The Health Products Regulatory Authority has said that up to 980 women in Ireland may have received breast implants, manufactured by a Brazilian company, whose products have been suspended due to concerns over potential contamination.
However the HPRA says to date there is no indication of any health risk for those who have received the affected implants.
Following an inspection at a Silimed manufacturing plant in Brazil, authorities suspended the CE certificate for all medical devices manufactured by the company.
It is understood particles of organic fibres were detected in implants tested by health authorities, which led to the suspension of Silimed products across the EU.
The HPRA says based on current information the products impacted on the Irish market are breast implants, gluteal implants and tissue expanders manufactured by Silimed.
The HPRA says up to 980 women in Ireland may have received the Silimed-manufactured breast implants over a seven year period.
About 17 people in Ireland may have received gluteal implants, and about 12 may have received tissue expanders made by Silimed.
A pan-European investigation is under way.
The HPRA says to date there has been no indication of any health risk to those who have received these implants.
It is advising anyone with any concerns to contact their surgeon, clinic or healthcare professional.
In a statement on its website, Silimed says that it assures that there is no contamination of its products.
It says it voluntarily suspended the sales of its products on the European market until local health authorities have received the official technical report.
The statement says Silimed has technical reports that prove the total safety of its products.
It says the level of particles found is extremely low, and complies with all of the markets.
