Dermal Filler
別名: 필러, hyaluronic acid filler
Dermal fillers are injectable gels, most commonly hyaluronic acid, used to add volume or smooth lines in the face; effects are temporary.
히알루론산 필러 지속기간은 얼마나 되나요?
미국 FDA는 히알루론산(HA) 필러가 몸에 흡수되며 효과가 대략 6~12개월 지속된다고 안내합니다. 칼슘하이드록실아파타이트는 약 18개월, 폴리-L-젖산은 최대 2년이고, PMMA는 흡수되지 않아 영구적입니다. 실제 지속기간은 제품, 주입 부위, 주입량, 개인의 대사 차이에 따라 달라집니다. 흡수되는 필러는 효과를 유지하려면 다시 시술해야 합니다.
主要な事実
| 項目 | 値 | 出典 |
|---|---|---|
| Definition | An injectable implant (soft tissue, lip, facial or wrinkle filler) used to make skin look smoother or fuller時点 2023年7月6日 | [2]governmentDermal Fillers (Soft Tissue Fillers)U.S. Food and Drug Administration |
| US regulatory status | Class III medical device that needs premarket approval (PMA); FDA product codes LMH (face) and PKY (back of hand) | [3]governmentFDA Executive Summary: General Issues Panel Meeting on Dermal FillersU.S. Food and Drug Administration |
| Minimum approved age (US) | 22 years時点 2023年7月6日 | [2]governmentDermal Fillers (Soft Tissue Fillers)U.S. Food and Drug Administration |
| Materials in FDA-approved fillers | Mostly bacterial-source cross-linked hyaluronic acid; also calcium hydroxylapatite and poly-L-lactic acid | [3]governmentFDA Executive Summary: General Issues Panel Meeting on Dermal FillersU.S. Food and Drug Administration |
| Newer US-approved indications | Infraorbital hollowing, jawline and temple, in addition to lips, cheeks, perioral lines and nasolabial folds (approvals are product-specific) | [3]governmentFDA Executive Summary: General Issues Panel Meeting on Dermal FillersU.S. Food and Drug Administration |
| Uses not approved by the FDA | Injectable silicone for any cosmetic use; breast or buttock augmentation; needle-free injectors; over-the-counter sale時点 2023年7月6日 | [2]governmentDermal Fillers (Soft Tissue Fillers)U.S. Food and Drug Administration |
| Most serious risk | Accidental injection into a blood vessel, which can cause skin necrosis, blindness or stroke; rare but possibly permanent | [4]governmentDermal Filler Do's and Don'ts for Wrinkles, Lips and MoreU.S. Food and Drug Administration |
| Reversal agent (HA fillers only) | Hyaluronidase, used off-label to break down HA nodules, excess filler and vascular complications時点 2022年12月19日 | [5]journalA Scoping Review of Hyaluronidase Use in Managing the Complications of Aesthetic InterventionsAesthetic Plastic Surgery (via PubMed Central) |
| Evidence for hyaluronidase in vascular occlusion | No RCTs or clinical trials; evidence is limited to retrospective case series (the review itself is rated Level III)時点 2022年12月19日 | [5]journalA Scoping Review of Hyaluronidase Use in Managing the Complications of Aesthetic InterventionsAesthetic Plastic Surgery (via PubMed Central) |
| Duration | Temporary; repeat treatments needed | [1]governmentBreast enlargement (implants)NHS (UK National Health Service) |
概要
A dermal filler (Korean: 필러) is an injectable implant that adds volume under the skin to smooth wrinkles, folds and hollow areas in the face, lips or back of the hands. Most use cross-linked hyaluronic acid (HA). HA is gradually absorbed, so results are temporary, and it can be dissolved with hyaluronidase (an off-label use). The US FDA regulates fillers as Class III devices that need premarket approval for specific uses in adults 22 and older. It has not approved injectable silicone or body-contouring use. Korea's MFDS classifies fillers as Class 4 medical devices. The main serious risk is injection into a blood vessel, which can cause tissue necrosis, blindness or stroke. Readers should check that the product is approved for the treated area and that the injector is qualified.
参考文献
独立出典比率 100% (5/5)- レベル A · governmentBreast enlargement (implants) — NHS (UK National Health Service) · 閲覧日 2026年11月12日 · 根拠ページ
- レベル A · governmentDermal Fillers (Soft Tissue Fillers) — U.S. Food and Drug Administration · 閲覧日 2026年11月12日 · 根拠ページ
- レベル A · governmentFDA Executive Summary: General Issues Panel Meeting on Dermal Fillers — U.S. Food and Drug Administration · 閲覧日 2026年11月10日 · 根拠ページ
- レベル A · governmentDermal Filler Do's and Don'ts for Wrinkles, Lips and More — U.S. Food and Drug Administration · 閲覧日 2026年11月10日 · 根拠ページ
- レベル B · journalA Scoping Review of Hyaluronidase Use in Managing the Complications of Aesthetic Interventions — Aesthetic Plastic Surgery (via PubMed Central) · 閲覧日 2026年11月12日 · 根拠ページ