Millions of Americans have hip and knee implants, and in part thanks to aggressive marketing to younger consumers and aging baby boomers, demand for implant surgeries will only grow: The number of hip and knee replacement surgeries is expected to quadruple by 2030, reaching 4 million a year, and more than 50 percent of the patients getting them will be under age 65.
The younger the patient getting replacement surgery, the longer that person will need an implant to last. So one concern for younger people is that the vast majority of knee and hip implants are not backed by a manufacturer's warranty. Shouldn’t patients have the right to know how long medical device makers are willing to stand by their implants?
Consumers Union, the policy and advocacy arm of Consumer Reports, has called on hip and knee implant manufacturers to provide a warranty that would entitle patients to have defective devices replaced at no cost. Warranties would give patients a better understanding of how long an implant is expected to last and a clear process to follow in the event that it fails prematurely. Ultimately, warranties will encourage companies to make their devices safer and more durable.
When implants turn out be defective, the cost for additional surgery and a replacement device is now largely paid by patients or their insurance companies, including Medicare. Revision surgery costs more, results in longer hospital stays, and can often lead to additional surgeries. An estimated 18 percent of hip replacements and 8 percent of knee replacements in the U.S. are for revisions, and the cost for these procedures is likely in the hundreds of millions of dollars per year.
A Consumers Union review of recalls for hip implants (PDF) and knee implants (PDF) found that all major manufacturers have recalled a product or a line of products for defects over the last decade. One of the most troubling recent examples is the Johnson & Johnson ASR XL metal-on-metal hip implant, which was recalled after it was found that one in eight of the devices failed within five years in Australia, England, and Wales, where devices are tracked through national registries. Some patients also have experienced debilitating symptoms from metal debris that flakes off the device over time, including cardiomyopathy and neurological problems.
Unfortunately, most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the Food and Drug Administration. Instead, under current law, the companies simply have to demonstrate that the devices are “substantially equivalent” to a product already being sold. Since most new hip and knee implants are similar to ones already on the market, manufacturers are able to sell their products after clearance through the FDA’s fast track 510(k) clearance process without having to prove the device is safe and effective.
Consumers Union and other patient safety groups urged Congress to require more premarket testing of devices such as hip and knee implants during last year’s reauthorization of the Medical Device User Fee Act. But those efforts were blocked by the politically powerful medical device industry.
Have you had a hip or knee implant? We’d like to hear about your experience and your opinions on whether these devices should come with a warranty. To share your story or to find out more about Consumers Union’s medical implant warranty campaign, go to www.safepatientproject.org.