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ANVISA: French brand breast implants have an easier time of rupture, but are not toxic

03/07/2012

This article was translated by an automatic translation system, and was therefore not reviewed by people.


 


Carolina Pimentel
Reporter Agency Brazil


Brasilia - Tests conducted by the National Agency of Sanitary Surveillance (ANVISA) show that silicone breast implants from French brand Poly Implants Prothese (PIP) used in Brazil are more easily break, but are not toxic.

Of the 306 samples of imported brand implants analyzed, 41% have failed the test of resistance. The tests also revealed the use of silicones different composition, some not authorized by the Health Surveillance and at high risk of leak and cause inflammation.

The gel used in the products of PIP, however, was not toxic, as noted Anvisa. "They are broken beyond what is expected, what is guaranteed when it is expected," said Dirceu Barbano, chief executive of the regulator.

The results are similar to ANVISA announced by the British Health Service (NHS, its acronym in English) last month, indicating that the implants do not offer the brand health risks.

Two years ago, there were reports of PIP products wore industrial silicone, were at high risk of rupture and could cause cancer. At the time, in several countries, like France, which housed the headquarters of the company, women were instructed to remove the prosthesis brand. Last year, the court ordered the arrest of the owner of the PIP.

Given the global scandal, ANVISA has banned the import and sale of breast implants IPP in the country. It was agreed that the National Health System (SUS) and health plans should cover the exchange of the implants ruptured. From there, companies interested in importing and selling silicone breast in Brazil should have a seal of the National Institute of Metrology, Quality and Technology (Inmetro). Last week, Inmetro granted the first certificate to a local manufacturer, the Lifesil, located in Parana.

In total, 18 plants should be evaluated by ANVISA. Since the beginning of the controversy with the PIP, 15 manufacturers were inspected by technicians from ANVISA, 13 and two foreign nationals. However, only Lifesil can sell dentures, so far, in the Brazilian market, being the only one to have the seal of quality Inmetro.

ANVISA has not done testing of implants Rofil Dutch brand, which also used the same type of silicone PIP because the importer had no copies of the trademark in stock.



Source: Agency Brazil

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This article was translated by an automatic translation system, and was therefore not reviewed by people.

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