Implant Files

Prosthetics, breast implants, pacemakers, insulin pumps…there are many medical devices destined to stay permanently in our bodies, and you probably thought they were just as closely monitored as medicines…

Well you’re in for a surprise. Last November, a consortium of over 250 journalists published the
results of their investigation into deficiencies in the systems that monitor our medical devices. Their
report is entitled Implant Files, and it makes for some uncomfortable reading.

In order to certify an implant for use, you simply need a CE label. No clinical trials are required, nor is
there any sort of means of tracking devices, which means that if there’s a problem it’s nearly
impossible to recall all affected devices. Just to show how lax the system is, one Netherlands
journalist managed to get one of those nets for holding mandarins from a supermarket approved as a
vaginal implant.

No wonder, then, that there are so many incidents. One particularly notable scandal was that of the
PIP breast implants that had four times the normal rate of rupturing. We have good news though -
new European regulations should come into effect in 2020 to improve the monitoring and
certification of medical devices.