Anvisa, Brazil’s health regulatory agency, announced Friday that it has suspended the production, sale and use of products from breast implant manufacturer Silimed after the company failed production standards in a recent inspection.
Brazil followed the decision of the European Union to ban the sale of Silimed’s silicone implants following a German investigation detecting contamination in the company’s manufacturing facility in Brazil.
Currently conducting tests on Silimed products for risk assessment, Anvisa called the ban a “precautionary measure.”
Silimed – now working with Brazilian and European authorities to reverse the bans – asserted in a statement that it has always adhered to the highest standards of quality, and that the existence of sterile particles does not equate to a health risk.
In the European Union, the suspension covers breast implants, vaginal stents, penile and testicular implants and other urological devices as well as a variety of surgical devices, according to Britain’s Medicines and Healthcare Products Regulatory Agency. The agency is still testing Silimed products and analyzing its manufacturing processes.
Other countries, such as Australia and Switzerland, have followed suit and called on plastic surgeons to postpone surgeries while health authorities are conducting their own investigation.
The Silimed ban in various countries is not the first time that breast implants were embroiled in controversy and subjected to government scrutiny.
In 2010, authorities found that France-based Poly Implant Prothèse, considered one of the top breast implant producers worldwide, did not utilize medical-grade silicone, and thus its products are believed to have twice the rupture rate of other implants. With thousands of implant users affected from Europe to South America, company head Jean-Claude Mas was given a four-year prison sentence in December 2013.
Silimed says it is the largest silicone implant manufacturer in South America and has been in the market for 37 years now.
With presence in over 75 countries around the world, the company claimed in an earlier statement that its products are safe and “the level of particles is extremely low and consistent with all markets.”