In a strongly worded press release issued on 9th January, relating to the ongoing scandal relating to PIP breast implants, European medtech industry body Eucomed seeks to make its position clear. The full statement is available here, but the excerpt reads as follows:
The European medical technology industry association Eucomed notes with great concern recent press reports that the French firm Poly Implant Prothèse (PIP) may have violated the regulations by using unapproved industrial-grade silicone in some of its implantable products and by allegedly falsifying or withholding documents. If these or other allegations are confirmed, Eucomed strongly condemns PIP’s behaviour and breach of trust. Patient safety, public confidence, and ethical behaviour should always be the top priorities of any organisation active in the healthcare industry.
The organisation is clearly using this scandal as an opportunity to restate its case for improvements to the current regulatory regime, specifically the relationship between competent authorities, notified bodies and medical device companies. At medlatest we’re pleased to be in agreement and to see a degree of common ground emerging from what is looking increasingly like the biggest medical device disaster story for a long time.