Selling of silicone breast implants by Brazilian maker Silimed has been suspended in the European Union following contamination reports. Australian and New Zealand regulators have followed suit and issued similar warnings.
Silimed products have come under fire after a German investigation detected foreign matter on the surface of breast implants in a Silimed manufacturing facility in Brazil.
In a statement, the German authority said it carried out the inspection and "established that the surfaces of some devices were contaminated with particles."
The suspension covers plastic surgery devices such as breast and pectoral implants; testicular and penile implants, vaginal stents, and other urological and surgical devices, according to Britain's Medicines and Healthcare Products Regulatory Agency (MHRA), which is currently testing Silimed products and reviewing its manufacturing practices.
Through a statement from its president Nigel Mercer, The British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) said it is aware of the Silimed concern, working closely with British regulators, and advising its members to contact any potentially affected patients.
The Australian government has also warned plastic surgeons against using the popular Brazilian brand of implants, with the Australian Therapeutic Goods Administration (TGA) conducting its own investigation.
As a precaution, distributor Device Technologies has stopped supplying the devices to the Australian and New Zealand markets and recommended surgeons who received the implants to postpone surgeries in the meantime. New Zealand's Medsafe has made the same move.
Saying it has been in the market for 37 years and exporting to more than 75 countries worldwide, Silimed asserted the safety of its products - and that "the level of particles is extremely low and consistent with all markets" in a statement to the AFP.
The company added that in the European Union, there are "no criteria to define particulate levels" to be able to create a "completely subjective analysis."
In 2010, medical authorities found that France's Poly Implant Prothèse (PIP) - one of the leading breast implant makers in the world - was not using medical-grade silicone in its products, which had double the rupture rate of other implants.
PIP president Jean-Claude Mas was sentenced to four years in jail in December 2013, with hundreds of thousands of implant users affected across Europe and South America.
