There are several items that come with a warranty these days. Whether it’s a computer, a car or a phone, manufacturers tend to supply consumers with a warranty in case a product turns out faulty. It is a common and fair practice for most of our purchases, yet body implants do not seem to have this type of insurance from a majority of it’s makers.
According to the Consumers Union, millions of Americans have hip or knee implants. More than 700,000 knee replacements and reconstructions were performed by doctors in 2011. Over 460,000 hip replacement surgeries were performed in that same year. It is projected that the demand for these replacement procedures could reach up to 4 million a year by 2030.
Consumers Union has initiated Safe Patient Project, a campaign dedicated to patient safety issues. Among their projects, the organization has been working extensively on getting hip and knee implant manufacturers to provide consumers with substantial warranties for their products. In an interview with the Director for Safe Patient Project, Lisa McGiffert shares why consumers need their hip and knee implants warranted.
Patients Don’t Know The Longevity Of The Implant
“It is good business practice to provide a period of time when you are willing to replace the product if it’s defective in some way,” said McGiffert. “With these particular products it is much more delicate because they are actually inside people’s bodies…When you discover problems, something invasive has to happen to fix it. That is why we are asking [manufacturers] to cover parts and labor.”
Consumers Union reports that almost 18 percent of hip replacement and 8 percent of knee replacement surgeries in the United States are for revisions. It is estimated that the costs for these procedures are hundreds of millions of dollars a year. McGiffert added that the costs fall onto patients, Medicare, and health insurance companies. “We don’t think that’s fair,” said McGiffert. “If the manufacturers of a hip or knee have put a defective product on the market, we think they should bear the costs of righting that problem not third parties.”
The Approval Process Needs Work
Hip and knee replacements are not subjected to the same rigorous pre-market testing that prescription drugs do. For medical devices, the U.S. Food and Drug Administration is not required to review a product for safety if the product is proven to be similar to another product already on the market – a procedure that is also known as a 510(k) clearance process.
“The law does not require them to demonstrate any clinical evidence for safety,” said McGiffert. “That is, they can be tested without being put into body parts. So a simulated test can be done for approval.”
In a U.S. Government Accountability survey, it was found that nearly 90 percent of the devices that were recalled between 2005-2009 were approved through the 510(k) clearance process. In addition, McGiffert added that the FDA is sometimes limited as to what questions they can ask companies about the product.
There’s No Standardized Way To Trace Implant Performance
Since the FDA does not primarily rely on pre-market safety testing for these products, that means they have to rely on post-market reporting to find out if there is a problem with a medical device. Consumers Union found that the FDA uses a system called Medwatch, where doctors and patients report the problems they are having with implants.
“There is a very fragmented system of collecting information about problems. There’s work being done to try to create a national network that would track these problems, but right now most doctors and patients are pretty clueless as to what the history or record of an implant is,” said McGiffert.
Too Many Recalls
A recent report by the FDA found that medical device recalls nearly doubled between 2003 and 2012, stated an article in the Wall Street Journal. Consumers Union also reports hundreds of knee implant recalls since 2003. A majority of the time, the knee devices were recalled due to a wrong size, wrong part, or even a missing part.
Moreover, metal on metal hip implants have caused thousands of health problems among patients in the past. As early as 2010, there was a recall of over 90,000 metal hip implants in the U.S.
“For the consumer right now they’re kind of in limbo. They talk to their doctor, the doctor might get a response from the company, they might not. There’s really no set process, and having a warranty will create a process for the patient,” said McGiffert. “…having a warranty would give everyone an option to have the part replaced if it’s defective.”