Clipping of news on Brazilian Culture, Law and Citizenship
01.29.2016
This article was translated by an automatic translation system, and was therefore not reviewed by people.
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Anvisa authorized the company Silimed implants Ltda. to resume marketing and use (implants procedure) of their products (breast implants). After analysis and risk assessment on the presence of surface particles identified in these prostheses, the Agency concluded that there is no evidence that the presence of such particles in silicone implants represent additional risk which is inherent in the product. However, Silimed is still prevented from manufacture and market new batches of implants until new inspection be performed to re-evaluation of compliance with good manufacturing practices.
Anvisa, together with the Health Surveillance Secretariat of Health of the State of Rio de Janeiro, held in September 2015, an inspection in Silimed, as were non-conformities identified with Good Manufacturing Practices, as recommended by the DRC 16 / 2013. As a result, the Health Surveillance of SES-RJ ordered the suspension of the manufacture of all the company's products.
In turn, the Anvisa has taken some precautions:
• precautionary Prohibition (for 90 days) the marketing and use (production of the implant procedure), through the RE No. 2759 of 01/10/2015, of all implantable products manufactured by Silimed. This ban, which expired on 01.02.2016, allowed the Anvisa perform risk assessment and decided to allow the products to be marketed normalmente.Toda precautionary ban is valid for 90 days and this term Anvisa deepens the risk analysis ;
• Cancellation of the Good Manufacturing Practices Certificate in view of non-compliance with Good Manufacturing Practices requirements, detected during the inspection conducted in September;
• Sample collection for fiscal analysis of various products in order to assess the conformity of manufactured products (in progress).
Even with the authorization for the Silimed return to market their implants have produced and who were interdicted, it is worth noting that Anvisa continues to monitor the quality and safety of these products. The Agency stresses the importance of the notification by the company, services or health professionals of adverse events or complaints related to the use of breast implants. Any change in the safety profile of these products will be reported to the population.
Silimed was the temporary suspension of the European Certificate (EC) recommended by the certification body of Germany, TÜV Sud. The EC allowed the trading company of medical devices in Europe.
Anvisa maintains constant contact with foreign regulatory authorities on the issue and, to date, Anvisa has not received any adverse event case notification abroad due to the use of implants produced by Silimed and related to the problem investigated. Thus, there is no need to adopt any procedures for those patients who have received them.
Source: Anvisa
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This article was translated by an automatic translation system, and was therefore not reviewed by people.