The Brazilian manufacturer says it voluntarily suspended sales
Silimed, a Brazilian manufacturer of silicone implants, has spoken out about the quality of its devices in an attempt to reassure the public.
The company asserts that its implants, which are designed for use in breasts, the chest, buttocks, calves and the face, as well as for gastric band and urology surgery, are not contaminated. It stated that all Silimed products are made “in accordance to the highest standards of safety and subjected to tests to ensure its sterility in all lots”.
Isabela Kopke, Associate Director of communications agency SA Krebab, which is handling enquiries on behalf of Silimed, told Cosmetics Business: “There is no contamination. The presence of these particles does not mean that the product is inadequate for use, because the particles are on the surface of the product and are not micro-organisms or toxins. We are being questioned by European authorities regarding a certain level of particles, which is normal for all medical products and does not represent damage to a patient’s health.”
The company also stated that it had voluntarily suspended sales of its products on the European market until local health authorities had received its official technical report. It noted that the “level of particles found is extremely low and complies with all of the markets”. It also confirmed that a risk analysis had been endorsed by Dr Wanda Elisabeth Massiere Y Correa, Coordinator of the Silicone Commission of the Brazilian Society of Plastic Surgery.
Silimed’s comments were prompted as a result of a release published in the UK on 23 September, which said The Medicines and Healthcare products Regulatory Agency (MHRA) together with European healthcare product regulators of member states had been informed that the CE mark for all of Silimed’s medical devices had been suspended following an inspection of its manufacturing plant in Brazil. The inspectors found the implants to be contaminated with fibres. The implants are thought to have been given to 20,000 women, according to a report by The Telegraph.
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