Companies responsible for approving new medical devices in the E.U 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 UK Newspaper, the Telegraph, several companies hired to approve new medical devices for the E.U approved a fake hip implant based on completely false evidence, including evidence that consisted of data on the serious risks of metal poisoning the implants posed to recipients.
The Changi TMH was the fake hip implant that the under-cover investigators submitted which 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 included statistics on the high rates of metallosis the proposed fake device would pose, device was approved by several companies to be used in the E.U.
The E.U routinely employs 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 wide spread 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.
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 in the British medical journal.