Events

Alerte De Sécurité sur POLYMETHYLMETACRYLATE - PMMA

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1136
  • Date
    2012-05-21
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    See the appendices: Requena et alli, 2011 - Adverse reactions to injectable facial fillers. Joint Ordinance SAS / SVS of JAN / 2009. ANVISA Resolution No. 2,732 / 2007. Manifestation CFM / 2006. SBCP / 2006 Manifestation Updated on 05/25/2012.
  • Cause
    Polymethylmethacrylate is a biphasic filler composed of polymethylmethacrylate (pmma) microspheres suspended in bovine collagen, carboxymethylcellulose or hydroxyethylcellulose solution. (in brazil, there is no product with valid registration based on bovine collagen - rdc 118/2001). it is known that the application of these substances may cause some undesirable side effects, including, local edema, inflammatory processes, telangiectasias, hypertrophic scars, allergic reactions and granuloma formation. granulomas usually appear 6 to 24 months after treatment, with an occurrence rate of 0.6%, but may also occur several years after injection (requena et alli, 2011). the use of this product in restorative surgeries shall comply with the provisions set forth in joint ordinance sas / svs no. 01 of january 20, 2009, which establishes strict criteria for accreditation of the highly complex network for the lipodystrophy. in terms of aesthetics, both the origin of the product and the qualification of the professional must be carefully observed. the orientation of the patient should be complete, so as to provide the patient with the free choice of undergoing the procedure or not. the establishments must have healthy and properly equipped conditions. the federal council of medicine (cfm) and the brazilian society of plastic surgery have already expressed their views on the subject, condemning its indiscriminate use in 2006. in 2007, after extensive discussion, anvisa prohibited the manipulation of the substance in pharmacies (sr no. 2,732 / 2007).
  • Action
    This is a Security Alert and should be disseminated as much as possible.

Device

POLYMETHYLMETACRYLATE - PMMA
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA