Update: February 2019
Edition The Guardian notes: a lot of people around the world
received damage to health or died at all due to improper
operation of medical devices. This was caused by insufficient or
incorrect testing and left-hand schemes for entering the market.
Among the devices that caused damage to health were prostheses
joints, artificial heart rate drivers, implants
mammary glands. Problems with them led to additional
surgery or even death.
In some cases, implants have not been tested on humans before
hit the market. For example, in England in the period 2015-2018. It was
received about 62,000 reports of similar incidents. In thirds of
patients had severe consequences for patients, and 1004
cases ended in death.
FDA, US Food and Drug Administration,
collected data on 5.4 million negative effects
use of medical devices over the past 10 years (part
information received from manufacturers worldwide), of which: 1.7
million health damage cases, about 83,000 deaths and 500,000
premature removal of products. Data was released after
an investigation conducted by 252 journalists from 59 media in 36 countries.
Material damage amounted to 400 billion dollars.
The Guardian has published the following data:
- patients lived with malfunctioning heart rate drivers,
moreover, manufacturers knew about these problems;
- hip joints and transvaginal meshes
were implemented by medical institutions without clinical
- complications were noted with mesh implants for hernias;
- surgeons did not give information to patients on implants due to
lack of sufficient information;
- federal authorities approve replacement of vertebral discs
implants that have shifted and collapsed right in
- Australian patients received medical devices only on
the basis of European conclusions;
- information about problems with medical devices was
not available to residents of many countries.
Professor Derek Anderson commented: medical devices, in contrast
from drugs are put into practice without clinical data
research and evidence base on safety. Member
European Parliament, Dagmar Roth-Berendt also reported that
lobbying by trade associations and industry is
the most “black”.
UK’s State Medicines Service
submitted reports to medical device manufacturers and started
investigations into individual cases.