Since 2003, about 750,000 Americans have received metal-on-metal hips, which were supposed to last longer than devices made with ceramic and plastic, yet nearly 20 percent of the hip replacements done each year and 10 percent of the knee replacements are revisions, often done because the original device was defective.
Some patients have experienced debilitating symptoms from metal debris that flakes off the device over time, including heart damage and neurological problems. Follow-up surgeries tend to require longer hospital stays than the initial procedures, pose additional risks, and have a higher price tag, while their costs are passed onto consumers or their insurance companies, including Medicare.
An $8000 Price Tag without a Warranty
The average price for an artificial knee or hip is $8000 for the device alone. When defective implants have to be replaced, the cost for additional surgery and a new device is now largely paid by patients or their insurance companies, including Medicare. Revision surgeries cost more, result in longer hospital stays and can often lead to additional surgeries.
Consumer Union Petitions Implant Manufacturers
Consumers Union, the action arm of Consumer Reports, is petitioning hip and knee implant makers for a 20-year warranty on their products.
“Millions of patients are expected to undergo hip and knee replacement surgeries in the decades ahead,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project (www.safepatientproject.org). “Medical device makers should be willing to provide a warranty that spells out how long they will stand by their products and a process for getting it replaced at no cost if the implant turns out to be defective. A warranty would cover the full replacement cost of a failed device, and the device maker should continue to work with the patient and surgeon if the device fails.”
The Safe Patient Project has urged the makers of hip and knee implants, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc., and Zimmer Holdings Inc., to provide a warranty that:
- Covers the full cost of the revision surgery, including the device itself, the surgeon and hospital costs, and patient out-of-pocket costs
- Establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient
- Does not eliminate the patient’s right to sue if he or she uses a warranty
“Medical device makers should have the confidence to stand by their testing and marketing claims and offer warranties covering product defects,” said Ms. McGiffert. “Patients and their insurance companies shouldn’t have to foot the bill to replace defective devices.”