Companies charged with approving new medical devices in the European Union have unknowingly given their stamp of approval to a fake new metal-on-metal hip implant.
In an undercover investigation conducted by the British Medical Journal in conjunction with the U.K. news source The Telegraph, several companies hired to approve new medical devices for the E.U. approved plans for a fake hip implant based on completely bogus evidence, even evidence that included data on the serious risks of metal poisoning the implants posed to recipients.
The Changi TMH is the figment of the investigators’ imagination, mostly. The undercover investigation submitted plans to create this fake hip implant and that included using data and product descriptions from the failed DePuy Orthopaedics ASR XL all-metal hip implant. Using that description and fake clinical data that did include statistics on the high rates of metallosis the proposed fake device would pose, the Changi TMH was approved by several companies to be used in the E.U.
The E.U. routinely employs private firms to review safety data and applications for new medical devices. There are more than a dozen approved companies that can grant a new medical device access to the market in the E.U. This system has come under widespread criticism lately, mostly from the problems caused by the entire class of metal-on-metal hip implants, troubles that were first noted by the failings of the DePuy ASR hip implant.
DePuy, a division of Johnson & Johnson, issued a worldwide recall on the ASR and ASR XL hip implant after widespread reports of complications among recipients of the devices. A defective design and the risk of metallosis caused the adverse event reports that prompted the recall. This spurred thousands of other reports of problems associated with other metal-on-metal hip implants.
In the U.K., the problems with the defective metal hip implants eventually were pegged on a flawed medical device approval system as much as it was the defective designs of the devices. Calls in recent weeks for reforms to this system echo those heard in the U.S. when it was realized that nearly every metal-on-metal hip implant was approved through the domestic Food and Drug Administration’s so-called “fast track” approval system. This grants approvals to medical devices that mirror designs of previously-approved devices. It begs the question: would this fake hip implant conjured up by the U.K. investigators have passed through the FDA’s system?
The Euro investigation revealed that some of the 14 companies which were sought to approve the fake hip implant were more interested in “repeat business and making profits,” according to a report from British Medical Journal reporters. One Czech Republic company even touted to the investigators that it was “on the side of the manufacturer” and not with the patient when it approved the fake hip implant.