Implants withdrawn in Britain over contamination fear

IMPLANTS given to 20,000 women in Britain have been withdrawn after watchdogs warned they could be contaminated.

The silicone implants have been used in thousands of operations, including breast implants, calf implants and gastric band surgery. The Medi- cines and Healthcare products Regulatory Agency (MHRA) has been informed of the suspension of the CE certificate for all medical devices made by the Brazilian manufacturer Silimed.

A medical device cannot be marketed in Europe without carrying a CE mark of conformity, which shows it has complied with European directives.

An inspection of the manufacturing plant in Brazil established that the surfaces of some devices were contaminated with particles. A spokesman for the MHRA said last night that an urgent investigation is being carried out to discover what the particles are.

“Fibres have been discovered on the products which should not be there,” he said. “It is as a result of the production process and we are examining whether the products are contaminated. We emphasise that for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety.”

The use of all the implants produced by Silimed has been suspended. John Wilkinson, of the MHRA, said: “We are urgently investigating this issue and are working closely with our European counterparts to decide whether there is any risk to health. In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic.”

Plastic surgeons have been informed not to implant the devices until further assessments have taken place and the CE mark reinstated.