Amid growing reports of serious health complications, federal authorities have ordered manufacturers of a type of artificial hip to conduct follow-up safety studies of the devices.
As The New York Times reports, the action by the Food and Drug Administration applies to 21 manufacturers of “metal-on-metal” hips. For the agency it is an unusually broad step to take against a category of products already on the market.
The hips sometimes shed metal particles, which can cause tissue damage. The FDA has warned that metal ions also can enter the bloodstream of patients with the hip replacements. The agency notes that, in rare instances, patients with high levels of metal ions in the bloodstream reportedly have developed heart, nervous system or thyroid gland problems.
Officials from the FDA, which issued the order in a letter to manufacturers on Friday, said that the studies are intended to provide better information about the failure rates and the health risks posed by the devices.
As Bloomberg reports, problems with the metal-on-metal hips have prompted recalls and more than 1,000 lawsuits against a leading manufacturer of the devices, Johnson & Johnson.
The 21 manufacturers that received the FDA order have 30 days to present the the agency with their plans for follow-up safety studies.
The metal-on-metal hip replacements used to account for roughly a third of the 250,000 or so hip replacement procedures performed in the U.S. every year. However, as reports of complications have grown more widespread, doctors increasingly have sought alternatives over the past two years.
The evidence against the apparatus has continued to mount. According to a March report from the British Orthopaedic Association, one particular model of a Johnson & Johnson hip was projected to fail in 50 percent of patients receiving the device within six years. Among metal-on-metal hips overall, the association estimated that the failure rate was 12 to 15 percent after five years of use, far higher than expected.
The dust-up over hip replacements also has renewed questions about the adequacy of the FDA’s procedures for evaluating the safety of medical devices before they are approved, as well as how safety is monitored for devices after they go on the market.