Contaminants found on individual implants during an inspection of the Brazilian manufac-turer Silimed. Swissmedic issues a provisional recommendation not to use implants from this company.
Swissmedic and all European regulatory authorities for medical devices have been informed of the suspension of a certificate held by the Brazilian manufacturer Silimed. The suspension followed the discovery by the German Notified Body that had issued the certificate of quality problems during an inspection of the manufacturer. The certificate applies to breast implants and other implants used in plastic surgery (see Product list for affected implants).
Swissmedic is involved in the ongoing joint investigations by its European partner authorities. To date, Swissmedic has received no reports of incidents involving this company's products which would indicate a health risk. Investigations to identify possible risks have been initiated. Swissmedic, in consultation with the other European authorities, recommends that implants manufactured by Silimed should not be used until the investigations have been completed.
Swissmedic will provide further information as soon as new findings requiring more extensive or new measures come to light.
|Product list (according to the certificate)|
|Silicone Implants for plastic surgery:
||Mammary Implants, Pectoral Implants, Gluteal Implants, Calf Implants, Implants for Hand Surgery, Tissue Expanders, Facial Implants, Nostril Retainers, Suspension Sheet for Mammoplasty
|Silicone Implants for Bariatric surgery:
||Gastric Balloons, Gastric Bands|
|Silicone Implants for Urology:||Testicular Implants, Penile Implants, Vesical Conformers, Periurethral Constrictors, Tubes for Hypospadias, Vaginal Stents|
|Silicone Implants for General Surgery:||Silicone Blocks and Sheets|
|Silicone Invasive Devices:||Sizers for Silicone Implants
Update of 12 October 2015