There is no evidence that women who have PIP breast implants are at higher risk of cancer, European regulators have concluded.
Women also do not need to have the faulty implants removed as a precaution although they may wish to have them taken out if they feel
anxious, according to a review of PIP safety published by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).
Around 47,000 British women are thought to have been given the implants manufactured by the closed French company Poly Implant Prothese (PIP).
The implants were filled with non-medical grade silicone intended for use in mattresses and have been linked to reports of rupture and swelling in the body.
In January last year, the Government announced that women given PIP breast implants on the NHS would be able to have them removed for free, with private firms told they should offer the same deal.
Any woman not helped by private firms would also qualify for NHS help. A review last year by NHS medical director, Professor Sir Bruce Keogh,
concluded the implants were not toxic or carcinogenic. But it acknowledged the distress caused to many women by having them in their bodies.
Today’s European study said PIP implants have not been associated with higher risks of cancer. It added: “Laboratory tests on PIP implants have been negative for cytotoxicity and genotoxicity.”
The study said PIP implants have been subjected to chemical analysis “in an effort to find organic and inorganic compounds (including heavy metals) that may be potentially toxic, but none have been found even at very low levels”.
It said the probability of rupture for PIP implants is estimated to be around 25% to 30% 10 years after implantation, while other silicone breast implants have a rupture rate of 2% to 15% after 10 years.
Professor Keogh’s review put the PIP rupture rate at 15% to 30% after 10 years compared to 10% to 14% after 10 years for other brands.
Today’s review said women should have the implants removed if they rupture while other women should have them reviewed regularly to make sure they were intact.
It said: “Because of the widespread concern of undetected ruptures, there is a need for women with PIP breast implants to seek regular clinical examinations, and where deemed appropriate, individual counselling and imaging with ultrasonography or MRI.
“There is currently no convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach.
“Implant removal in the absence of malfunction may be considered for women who are experiencing significant anxiety because they have a PIP breast implant.
“However, the decision to remove an intact PIP implant for this reason should be based on an individual assessment of the woman’s condition by her surgeon or other treating physician after consultation.”
John Wilkinson, director of medical devices at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, 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.”