In an industry analysis forecast report, the global hip replacement market has been estimated to expand at a compound annual growth rate of 4.1 percent between now and 2024, which is about $9.1 billion.
The number of incidences of arthritis, hip fractures, and hip bone infection, which increase demand for hip replacements, as well as the development of new hip implants using new methods such as 3D printing technology are responsible for the rapid growth of the hip replacement market.
Despite the positive growth, however, around 578 hip implant products were recalled from 2002 to 2013, including metal-on-metal hips, per the U.S. Food and Drug Administration (FDA). The agency warns that faulty or less effective devices can lead patients to experience serious adverse health consequences or death.
Metal-on-metal hip designs, made primarily of cobalt and chromium alloy have been under fire in recent years for their design, resulting in thousands of lawsuits. In the multidistrict litigation (MDL) against DePuy, patients are alleging that the manufacturer pushed the metal-on-metal design “aggressively,” despite knowing that the design was riskier than others that were available.
The MDL also alleges that DePuy even paid kickbacks to surgeons for encouraging the use of its hip implant, selling 150,000 of them in the 2000s. The hip device evaded standard regulatory review by going through a 510(k) FDA approval, which allows a device to be sold on the market as long as it is similar to a model previously sold. In one case the similar model that provided the fast-track FDA approval was one that predated 1976 regulations regarding premarket review and approval.
Patients who have received this type of hip have complained of loosening, bone erosion, damage to surrounding tissue, and metallosis, a dangerous blood condition that occurs when metal bits flake off the device and pollute the bloodstream. In some patients, the metal wear has resulted in cobalt poisoning, with symptoms including blindness, deafness, numbness of the hands and feet, and weakness that have forced them to be wheelchair bound.