A research journalistic world has revealed up to 25,000 incidents in Spain in the last decade by the failure of control in used implants health

The Ministry of Health has come together today with patients and scientific societies related to implants and medical devices to analyze the situation

The Ministry of Health will convene a meeting with patients ‘ associations and with scientific societies related to implants and medical devices to analyze the situation of the same in Europe. So has announced hours after made public a journalistic investigation in which it is revealed that in the last 10 years there have been up to 25,000 incidents in Spain by control failures in implants for sanitary use.

After a year of work, this global analysis, carried out by 59 international media (in Spain, El confidencial and La Sexta) and co-ordinated by the International Consortium of Investigative Journalists (ICIJ), has collected at least 5,47 million of adverse incidents across the world between 2008 and 2017. That is to say, some 1,500 reported failures each day. In Spain, nearly eight every day.

The figures in this research (‘The Implant Files’) show that failures in the control of medical implants are more common than they should be. However, Health argues that “Spain has a strict control of sanitary products, which guarantees to the citizens the highest levels of protection of health”.

in spite of this, say sources in the Ministry of Healing, “it will drive the necessary improvements of the system, aimed at providing guarantees for the products and safety to the patients.” In this line, recall that “the minister, María Luisa Carcedo, presented in October, the Guide to Action for patients who are carriers of the birth control ‘Essure'”, elaborated by the Spanish Society of Gynecology and Obstetrics (SEGO) at the request of the Spanish Agency of Medicines and Health Products (AEMPS), and that “the work and the dialogue shared between administrations, professionals and patients” will be the keynote of the proceedings that are going to take.

In the words of Marta García Redondo, specialist in Plastic and Reconstructive Surgery at the University Hospital La Paz, Madrid, “yes, I think that is good any effort made by the State to improve the control. This is not to convey a false alarm of insecurity, but yes it is true that not all implants are equal or of the same quality”.

The international research points out that, according to data from the u.s. Agency of the Drug (FDA, for its acronym in English), over the last decade, more than 82,000 people across five continents have died and 1.7 million have been victims of the faulty operation of different types of medical implants.

‘The Implant Files’ has created the first global database of advisories on health products, in such a way that you can find safety alerts, separation of marketing or notifications of malfunctions regarding implants, pacemakers, defibrillators and other healthcare products. In many countries, such as Spain, Finland or Mexico, this information is not even public access.

Specifically in our country, as it published The Confidential and The Sixth, fewer than 10% of the alerts related to health products made public in the website of the Spanish Agency of Medicinal Products and Health (AEMPS).

The information obtained in the framework of this research point to the lack of control and oversight bodies pressures by large multinational health, who fund trials and research to prove the absence of risks associated to the products.

According to details, the european system is especially permissive despite having 56 notified bodies with the capacity to grant the CE marking. In Spain, the AEMPS estimated that there are about 50,000 sanitary products with CE marking, although it recognizes that, due to the current legislation, “cannot be known for sure the number of products with CE marking are using”. In addition, he also admits that “many adverse events were referred to the system of surveillance of drugs and not the health products, where appropriate, generating an “information chaos”.

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