Silimed, a Brazilian manufacturer of silicone implants, is facing an investigation into the safety of its products over fears of contamination.
The Medicines and Healthcare products Regulatory Agency (MHRA) together with European healthcare product regulators of member states were informed that the CE certificate for all of Silimed’s medical devices had been suspended on 23 September, following an inspection of the Brazilian manufacturing plant where the implants are made.
The implants, which are designed for use in breasts, the chest, buttocks, calves and the face, as well as for gastric band and urology surgery, were found to be contaminated with fibres, the exact nature of which has not yet been announced. The implants are thought to have already been given to 20,000 women, according to a report by The Telegraph.
MHRA Director of Devices, John Wilkinson said: “There has been no indication at this time that these issues would pose a threat to patient safety. We are urgently investigating this issue and are working closely with our European counterparts. In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic.”
However, in a report by The Guardian, Silimed is said to have explained that there is “no need for a recall at the moment and that the issue was restricted to the European Union”. Silimed is reported to be preparing a “technical note” to demonstrate its products are compliant with national and international standards.
The British Association of Aesthetic Plastic Surgeons (BAAPS) and British Association of Plastic, Reconstructive and Aesthetic Plastic Surgeons (BAPRAS) have been informed that plastic surgeons should not implant Silimed’s devices until further assessments have taken place and the CE mark is reinstated. The CE mark is a symbol that a product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
Surgeons from both BAAPS and BAPRAS are said to be working alongside the MHRA to further investigate the matter.