The UK’s health regulator has suspended the use of silicone implants made by the Brazilian company Silimed after some devices were found to be contaminated with particles, although the nature of the contaminant is not specified.
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An audit of the Silimed’s manufacturing practices revealed the contamination and now the Medicines and Healthcare Products Regulatory Agency (MHRA) and other European regulators are testing their products for further information.
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”.
“There has been no indication…that these issues pose a threat to patient safety, however we are advising our members to contact any patients who may be affected”, BAPRAS president Nigel Mercer said in a statement.
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 United Kingdom sales.
Silimed manufactures a wide range of devices used by Australian plastic surgeons, but breast implants are by far the most common.
Concerns have been raised about breast implants which were inserted into nearly 1,000 women over the last seven years.
The need for such a register was triggered by the PIP implant scandal in 2010 when the silicone-gel implants were banned internationally after their French manufacturer was found to have used cheaper, unapproved industrial-grade silicone.
“We don’t know any more at this stage, other than the manufacturing licence and Australian sales have been suspended”, said ASPS spokesman Dr Rod Cooter.
In its letter to surgeons, Silimed states that the particles “show low risk”. SIEN, -52.87% concerning the Company’s and its officers’ possible violations of federal securities laws in connection with Sientra’s alleged intentional misleading of investors regarding its compliance with relevant safety and production standards.
“We are urgently investigating this issue and are working closely with our European counterparts to decide whether there is any risk to health”.
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Silimed is the third-largest implant maker in the world, according to the company’s website.
