Poly Implant Prosthese (PIP) breast implants update
23 December 2011
Following the announcement in France today, the Medicines and Healthcare products Regulatory Agency (MHRA) is not recommending routine removal of PIP silicone gel breast implants in the UK.We recognise the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.
We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence.
We will continue liaising with the French medicines and medical devices regulator and we are awaiting the evidence to support the decision made in France. This will be evaluated as a matter of priority by our clinical and toxicological experts and we will issue further advice if necessary.
In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants.
In the meantime we would recommend that all patients who have questions about their PIP breast implants should seek advice from their implanting surgeon.
We had discussions on 21 December 2011 with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority (TGA) is consistent with the figures from all the above European countries other than France in terms of rupture. They have no reported cases of lymphoma.
We have continually monitored the safety of these breast implants. In March 2010 we advised clinicians not to implant these devices and at the same time advised patients who were concerned about their PIP implants to consult their implanting surgeon. MHRA commissioned toxicity testing on the unapproved silicone gel used to fill PIP breast implants, including genotoxicity and chemical toxicity. The results of these tests have been discussed with relevant experts and we have concluded that there is no safety issue related to this filler material. Similar testing carried out by the French medicines and medical devices regulator confirmed these conclusions.
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