Approximately 20 percent of hip replacement surgeries and 10 percent of knee replacement surgeries are revision surgeries, which means surgeries are being conducted to remove defective devices from patients’ bodies. These disturbing data have prompted Consumers Union to suggest implementation of a lemon law, similar to what is in place for defective motor vehicles, for defective hip and knee implant devices
Revision surgeries are more complex, more expensive procedures that are riskier and require longer healing times and, as Consumers Union points out, involve longer hospital stays. Despite that revision surgeries are typically performed to remove a device maker’s faulty device, the costs are assumed, not by the device maker, but by consumers and insurers, such as Medicare.
Consumers Union, the policy arm of Consumer Reports, said that device makers should be made to provide consumers with warranties and guarantees that indicate that device makers would be responsible for replacing hips and knees at no cost to consumers. Consumers Union stated that these measures might encourage 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 Union’s Safe Patient Project. The Project recently gathered U.S. Food and Drug Administration (FDA) information on hip and knee implant recalls over the past 10 years and learned that each major manufacturer has issued a recall over a product or a product line. In some cases, products were associated with significant risks, according to Consumers Union.
Since 2003, some 750,000 Americans have been implanted with metal-on-metal hips, which were developed for greater durability and longevity and with the objective that the seemingly stronger parts would be far superior over their more traditional counterparts that were constructed with plastic or ceramic elements. Research has tied metal-on-metal hip devices, such as DePuy Orthopaedic’s ASR, to adverse events such as 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 with devices appears to be with the metal used in these implants, which were hyped 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.
Safe Patient urges hip and knee implant makers such as Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc., and Zimmer Holdings Inc., for example to:
- Provide a 20-year warranty for the full cost of revision surgery: Device, surgeon and hospital costs, and patient out-of-pocket costs;
- Establish a clear system for patients: toll-free telephone line, registration number for claims process tracking, and with physicians charging device makers; and
- Provide patients with the right to sue regardless if they choose to use the proposed warranty.