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Joint Implant Makers Rarely Foot the Bill When a Device Fails

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The makers of artificial joints don’t guarantee or provide warranties for their products. When artificial joints fail due to a defect, the manufacturers generally won’t pay for revision surgeries. Even worse, some device makers may actually profit when an implant fails. In many cases, the manufacturer of the defective implant provides the replacement – at full price.

According to The New York Times, when a device fails, the cost is borne by Medicare (i.e. the taxpayer), insurance companies and even the patient. At about $15,000 per implant, the cost to the healthcare system is huge, even if only a small percentage of implants fail because of a defect.

Arthur Levin, the executive director of the consumer advocacy group Center for Medical Consumers, told the time that the lack of warranties for joint implants borders on unethical behavior. “Either they do not have faith in their products, or they are just saying tough luck to patients,” Levin said.

An artificial hip or knee should last about 15 years. But sometimes, design defects or other problems cause a device to fail early. Just last month, for example, DePuy Orthopaedics, a unit of Johnson & Johnson, warned that its ASR artificial hip implant appears to have a high early failure rate in some patients. The warning from DePuy followed more than two years of reports that the device was failing in patients only a few years after implant, requiring costly and painful replacement operations. Since 2008, the Food & Drug Administration (FDA) has received about 300 reports of early replacement operations involving the ASR device.

DePuy said in a statement that while it does not guarantee its devices with product warranties, it does “evaluate and address all complaints and issues on a case-by-case basis and take actions based on the specific circumstances.”

An official with implant maker Zimmer Holdings told the Times that that the success or failure of a joint implant depends on too many factors – including a surgeon’s skill, a patient’s weight and a patient’s adherence to postoperative restrictions on activity – factors that are not under the manufacturer’s control. This, according to the official, makes offering warranties impossible.

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