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publicado em 05/12/2012 às 12h42:00
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Anvisa suspends distribution and sale of implants for reconstructive plastic

Decision regulatory agency ordered the suspension of the distribution, trading, disclosure and deploy throughout the country

 
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The National Health Surveillance Agency (ANVISA) determined as a measure of sanitary interest, suspension of distribution, trade, publicity and implant in any

Nationwide, the product Biossimetric (Implant for repairing plastic) in its different presentations, manufactured by MTC Medical Trade Industry Import and export of Biomedical Products. A decisão foi publicada no Diário Oficial da União.

According to yet Anvisa was determined gathering of all batches remaining on the market and not implanted Biossimetric product.

According to the text of the Board of the National Health Surveillance Agency, the agency certifies that the company does not manufacture the product according to the registration granted.

The inspection report investigative leads to a high degree of risk to the health of users.

The Biossimetric is a Polymethylmethacrylate where the particles are part of its microspheres between 45 and 65 microns. The product is homogeneous with pH equivalent to the body for reducing pain in application.

The representative of ERM Medical in Rio said it had not yet been informed and that still does not rule on the suspension.

Source: Isaude.net
   Palavras-chave:   Implant    Cosmetic filling    National Health Surveillance Agency    Anvisa    MTC Medical   
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