Events

Safety Alert for TEXTURIZED GEL MELLAR IMPLANTS (PERTHESE® ESTHEA Silicone gel-filled breast implant - textured - 210 cc) - Record 80145901328

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1377
  • Date
    2014-04-04
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    The company reports that to date, there are no reports of customers reporting product complaints or adverse events related to this problem. According to the risk analysis of the manufacturer, in relation to the deviation found, it is unlikely that an adverse health consequence will occur.
  • Reason
    The company holding the registration informs that the manufacturer has identified that some units of the texturized gel mammary implants product manufactured between 2002 and 2010 were identified with an incorrect expiration date and distributed to some countries between 2006 and 2010, in addition to the date of expiration. this deviation was detected after reviewing the quality data in december 2013.
  • Action
    The company asks physicians who have used the product to verify the period of coverage of this field action, as well as the product code, serial number and lot involved (Appendix I - Customer Letter). The company also recommends that the physician monitor patients according to standard protocols. If there is any medical doubt, the professional should contact the local representatives for the best assistance.

Device

TEXTURIZED GEL MELLAR IMPLANTS (PERTHESE® ESTHEA Silicone gel-filled breast implant - textured - ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda