Independent testing concludes particles found on Silimed implants do not represent a significant increased health risk for implanted patients

News Category: Regulatory news

Date: 17/10/2016

Patients advised that there is no need for removal of affected implants

The HPRA today confirmed that the results of a risk analysis published by the Dutch National Institute for Public Health and the Environment (RIVM) indicate no significant increased health risk from particles detected on Silimed silicone breast implants. The presence of particles was discovered in 2015 during an inspection of a Silimed manufacturing plant. Based on the results of testing and an independent risk analysis published today, patients are advised that there is no need for removal of affected implants. If patients do have any concerns regarding their implants they should contact their implanting surgeon or clinic.  

In September 2015, the German notified body responsible for the certification of Silimed implants, TÜV SÜD, suspended the CE certification for medical devices manufactured by the company. 

A communication was issued by the HPRA on 24 September 2015 which noted that preliminary testing did confirm the presence of particles on implants. The advice of the HPRA at that time was recipients of implants did not need to take any action and that the regulatory measures being introduced were precautionary in nature. The HPRA indicated that, in conjunction with other EU health regulators, it would commence efforts to determine any health risks associated with the presence of these particles, which resulted in the publication of today’s report. 

European health regulators asked RIVM to conduct independent testing of Silimed breast implants retrieved from European clinics prior to being implanted. Testing revealed that foreign particles were present on implants. 

The RIVM risk analysis found that, given the small amounts of particles present, there is no additional risk of inflammation or scarring. The RIVM report also considered the risk of cancer due to exposure to particles on the surface of affected Silimed breast implants. It concluded that based on the scientific evidence available the additional cancer risk associated with exposure to these fibres was not significant. 

Based on the RIVM risk analysis, the HPRA position remains that there is no reason for patients to consider removal of Silimed breast implants as a result of this issue. The risk associated with surgery is far higher than any health risk associated with the implants. People who are experiencing clinical symptoms associated with their breast implants or that are concerned should seek advice on follow up from their implanting surgeon.


Further Information:
View the HPRA's previous communication regarding Silimed devices covered by the suspended CE certificate. 

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