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Medical devices probe uncovers need for “drastic regulatory changes”

Report uncovers lax European regulatory system for medical devices

A report linking 83,000 deaths and 1.7m injuries to faulty medical devices was released this week, calling for radical reform of a “lax” regulatory system in Europe.

Led by the International Consortium of Investigative Journalists (ICIJ) and its partner news organisations (The BMJ and BBC Panorama), the year-long investigation concluded that safety regulations in Europe were unable to keep up with advancements in med tech, and were too open to gaming by the medtech industry.


Reporters working on the Implant Files met in Washington, D.C. in 2018

Europe has no single EU or governmental authority that reviews medical devices before they reach the market. Instead, medical device companies seek approval from one of 58 private notified bodies across the continent in order to gain the CE seal of approval.

However, if one of these notified bodies deems a medical device unsuitable, then the manufacturer can go to a different one until it gets the green light.

On top of this, devices’ safety and efficacy profile are not subject to the same transparency rules as medicines; so much so that surgeons performing these procedures don’t always see the evidence related to the devices.

The UK’s Royal College Of Surgeons has responded to the report, calling for “drastic regulatory changes” in the way medical devices are evaluated.

Derek Alderson

Derek Alderson, president of the Royal College of Surgeons (pictured above), said, “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long term.”

The approval process was probed after Dutch investigative journalist and broadcaster Jet Schouten convinced one notified body that mesh netting from a bag of oranges was surgical mesh.

MedTech Europe, which represents the European industry, responded to the investigation. “Medical devices undergo strict regulatory controls that give patients continued access while safeguarding high levels of safety”.

It added: “The ICIJ investigation shares the same fundamental belief that it is important to provide products that work and are safe. Its perspective, however, on how the industry works does not align with ours. Delivering safe, effective products, as our industry does, means that every day millions of people benefit from medical devices. They live healthier, more productive and more independent lives.”

In light of the report, the ICIJ has launched a database allowing users to explore more than 70,000 recalls, safety alerts and field safety notices issued across the globe.

An additional report by the ICIJ looks into industry lobbyists overhauling safety regulations for medical devices in Europe.

It says leading surgeons, regulators, lawyers and campaigners have said Europe’s approach to evaluating and approving new implants means that citizens are treated “like guinea pigs”.

The EU is currently reviewing shared public information on a system called Eudamed, but despite this, the European Commission told ICIJ that injury and malfunction reports were “likely to remain confidential as they are commercially sensitive for manufacturers”.

J&J sold implant against warnings


The investigation has coincided with further allegations around Johnson and Johnson (J&J) and its faulty vaginal mesh implant. New allegations say the company allowed the product to be used in patients despite warnings that the plastic material could shrink and harden inside the body.

According to the Guardian, emails shared between executives detailed that the mesh could become “hard as a rock” and roll up like a “folded potato chip” inside patients.

The implant was launched back in 2005, with FDA approval based on similar existing products, which allowed the device to be approved without a comprehensive review of data.

J&J is facing court cases from hundreds of patients worldwide who were fitted with the implant, with one patient reporting nine surgeries post-implant to help alleviate the pain.

Read the full report from the International Consortium of Investigative Journalists (ICIJ) - The Implant Files

Article by
Gemma Jones

28th November 2018

From: Regulatory, Healthcare



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