Nine Maltese patients identified with PIP breast implants
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At the end of March 2010 the French Health Authorities suspended the availability of Poly Implant Prosthesis (PIP) breast implants which contained unauthorized silicone. The product was withdrawn from many other European countries including Malta where the product was withdrawn on the 8th April last year.
In Malta, to date, nine patients have been identified as having received this PIP implant though investigations are still going on. Such patients are advised that there is no cause for alarm and that they will be informed of any action that may need to be taken in respect of their implant should such need arise. In case of doubt such women are advised to contact the surgeon who performed the operation.
There have been no adverse events reported in Malta to date.
It is to be stressed that these issues concern these specific PIP implants and have no relevance to other types of implants.
After the discovery of six cases of cancer by the French authorities an expert committee met to evaluate the adverse events in women who had received this implant and discovered a significant number of such events the commonest of which was a leakage of the implant resulting in inflammatory reactions of various types. During the evaluation 8 cases of malignancy were identified. Other member states have reported cases of leakage/rupture of the implant but no cases of cancer while some member states have reported no adverse events.
During an audio-conference carried out between the competent authorities of the EU member states it was established that such adverse events were not identified in all member states. It was also confirmed that to date there is no scientific evidence to indicate an association between the implant and breast cancer. The general opinion was that to date there is no evidence to suggest the need for the removal of such implants. At present experts are evaluating what further measures may need to be taen in those women who have received such an implant.


























