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Feature Medical Device Regulation

Faulty hip implant shows up failings of EU regulation

BMJ 2012; 345 doi: (Published 23 October 2012) Cite this as: BMJ 2012;345:e7163
  1. Deborah Cohen, investigations editor
  1. 1BMJ, London WC1H 9JR, UK
  1. dcohen{at}

Deborah Cohen describes an investigation showing how a fake hip prosthesis with dangerous design flaws stood to be approved for the EU market

A joint undercover investigation by the BMJ and the Daily Telegraph has exposed flaws in the EU system used to grant market access for devices such as replacement hips, cardiac defibrillators, and breast implants.

Deborah Cohen comments on the undercover video taken as part of the investigation.

The investigation involved submitting a fake application for a large diameter metal-on-metal total hip prosthesis for approval by a notified body in Slovakia—the commercial organisations charged with evaluating the safety and performance of medical devices across Europe by granting them a CE certificate.

The hip—whose specification was designed for the purposes of the investigation—had similar specifications to the DePuy ASR XL acetabular system—a device that has been recalled from the market after failing at unacceptable rates and releasing metal ions into patients’ blood.1 Nevertheless, last week the notified body provisionally allowed the product to go forward to certification.

One notified body authorised to certify products for medical use across Europe, has been secretly recorded admitting that it is “on the side of the manufacturer.”

Last night, Jeremy Hunt, the health secretary, said it was “completely unacceptable” that patient safety could be endangered by potentially dangerous implants.

“The safety of patients is paramount so it is completely unacceptable that patients could be subject to substandard implants,” he said. “I will ask the Medicines and Healthcare Products Regulatory Agency and British Orthopaedic Association what we can do to ensure that patients can be confident they will receive the highest quality of devices when they need …

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