Most manufacturers of new cars, refrigerators, computers and other expensive items offer consumers some kind of money-back warranty.
But that’s not true for the manufacturers of knee and hip implants, even though those devices cost thousands of dollars each and have been subject to many recalls.
Consumers Union, the organization that publishes Consumer Reports magazine, wants this situation to change. This week it has launched a new campaign to urge the manufacturers of hip and knee devices to warranty their products “so consumers have clear actions to take if their implants fail.”
“Patients have a right to know how long medical device manufacturers are willing to stand by their products,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project in a press statement. “While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty.”
Warranties are especially important given the increasing number of Americans who are undergoing hip and knee implant surgery. There were 1.2 million such procedures in the U.S. in 2012 — a figure that is expected to quadruple over the next two decades as baby boomers age.
Furthermore, these surgeries are no longer just for the elderly. The number of Americans between the ages of 45 and 64 who underwent knee-replacement surgery tripled during the first decade of this century.
As Consumers Union notes, “it is critical for manufacturers to tell consumers who are considering an implant how long these joints will last so they can factor in the revision [surgery] equation — how long will I live and how long will this implant last?”
A warranty would help consumers do that, the organization says.
Equal to the price of a car
The cost of an artificial hip or knee rivals that of a new car. Hip implant surgery in the United States costs $19,000, on average, and knee replacement surgery costs $17,500, according to Consumers Union. Up to half of that price tag is for the implant itself, they add.
Surgery to replace a failed hip or knee implant with a new one is even more expensive: an average of around $25,000, according to Consumers Union.
“As more Baby Boomers get implants, as well as revision surgeries for failed products, joint replacements could make up a significant percentage of all Medicare spending,” the organization notes.
(The Consumers Union numbers seem conservative compared to those cited elsewhere, including in an “NBC Nightly News” story on knee-replacement surgery broadcast last month. In that report, NBC’s physician-reporter Dr. Nancy Snyderman said the cost of a total knee replacement procedure ranged from $23,000 to $70,000, depending on the patient’s age, health and location.)
More than 1,000 recalls over 10 years
About 18 percent of hip replacements and about 8 percent of knee replacements in the U.S. are for revision surgery resulting from defective or failed devices.
The six best-selling hip and knee implant companies collectively issued 1,334 recalls for components of their devices over the past 10 years.
During last year’s reauthorization of the Medical Device User Fee and Modernization Act, the Consumers Union, along with other consumer-advocacy groups, tried to get Congress to require medical device manufacturers, including those making hip and knee implants, to provide evidence that a new product is safe and effective before it goes on the market.
But the medical-device industry successfully blocked those efforts. Under current law, manufacturers only need to show that their new medical device is similar to one already on the market.
As a result, more than 90 percent of devices are cleared without safety testing.
“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” said McGiffert. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when the fail.”
You can read more about Consumers Union’s new device-warranty project on the organization’s website.