About 76,000 people implanted with St. Jude Medical's ($STJ) Riata defibrillator lead remain in limbo, three months after the FDA recalled the wire over electrical failure-related safety concerns. The Minneapolis Star Tribune reports on the little-discussed reality about recalls that explains why: Recalls can't take back implants already inside patients.
Interestingly, doctors and patients still aren't sure what to do about it. The key concern here is that it's difficult and risky to remove implantable medical devices such as defibrillators, according to the article.
Figuring out what to do was enough of a concern that Abbott Northwestern Hospital cardiologist Dr. Robert Hauser conducted a Riata summit in late January, along with the Mayo Clinic's Dr. David Hayes. Doctors "are ill-prepared to counsel our patients because we do not have the clinical evidence to support any recommendations," Hauser explains, as quoted by the Star Tribune.
So far, St. Jude has said it needs more information. It is running an ongoing evaluation of 500-plus patients in the U.S., Canada and Japan, according to the article. St. Jude also has told doctors to monitor their Riata patients. If they see any evidence that the lead is in electrical failure, they're urged to use X-rays or fluoroscopy.
Doctors have two options if the electrical failure takes place, the article notes. They can disconnect the lead but leave it and insert new wires next to the malfunctioning ones. Surgical removal is possible--but challenging--because the cable can be concealed by scar tissue, and the procedure can damage the heart.
The FDA issued its recall following problems dating back to 2010. That's when St. Jude reported that 15% of 212 patients in Ireland who received the Riata defibrillator lead faced an "insulation breach" that could interfere with the device. Unfortunately, patients may not have any idea of the problems occurring inside their bodies, according to the story.
- read the Star Tribune story