Comparison of Smooth-Gel Hyaluronic Acid Dermal Fillers with Cross-linked Bovine Collagen: A Multicenter, Double-Masked, Randomized, Within-Subject Study

Baumann, Leslie; Shamban, Ava; Lupo, Mary P.; Monheit, Gary D.; Thomas, Jane A.; Murphy, Diane K.; Walker, Patricia S.

doi:10.1111/j.1524-4725.2007.33352.x

Cited by 117 publications

(121 citation statements)

References 5 publications

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“…Pain and bruising are frequent and increase with the viscosity of the filler [52,53]. A too superficial injection as well as an insufficient posttreatment massage in terms of product distribution in the tissue can increase the risk for temporary skin induration [54,55] and nodules [6,39].…”

Section: Adverse Events Related To Temporary Fillersmentioning

confidence: 99%

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Luebberding

Alexiades-Armenakas

2013

Curr Derm Rep

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Injectable cosmetic wrinkle fillers are soft-tissue fillers approved as medical devices by the U.S. Food and Drug Administration (FDA). These devices are injected into the skin for correcting soft-tissue contour defects, such as moderate and severe wrinkles and folds, and for restoring the signs of facial fat loss in people with human immunodeficiency virus. Although the aesthetic treatment with injectable dermal fillers is considered to be safe, adverse events are involved with this minimally-invasive treatment. The FDA received 930 post-marked reports of adverse event from 2003 through 2008, of which 823 were deemed severe and 638 required medical treatment and follow-up.

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Section: Adverse Events Related To Temporary Fillersmentioning

confidence: 99%

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Luebberding

Alexiades-Armenakas

2013

Curr Derm Rep

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“…6-7). Different studies agree (1,(20)(21)(22)(23)84) that the mean duration of HA, regardless of the type and brand, is multifactorial and also depends on:…”

Section: A B C Dmentioning

confidence: 99%

“…The following classifications were also used in the postimplant check-ups: WSRS, as well as the patient and investigator Global Aesthetic Improvement Scale (GAIS): 1 to 5; and the Patient Satisfaction Scale (PSSS): -2 to + 2. (19)(20)(21)(22) . Fig.…”

Section: Introductionmentioning

confidence: 99%

Estudio clínico de eficacia, duración y efectos adversos del implante de ácido hialurónico en área buco-maxilo-facial

Scardovi

Goglian

Gendra

et al. 2017

Odontoestomatología

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“…We observed very large differences in the occurrence rate of complications with semi-permanent tissue fillers, between 0 and 56% (TABLE 3). Some authors did not specify the number of complications observed [25][26][27][28]201]. Moreover, in some cases the complications were described per injection site instead of per participant [29,202,203].…”

Section: Semi-permanent Tissue Fillersmentioning

confidence: 99%

“…Most mild or moderate adverse events, in 1 subject an abscess was reported after 4 months Treatment related [27,201] Prospective study (n = 56), 6 months follow-up…”

Section: Hyaluronic Acid (Cross-linked)mentioning

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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Comparison of Smooth-Gel Hyaluronic Acid Dermal Fillers with Cross-linked Bovine Collagen: A Multicenter, Double-Masked, Randomized, Within-Subject Study

Abstract: The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen-which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects-which should promote patient satisfaction.

Cited by 117 publications

References 5 publications

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Critical Appraisal of the Safety of Dermal Fillers: A Primer for Clinicians

Estudio clínico de eficacia, duración y efectos adversos del implante de ácido hialurónico en área buco-maxilo-facial

Clinical data on injectable tissue fillers: a review

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