Adverse Reactions to Injectable Aesthetic Microimplants

Requena, Celia; Izquierdo, M J; Navarro, M.D.L.A. Canseco; Martinez, Antonio; Vilata, J.J.; Botella, Rafael; Amorrortu, J.; Sabater, Vicente; Aliaga, Adolfo; Requena, Luis

doi:10.1097/00000372-200106000-00006

Cited by 163 publications

(149 citation statements)

References 10 publications

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“…Interestingly, the amount of tissue reaction is no indication for the rate of granuloma formation. In the studies described here, Dermalive evoked the least new tissue formation but clinically causes a rather high rate of granuloma formation [54].…”

Section: Hema Fragmentsmentioning

confidence: 74%

“…The differential diagnosis could also be of medico-legal interest because adulterated or improper substances are sometimes injected fraudulently [54]. PMA-particles (Dermalive) showed multiple sharp edges and points taking on a ''broken glass'' appearance, whereas microspheres are devoid of any jagged or sharp edges that might serve as a continued source of irritation.…”

Section: Calcium-hydroxylapatite Microspheresmentioning

confidence: 99%

“…Larger microspheres from nonresorbable polymers with a smooth surface [35,38,51] are encapsulated with fibrous tissue and escape phagocytosis. Clinically, all injected fluids [45,59] and particles [54,56] have been shown to cause foreign body granulomas in a small percentage of patients. Until the mechanism of granuloma formation is fully understood, the chance of development is not predictable.…”

mentioning

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

456

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: Hema Fragmentsmentioning

confidence: 74%

Section: Calcium-hydroxylapatite Microspheresmentioning

confidence: 99%

mentioning

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

456

311

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“…Therefore, mainly shortor mid-term reactions, like immediate sensitivity reactions, formation of granulomas and swelling, could be picked up in these studies. In a number of case reports, long-term complications occurring after more than 12 months and even more than three years were described [8,16,19,44,[54][55][56][57][58][59][60]. These case reports indicate that more extended follow-up periods are needed to determine long-term effects of permanent fillers.…”

Section: Permanent Tissue Fillersmentioning

confidence: 99%

“…Not specified/ not known [120] PMMA in collagen or carboxymethyl-cellulose [16,19,54,55,58,59,121,122] Polyethyl methacrylate (copolymer HEMA and EMA) in hyaluronic acid…”

Section: Five-year Viewmentioning

confidence: 99%

Clinical data on injectable tissue fillers: a review

Vries

Geertsma

2013

Expert Review of Medical Devices

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Treatment with injectable tissue fillers for aesthetic purposes is increasingly popular. In parallel with this success, questions related to the safety of these treatments and the products involved are being raised more prominently. To gain insight in the safety aspects of injectable tissue fillers, we performed a literature review to collect studies reporting clinical data of injectable tissue fillers. We found several case reports where serious complications after more than three years are described. However, there are only a limited number of well-defined prospective clinical studies available with follow-up periods longer than three years. Furthermore, causes of complications, that is, treatment or product related, are often not specified in literature. Considering the intended functional period of fillers in combination with the known occurrence of long-term complications, there is a need for well-defined prospective clinical studies. In order to be able to discriminate between product failure (a product safety issue) or application methodology (a physician expertise or training issue), better identification of observed complications and whether they are product or treatment related, is needed. For the safe use of the fillers it is important that treatment with injectable tissue fillers is performed by a trained physician, who knows the product specifications and its applications. . Moreover, it is expected that due to increase in life expectancy, the demand for anti-aging treatments, like tissue augmentation with injectable tissue fillers, will grow [2]. Their success has been attributed to the fact that treatments with injectable tissue fillers are fast and appear to be relatively easy [2]. Only a relatively 'simple' subcutaneous injection is needed. Today, various injectable tissue fillers with different characteristics are available, for example, duration of the effect, material type and intended anatomical location.Although the application of an injectable tissue filler seems to be relatively simple and safe, reports of serious adverse effects have appeared in the literature [2][3][4][5][6][7][8]. Estimates of the occurrence of severe complications after treatment with various types of injectable tissue fillers range between 1:80 and 1:50,000 patients [9,10]. Adverse side effects can be caused by incorrect injection techniques (treatment related) or by the characteristics of the products (product related) [11,12]. Short-, mid-and long-term complications can be discerned (TABLE 1) [2,13-15]. Short-term complications like pain, swelling, fever, immediate hypersensitivity reactions, occur immediately or within several days past treatment and disappear after several weeks. A more severe short-term complication is necrosis [5,16]. Necrosis occurs immediately or within a few days if blood vessels are obstructed by the filler material or if they are injured during the treatment [17]. Mid-term complications such as delayed inflammatory reactions, ulceration and granuloma reaction may occur after 2-12 months. I...

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Foreign Body Granulomas Caused by Polymethylmethacrylate Microspheres: An Added Perspective

Thaler¹

2003

Arch Dermatol

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Adverse Reactions to Injectable Aesthetic Microimplants

Cited by 163 publications

References 10 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

Clinical data on injectable tissue fillers: a review

Foreign Body Granulomas Caused by Polymethylmethacrylate Microspheres: An Added Perspective

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