On Friday, ANVISA, the health regulation agency of Brazil announced that the production, sale and use of Silimed breast implants is currently paused.
The Brazil-based breast-implant producer has also declared that for the time being it has halted the production and sale of the breast implants that were found to be irregular in the European Union. The inspection is ongoing, yet it seems that production standards were not fully complied with in some product batches.
ANVISA made the announcement one week following the announcement of the German health regulation institution. According to the German declarations, the manufacturing surfaces that were subject to control were found to be contaminated with dangerous particles. Thus, the Silimed breast implants could become a danger to patients.
In Brazil, the move was described as a precautionary measure to allow authorities to further establish the facts. The Brazilian regulator also stated that all tests are carried out currently in order to assess the risks involved. Silimed announced that it is working closely with both the European regulators and the Brazilian one in order to come to a conclusion and resume production and sales of breast implants.
Silimed is the first producer of breast implants in Brazil. At the same time it ranks third on a global scale, while delivering the company’s products to over 75 countries.
The UK health regulator also took notice of irregularities in the manufacturing process at Silimed. According to the agency, the suspension of Silimed certificates in the European Union is also just a precautionary measure for the time being, while any risks to patients are being assessed.
John Wilkinson of the MHRA, commented:
“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. In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic”.
Official statements of Silimed indicate that while the company is complying with all required investigations, neither the European regulators, nor the Brazilian one have any technical specifications regarding the type of particles or the quantity found on the manufacturing lines. No patients reported irregularities with the Silimed breast implants.
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