Clipping of news on Brazilian Culture, Law and Citizenship
02.10.2015
This article was translated by an automatic translation system, and was therefore not reviewed by people.
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Silicone prosthesis would have particles on the surface Photo: Juan Carlos Ulate / Reuters / File
The National Health Surveillance Agency (Anvisa) ordered the precautionary ban on all silicone implants Silimed brand. The temporary measure was taken after the company lost the CE Mark, European certification of quality products, on suspicion of the presence of particles on the surface of breast implants manufactured by Silimed.
In addition, ANVISA took into account an inspection carried out in Silimed implants industry in the period from 28 to 30 September, during which were identified non-compliances related to good manufacturing practices, which can be linked to the existence of particles on surfaces of breast implants.
The precautionary ban is a preventive approach that seeks to reduce risks and prevent damage to health. The manufacturer can still appeal the decision and request the opening of new tests to confirm or not irregularities. The ban is already in place from this Friday and will be valid for 90 days.
In the resolution published in the "Official Gazette" on Friday, Anvisa pointed out that there are no technical specifications on the qualitative and quantitative limits of particles on surfaces of breast implants, but it is necessary to carry out studies on the risks related to the use of prostheses with the presence of these particles.
Source: Extra
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This article was translated by an automatic translation system, and was therefore not reviewed by people.