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Silimed silicone implants use halted
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Britain鈥檚 health regulator has suspended sales of silicone implants made by Brazil鈥檚 Silimed due to contamination, and recommends none of the devices, including breast, penile and testicular implants, be used until further notice.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said it and other European regulators are testing Silimed鈥檚 products after contamination was detected during an audit of the company鈥檚 manufacturing practices.
A German authority appointed to monitor Silimed 鈥渉as recently carried out an inspection of the manufacturing plant in Brazil and established that the surfaces of some devices were contaminated with particles,鈥 it said in a statement.
The Silimed suspension covers devices used in plastic surgery such as breast and pectoral implants, urological devices including testicular and penile implants and vaginal stents, as well as other surgical devices, the MHRA said.
A spokesman for the MHRA said it did not yet know whether any potentially contaminated products would have reached patients, and did not know how many Silimed products might be affected. 鈥淎ll those questions are part of our current investigations,鈥 he said.
The MHRA statement said however that 鈥渇or the moment there has been no indication that these issues would pose a threat to the implanted person鈥檚 safety.鈥
鈥淓U health regulators have initiated testing of samples of products to establish if there are any health risks,鈥 it said.
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