The U.S. Food and Drug Administration says patients who received Johnson & Johnson’s all-metal hip replacements need more frequent testing, according to Bloomberg.
In light of almost 16,800 reports of problems with all-metal hip implants since 2000, federal regulators hope that precaution will help prevent risky replacement surgery for some recipients. The FDA recommendation was part of a report advising members of a panel discussing the devices this week.
According to the report, panel members should consider when and how patients should undergo imaging and ion testing to measure the metal’s effect on surrounding tissue, given the implants’ tendency to break down altogether and shed toxic metal debris.
The “metal-on-metal” implants – which include both a ball and socket covered with cobalt and chromium – were initially introduced as an ostensibly more durable model than plastic and ceramic models already on the market.
In 2010, Johnson & Johnson division DePuy Orthopaedics recalled the models because of their high early failure rate, but plaintiffs have filed more than 6,000 lawsuits in federal and state courts. Among the complaints are allegations that Johnson & Johnson knowingly marketed the implants despite being aware of their problems, and that regulators initially approved them without adequate testing through a federal loophole.
Bloomberg cites an FDA document stating that adverse event reports in 2011 totaled 12,137 for the metal-on-metal devices, compared with 6,332 associated with other types of hip implants. The most- reported side effect was revision, or surgery to remove or replace the implant.
FDA staff also found higher rates of revisions for metal implants during a review of U.S. and domestic registries, Bloomberg reports. The national registry in England and Wales found the rate of replacement surgeries after five years for metal-on-metal implants was 6.2 percent, or almost three times as high as other versions. And a registry of implant procedures in Minneapolis and St. Paul found metal-on-metal systems were associated with a four-times higher occurrence of revision surgeries than metal and polyethylene.
If you’ve received an all-metal hip implant, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with a DePuy hip lawyer familiar with the case to discuss your legal rights.
See the Bloomberg story here: