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ICIJ Investigation Identifies Concerns With Medical Device Industry

Group Action Lawyers Highlight Problems Faced By 1000s Of Patients

26.11.2018

Dave Grimshaw, Press Officer | 0114 274 4397

Leading Group Actions lawyers representing hundreds of patients affected by defective products have welcomed an international investigation into the use of medical implants.

The International Consortium of Investigative Journalists (ICIJ) has carried out a global investigation into the medical device industry and the system of regulation. More than 250 journalists across 36 different countries were involved in analysis more than eight million documents including death and injury reports and recall notices. The information was obtained through more than 1500 freedom of information requests. 

The investigation by the ICIJ covers how medical devices are tested, approved, marketed and monitored and saw a series of articles published this weekend in key news outlets in the UK including The Guardian, Irish Times and on the BBC.

Irwin Mitchell has been highlighting the need for more stringent testing for years under the banner of its #SafetyAsStandard campaign. Specialist lawyers at the firm represent hundreds of patients affected by defective medical products.

Expert Opinion
“This is a significant investigation which asks important questions about the medical device market and the way it is regulated across the globe.

“The ICIJ conclude, and we agree that the system for testing and approving medical devices is currently inadequate. The requirement for clinical trials of new devices is very much less stringent than that for pharmaceuticals which simply doesn’t make sense for complex implantable devices like prosthetic joints or pacemakers. These devices have the potential to cause serious harm or death in the event of failure, and should be subject to far more extensive testing before they are released for use.

“At Irwin Mitchell we have been saying for some time that the CE mark system involves a fundamental conflict of interest, in which the business of the ‘notified bodies’ designated to provide marketing approval for medical devices depends upon provision of approval at the best price. Effectively, these notified bodies compete with each other to award approval to manufacturers. A stronger and safer system would see an independent body put in place to manage the suitability and safety of medical devices.

"The ICIJ should be applauded for their work on this subject, and for their contribution to making medical devices safer for all of us."
Matthew Newbould, Associate Solicitor

BBC Panorama will broadcast “The Great Implant Scandal” tonight at 8.30pm.

Read more about Irwin Mitchell's expertise in product liability cases.