Brazil tightens breast implant regulations

May 11, 2012

Brazil tightens breast implant regulations
Brazil tightens breast implant regulations

Breast augmentation surgery is a popular procedure throughout the world, especially in Brazil. Now regulators in the South American country are tightening their regulations on breast implants. The country's National Health Surveillance Agency (ANVISA) temporarily suspended the import of foreign implants, but then shifted their plan, and developed more stringent testing rules to ensure the quality of all products available. Will these mean some Brazilian citizens will be traveling to the U.S. and other nations to undergo the procedure?

According to Reuters, all implants sold in Brazil will now have to undergo testing to guarantee their physical strength, tear resistance and absence of toxic substances.

"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," Reuters reported.

The New York Daily News reports that the certification process could take up to two weeks.

The more stringent rules come in the wake of the recent French PIP implant scare that affected patients worldwide. The company, Poly Implant Prothese, is accused of using industrial-grade silicone as a filler. In addition, they are believed to be prone to leaking and rupturing and may cause various illnesses in those who have them. Jean-Claude Mas, owner of the company that manufactured the faulty implants, now faces charges, according to the BBC.

As many as 400,000 women worldwide had the implants before they were pulled from the market, and authorities revealed their potential for health problems, according to the news station. They were not sold in the United States.

According to the American Society for Aesthetic Plastic Surgery, breast augmentation surgery remained one of the most popular surgical cosmetic procedures in 2011,with more than 316,000 performed by ASAPS members.

Many women who choose to have the surgery do so to improve the size and shape of their breasts and to improve their self-esteem.

The mission of the Aesthetic Society includes medical education, public education and patient advocacy. Plastic Surgery News Briefs are summaries of current stories found through various news and magazine outlets that relate to or mention plastic surgery and cosmetic procedures. The views expressed in these news articles do not necessarily reflect the opinions of the Aesthetic Society, but are merely published as an educational service to our members and the general public. For additional information on these subjects and other plastic surgery related topics, please go to

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