Faulty medical implants investigation: Patients’ health put at risk by unscrupulous EU regulators
British patients’ health is being put at risk by unscrupulous European regulators who are prepared to license potentially dangerous medical implants for sale in this country, The Telegraph discloses.
The investigation involved submitting a formal application for a “metal-on-metal” implant for approval in Slovakia.
The official regulatory body there last week offered provisional approval for the design of the artificial hip, despite the specifications being similar to a product that had been withdrawn in the UK, America, Australia and other developed nations outside Europe.
Another regulatory organisation in the Czech Republic, ITC, was also prepared to consider licensing the product. One representative of ITC told reporters that his company would not put “obstacles” in the way and said it was “on the side of the manufacturer and their products, not on the side of the patients”.
The disclosure raises serious questions over the safeguards for British patients. Licensing of medical devices and surgical implants is Europe-wide and regulators in this country refuse to disclose where products have been approved.
More than 70 private regulators compete for business, leaving the system susceptible to corrupt practices, such as those uncovered during the PIP breast implant scandal earlier this year. It works in the same way as licensing of household appliances and toys rather than the far more rigorous system for drugs.
Medical experts last night demanded an urgent review to prevent another “inevitable” scandal.
Dr Carl Heneghan, of Oxford University, who provided advice on the investigation, said: “Device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is substandard, and individuals supposedly representing the regulatory system are conflicted and in many cases underqualified.”
Reporters purporting to represent a Chinese company contacted the regulatory organisations – known as notified bodies – about approving a hip implant for the European market.
The proposed product was a metal-on-metal total hip implant made from chromium cobalt. Experts said it should have been rejected immediately because of concerns that these products have a high failure rate and pose a risk of metal ions being deposited in the bloodstream. But some regulators said clinical studies would not be necessary since similar implants were already on the market.
The reporters submitted a detailed technical dossier to a notified body in Slovakia. The firm is only supposed to approve or reject a product, but it appeared willing to give advice while its fee depended on passing the implant. At a meeting in northern Slovakia, Peter Luley, a representative of EVPU, said that they could not give “exact advice”. But he added: “We just cross the line and say just do this and it will be OK. Therefore we have so high rate of successful certification [sic].”
The cost of approval would be €2,750 (£2,240), with half paid up front. A colleague, Lubica Skrovanova, said that only four applications had failed in five years.
The Telegraph and BMJ submitted a dossier explicitly based on the DePuy ASR XL Acetabular System, which surgeons are no longer allowed to use in Britain and that is subject to legal complaints worldwide. But Miss Skrovanova indicated she would provisionally approve the fake implant. The technical file included a test report which said that it had performed badly in tests to assess “wear”.
Once the contract was signed and payment made, EVPU emailed their comments. They noted that some sections of the dossier were missing but the pages detailing the “product” features and “principle features of the device” were described as “OK”.
Miss Skrovanova said the fictional company needed to submit documents relating to the manufacturing process for final approval and the licence to be issued. But these were not related to the design specifications.
At ETI/Szutest in Brno, Czech Republic, an executive admitted that the system was riddled with problems. Michael Bauer said: “When I have seen some certificates issued for some products, it was horrible.” He added: “I have seen some notified body… that certified some product that, well, was from South Korea and the product was completely different …And it caused here in Czech Republic some issue and it [caused] some injury.”
EVPU declined to comment.
ITC said that they “comply in full accordance with the law” and that in the last 10 years they had “seen serious problems in practice and medical devices”.
ETI/Szutest said that their organisation “fully complies” with EU procedures and the meeting was “merely an introductory session before commencement of the contract”. It said that even had they accepted the order, it would not have guaranteed success. It said that Mr Bauer’s statements were “entirely his personal opinion”.