This is part of a series of “Implant Files” stories, which are based on the findings of an international coalition of journalists that raise serious concerns about the safety of certain medical devices.
A worldwide group of journalists who investigated problems with medical device implants for more than a year, have launched a new database for medical device recalls, safety alerts and other warnings.
The International Consortium of Investigative Journalists (ICIJ) announced the launch of the International Medical Devices Database (IMDD) late last month, which is designed to provide information and documents on more than 70,000 medical device recalls, as well as safety warnings and field safety notices. The group claims that it includes data on all types of medical devices, not just implants.
The database grew out of the investigation and reporting on what the ICIJ calls the “Implant Files”: a year long investigation into problems with the medical device industry.
According to the investigation, less than 20% of countries in the world maintained an online public database which allows consumers to find information on medical device recalls. The database is starting with information from 11 countries, but the group expects that number to increase rapidly.
The group notes that the database contains more than 6,700 records that were never made public, but pertained to potentially dangerous medical devices, from Finland, Mexico and Spain.
Analyzing the database, investigators found that the most common cause for medical implant recalls was device design, which accounted for nearly 23 percent of all cases identified by the FDA. Process control issues resulted in more than 11 percent of recalls, and the use of nonconforming material or components was blamed for just under 10 percent.
Despite thousands of recalls, and tens of thousands of injuries and deaths, the FDA has only ever banned two medical devices. The rest were voluntarily recalled, the investigators determined. However, the U.S. agency is the most forthcoming in the world about recalled medical devices, and is the only agency on Earth that informs consumers that recalled medical devices were sold in other countries.
Over the last decade, there have been nearly 500,000 reports of revision surgeries, where medical devices had to be removed due to problems, around the world. In addition, medical device adverse events were linked to 1.7 million injuries and nearly 83,000 deaths since 2008.