Tens of thousands of patients are stuck in the difficult situation of hearing about a defective medical device — such as a hip implant, knee implant — but not knowing which product they had implanted during a recent surgery. When a medical device is recalled, how should patients react? And how can they find out which implant is inside of them?
Beginning in 2014, some medical devices used in the United States will begin to carry a unique device identifier (UDI) that will allow patients, health care providers, manufacturers and federal regulators to track each device. With the new program, problems could be identified more quickly and recalled products could be tracked down and handled efficiently. Patients could rest more securely because they would be able to identify which product was used in their surgery. Patient information would not be attached to the UDI. By 2018 or thereafter, every medical device could be required to carry a UDI.
For now, patients who have a problematic implant should first try to secure their medical records. If that doesn’t work, a qualified attorney can provide counsel.
WARSAW, Ind. — Michael Shopenn’s artificial hip was made by a company based in this remote town, a global center of joint manufacturing. But he had to fly to Europe to have it installed.
Mr. Shopenn, 67, an architectural photographer and avid snowboarder, had been in such pain from arthritis that he could not stand long enough to make coffee, let alone work. He had health insurance, but it would not cover a joint replacement because his degenerative disease was related to an old sports injury, thus considered a pre-existing condition. As you read this article, please share your experiences by responding to the questions that appear. I will write a follow-up article about your responses on Monday, Aug. 5, and they will inspire future articles in this series.— Elisabeth Rosenthal, Reporter
Desperate to find an affordable solution, he reached out to a sailing buddy with friends at a medical device manufacturer, which arranged to provide his local hospital with an implant at what was described as the “list price” of $13,000, with no markup. But when the hospital’s finance office estimated that the hospital charges would run another $65,000, not including the surgeon’s fee, he knew he had to think outside the box, and outside the country.
“That was a third of my savings at the time,” Mr. Shopenn said recently from the living room of his condo in Boulder, Colo. “It wasn’t happening.”
“Very leery” of going to a developing country like India or Thailand, which both draw so-called medical tourists, he ultimately chose to have his hip replaced in 2007 at a private hospital outside Brussels for $13,660. That price included not only a hip joint, made by Warsaw-based Zimmer Holdings, but also all doctors’ fees, operating room charges, crutches, medicine, a hospital room for five days, a week in rehab and a round-trip ticket from America.