From September, the implants sold in Europe will be reclassified to the highest risk category for medical devices. Breast surgery is one of Ireland’s most popular cosmetic surgery treatments, costing from €4,500 upwards.
More than 2,000 breast implant operations were carried out in Ireland last year. The number of procedures also increased by over 50% during the same period. However, health fears over breast implants have been raised by cases where women have had to have them removed because of leakage.
The new regulations follows a European Commission directive published last February that amends the classification of breast implants as medical devices within a 1993 EU directive. The Irish Medicines Board has confirmed the new measures will mean that manufacturers of breast implants sold in Ireland will have their design dossiers examined and clinical data checked by an independent body. The Harley Medical Group welcomed the new measures to improve the safety of breast implants. Group chairperson Mel Braham said they always ensured that their customers were offered the most rigorously tested and scrutinised implants available and welcomed any guidelines that sought to further this aim. “These new guidelines will relate to the manufacturers of the implants and we will obviously utilise only those that pass all of the official stringent testing and observe the guidelines,” said Mr Braham.
He added that the safety and welfare of customers had and would continue to be central to their ethos.