Events

Safety Alert for SILICONE MAMMARY IMPLANTS IN GENERAL.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

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
    1046
  • Date
    2011-02-01
  • 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 US FDA agency said in an article published on 01/26/2011 that it is exploring the possible association between silicone breast implants and a very rare type of cancer, anaplastic large cell lymphoma (ALCL). On 01/31/2011 this Unit of Technovigilance requested statistical data on the incidence of ALCL cases in Brazil to the National Cancer Institute - INCA / MS. The Division of Information / Coordination of Prevention and Surveillance - Conprev stated that ALCL is an extremely rare tumor and that considering the anatomical location of the breast, the occurrence is even rarer. Data available for Brazil show that the median incidence in men was 0.3 cases per 1 million or 3 cases per 10 million and in women the median incidence was 0.15 cases per 1 million women or 1.5 cases to 10 million. Regarding the anatomical location, the cases were observed in lymph nodes (most frequent), spleen, stomach, breasts of the face and skin. There was no occurrence in the breast. At this time there are no data in the NOTIVISA system that point to this type of problem. Further details on the subject are available in Anvisa's Clarification Note: http://portal.anvisa.gov.br/wps/wcm/connect/8920ea8045a23adba87ae83de4fc28bf/nota.pdf?MOD=AJPERES
  • Reason
    Safety statement published by the food and drug administration on a possible association between silicone breast implant and anaplastic large cell lymphoma. the text published by the fda is available at http://portal.Anvisa.Gov.Br/wps/wcm/connect/0f832b0045a23c9aa8b7e83de4fc28bf/noticia.Pdf?mod=ajperes.
  • Action
    Patients who have breast implants do not need to change their routine care and follow-up care. ALCL is very rare and has occurred in only a small number of the millions of patients who have breast implants. Although not specific to ALCL, patients should follow standard medical recommendations that include: (A) Regular monitoring of breast implants as well as performing self-examination of the breasts. If any changes are noted, it is important that the physician is consulted; (B) Routine mammography, according to medical guidelines; (C) Periodic Nuclear Magnetic Resonance to detect the occurrence of ruptures, according to medical recommendation; (D) Women who wish to undergo breast implant should discuss the risks and benefits with their physician.

Device

SILICONE MAMMARY IMPLANTS IN GENERAL.
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA