Plastic surgeon Denis Boucq poses at his office in a clinic in Nice December 16, 2011, holding a defective silicone gel breast implant, which was removed from a patient and manufactured by French company PIP.
Plastic surgeon Denis Boucq poses at his office in a clinic in Nice December 16, 2011, holding a defective silicone gel breast implant, which was removed from a patient and manufactured by French company PIP. Reuters

Breast implant manufacturer Silimed has been barred from producing and selling its products after the company failed to meet the production standards during an inspection carried out by Brazil's health regulatory agency, Anvisa.

Anvisa announced its decision to suspend the use of the Silimed's breast implants on Oct. 2, 2015. The decision came soon after the European Union announced its plan to ban the sale of the breast implants following an investigation carried out by a German team which detected the contamination in Silimed's manufacturing unit in Brazil.

Describing the ban as "a precautionary measure," Anvisa is currently conducting a series of risk assessment tests on the products manufactured by Silimed. Reuters reports that a recent inspection conducted by Anvisa confirmed the German authority's findings regarding some manufacturing surfaces being contaminated with unwanted particles.

However, Silimed responded saying that it has constantly maintained the highest standards of quality while manufacturing its products. In addition, Silimed officials argued that the presence of sterile particles do not possess any health hazard and that the company is working with German and Brazilian authorities to figure out a way to reverse the suspension decision.

Following the announcement made by Anvisa, other countries such as Switzerland and Australia called on their plastic surgeons to postpone their surgeries while the investigation was being carried out by health authorities. Meanwhile, the Australian Therapeutic Goods Administration, or TGA, found no adverse reactions reported for the products supplied by Silimed. However, TGA advised patients to contact their surgeons in case of concerns.

Meanwhile, The Australian Society of Plastic Surgeons has asked all its members to contact patients with Silimed breast implants.

A number of devices manufactured by Silimed are used by the Australian plastic surgeons but the breast implants are the most common. Silimed is the third largest manufacturer and seller of silicone implants in the world and exports its products to nearly 75 countries.

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