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08-01-2012 | Surgery | Article

Disagreement over routine removal of PIP breast implants in UK

Abstract

MHRA website

MedWire News: The Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has recommended that women with Poly Implant Prothesis (PIP) breast implants should have them removed as a precautionary measure.

However, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have not recommended routine removal of these implants. They say that there is currently insufficient evidence to justify the associated risks for surgery from breast implant removal.

The PIP implants, which were manufactured in France, have been shown to have an increased risk for rupture and can cause irritation and inflammatory reactions due to the use of nonclinically approved industrial-grade silicone gel; marketing, distribution, export, and use of the implants was suspended by AFSSAPS in March 2010.

Despite reports in the scientific and medical community suggesting a possible link between anaplastic large cell lymphoma (ALCL) and the PIP breast implants, there is no significant evidence to suggest that this is the case.

The updated French recommendations suggest that all women with PIP implants should be advised to have them removed as a precautionary measure, even if there are no signs of clinical deterioration of the implants, whereas the MHRA has suggested that women in the UK with PIP implants should seek the advice of their implanting surgeon to help them decide on what action to take.

Despite the MHRA recommendations, the British Association of Aesthetic Plastic Surgeons (BAAPS) suggests that the French approach is "not unreasonable."

In a press statement, former BAAPS president Nigel Mercer commented: "The reality is that the industrial-grade silicone gel used in these implants was not meant for the human body. In some instances women who have no rupture of the devices will be happy to be monitored regularly, but others may wish for the PIPs to be removed, regardless of symptoms. The French Government's stance is certainly not unreasonable."

The current BAAPS president Fazel Fatah added: "The main reason for explantation in France is not any new scientific evidence linking these implants to cancer - none has been proven despite exhaustive testing. It is the nature of the irritant gel within them, which makes removal post-rupture a more complex and extensive surgery. Therefore some patients will prefer them removed as a preventative measure and this is an entirely rational approach in view of the quality issues associated with PIPs."

The argument about whether the implants should be routinely removed seems to hinge on the reported rupture rates, which varies from 5% in France to around 1% in the UK in line with other implants.

Public concern and conflicting data on rupture rates in different clinics have prompted the UK government to commission a review of the scientific data, which is being lead by Bruce Keogh, the National Health Service medical director in the UK.

By Helen Albert

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