In 2011 the world’s third biggest supplier of breast implants, Poly Implant Prostheses in France, allegedly used industrial silicon in its implants. The substance was never intended for medical use. The implants were prone to rupture, and ruptures caused dangerous, toxic leakages of the silicon. In Europe, 100,000 women were affected, as well as an additional 400,000 women globally.
In order to avoid continuing risks to women from silicon implants, the EU is struggling to update existing legislation on medical devices. Some suggest that a centralized pre-marketing authorization for high risk devices is the answer. Others claim that Europe has a history of providing “timely access” to technology because of the decentralized system, and that a centralized system will undermine patient access to much needed technology and stifle innovation. Read more here.