MHRA updates its advice on the suspension of Silimed devices
In a statement issued on 8 January 2016 to UK distributors of Silimed products, the Medicine and Healthcare products Regulatory Agency (MHRA) has confirmed its previous advice that all medical devices/products made by Silimed should continue to be quarantined due to their potential health risks.
In September 2015, the MHRA, along with other European healthcare-product regulators, suspended the CE certificate for all medical devices manufactured by the Brazilian company, Silimed. The decision to revoke the company’s CE certificate was made after it was found that the surfaces of some the company’s implants had been contaminated by unidentified particles at factory level (see our previous reports).
The MHRA issued a further safely alert on Silimed products in October 2015.
Despite Silimed’s statements suggesting there are no risks to patients, today’s statement by the MHRA makes it clear that tests are being carried out by the MHRA and EU health experts to establish whether or not there are any potential health risks. It is expected that the conclusions of these tests will be made public shortly.
The statement notes that Silimed’s CE certificate suspension has been extended to the end of June 2016.