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UK Healthcare Regulator Suspends CE Certificate for Medical Devices Manufactured by Silimed

Posted on 28 September 2015

The Medicines and Healthcare Products Regulatory Agency (MHRA) has, along with other European product healthcare regulators, suspended the CE certificate for all medical devices manufactured by by Brazil based company Silimed.

Silimed is the largest manufacturer of silicone implants in South America and exports its devices to more than 75 countries worldwide, these include breast and pectoral implants, urological devices including testicular and penile implants and vaginal stents, as well as other surgical devices.

Surgeons have been told to stop using implants manufactured by Silimed and that they may have to contact patients implanted with Silimed products.

The announcement was prompted by the decision of inspectors to revoke Silimed’s CE mark after finding that some implants were contaminated by unknown particles whilst at a factory.

The MHRA has advised that they are investigating this as a matter of urgency. MHRA Director of Devices, John Wilkinson said:

“There has been no indication at this time that these issues would pose a threat to patient safety.” However, he recommended that people who have questions about their implants should seek advice from their implanting surgeon or clinic.

Eurosurgical, a company which distributes Silimed's products in Britain, said it had supplied around 13,000 implants in the UK over the past five years.

Jill Paterson, Partner in the Consumer Law and Product Safety team at Leigh Day said:

“Whilst this news may bring to mind the PIP breast implant scandal, the implications of this contamination are potentially much more extensive, with other products such as gastric bands and balloons involved.

“Implants used for plastic surgery throughout the body and for general surgery, including blocks and sheets, may also be affected.

“The fact that these devices were used widely in NHS surgeries widens the scope of people who could potentially be affected. It is unclear at this stage what the contaminant is, if it is dangerous, or the severity of the contamination.”