Suspension of Silimed's CE Certificate for Silicone Implants in Europe

TüV Süd, a global testing, certification, inspection and training provider, has announced it will be suspending the CE Mark for all products manufactured by the 37 year old Brazilian manufacturer, Silimed. The CE Mark on a product is a manufacturer’s declaration that the product complies with essential requirements of relevant European health, safety and environmental protection legislation. The suspension affects Silimed products in the European, Australian and New Zealand markets only. The reason given was that potential particles identified as microscopic silica and cotton were identified during a routine inspection of one of Silimed’s manufacturing facilities. There is no information suggesting that the identification of the potential particles represents any threat to patients. 

The ISAPS Patient Safety Committee Chair, Dr. Lokesh Kumar says, “Silimed has been a partner with whom we have had a solid relationship with for many years. We are encouraged by the speed of their response in working with the appropriate regulatory authorities to investigate the incident and trust their efforts to find an acceptable solution.  We are carefully monitoring the situation and will keep our members updated as soon as we have more information. However, based on what we know at present, the safety of patients who have Silimed or Sientra implants is not a risk.  As plastic surgeons, patient safety is and always will be our top priority.  We hope that this incident can be resolved by Silimed expediently and that the suspension will be lifted in due course.”