or drug - talk to an experienced product liability attorney about your legal rights and potential remedies.