UK Regulator Suspends Sale Of Silimed Silicone Implants

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.

If you or a loved one has suffered due to PIP breast implants, our expert personal injury solicitors could help you claim compensation. View our PIP Breast Implants Claims page for more information.

Expert Opinion
“It is encouraging to see notified bodies taking proactive action to carry out inspections of medical device manufacturing sites and we are happy to see that some lessons have been learned following the PIP Breast Implant Scandal.

“When there is a safety breach then the public’s health and wellbeing should always be the number one priority whatever the issue. That being said, this will be a worrying time for many women who have these implants and we call for the regulatory investigations to be carried out as quickly as possible.

"It is worrying to see further breast implant products being recalled, especially only a few years after the PIP scandal. Answers need to be provided to inform the public how long these non-compliances have been occurring and there should be complete transparency in the investigation to ensure users of these products can be protected.

“Research earlier this year from Irwin Mitchell suggests that up to four in every ten Brits are considering having plastic surgery. With millions of adults going under the knife it is crucial that these surgeries are performed correctly and the implants they use are completely safe. It’s very difficult to undo or correct a procedure which has gone wrong.

“It is vital that health companies take all the necessary steps to protect the public and enforce rigorous safety standards during all stages of their production process. The company should be doing their own investigation to find out how this has occurred and take steps to ensure it will never happen again.

We hope this will reignite calls for a government backed breast implant registry”
Kevin Timms, Solicitor