EU regulators crack down on Brazilian devicemaker for implant safety scare

MHRA Director of Devices John Wilkinson

European regulatory authorities are cracking down on Brazilian devicemaker Silimed, suspending sales of the company's silicone implants for plastic surgery in light of safety concerns.

The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA), along with other European regulators, is testing Silimed's devices including its breast implants, calf implants, penile implants and vaginal stents after a German authority, BfArM, uncovered contaminated products at an inspection of the company's Brazil manufacturing plant. There's still no word on whether the devices pose a threat to individuals with the implants. But for the time being, the MHRA is recommending holding off on implanting Silimed's products, it said in a statement.

"We are urgently investigating this issue and are working closely with our European counterparts," MHRA Director of Devices John Wilkinson said in a statement. "In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic."

Silimed is responding to the backlash, saying that it is planning to send European health authorities a note showing that its products meet national and international standards, the company told Reuters in an email.

But the news could deal a costly blow to Silimed, which relies on U.K. sales to bolster business. Eurosurgical, one of Silimed's distributors in Brazil, has supplied around 13,000 implants in the U.K. over the past 5 years, the company told Reuters. "The vast majority would have been breast implants, and around 60% of those would have been for use in cosmetic breast enlargement," Eurosurgical's Managing Director Peter Cranstone said, as quoted by the news outlet.

The latest action also follows a string of breast implant scandals in the U.K. and Europe. In 2010, French implant maker Poly Implant Prothèse (PIP) came under fire after medical authorities found that its breast implants were leaking, affecting thousands of patients in Europe and South America. The controversy sparked regulatory action and resulted in a four-year jail sentence for PIP President Jean-Claud Mas.

In February 2014, French company Cereplas faced a government-ordered recall in the country over its breast implant products. Regulators found that the company's devices came off the production line without being sterilized correctly and suspended sales in Australia pending further investigation.

- here's the MHRA statement
- read the Reuters story
- get the BfArM statement

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