Consumers Union Seeks 'Lemon Law' Protection for Hip and Knee Implant RecipientsSep 11, 2013
Given that some 20 percent of hip replacement surgeries and 10 percent of knee replacement surgeries are revision surgeries—procedures to remove defective devices—Consumers Union suggests the implementation of a lemon law similar to what is in place for defective motor vehicles.
Revision surgeries are more complex, riskier, costlier, and require longer healing times and, as Consumers Union notes, involve longer hospital stays. Despite that, revision surgeries are typically performed to remove a faulty device, with the costs assumed by consumers and insurers, even Medicare.
Consumers Union, the policy arm of Consumer Reports, said that device makers should provide consumers with warranties and guarantees that they will replace these hip and knee implants at no cost. According to Consumers Union, these measures might induce device makers to create safer, more durable medical devices.
“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 a warranty,” said Lisa McGiffert, director of Consumers Unions’ Safe Patient Project. The Project recently collected U.S. Food and Drug Administration (FDA) data on hip and knee implant recalls over the past decade and discovered that every major manufacturer issued a recall over a product or a product line; some involved products tied to significant risks, according to Consumers Union.
Since 2003, about 750,000 Americans have been implanted with metal-on-metal hips, which were developed for increased durability and longevity and with the intention that the seemingly stronger parts would be far superior over their more traditional counterparts, made with plastic or ceramic elements. Research has tied metal-on-metal hip devices, such as DePuy Orthopaedic’s ASR, to adverse events that include tissue necrosis, pain at the implant site that may spread to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and fluid collection/solid masses around the hip joint. The issue appears to be with the metal used in these implants, which were touted to last for at least two decades.
“Knee implants have not failed as often or as dangerously, but the Safe Patient analysis found that hundreds of knee-implant components have been recalled since 2003, often because they were shipped with the wrong part, a wrong-size part, a missing part, or a part built for the left side etched as a right, or vice versa…. most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the FDA. 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 can gain approval through the FDA’s fast track 510(k) clearance process without having to prove the device is safe and effective.
“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” said McGiffert. “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,” McGiffert added.
The Safe Patient urges hip and knee implant makers—Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc., and Zimmer Holdings Inc.—to provide a 20-year warranty for the full cost of revision surgery (device, surgeon and hospital costs, patient out-of-pocket costs); establish a clear system for patients (toll-free phone line, registration number for claims process tracking, with physicians charging device makers); and provide patients with the right to sue regardless of their use of a warranty.