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article imageContamination risks halt use of Silimed implants in UK

By Karen Graham     Sep 24, 2015 in Health
The sale of silicone implants manufactured by Brazil's Silimed has been halted in the UK because of safety concerns, British medical regulators and suppliers announced on Thursday.
Silicone implants are used in thousands of patients in Britain and other parts of the world. Silimed's website points out it is first in Brazil, and third in the world in implant sales that include breast, penile and testicular implants. Their devices are exported to 75 countries worldwide.
Reuters reported on Thursday that the Medicines and Healthcare Products Regulatory Agency (MHRA) and other European regulators are testing Silimed's products after an audit of the company's manufacturing practices discovered contamination on some of the products.
A German authority was used to do the monitoring, and in a statement said it "has recently carried out an inspection of the manufacturing plant in Brazil and established that the surfaces of some devices were contaminated with particles."
The suspension of sales of Silimed devices covers an array of products, including breast and pectoral implants, urological devices including testicular and penile implants and vaginal stents, as well as other surgical devices, according to the MHRA. (Silimed has a catalog describing 5,000 products).
Eurosurgical is the distributor of Silimed products in Britain, and they have distributed over 13,000 implant products in the UK over the last five years. Eurosurgical's Managing Director Peter Cranstone told Reuters, "The vast majority would have been breast implants, and around 60 percent of those would have been for use in cosmetic breast enlargement."
According to the Daily Mail, an MHRA spokesman said they don't know if any contaminated products have reached patients, nor how many products are affected. "All those questions are part of our current investigations," he said.
But the MHRA statement said that "for the moment there has been no indication that these issues would pose a threat to the implanted person's safety."
Silimed responded to the allegations in an email, writing the company was preparing a technical note to show its products comply with national and international standards, and they would be sending it to European health authorities.
This product suspension comes after medical authorities in 2010 found that one of the world's leading breast implant manufacturers, France's Poly Implant Proth├Ęse (PIP), was not using medical-grade silicone in the devices, causing them to have double the risk of rupturing than other implants.
In the outcome to that investigation, which affected hundreds of thousands of patients in Europe and South America, PIP's president, Jean-Claude Mas, received a four-year prison sentence in 2013.
More about silicone breast implants, silimed, Contamination, audit of manufactoring plant, Eurosurgical
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