Medical device industry: international investigation exposes lax regulation

The results of an international investigation tracking the harms of medical devices that have been tested inadequately or not at all are being released today. The investigation, called the Implant Files, was led by the Pulitzer prize winning International Consortium of Investigative Journalists (ICIJ) and conducted by 252 journalists from 36 countries representing 59 media partners, including The BMJ and UK partners BBC and the Guardian.

The investigation was inspired by a Dutch investigative journalist and broadcaster, Jet Schouten, who led a sting operation by convincing the private companies called notified bodies that are responsible for assessing devices that mesh netting from a bag of mandarin oranges was surgical mesh. Schouten said that the results made her want an investigation into device approval around the world.

Over the course of the Implant Files investigation ICIJ and its partners filed more than 1500 public records requests and collected more than eight million device related health records. These included recall notices, safety warnings, legal documents, and corporate financial filings. More than 5.4 million “adverse event” reports sent to the US Food and Drug Administration over the past decade make up the greatest share of this trove. These reports came from doctors, manufacturers, patients, and even lawyers and described cases where a device was suspected to have caused or contributed to a serious injury or death or had experienced a malfunction that would be likely to lead to harm if it were to recur.

Medical devices that broke, misfired, corroded, ruptured, or otherwise malfunctioned after implantation or use—despite assurances by regulators, the industry, and doctors that they were safe—were linked to 1.7 million injuries and nearly 83 000 deaths over the past decade, an ICIJ analysis found. Nearly 500 000 reports mentioned an explant—a surgery to remove a device—in connection with an adverse event.

In some cases, the connection between the harm described in an adverse event report and the device wasn’t clear, and the FDA said that conclusions about a device’s safety or role in an injury or death could not be made just from an adverse event.

Nevertheless, ICIJ’s analysis, which included identifying some devices listed under hundreds of different brand names or spellings, gives an unprecedentedly comprehensive view of medical product safety.

The ICIJ has established a publicly searchable international Medical Device Database (https://medicaldevices.icij.org) that tracks faulty versions of medical devices across the globe for which there have been special warnings or alerts. A description of how and why the database was built is available on the ICIJ’s website (https://www.icij.org).

Deep dive investigations from the Implant Files will be released throughout the week on devices ranging from nerve stimulators and cardiac defibrillators to hip implants, transcutaneous aortic valve replacements, breast implants, surgical mesh, and Essure, a permanent implanted contraceptive, among other devices.

Reports released today include an investigation into the world’s largest medical device manufacturer, Medtronic.

The BMJ and ICIJ investigations include an expose into how far reaching reforms to overhaul safety regulations for millions of patients with medical implants in Europe have been successfully dismantled by industry lobbyists. A joint investigation between The BMJ, BBC Panorama, and the Guardian newspaper, released tomorrow, will highlight the lax regulatory system in Europe that continues to allow medical devices that are unsafe and unproved ending up inside patients. And doctors are unable to find out about the true risks of treatments they are recommending because the evidence on which devices were approved is kept secret. In response, the Royal College of Surgeons has called for “drastic regulatory changes.”

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

Tomorrow The BMJ publishes Jeanne Lenzer’s investigation into the activities of the world’s biggest device manufacturer, Medtronic, and how the company is “transforming” into an “integrated health service provider,” including in the NHS and overseas, and whether this threatens clinicians’ autonomy.