ALMOST 1,000 IRISH women have been warned that they may have received contaminated breast implants.
The Health Products Regulatory Authority (HPRA) has announced in a statement that it believes around 980 women may have received these breast implants over a seven-year period between 2009 and 2015.
It is also been stated that there is not believed to be a health risk to anyone who has received these implants.
Certificate of conformity
The implants in question were produced by Brazilian manufacturer Silimed, who have had their CE quality control certificate withdrawn for all medical devices produced by the factory.
Generally medical products cannot be marketed in Europe without a CE marking, issued by an EU-backed regulatory body based in Germany.
It is understood that breast implants, gluteal implants and tissue expanders have been supplied to the Irish market by Silimed.
What happens now?
The HPRA has said that it is investigating the matter and that none of these products should be implanted until further notice. EU health regulators are testing sample products to determine if there is any healthrisk.
Until the risk assessment has been completed recipients of implants are advised that they are not required to take any action.
Anyone with any concerns is urged to contact their surgeon, clinic or healthcare professional.
Other products impacted across Europe include gastric bands and balloons, implants for urology, facial implants and nostril retainers.
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