Brazil Tightening Breast Implant Rules

Brazil is one of the major world centers for plastic surgery, but some of the country’s regulators fear that the country lacks sufficient mechanisms to ensure the safety of breast augmentation patients. According to a recent article by the American Society for Aesthetic Plastic Surgery, Brazilian regulators are bringing new rules in place that will ensure greater oversight for breast implants.

While the United States was unaffected by the PIP breast implant scandal that rocked Europe last year, its implications continue to reverberate throughout many other parts of the world. After French breast implant manufacturer Poly Implant Prothese was found to have been using industrial-grade silicone in its breast implants, there was a massive outcry, as about 400,000 women were affected. The implants had been sold in many countries throughout the world.

Brazil’s National Health Surveillance Agency (ANVISA) temporarily stopped imports of foreign implants after the PIP scandal broke. Soon afterwards, however, they changed their approach by developing new testing rules. Breast implants sold in Brazil will now have to undergo new testing procedures to ensure strength, durability, and safety.

According to Reuters, “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.”

Despite these new rules, many prospective patients may nonetheless wish to seek their plastic surgery in the United States, where only three silicone-filled breast implants have been approved by the FDA. None of these implants were implicated in the PIP scandal.

The ASAPS article suggests that many Brazilians may decide to simply fly to the United States in order to receive breast implants. To date, the FDA has only approved three silicone breast implants for use in the US, none of which were implicated in the PIP scandal. As elective medical devices, they are subject to the highest scrutiny, and it can take months or even years for a new breast implant to be approved. Filled with either saline or silicone, breast implants are most often used for augmentation surgery, but are also used for breast reconstruction.

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Posted in: Breast Enhancement

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