Silicone breast implants in safety alert: Surgeons warned not to use one of the most popular brands over contamination fears
Silimed has told surgeons not to use its silicone gel-filled implants.
At least 10,000 Brits already have implants at centre of safety alert.
Silimed, world’s third-biggest implant maker, has had CE mark suspended.
By FIONA MACRAE SCIENCE CORRESPONDENT FOR THE DAILY MAIL
PUBLISHED: 23:58 GMT, 23 September 2015 UPDATED: 00:42 GMT, 24 September 2015
One of Britain’s most popular breast implant brands is at the centre of a safety alert.
Manufacturer Silimed has told surgeons not to use its silicone gel-filled implants until further notice due to contamination fears.
It is thought at least 10,000 British women already have the implants and the medical safety watchdog is urgently investigating whether anyone’s health is at risk.
At risk: It is thought at least 10,000 British women already have implants by manufacturer Silimed
All of Silimed’s other cosmetic surgery implants – including those designed to enhance the calves and buttocks – are also covered by the alert.
In a letter to cosmetic surgeons, the Brazilian firm says it ‘identified a potential source of particles’ during a safety audit. The type of particles is not known, but they were found to be contaminating the surface of some implants in the factory.
Silimed, the world’s third-biggest breast implant maker, has had its CE mark suspended and says that surgeons should not use its breast implants until further notice.
The government watchdog responsible for the safety of drugs and medical devices is taking the warning seriously.
John Wilkinson, of the Medicines and Healthcare products Regulatory Agency, said: ‘We are urgently investigating the issue and working closely with our European counterparts to decide whether there is any risk to health.
Stop: Silimed, the world’s third-biggest breast implant maker, has had its CE mark suspended and says that surgeons should not use its breast implants until further notice
‘In the meantime, we would recommend that people with these implants who have questions should seek advice from their surgeon or clinic.’
He added that there is no indication – at this time – that the contamination poses a threat to patients’ safety.
Although all of Silimed’s cosmetic implants are involved in the alert, it is thought that breast implants will make up the bulk of is UK sales.
The alert will alarm many of the 30,000-plus British women who have breast enlargements each year, many of whom will have no idea which brand of implant was used.
It also raises concerns about the regulation of the multi-million-pound cosmetic surgery scandal which is still reeling from another breast implant scare.
The sector was meant to be subject to tough new standards after 47,000 British women were fitted with cut-price implants which were fraudulently filled with an industrial-grade silicone meant for mattresses.
The French-made PIP implants were up to six times as likely to rupture as other brands.
Many women struggled to find out what sort of implant they had, far less get them removed or their money refunded.
In its letter to surgeons, Silimed states that the particles ‘show low risk’.
It adds: ‘It is important to know that no incident has occurred and our constant, long-term post-marketing surveillance has shown no alarming data.’
It says it is working to solve the problem and hopes that its CE mark – a sign that the implants meet European quality standards – will be restored as soon as possible.
Gabriel Robert, Silimed’s CEO, and Carolina Forte, the company’s quality manager, said that while they are not recalling the breast implants, surgeons should not use any until further notice.
The British Association of Aesthetic Plastic Surgeons and British Association of Plastic, Reconstructive and Aesthetic Plastic Surgeons said they were ‘not aware of any documented patient safety issues’.
A spokesman added that its surgeons are ‘working closely with the MHRA to further investigate the matter, as patient safety remains foremost’.
Read more: http://www.dailymail.co.uk/health/article-3246931/Silicone-breast-implants-safety-alert-Surgeons-warned-not-use-one-popular-brands-contamination-fears.html#ixzz3nKpfeIMH