Contamination Found At Company’s Manufacturing Plant

Specialist product liability lawyers at Irwin Mitchell have welcomed the swift action taken by the UK’s health regulator to suspend sales of silicone implants made by Brazilian company Silimed.

The Medicines and Healthcare Products Regulatory Agency (MHRA) and other European regulators are now urgently testing the products after contamination was found on some devices during a routine inspection of the company’s manufacturing plant in Brazil.

Silimed is the third-largest implant maker in the world and claims to have the largest and most diverse line of products for the plastic surgery market. They have a range of over 5,000 items that are exported to over 75 countries in five continents.

It has been recommended that none of their products are used by surgeons until further testing has been completed and an update is issued from the MHRA. This includes all silicone face, breast and urological implants, as well as other surgical devices.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. They are urging caution at the moment stating that “there has been no indication at this time that these issues would pose a threat to patient safety”.

In the meantime, people who have questions about their implants are being urged to seek advice from their implanting surgeon or clinic.

Silimed is preparing a technical note to show that its products are in compliance with national and international norms and standards, and have confirmed they will be sending this to the European health authorities.

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