The Guardian: Patients worldwide harmed by faulty medical implants

The Guardian has published an investigation into the global implants industry conducted by a total of 59 media organisations in 36 countries, coordinated by the International Consortium of Investigative Journalists, dubbed The Implant Files, which has found that faulty devices have led to many patients around the world being in pain or even dying, due to the poor regulation and lack of transparency in the market.

The types of faulty implants that have been the cause of complications or deaths include pacemakers, artificial hips, contraceptives or breast implants, which in many cases had not even been tested in patients before being allowed on the market.

In the UK, authorities received 62,000 “adverse incident” reports linked to medical implants, just between 2015 and 2018. 1,004 of these incidents resulted in the patient’s death.

The Food and Drug Administration in the US received 5.4 million “adverse event” reports in the past decade, including almost 83,000 deaths.

The global implants industry is worth USD 400 billion, but there seems to be very little regulatory scrutiny to ensure the patients’ safety.

The issues found by the investigation include products sold to hospitals without clinical trials, manufacturers being aware of problems but still sold their devices, approved implants that later disintegrated or migrated in patients’ bodies, or a lack of central registers leading to surgeons not knowing the risks of implants.

Manufacturers are in charge of testing their own products after faults develop, and they are allowed to seek approval to market their products without declaring any refusals. Furthermore, it seems that doctors with close industry ties are eager to be early adopters of various devices in order to enhance their professional standing.