Cereform Silicone Gel filled Breast Implants and Corresponding Sizers 의 리콜

Recall

RC-2014-RN-00161-1

Class II

2014-03-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00161-1

French regulatory body, ansm after an inspection of the manufacturing facility determined that the validation of the sterilisation provider was not consistent with the requirements of international regulatory standards. therefore, sterility of the cereform breast implants and corresponding sizers cannot be fully assured. cereplas was in the process of validating a new sterilisation provider but due to the lengthy process of such validation cereplas did not meet the deadline set by the french regulatory body ansm resulting in suspension of the ce certificate on the 10th february 2014. the suspension remains in place until the sterilisation validation with the new provider is completed and accepted by ansm. following the suspension of the ce certificate ansm requested that all non-implanted cereform products be recalled in france clearly stating the recall was based on the licensing and regulatory issue and not a “sanitary” (safety) issue.

Medical Vision Australia Plastic & Cosmetic Pty Ltd has recalled all the non-implanted stock and is returning the recalled stock and all stock under their control to the manufacturer Cereplas, France. For more details, please see http://www.tga.gov.au/safety/alerts-device-cereform-breast-implants-140311.htm .