An artificial joint registry will soon be implemented to track hip implants and knee replacement surgeries performed in the United States every year, the Wall Street Journal just reported.
The American Joint Replacement Registryâ€™s purpose is to reveal implant issues sooner, which could lead to more recalls, said the Journal, noting that device makers are in favor of the registry and have even contributed to â€œstart-upâ€ financing. Manufacturersâ€™ motivation isnâ€™t purely altruistic. They might be able to avoid some future mandates; stave off some costs associated with recallsâ€”no small issue in an industry estimated at $12 billion dollars; and learn more about product durability as emerging, expensive devices will have to be justified via comparison and efficacy testing, said the Journal.
The registry originates from the American Academy of Orthopaedic Surgeons and is slated to initiate this month as a pilot involving 15 hospitals that will track general information on â€œpatients, doctors, hospitals, and implants,â€ said the Journal. Expansion is expected to occur next summer while officials with the registry determine how data will be reported and how the registry will be funded.
Some see flaws, including that data access and use have not been fully firmed up, said the Journal. For instance, information is given in the form of â€œraw dataâ€ meant to point out potential problems; however, some worry that insurers could use information to minimize coverage, said the Journal, noting that there are concerns that the information could also be used in lawsuits or for marketing â€œwithout appropriate context.â€
The devices require US Food and Drug Administration (FDA) approval; however, a nationwide registry does not exist that tracks long-term effects for those implanted, said the Journal. The registryâ€™s goal is to find cases in which devices and device parts wear out or are defective, causing patients to undergo repeat surgery, noted the Journal.
Replacement joints have been making headlines over a variety of issues related to defective devices. For instance, we recently wrote that a prominent surgeon who was once a consultant for Zimmer Holdings, a maker of surgical tools and joint replacements, believes Zimmer terminated its relationship with him because he questioned the performance of one of its artificial knee components. According to The New York Times previously, Dr. Richard A. Berger alleged that a version of Zimmerâ€™s NexGen CR-Flex Porous Femoral Component is prone to premature failure.
We also just wrote that beleaguered pharmaceutical giant, Johnson & Johnson (J&J), issued the DePuy recall recently through its artificial joint business, DePuy Orthopaedics Inc., just one of many such device recalls issued by a number of manufacturers.
In June we wrote that some orthopedic surgeons were souring on metal-on-metal hip implants. A survey at that time found that a significant number said they planned to reduce their use of the devices. Hip implants should last about 15 years; however, a New York Times investigation published earlier this year found that, in many cases, metal-on-metal hip implants require replacement surgery within a year or two.
Meanwhile, according to a New York Times investigation, some device makers may actually profit when an implant fails. Often, the manufacturer of the defective implant provides the replacementâ€”at full price. Worse, the million or so artificial hips and knees implanted annually in the US donâ€™t come with a guarantee or warranty. Instead the Times said, when a device fails, the cost is borne by Medicare (i.e. the taxpayer), insurance companies, and even the patient. At about $15,000 per implant, the cost to the healthcare system is huge, even if only a small percentage of implants fail because of a defect. The lack of warranties for joint implants is unusual. Other implant makers have issued warranties for more than 30 years and have provided free or discounted replacements when devices fail prematurely, the Times said.