A Superb Expose About an Unsafe Medical Device
Tony Saavedra and Courtney Perkes, reporters for The Orange County Register, deserve a laurel for their superb piece about harmful medical devices that have gravitated into widespread use with minimal oversight by the Food and Drug Administration, and without testing on humans. This is one of the best patient safety stories I’ve read in a long time.
What makes it so compelling is a blend of narrative, regulation, public policy, and business practices that should make any patient think twice before agreeing to invasive procedures without knowing about the risks, the materials used in the procedure, and how much, if any, clinical testing has been done.
In the story, we meet 58-year-old Laurie Kelly, who underwent breast cancer surgery at Hoag Hospital in a Newport Beach, California, two years ago. After doctors removed her tumor, they delivered a high dose of radiation to surrounding breast tissue; the idea was to eliminate six weeks of treatments. They protected healthy tissue against this high dose with something called the Axxent FlexiShield Mini, a malleable metal pad made of silicone-wrapped tungsten. Six months later a routine mammogram and MRI revealed tungsten particles from the shield had been driven into her breast during the procedure, and some of the metal later showed up in her urine. “Even though the day I had my surgery the cancer was removed, something potentially worse was put inside of me. It was the most frightening thing I ever heard,” Kelly told the paper. Eventually, fearing that the tungsten particles would make it hard to diagnose a cancer recurrence, she opted for a double mastectomy. The manufacturer—Xoft—voluntarily recalled the shield in February 2011 after the first two hospitals to use the shield, including Hoag, reported that a “metallic, powdery substance was found inside the breasts of ten women treated with the device.” The number of women with the powder in their breasts now totals 29. In a letter sent to hospitals, Xoft’s director of regulatory affairs said: “We have determined that the toxicity of these very pure tungsten particles is low as few health effects have been reported in humans.” Xoft and its parent company, iCAD, would not talk to the reporters.