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 extensive study involving over 250 journalists across 36 countries. The investigation found that, in recent decades, medical implants have caused patients a great deal of harm because governments have approved them as “safe for use” with little or no human testing. The investigation also found that it is common for devices to be recalled and pulled from the market in some countries but remain on the market in others. In the last ten years, there have been more than 83,000 deaths and 1.7 million injuries associated with medical devices — such as metal-on-metal hip implants — in the United States alone. The article tells the story of Vijay Vojhala, who received a metal-on-metal hip implant from Johnson & Johnson’s subsidiary, DePuy Orthopaedics, Inc. Due to his implant, Vojhala now has vision problems, heart problems, and difficulty walking. The implant Vojhala received has since been found to poison patients, as have other metal-on-metal hip implant models. The authors note that over half a million people have received metal-on-metal hip implants, but most models have been recalled or pulled from the market. Later on, the article mentions that, since 2015, Johnson & Johnson has been ordered to pay $4.3 billion to Americans who have been injured by their medical products, including their metal-on-metal hips. Additionally, the authors discuss the fact that the medical device industry can be extremely profitable for manufacturers, even when their devices are complete failures. For instance, orthopaedic surgeon Thomas Schmalzried has made almost $30 million for designing two of DePuy Orthopaedics’ most dangerous metal-on-metal hip implants: the Pinnacle
and the ASR XL. One of his devices was recalled worldwide, and both of them have been removed from the market because they have been found to cause metal poisoning. Furthermore, the authors find that there are gaps in the way that medical device recalls are issued worldwide. As an example, the authors talk about one of Zimmer Biomet’s metal-on-metal hip implants. After Biomet’s implant
was linked to “flesh-rotting metallosis,” the company stopped selling it. And because the implant was formally recalled in Australia and some European countries, Biomet had to send alerts to surgeons in those countries, informing them about the product’s hazards. However, because the FDA did not attempt to recall the device in the United States, Biomet did not have to issue such notifications to doctors in the US. Finally, the article discusses attempts to correct the broken system that makes it difficult to trace the impact of medical implants. The authors interview Stephen Graves, a surgeon from Australia. In the 1990s, Graves started a registry that tracks almost all hip and knee replacements in Australia. He has since found that hip and knee devices cause many problems to patients. Graves’ database was a key piece of evidence in the fight to recall the ASR XL implant in 2009. His database has identified over 150 faulty joint implant models.