Events

Alerte De Sécurité sur Hyaluronic Acid for Aesthetic Fillers

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia 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
    A1510-464
  • Date
    2015-10-09
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=170
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notes supplémentaires dans les données
  • Cause
    There are numerous filling materials used in daily clinical practice for cosmetic and medical purposes, they can be classified: depending on their duration in the tissue (temporary, semi-permanent and permanent), they can also be classified according to the composition of the filling as: collagen (bovine, porcine) and human), hyaluronic acid, polylactic acid, calcium hydroxyapatite, sodium hyaluronate, polymethyl methacrylates and depolyacrylamide gels, among others.

Device

Hyaluronic Acid for Aesthetic Fillers
  • Modèle / numéro de série
    Hyaluronic Acid in all your commercial presentations.
  • Description du dispositif
    Hyaluronic acid is a non-sulfated polysaccharide, composed of repeated units of disaccharides: D-glucuronic acid and N-acetylglucosamine, these two molecules combine to form monomers, which, in turn, combine to form polymers; It is highly hydrophilic, has the ability to dissolve in water and form a viscous and transparent gel, whose turgidity is very similar to the surrounding tissue. Hyaluronic acid is a compound with high biocompatibility because it is immunologically identical in all species, there are variations in its presentation, which make it vary its useful life, in this the consistency of the gel, the viscosity, the degree of junctions between the fibers, what each material is different from the others1. It is noteworthy that the Hyaluronic Acid is generally indicated to be implanted in the dermis at its different levels (superficial, medium or deep) in order to perform facial fillers, attenuation of expression lines, redefinition of contours or to give volume; for the management of acne scars, lipoatrophy for HIV, periocular melanosis, volume in the lobe of the ear, rejuvenation of the hands and neck2,3; It has even been approved by INVIMA to be used as an intra-articular filler, culture medium, ophthalmic surgeries, soft solutions, mucosal protector, bone implants, solution for wound management and contact lens wetting (See Annex of Authorized Sanitary Records).
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA