Hyaluronic Acid for Aesthetic Fillers 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    A1510-464
  • 날짜
    2015-10-09
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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

  • 모델명 / 제조번호(시리얼번호)
    Hyaluronic Acid in all your commercial presentations.
  • 제품 설명
    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