Anvisa requests the recall of breast implants due to manufacturing irregularities

The National Health Surveillance Agency (Anvisa) determined the recall and ban on the sale of batches of breast implants with silicone gel manufactured from May 19, 2021 by the Chinese company Guangzhou Wanhe Plastic Materials. Check Anvisa’s determination.

The National Institute of Metrology, Quality and Technology (Inmetro) suspended the product’s Certificate of Conformity. The certificate is responsible for evaluating technical aspects, such as composition and resistance of the product.

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Anvisa reported that irregularities were found in relation to good manufacturing practices for breast implants. The discovery was made during an audit of the Chinese manufacturer.

“In Brazil, breast implants have a specific control regime and, therefore, in addition to registration with Anvisa and the need for Certification of Good Manufacturing Practices, they must also undergo the certification of conformity made by Inmetro. […] The sanitary measures adopted have the objective of reducing possible sanitary risks that could affect the quality of the product”, states the note.

Anvisa requests the recall of breast implants due to irregularities. Image: Marcelo Camargo/Agência Brasil

Anvisa asked people who implanted breast implants to maintain the postoperative routine and talk to the surgeon in charge. “The measure seeks to reduce risks already foreseen for this type of product. The units of the product that are not deployed must be separated and cannot be used”, he adds.

In December 2021, the regulatory agency had ordered the recall of some batches of the SCI-ESTHE breast implant that is produced by the same company.

After the announcement that batches of drugs with the active ingredient losartan were recalled by pharmaceutical Sanofi Medley, the National Health Surveillance Agency (Anvisa) released another statement clarifying doubts about the drug and its recall.

Via: Anvisa

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