U.K. halts use of Silimed breast implants amid contamination fears

(Reuters) — Sales of silicone implants made by Brazil’s Silimed and used in thousands of patients in Britain have been suspended due to safety concerns, British medical regulators and suppliers said today. The Medicines & Healthcare Products Regulatory Agency (MHRA) said it and other European regulators are testing Silimed’s products – which include breast, penile and testicular implants – after contamination was detected during an audit of the company’s manufacturing practices. A German authority appointed to monitor Silimed “has recently carried out an inspection of the manufacturing plant in Brazil and established that the surfaces of some devices were contaminated with particles,” 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. Eurosurgical, a company which distributes Silimed’s products in Britain, said it had supplied around 13,000 implants in the U.K. over the past 5 years. “The vast majority would have been breast implants, and around 60% of those would have been for use in cosmetic breast enlargement,” managing director Peter Cranston told Reuters. A spokesman for the MHRA said the agency didn’t yet know whether any potentially contaminated products would have reached patients, and did not know h...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cosmetic/Aesthetic Regulatory/Compliance Urology Women's Health Medicines & Healthcare products Regulatory Agency (MHRA) Silimed Source Type: news