* Regulator sets minimum standards for breast implants
* Lot-by-lot inspections or more factory checks planned
* Checks respond to global scare over faulty PIP implants
By Peter Murphy
BRASILIA, March 22 Brazil will introduce
tightened controls on sales of breast implants including
lot-by-lot testing, the government said on Thursday, after
thousands of defective French implants were sold in the country
and across Latin America.
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.
Previously, no specific standards existed for breast
implants in Brazil beyond the proforma criteria that exists for
health products in general, an Anvisa spokesman told Reuters.
Around 25,000 implants produced by now-defunct and bankrupt
French company Poly Implant Prothese (PIP) were sold in Brazil
and 300,000 worldwide. They were taken off the market in Brazil
in December after it was discovered they were made with cheap
industrial silicone, making them prone to rupturing and leaking.
The founder of the company, Jean-Claude Mas, is now in jail
and facing both civil suits and criminal charges of bodily harm
in France. Hundreds of women in France, Venezuela and elsewhere
are preparing to sue surgeons and importers of the implants.
Brazilian lawyer Anderson Macohin said he intends to sue
Anvisa on behalf of 34 PIP wearers for failing to prevent the
products reaching the market. Anvisa argues PIP stopped using
approved clinical silicone after it inspected the factory.
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.
The more stringent rules will apply to any new implant
product seeking to launch in Brazil. Existing brands will also
be subject to the new tightened checks once their five-year
licenses come due for renewal, the Anvisa spokesman said.
(Editing by Anthony Boadle)