Particles were found on Silimed silicone-based breast implants that should not be there. These included man-made mineral fibres, such as glasswool and rockwool. The health risk of these particles is minimal. These are the findings of research conducted by RIVMNational Institute for Public Health and the Environment , commissioned by the Dutch Health Care Inspectorate (IGZ) and other European health care authorities.
Reason for this study
The notified body TÜV SÜD Product Service GmbH is responsible for the market acceptance (by providing a CE-certificate) of Silimed medical devices. Last year, TÜV SÜD conducted an inspection at Silimed. During this visit, particles where found on the surface of Silimed breast implants. Therefore, the notified body suspended Silimed’s CE-certificate in September 2015. Following this, RIVMNational Institute for Public Health and the Environment performed a study on the health risks of these man-made mineral fibres. The Dutch Health Care Inspectorate (IGZ) and other European health care authorities commissioned the study.
The study showed the presence of man-made mineral fibres (MMMF), such as glasswool and rockwool, on the surface of implants. The amount of MMMF’s found was small. The worst case scenario shows a chance of 1 in a million that adverse health effects may occur.
Since silicones tend to attract dirt, RIVM urges manufacturers to pay more attention to this property in the manufacturing process.