BfArM warns against possible contamination of silicone implants

Silicone Implants of the manufacturer Silimed potentially contaminated
After the so-called CE certificate was withdrawn for implants of the manufacturer Silimed, the Federal Institute for Drugs and Medical Devices (BfArM) warns against further use. Inspections of the production site in Brazil by TÜV Süd recently revealed contamination with particles on the surface of some products, according to the BfArM communication. Patients are advised to contact their treating doctor with their questions regarding the implants.

Together with other European health authorities such as the British Medicines and Health Care Products Regulatory Agency (MHRA), the BfArM has informed about the suspension of the CE certificate (EC certificate) for all medical devices of the manufacturer Silimed. The certificate is a prerequisite for distribution within the European Union. The suspension of the certificate will affect many different types of silicone implants, including breast, testicular and penile implants. The BfArM advises not to implant these products until further notice.
The Federal Institute for Drugs and Medical Devices (BfArM) warns of possible contamination of Silimed implants. (Image: hikdaigaku86 / fotolia.com)

Risks so far unclear
In the current press release, the BfArM also provides an overview of the affected products, such as the silicone implants for plastic surgery, for bariatric surgery, for urology or for general surgery. What health risks can emanate from the implants remains unclear. So far, the BfArM claims to have received only a report on incidents with the products of the manufacturer Silimed. However, there was no indication that this message was due to particulate contamination. The extent to which potentially contaminated products have reached patients is unclear, according to a spokesperson for the UK's MHRA. How many affected persons were implanted with corresponding Silimed products must be clarified by further investigations. In addition, analyzes of product samples have been initiated by the EU Health Inspectorates to determine whether health risks stem from the implants.

Suspension of the CE certificate
After the scandal surrounding the inferior silicone breast implants of the French manufacturer Poly Implant Prothèse (PIP), in which hundreds of thousands of patients use silicone cushions made of low-grade industrial silicone, which subsequently caused more serious complications, the health and supervisory authorities seem to be increasingly sensitized across Europe. By suspending the CE certificate for the Silimed products, potential risks to patients should be avoided. (Fp)