The Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the CE certificate for all medical devices made by Brazilian manufacturer Silimed.
A CE mark is applied by the manufacturer and means that the device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.
The devices covered by the suspended CE certificate include:
- silicone implants for general and plastic surgery
- gastric bands and balloons
- implants for urology
The MHRA is investigating the matter in collaboration with other European regulators and recommends that none of these devices should be implanted until further advice is issued. EU health regulators have initiated testing of samples of products to establish if there are any health risks.
At Spire Healthcare, we are reviewing our systems to identify how many of the potentially affected products have been supplied to us, and when and where these were used. Until the investigation is complete, Spire Healthcare’s use of Silimed implants remains on hold.
The MHRA emphasises that for the moment there has been no indication that these issues would pose a threat to patient safety, but if you are worried about a procedure that you have had at a Spire hospital, please contact the hospital direct.