Silicone implants for plastic and general surgery, implants for urology and surgical products for obesity treatment 에 대한 현장 안전성 서한

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices (HALMED) has recommended a temporary suspension of implantation of the Brasilian manufacturer SILIMED. According to the recommendation, further sale of these products has been discontinued in the Republic of Croatia. The suspension has been due to precautions after an unannounced inspection at the manufacturing site in Brasil discovered a impurity with particles on the surface of certain products of this manufacturer. According to the currently available safety data there are no indications that this issue could have a harmful effect on the health of patients with these implants.
HALMED, in collaboration with other European competent authorities for medical devices, recommends a temporary discontinuation of implantation of all implants of the Brasilian manufacturer SILIMED. According to the recommendation, further sale of these products has temporarily been suspended. The suspension is due to a particle impurity detected on the surface of the product discovered in an unannounced inspection. The manufacturer has been temporarily suspended for CE marking of the products, which is a prerequisite for placing products on the EU market. The temporary suspension of use of these products will be in effect until release of further recommendations, or finalisation of the investigation jointly conducted by the European competent authorities, including HALMED. Within this comprehensive European investigation, relevant tests will bill conducted in order to identify possible risks for users of the concerned products. According to the all currently available data, there are no indications that this issue could have a harmful effect on the health of persons with these implants.
Therefore, individuals with these implants are for now advised not to take any further steps than ordinary ones and regular controls according to doctor’s recommendations. In the case of concern patients should speak to their doctor who implanted the product.
All products of the manufacturer Silimed are subject to suspension: silicone implants for plastic and general surgery, implants for urology and surgical products for obesity treatment.
HALMED has not received by now any adverse incident associated with these medical devices.
HALMED continuously monitors the safety of all medical devices from the close through the Croatian medical device vigilance system and will promptly make any new information publically available.
Further information
HALMED has together with other European competent authorities for medical devices received a notification on the temporary suspension of validity of the certificate of conformity including all medical devices of the Brasilian manufacturer Silimed. This also includes the suspension of the manufacturer’s right to CE mark its products as a prerequisite for placing products on the EU market. A German competent authority that initially issued the certificate of conformity, in an unannounced inspection of the manufacturing site in Brasil discovered particle impurities on the surface of certain products.
Medical devices may not be placed on the EU market without the CE mark. The CE mark is affixed on the product by the manufacturer after the product has complied with all regulatory requirements. This mark confirms that the medical device is correct and safe if handled as indicated in the instructions and according to the use declared by the manufacturer. The CE mark guarantees the conformity of the product with the essential requirements set out in the EU directives that are transposed in the Croatian legislation.