Healthcare regulators have concluded there is no ‘convincing medical, toxicological or other data’ to justify the routine removal of PIP breast implants.
The ruling comes after Jean-Claude Mas, the founder of the PIP company, was jailed for four years for fraud and fined €75,000 by a court in Marseille.
PIP's sale of faulty implants caused a global health scare which affected around 300,000 women in 65 countries.
The report findings support the scientific conclusions from Professor Sir Bruce Keogh’s independent expert group report that there is no evidence of a long-term threat to human health from PIP breast implants
The company was found to have used sub-standard silicone gel - rather than medical-grade silicone - with the result that many implants ruptured.
But the UK Medicines and Healthcare products Regulatory Agency (MHRA) has this week shared the final European report about the safety of the fraudulently-manufactured silicone implants.
The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) document gives its final opinion following a public consultation on a preliminary report which was published in October 2013. The report highlights that:
- There is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone breast implant from another manufacturer
- The decision to remove an intact PIP implant should be based on an individual assessment of the woman's condition by her surgeon or other treating physician after consultation
- There are currently no convincing medical, toxicological or other data to justify removal of intact PIP implants
These findings support those of a report by an expert group put together by NHS Medical Director for England, Professor Sir Bruce Keogh, which was published on 18 June 2012.
John Wilkinson, MHRA’s director of medical devices, said: “We recognise that the criminal PIP episode has been very distressing for women who have had breast implants and I hope this final European report provides some reassurance for them.
While the PIP episode was found to be one of deliberate fraud, it has highlighted areas where the current European system of regulation may need strengthening
“The report findings support the scientific conclusions from Professor Sir Bruce Keogh’s independent expert group report that there is no evidence of a long-term threat to human health from PIP breast implants.
“While the PIP episode was found to be one of deliberate fraud, it has highlighted areas where the current European system of regulation may need strengthening. MHRA is working with its European partners to ensure that this happens where necessary and that patients continue to be well protected.”
