It may be tough to view a hip or knee replacement in the same light as a car, appliance, or piece of expensive technology. In many cases, if one of these items breaks or has a defect, a consumer can utilize a contractual warranty to get some or all of their money back or even replace the product at minimal cost.
Patients implanted with artificial knees or hips, however, have no such options available in the event their implant should fail or be recalled. One consumer activist group wants to change this by having implant manufacturers stand by their products—in writing.
Through a new campaign called the “Safe Patient Project,” Consumers Union, the group responsible for publishing Consumer Reports, has suggested artificial hip and knee manufacturers offer warranties on their products so that “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,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in a press statement published by the Consumerist. “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 warranty.”
If the Safe Patient Project is successful, hip and knee manufacturers will have to stand by the quality of their products for at least 20 years, a number that may be frightening to some companies considering the increasing number of worldwide recalls and baby boomers who may need hip and knee replacements in the near future. By some experts’ estimates, the demand for hip and knee replacement surgeries could surpass four million a year by 2030, with more than half of those patients under 65 years old.
The sheer number—1.2 million surgeries in 2011 alone—and cost of artificial hip and knee implant procedures and recalls in recent years—as well as the hundreds of millions of dollars America’s healthcare system spends on corrective surgeries—is staggering. On average, according to a MinnPost article detailing the issue, the average cost of hip and knee replacement surgeries is $19,000 and $17,500, respectively, with half of those prices covering only the cost of the implant itself. Corrective surgery, according to Consumers Union, can average roughly $25,000. Those prices, when added to the costs accumulated by the thousands of recalls issued by the six top-selling hip and knee implant manufacturers over the past decade, the report continues, create major financial burdens for both taxpayers and patients.
Current regulations require medical device manufacturers to merely show new products are similar to ones already on the market. Although Congress attempted to create legislation that would mandate medical device companies provide firm evidence that new products are safe and effective before being granted federal approval, the industry blocked the law from being passed. Because of this, according to MinnPost, more than 90 percent of medical devices, including artificial knees and hips, are cleared for sale without safety testing.
McGiffert feels, however, that if medical device manufacturers truly feel their products pose no harm, then they should have no problem putting it in writing.
“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” McGiffert said. “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 they fail.”
To date, only Biomet offers patients a warranty covering just one partial knee implant. In addition to Biomet, Consumers Union has sent letters to DePuy Synthes, Smith & Nephew, Zimmer Holdings Inc., Wright Medical Technology, Inc., and Stryker, among others, urging the companies to provide a 20-year warranty with each of their hip and knee products.