A journalistic investigation carried out worldwide has revealed 25,000 incidents in Spain in the last decade due to control failures in medical use implants.
The global research of 59 international media -published in Spain by 'El Confidencial' and 'La Sexta'- and coordinated by the International Consortium of Investigative Journalists (ICIJ) has unveiled failures in the control of medical implants that end up in the patients' body.
The investigation 'The Implant Files', carried out during a year in 36 countries, collects at least 5.47 million adverse incidents around the world between 2008 and 2017, which are recorded when these medical products pose a significant problem for the patient's health. In Spain, the figure rises to 25,000 incidents in the last decade.
In the last ten years, according to the research, more than 82,000 people from five continents have died and 1.7 million have been victims of the defective operation of medical implants, according to data from the Food and Drug Administration of the United States (FDA).
Based on this information, an International Medical Devices Database (IMDD) has been prepared, which allows us to consult approximately 70,000 product recall notices and manufacturer safety alerts that were made in more than 11 countries. and that can be consulted on the website medicaldevices.icij.org.
The information obtained in the framework of this investigation points to the lack of control of the supervisory bodies and to pressures from the large health multinationals, that finance trials and studies to prove the absence of risks associated with the products.
As detailed, the European system turns out to be especially permissive despite having 56 notified bodies with the capacity to grant the CE mark. In Spain, the Spanish Agency for Medicines and Health Products (AEMPS), attached to the Ministry of Health, Consumption and Social Welfare, estimates that there are some 50,000 medical devices with CE marking, although it recognizes that, due to current legislation, "it can not know for sure the number of products with CE marking that are being used ".