Suspension of devices manufactured by Silimed
23 September 2015
CE certificate for all medical devices made by Brazilian manufacturer Silimed suspended.
The Medicines and Healthcare products Regulatory Agency (MHRA) jointly with European healthcare product regulators of member states has been informed of the suspension of the CE certificate for all medical devices made by the Brazilian manufacturer Silimed. The German notified body, has recently carried out an inspection of the manufacturing plant in Brazil and established that the surfaces of some devices were contaminated with particles. The devices covered by the suspended CE certificate are implants for:
- silicone implants for plastic surgery: implants: breast implants, pectoral implants, gluteal implants, calf implants, implants for hand surgery, tissue expanders, facial implants, nostril retainers, suspension sheets for breast surgery
- bariatric surgery: gastric bands and balloons
- implants for urology: testicular implants, penile implants, vesical conformers, periurethal constrictors, tubes for hypospadias, vaginal stents
- silicone implants for general surgery: blocks and sheets
- silicone invasive devices: sizers for silicone implants
MHRA is investigating in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued.
We emphasise that for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety. EU health regulators have initiated testing of samples of products to establish if there are any health risks.
See: https://www.gov.uk/government/news/suspension-of-devices-manufactured-by-silimed for the complete Press Release.