Breast implant manufacturer suspends production, sales over contamination

European regulators discovered particles on Brazilian company Silimed's individual devices and implants, as well as at its production facility, during inspections.

By Stephen Feller

RIO DE JANEIRO, Oct. 5 (UPI) -- A Brazilian breast implant manufacturer shut down its production facility over concerns discovered by German regulators.

The German Notified Body and the United Kingdom's Medicines and Healthcare products Regulatory Agency in late September suspended Silimed after the surfaces of devices were found to be contaminated with particles of some type.


While an investigation is being conducted into what the particles are and how they ended up on Silimed's products -- which include silicone implants for breasts and other surgeries, implants for urology, and gastric bands and balloon bariatric surgery -- the Brazilian health agency, ANISA, asked the company to shut down its production facility in Rio de Janeiro.

The UK's MHRA said there are no urgent health risks with Silimed's products, the suspension of its CE certificates in the EU, an approval stamp required on all medical products in Europe, was done to establish whether the particles pose a health risk.

"There has been no indication at this time that these issues would pose a threat to patient safety," said John Wilkinson, director of the MHRA, in a press release. "We are urgently investigating this issue and are working closely with our European counterparts. 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 complying with the investigation to be sure its products are safe, however it noted in a press release that both the Brazilian and European health agencies have no "technical specifications" on the presence of either quantitative or qualitative levels of particles on devices.

"The technical literature, the risk analysis and also the post production surveillance show that over the years the presence of sterile particles -- which are not micro-organisms -- is common to all medical devices and it does not reveal any risk to patients' health," the company said in the release.

Silimed's products are available in 75 countries and it claims to be the third largest manufacturer of silicone medical products in the world.

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