Regulators recommend that devices including breast and penile implants should not be used until further advice is issued.European regulators have urged people not to use implants made by a Brazilian company after a factory inspection found some may have been contaminated.
The medical devices manufactured by Silimed include silicon breast, pectoral and calf implants.Testicular and penile implants as well as gastric bands and gastric balloons are also affected by the alert.
Regulators have suspended the CE certificate for the products. In general, a medical device cannot be marketed in Europe without a CE mark.
The mark shows it meets the relevant regulatory requirements, and works properly and is safe.
During an inspection of the company's manufacturing plant in Brazil, German regulators found the surfaces of some devices were contaminated with particles.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) along with European counterparts have recommended none of these devices should be implanted until further advice is issued.
They say that at the moment there is no safety threat and tests are being carried out on samples of products to find out if there are any health risks.
MHRA director of devices John Wilkinson said: "There has been no indication at this time that these issues would pose a threat to patient safety.
"We are urgently investigating this issue and are working closely with our European counterparts to decide whether there is any risk to health.
"In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic."
Silimed did not immediately comment on the MHRA announcement.
Silimed is the third-largest implant maker in the world, according to the company's website.
It is not the first scare involving silicon implants.
In 2012, breast implants made by French firm Poly Implant Prothese (PIP) were found to contain substandard, industrial-grade silicone gel.
Some 300,000 women in 65 countries were believed to have received the faulty implants. Read more
Implants given to thousands of patients suspended over contamination fears
Suspension of devices manufactured by Silimed
This isn`t the 1st Time For Silimed Either In 2012 !!!!!
Now German implants spark cancer fears for 20,000 British women
One of the country’s top private hospital chains has warned surgeons not to use a second type of breast implant because of fears it could be linked to cancer.
Following the scandal over faulty PIP implants, a senior manager at Nuffield Health has written to doctors advising them not to offer patients a product called Silimed and to quarantine existing stocks. The Silimed implants, which may already have been fitted in as many as 20,000 women in the UK, have a coating which previous studies have found could release a cancer-causing toxin into the body over a number of years.
Read more
The Cancer Prevention and Treatment Fund Responds to the Silimed Breast Implant Scandal
