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.
The Register placed Kelly’s story in the larger context of the FDA’s regulation of medical devices and discussed five other examples of failed technology, ranging from a vaginal mesh to treat incontinence to faulty hip implants designed to last fifteen years but that sometimes failed after only two or three. It told how such devices are regulated under a 1976 law that’s supposed to provide quick approval of devices posing low and moderate risks, which allows manufacturers to sell them without human testing. The paper reported that this process “clears new inventions if they are ‘substantially equivalent’ to devices already on the market. But there is a lot of leeway in that rule.” The FlexiShield Mini, in fact, was approved based on another product made from a different metal.Sometimes, the Register reported, the FDA has approved devices that were similar to others that “proved faulty after their release.”
Saavedra and Perkes did a lot of reporting, and that showed in the quality of their work. Peter Barton Hutt, the FDA lawyer who helped write the 1976 law, told the paper “there’s no proof that it is a broken system. I’ve yet to hear anybody suggest a better approach. Any system run by human beings is going to occasionally misfire.” That’s little comfort to victims injured by faulty devices, and reporters probed further. They talked to a retired medical professor who headed a recent Institute of Medicine study critical of the FDA approval process. He said that Congress expected that eventually most devices would be new and subject to the highest level of scrutiny, and that the current process would be phased out. “What happened,” he said, “industry, with the help of Congress, has kept this more convenient clearance process in place.”
The reporters examined legal records—yes, there have been lawsuits. And they looked at government reports like the one from the Government Accountability Office, which revealed that too many devices were going via the fast-track process when they required more intense testing. They talked to consumer advocates. Lisa McGiffert who heads a patient safety project at Consumers Union, observed: “The industry keeps saying we’re going to stifle innovation, but it’s not innovative if it’s not safe and does not work.”