The Implant Files

The Implant Files are the creation of a group of journalists in the ICIJ (International Consortium of Investigative Journalists).  They document the unexpected and excruciating side effects victims suffer from medical devices that go through the bare minimum of testing. The testing on many of these devices typically include an expedited clinical trial period that never actually has the device implanted in a living person before it goes on the market.

The Implant Files website features articles and videos documenting how faulty medical devices have vastly uprooted victim’s lives.  They also built the International Medical Devices Database, which is a compilation of recalls, safety alerts, and similar documents on medical devices across the globe.

The International Medical Devices Database

The Implant Files investigators realized that one of the biggest problems in the medical device industry is the lack of information. Patients and doctors don’t always know when their products have been recalled, banned or flagged in other countries. Sometimes, patients don’t even find out when their implants have been recalled in their own countries.
For this reason, the investigators created a database containing over 76,000 files about medical devices from around the world. They call it the International Medical Devices Database, and it’s the first of its kind. The files were accumulated from 36 different countries over a year-long period.  These files include recalls, bans, and safety alerts regarding different medical devices. In this database, people can input the names of specific medical devices or manufacturers to see if they’ve ever been recalled or flagged as unsafe in other countries.
The Implant Files investigators also ranked many of the recalls from 1 to 3.  According to the website, a class 1 recall is one “in which there is a reasonable probability that the use of…a product will cause serious adverse health consequences or death.”

Search the International Medical Devices Database

Search for any medical product in their database.  If there have been any recalls, safety warning, or similar notices out, it may be listed here.

 

Information About Metal on Metal Hips in the Database

Here, we summarize some of the information we found about metal-on-metal implants using the database.

  • The database contains over 14,000 files about orthopaedic devices, many of which are for metal-on-metal hip implants.
  • There are over 1,300 files about Biomet, including recalls, field safety notices, and safety alerts. Biomet produces the Biomet Magnum and M2A hip systems.
  • A search for DePuy yields almost 700 files. DePuy, a medical device company owned by Johnson & Johnson, is responsible for some of the most damaging metal-on-metal hip models, such as the DePuy ASR hip system and the DePuy Pinnacle.
  • There are 2,142 events linked to Stryker, a company that manufactures multiple metal-on-metal hip implants and components, such as the Stryker Rejuvenate and ABG II, and the Stryker LFIT V40 Femoral Head. Many of these files are recalls.
  • A search for “Zimmer” shows a total of 1,673 files. Zimmer Inc. is the manufacturer of the Zimmer Durom metal-on-metal hip system.

Articles From the Implant Files

Victim Hope Fluctuating

Article Link: https://www.icij.org/investigations/implant-files/patient-hopes-rise-and-fall-as-an-industry-balances-progress-and-profit/ Article Title: Patient Hopes Rise and Fall as An Industry Balances Progress and Profit By Dean Starkman and Delphine Reuter The...

Medical Devices Cause Unexpected Issues in Patients

Article link: https://www.icij.org/investigations/implant-files/medical-devices-harm-patients-worldwide-as-governments-fail-on-safety/ Article Title: Medical Devices Harm Patients Worldwide as Governments Fail on Safety By ICIJ This article is the result of an...

Defective Medical Device Victims Speak Out

Article Link: https://www.icij.org/investigations/implant-files/patients-fight-for-answers-as-broken-implants-cause-unseen-agony/ Article title: Patients Fight For Answers as Broken Implants Cause Unseen Agony. By: Spencer Woodman This article highlights the...

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