UK Halts the use of Silimed Silicone Implants
About the Silicone Implants
Sales of Brazil's Silimed silicone implants have recently been suspended in the United Kingdom amid safety concerns from medical regulators. Silimed is the largest manufacturer of silicone implants in South America, exporting devices to more than 75 countries worldwide.
After contamination was detected in the company's manufacturing practices, the Medicines and Healthcare Products Regulatory Agency (MHRA) has initiated testing of Silimed's products for potential health risks. Products include breast, penile and testicular implants.
The suspension of Silimed also covers devices used in plastic surgery.
Currently, there has been no announcement concerning whether sales will also be suspended in the United States.
Reports of Particle Contamination Remain Under Investigation
A German figure that monitors Silimed inspected its manufacturing plant in Brazil and agreed that “the surfaces of some devices were contaminated with particles”.
The MHRA is currently investigating whether any contaminated products reached patients as well as how many products could be affected.
British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) says they are aware of the Silimed issue and are working closely with British regulators.