Nine patients have been confirmed with undergoing a breast implant in Malta that contained unauthorised silicone but efforts to establish the exact number continue.
So far, no adverse events resulting from the French-manufactured Poly Implant Prosthesis products had been reported in Malta, the government said, assuring that there was no cause for alarm.
The women who received these implants will be informed of any action they may need to take should the need arise. In case of doubt, they are advised to contact the surgeon who performed the breast augmentation operation.
France has recommended that 30,000 women have their faulty breast implants removed as a precaution. The French government, which says there is no evidence of a cancer link, will cover the cost.
The UK has ruled out routine removal, saying there was “no evidence” of a safety concern.
The government said the PIP breast implants, which were found to contain a non-medical grade silicone filler, were withdrawn from Malta on April 8 last year.
It said that at the end of March 2010, the French health authorities suspended the availability of the product.
Investigations on the implants throughout the EU were carried out following the discovery of six cases of breast cancer in France. An expert committee then established that there were incidences of a leakage of the implant, resulting in inflammatory reactions.
Other countries reported cases of leakage and rupture of the implant but no cases of cancer and some have reported no adverse events.
The government said the competent authorities of the EU member states have confirmed that no scientific evidence exists to indicate an association between the implant and breast cancer and the general opinion is that there is no proof of the need for their removal.
Experts are evaluating what further measures may need to be taken in the case of women who received the implant, it said.
“It is to be stressed that these issues concern the specific PIP implants and have no relevance to other types,” the government said.
Plastic surgeons contacted on Thursday said they had not used the PIP implants and Saint James Hospital said these were used several years ago and three women were recalled to have them replaced free of charge three years ago.
The issue is not new to the experts even though the scare only recently hit the headlines, with news that over 250 British women are taking court action after more than half experienced ruptures in their PIP-manufactured implants.
Plastic surgeons have played down the “hype”, insisting there was no cause for alarm and even putting the incident down to the ploys of competing companies to gain business advantage.
Globally, it is thought that more than 300,000 implants were sold by PIP over the last 12 years.