The health regulator in Brazil has decided to suspend the operations of one of the biggest manufacturers of silicone implants in South America allegedly for not meeting quality standards.
Anvisa has announced on Friday, Oct 2, that it has prevented Silimed from selling, producing, and using its silicone products following the ban issued by European regulators.
During the last week of September, the Medicines and Healthcare Products Regulatory Agency (MHRA) along with the agency representatives of the member states issued a withdrawal of no less than 20,000 implants after they believed that the product had been contaminated. It also suspended the CE mark of the products. With no CE mark, the device will not be allowed in European countries. Women who had received implants were then requested to approach their surgeon for more information.
During their inspection of the products, they discovered the presence of fiber-like particles that should not have been there. Their inspection of the Silimed breast implant facility in Brazil yielded the same contaminants, which were found in a number of the surfaces used for the manufacturing of the product.
However, the European regulators stressed that so far, the products that were used didn't have any indication of possible health issues, but they continue to investigate the possible health implications.
Anvisa, on the other hand, explains that the ban is to allow them to conduct a more thorough investigation and assess the health risks.
On its part, Silimed has already issued a statement, saying that quality is always its utmost priority. The company, which also manufactures penile implants, believes that sterile particles in the implants do not pose any health risk, but it will continue to work with the different health regulators for decision reversal.
Silicone implants are commonly being used in cosmetic surgeries, especially in breast, calf, and butt. The implants, filled with silicone gel, are preferred by many over saline because they feel more natural, with the gel mimicking the breast's fatty tissue.