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Regulatory Focus™ > News Articles > Brazil's Anvisa Introduces Additional Controls on Breast Implant Products

Brazil's Anvisa Introduces Additional Controls on Breast Implant Products

Posted 23 March 2012 | By Alexander Gaffney, RAC 

Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global scandal, reports Reuters.

"Health regulator Anvisa will require implants to be certified through the national quality control institute Inmetro to ensure products meet new criteria including physical strength, tear resistance and absence of toxic substances," wrote Reuters.

The new certification scheme and controls come after reports that implants manufactured by now-defunct French company Poly Implant Prothese (PIP) were not subject to adequate regulatory oversight, potentially engendering patients around the globe.

Reuters reports "manufacturers will be able to choose between certification through on-going pre-market tests on batches of their products, or on-site inspections of production processes that will come on top of existing factory inspections by Anvisa."


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Reuters - Brazil tightens quality controls on breast implants

 

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