Update on PIP implants following release of data from French & Australian studies

6th October 2010

 

Further to our earlier advice about PIP breast implants, implanted after January 2001, the results of studies by the French authorities have now been released and can be viewed here

These concur with the UK studies that show no evidence of toxicity or geno-toxicity in these implants. The shell failed one of the physical tests of robustness (the elongation by 350% test which is of questionable real-world relevance) and the gel has been shown to cause inflammation in sub-dermal injection. It was already known that the life of these implant shells might be reduced compared to some others on the market (it was this that triggered the current investigation).

The advice to our members and patients remains unchanged in the light of this data.  In particular there is no evidence of danger to health from these implants, whether ruptured or not, and at present BAPRAS (working with ABS and the MHRA experts) sees no reason on the basis of the findings so far, to recommend explantation or even routine ultrasound examination. We do believe women who are symptomatic should be carefully reviewed in the normal way and that all women with these implants should be kept informed of the developments and the current recommendations.

BAPRAS is represented on the Medical Devices Committee at MHRA and if the situation changes we will again contact our members, but for the present, our advice remains unchanged from the earlier posting. The most recent advice from MHRA may be found here

Members are reminded that any adverse implant incidents, including lymphadenopathy associated with PIP implants, should be reported to MHRA using their online forms at www.mhra.gov.uk

 

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