The History of Substances for Soft Tissue Augmentation

Klein, Arnold William; Elson, Melvin L.

doi:10.1046/j.1524-4725.2000.00512.x

Cited by 147 publications

(95 citation statements)

References 45 publications

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“…This process goes along with slow resorption of the crosslinked eosinophilic opaque material with gradual and scarce infiltration of inflammatory cells, and little or no deposition of structures, which resemble new collagen fibers at 3 months [32]. At 6 months, no residue of cell-free Zyplast could be found in the human skin.…”

Section: Zyplastmentioning

confidence: 98%

“…To date, Zyderm and Zyplast have been the only FDA-approved dermal filler substances in the U.S. for more than 20 years. The limited longevity of Zyderm and Zyplast, ease of use, low incidence of allergic reactions (<1%), and safety are well established [32]. Late granuloma formation occurs at a lower rate [26,45] than with slowly resorbable gels and particulate materials.…”

Section: Collagen Gelmentioning

confidence: 99%

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Human Histology and Persistence of Various Injectable Filler Substances for Soft Tissue Augmentation

Lemperle

Morhenn

Charrier³

2003

Aesthetic Plastic Surgery

453

311

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Abstract. An increasing number of soft tissue filler substances have been introduced to the beauty market outside the U.S. which lack experimental and clinical data in support of their claim. Ten commercially available filler substances were examined for biocompatibility and durability: 0.1 cc of each substance was injected deep intradermally into the volar forearm of one of the authors and observed for clinical reaction and permanence. At 1, 3, 6, and 9 months the test sites were excised, histologically examined, and graded according to foreign body reactions classification. Collagen (Zyplast) was phagocytosed at 6 months and hyaluronic acid (Restylane) at 9 months. PMMA microspheres (Artecoll) had encapsulated with connective tissue, macrophages, and sporadic giant cells. Silicone oil (PMS 350) was clinically inconspicuous but dissipated into the tissue, causing a chronic foreign body reaction. Polylactic acid microspheres (New-Fill) induced a mild inflammatory response and had disappeared clinically at 4 months. Dextran microspheres (Reviderm intra) induced a pronounced foreign body reaction and had disappeared at 6 months. Polymethylacrylate particles (Dermalive) induced the lowest cellular reaction but had disappeared clinically at 6 months. Polyacrylamide (Aquamid) was well tolerated and remained palpable to a lessening degree over the entire testing period. Histologically, it dissipated more slowly and was kept in place through fine fibrous capsules. Polyvinylhydroxide microspheres suspended in acrylamide (Evolution) were well tolerated, slowly diminishing over 9 months. Calcium hydroxylapatite microspheres (Radiance FN) induced almost no foreign body reaction but were absorbed by the skin at 12 months.Host defense mechanisms react differently to the various filler materials, but all substances-resorbable or nonresorbable-appeared to be clinically and histologically safe, although all exhibit undesirable side effects. Since the mechanism of late inflammation or granuloma formation is still unknown, early histological findings are not useful in predicting possible late reactions to filler substances.

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Section: Zyplastmentioning

confidence: 98%

Section: Collagen Gelmentioning

confidence: 99%

Human Histology and Persistence of Various Injectable Filler Substances for Soft Tissue Augmentation

Lemperle

Morhenn

Charrier³

2003

Aesthetic Plastic Surgery

453

311

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“…The ultrasound showed to be an appropriate tool to assess the product behavior in vivo, since it allows its localization and measurement, in addition to being a painless and non-invasive method [16][17][18][19][20][21][22][23][24][25][26][27]. Its durability in up to 01 year after application is demonstrated because no significant reduction in the volume deposited in the procedure location was observed.…”

Section: Ultrasoundmentioning

confidence: 99%

Injectable Polyethylene Glycol Gel as Dermal Filler: 01 Year Clinical and Ultrasound Follow-Up

Addor¹,

Neri²

2016

J Clin Exp Dermatol Res

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Facial alterations that occur with aging are result of combined effects of soft tissue atrophy with loss of facial volume, gravitational factor and decrease of elastic tissue. In order to minimize these alterations, minimally invasive procedures such as cutaneous filling have been gaining space in clinical practice. In 2008, Scientech CorporationItalia introduced hydrogel of polyethylene glycol (PEG) REMAKE ® as cutaneous filler. This prospective study was developed to prove the effectiveness, safety and durability over the 12 months after the application of PEG hydrogel, commercialized under the name of REMAKE ® . 40 female volunteers were included, between 30 and 60 years, with signs of malar region volume loss between 2 and 3 (Raspaldo's classification) and Nasogenian furrow accentuation, with score between 2 and 3 (Day and collaborators' classification). No patient had carried out procedures of temporary filling for 1 year or permanent filling at any time. Objective parameters always show the scale of the improvement and an evaluation was selected through ultrasound exams and surface scan for evaluation of size and depth of wrinkles improvement. Evaluations by the US were carried out for 30, 120 and 360 days of product use, in a pilot group of 18 patients randomly selected to measure the product in the application plan and numerically assess alterations of volume (absorption/migration). Its durability of up to 01 year after application is proved when no significant reduction.

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“…En los raros casos en que la piel se fistuliza, la sustancia sale con un aspecto de crema dental. Las ulceraciones tardan meses o años en sanar, pero generalmente curan con el tiempo (12,13).…”

Section: Síntomas Y Signosunclassified

Alogenosis iatrogénica: Una nueva enfermedad

Coiffman

2008

Cir. plást. iberolatinoam.

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Numeral Code 266Palabras clave Alogenosis iatrogénica. Sustancias de relleno. Biopolímeros. Código numérico 266La necesidad de rellenar arrugas y otras depresiones en la piel ha llevado a la creación de múltiples sustancias inyectables. Los desastrosos resultados producidos por varias de estas sustancias meses o años después de ser inyectados, llevaron al autor a crear el término "Alogenosis Iatrogénica", pues se trata de una nueva enfermedad que solo en Iberolatinoamérica tiene más de un millón de victimas: "Alogenosis", porque es producida por sustancias alógenas, es decir, ajenas al organismo e "Iatrogénica", porque la producen los médicos o las personas que inyectan estas sustancias.Hemos estudiado 358 casos en lo últimos 10 años, agrupados y catalogados según las sustancias inyectadas, los síntomas, signos, tiempo de aparición de los mismos, etc. El objetivo era aprender cómo se manejan y tratan sus complicaciones. ya que en ningún libro se encuentra claramente descrita la nueva enfermedad.Las sustancias inyectables de relleno más usadas fueron: silicona líquida, parafina, petrolato líquido, vaselina, "biopolímeros", aceite mineral, grasa animal, etc. No se incluyeron en el estudio otras sustancias más o menos aceptadas como rellenos biocompatibles (ácido hialurónico, grasa autógena, colágeno bovino tratado, hidroxiapatita, etc.).Las reacciones, que afortunadamente no se presentan en todos los pacientes, aparecieron entre las 6 horas y los 25 años del tratamiento y fueron locales (dolor, eritema, pigmentaciones, edemas, fibrosis, queloides, infecciones, fístulas, necrosis de piel, desplazamiento por gravedad, etc.) y generales (fiebre, dolor generalizado, artralgias, decaimiento, malestar general, aumento de caída del cabello, depresión, etc.). No se encontró relación con enfermedades autoinmunes tales como artritis, dermatomiositis, esclerodermia, etc. Los síntomas y signos se exacerban cada dos o tres meses durante períodos que duran de 1 a 3 semanas y mejoran con o sin tratamiento.El tratamiento es sintomático. Las resecciones quirúrgicas solo deben hacerse en zonas muy limitadas, pues producen depresiones cutáneas y cicatrices retráctiles. Las masas muy grandes no se deben resecar debido a las deformaciones consecuentes. Se debe proteger la piel con sustancias emolientes.El aspecto más importante de este estudio es lo que no debe hacerse: los corticoides locales o generales no sirven y aumentan la atrofia de la piel; las punciones y la liposucción no ayudan, pues las masas son sólidas y fibróticas; los masajes, el ultrasonido y el láser no ayudan y a veces empeoran la situación.En todos los países se deben realizar campañas oficiales de prevención contra estas sustancias. Alogenosis iatrogénica. Una nueva enfermedadResumen AbstractA new desease: Iatrogenic allogenosis

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The History of Substances for Soft Tissue Augmentation

Cited by 147 publications

References 45 publications

Human Histology and Persistence of Various Injectable Filler Substances for Soft Tissue Augmentation

Human Histology and Persistence of Various Injectable Filler Substances for Soft Tissue Augmentation

Injectable Polyethylene Glycol Gel as Dermal Filler: 01 Year Clinical and Ultrasound Follow-Up

Alogenosis iatrogénica: Una nueva enfermedad

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