It’s a novel idea that actually makes sense – the consumer group, Consumers Union, wants hip and knee implants to come with a warranty. In case a medical device fails the patient prematurely, the patient would not have to carry the burden of the costly revision surgery.
This idea is the brainchild of the Safe Patient Project, a campaign by Consumers Union. The group says at the present time, patients receiving implants have no assurances of their safety. Even a new car or big screen television comes with a warranty and when you consider that the devices are marketed under the U.S. Food and Drug Administrations’ 510(k) approval process, which is an approval for marketing without clinical trials, it’s even more necessary.
With thousands of failed metal-on-metal hip implants, patients not only lose a good deal of their hip, bone and muscle due to metal debris shavings, but they are also out thousands of dollars.
The warrantees would be sought from orthopedics giants, Biomet, Stryker, DePuy, and Wright Technologies. Biomet actually offers a form of guarantee which covers a single partial knee implant, according to the group.
Project director, Lisa McGiffet says “Patients have a right to know how long medical device manufacturers are willing to stand by their products.”
Clearly there are dual benefits to having a warranty over a medical device. Not only would it cover the very expensive costs of revision surgery, but it would encourage manufacturers to think about safety before they market a device knowing the real cost would be borne by the company if there is a failure. Otherwise, the burden falls on the patient, the hospital or in some cases, the taxpayer.
If medical device companies say warrantees are not necessary, how then do they explain the numerous recalls? With about 750,000 Americans receiving metal-on-metal hip implants, international registries have shown one in eight failed within five years. Knee implants have been subjected to recalls since 2003 because of missing or misfit parts or an early failure rate.
With an aging Baby Boomer population, hip and knee surgeries should increase to about 4 million in 2030 up from 1.2 million in 2011 in the U.S.
The 20-year warranty request is going out to consumers in the form of a sign-on letter and it will ask for full replacement cost of the failed device including payments to the hospital, doctor and to cover the cost of revision surgery. A medical device would have to be registered with the device company. Under the proposal, patients would not lose their right to file a defective product lawsuit, even if the product is covered under warranty.
If indeed the manufacturers offer no or low-risk hip and knee implants, they should have no problem offering a warranty to be held accountable to their word.