It’s Article 8 of the European Union’s Medical Devices regulations
It means the authorities can act to prevent harm.
Why then, are they choosing not to?
On the 23rd December 2016, PIP Action Campaign members forwarded a request to the European Commission to implement Safeguarding❉ measures with immediate effect.
We submitted concerns and demonstrated how these concerns were (1) supported by unequivocal evidence and (2) laid out plainly within Medical Devices Regulations. MDD93/42/EEC.
The demand specifically related to PIP and all other non-compliant brands of textured and polyurethane implant bearing the CE Mark.
The European Commission responded some weeks later in 2017, saying the national regulatory authorities are responsible for initiating Safeguarding❉action and that, after contacting them, the Commission had been informed no enforcement action is planned.
This inertia by the regulatory authorities shows very clearly that PIP is far from an aberration but business as usual for medical devices manufacturers: safety seems to be the least of the regulators concerns.
When regulators fail to regulate medical devices properly they put lives at risk.
Why aren’t the authorities responding to concerns surrounding the growing number reports of breast implant cancer (BIA-ALCL) cases? How many more women are going to die before Safeguarding❉ measures are put into place? How much more can women exposed to PIP implants bear? This is not responsible regulation this is Regulatory Capture. Regulatory Capture is a form of healthcare corruption that the EU identified in a special report, it is the term used for when regulators have lost sight of their public duties, and act instead in the interests of the manufacturers and industry: effectively regulators are putting industry profits before patient safety. PIP Action Campaign members will continue to press the European Commission, national and international regulators to take Safeguarding❉action on PIP, textured and polyurethane implants. Join us in holding regulators accountable at PIP Action Campaign
You can review the demand for Safeguarding❉ PIP Action Campaign sent to the European Commission on the 23rd December 2016 by clicking on the word Safeguarding❉