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null EEA to temporarily suspended use of Silimed implants

EEA to temporarily suspended use of Silimed implants

25.9.2015 15:22 / News

Use of Silimed implants has been temporarily suspended (for three months) in the European Economic Area. Irregularities were found in the manufacturing process, and the manufacturer has been advised to rectify the issues. At the moment, however, there is no indication that these issues would cause a health risk to patients.

According to the information obtained by Valvira, a total of 329 breast implants have been sold in Finland between 2010 and 2015. The manufacturer's implants are used particularly in plastic surgery in numerous countries, and their other uses include urology and general surgery. Valvira has not received any incident report notifications concerning the implants. European health authorities continue to monitor the situation, and authorities in each country will take action should it be established that the irregularities in the manufacturing process cause health risk for user. According to Valvira's preliminary assessment, those with the implants need not take any action. In inquiries regarding Silimed implants, Valvira advises patients to contact their doctor who performed the surgery.

European healthcare product regulators of member states have agreed on the coordination of operations and sharing of responsibilities after the sales and distribution of the implants were suspended. In Finland, Valvira is the investigating authority. Valvira's duties include the promotion of safe use of medical devices through supervisory practices in Finland. Should there be any problems in regard to the safety or functionality of a medical device, Valvira researches all incident report notifications it receives and takes necessary measures.

For more information, please contact:
Jussi Holmalahti, Director, Department for Healthcare Legal Rights and Technology, tel. +358 295 209 500
Minna Kymäläinen, Officer, Department for Healthcare Legal Rights and Technology, tel. +358 295 209 503