The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the suspension of the CE certificate for all medical devices made by the Brazilian manufacturer Silimed.
This decision has been taken jointly with the European healthcare product regulators of all EU member states.
The verdict on Silimed comes in the light of an inspection of the manufacturing plant related to the company in Brazil.
This established that surfaces of some devices contained within the plant were contaminated.
MHRA continues to investigate the situation in partnership with other major European regulators.
It is recommended for the time being that none of the devices manufactured by Silimed listed below should be implanted until further advice is provided by regulators.
Although this action has been taken by the MHRA, the regulatory body has also been at pains to point out that no threat to patient safety has been established at the time of writing.
Silimed provides a range of implants, and there is no evidence to suggest that these should be considered unsafe, or that the the impartation procedure carried out with the products previously should be a cause for concern.
Nonetheless, health regulators from the European Union continue to test samples of products from the Brazilian manufacturer in order to establish if there are any health risks.
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
The MHRA monitors the health of all medical devices used in Europe, and it is generally impossible for a medical device to be marketed within the continent if it does not carry a CE mark of conformity.
This marking is applied by the manufacturer; an indicator that the device meets development regulatory requirements.
Speaking about the decision to suspend Silimed products, MHRA Director of Devices, John Wilkinson, struck a note of caution.
“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,” Wilkinson advised.