Brazil said Wednesday it has temporarily suspended the import of breast implants pending quality control tests in the wake of last December's health scare over defective French-made implants.
A spokeswoman for the National Health Surveillance Agency (ANVISA) said a resolution had been approved to insist that the implants be allowed into the country only after quality certification.
ANVISA set minimum requirements for the implants, which means they will have to go through laboratory testing to verify material resistance, silicone composition and biological trials, a statement said.
The agency said the certification process might take two weeks.
In December, Brazil banned French-made PIP and Dutch-made Rofil silicone implants over their potential rupture risks.
Breast implants produced by the now-bankrupt Poly Implant Prothese (PIP) were banned in Brazil in April 2010 when problems were first reported, but 25,000 implants had already been performed, according to ANVISA. Around 100,000 women get silicone breast implants in Brazil each year.
PIP was shut down and its products banned in 2010 after it was revealed to have been using industrial-grade silicone gel that caused abnormally high rupture rates.
Some 300,000 women in 65 countries are estimated to have had PIP implants and more than a dozen countries in Europe and Latin America urged women to have checkups.
Jan 12, 2012
