\'No evidence of risk\' over PIP implants


European probe rules no justification for removal of intact breast implants

The Medicines and Healthcare products Regulatory Agency (MHRA) has today shared a new European report that states that there is currently no convincing medical, toxicological or other data to justify the removal of intact PIP breast implants as a precautionary approach.

The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published its report on the safety of PIP breast implants. The findings support the findings of the report of Professor Sir Bruce Keogh’s Expert Group on PIP breast implants published in June 2012.

The SCENIHR report highlights that:

  • Tthere is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach
  • 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

John Wilkinson, the MHRA’s director of medical devices, said: “The PIP breast implants episode has been very distressing for women and I hope this new report provides reassurance for them.

”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 is believed to be one of deliberate fraud, it has highlighted areas where the current European system of regulation needs strengthening. The MHRA is working with its European partners to ensure that this happens and that patients are protected.”

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The investigation followed the revelation that the PiP implants contained non medical-grade silicon and had a significantly higher rupture rate than other brands. It was later discovered that the manufacturer, Poly Implant Prothese, changed the type of silicon used in the implants from that originally given CE Mark approval.