Silimed silicone implants

1st October 2015

 

The Brazilian Society of Plastic Surgery has released the following advice statement on Silimed silicone implants:

The SBCP has been informed about the international questioning over SILIMED silicone implants, by the european certification body TÜV SÜD (17 / September / 2015). On September 23rd 2015, the Medicine & Healthcare Products Regulatory Agency (MHRA), issued a press release to the British media informing that Silimed implants were suspended by reason of contamination.

Due to that, the SBCP took immediate actions to gather information about the facts with official regulators and with Silimed, aiming the safety of the population, in accordance with the permanent vigilance of the brazilian Plastic Surgery.

The preliminary reports mention the presence of particles (common in every medical product) although there is no european standard that states the acceptable level of particles. According to the company and literature, it is not evidence of any risk.

Therefore, the SBCP announces:
• In Brazil, Silimed is in compliance with the rigorous criteria of vigilance and certification by ANVISA and INMETRO. Until the present moment there is no announcement from the Brazilian health authorities on the matter;
• There are no reasons that justify any kind of unrest, panic and/or medical monitoring of SILIMED products users;
• The SBCP engages its solidarity and trust in the SILIMED brand, once in 37 years, there hasn’t been any blemish questioning the quality of its products. Therefore, the SBCP express its repudiation to any attempts to establish value judgment before the facts have been evaluated. Furthermore, they have always been an important sponsor of scientific events in support to the Brazilian Plastic Surgery;
• The SBCP stands in attention to the findings of the facts, by the international health authorities, and the SILIMED company; as well as any future decisions

Dr João de Moraes Prado Neto
President
Brazilian Society of Plastic Surgery

 

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