Evaluation of a Calcium Hydroxylapatite-Based Implant (Radiesse) for Facial Soft-Tissue Augmentation

Jansen, David; Graivier, Miles

doi:10.1097/01.prs.0000234903.55310.6a

Cited by 123 publications

(119 citation statements)

References 15 publications

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“…The complete resolution of edema may require months. Injection of CaHA into mid-or superficial dermis may result in visible white nodules and mild throbbing pain [58,59]. The development of palpable nodules was reported frequently by lip mucosa augmentation subjects and by subjects who had treatment for radial lip lines.…”

Section: Adverse Events Related To Temporary Fillersmentioning

confidence: 99%

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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%

“…The development of palpable nodules was reported frequently by lip mucosa augmentation subjects and by subjects who had treatment for radial lip lines. In this location, palpable nodules occur at a rate of 11.6 % [59]. Therefore, the injection of CaHA lip augmentation is contraindicated [9].…”

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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“…2, above). A relatively high incidence of nodule formation [103][104][105] has led to caution in its use in lip augmentation; however, true granuloma formation in the above sense has been reported only twice to the main clinical investigator (M. H. Graivier) in approximately 35,000 patients treated between 2002 and 2004 in the United States. Two male patients with acne received Radiesse in many depressed scars in both cheeks and developed foreign body granulomas mainly in three areas of 3 ϫ 2 ϫ 0.5 cm, dimensions that were far beyond those of the injected sites.…”

Section: Calcium-hydroxylapatite Microspheres (Radiance/radiesse)mentioning

confidence: 99%

Foreign Body Granulomas after All Injectable Dermal Fillers: Part 1. Possible Causes

Lemperle

Gauthier-Hazan

Wolters

et al. 2009

Plastic and Reconstructive Surgery

216

243

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Summary Genuine granuloma formation following implantation of injectable dermal fillers is a rare complication, with incidences ranging from one in 100 patients (1 percent) to one in 5000 (0.02 percent). Foreign body granulomas occur several months to years after injection at all implantation sites at the same time. Without treatment, they may grow to the size of beans, remain virtually unchanged for some years, and then resolve spontaneously. Three clinical and histologic types of foreign body granulomas can be distinguished: 1. Cystic granulomas (synonyms: inflammatory, palisading, collagenolytic): these are caused mainly by injected biological gels such as collagens and hyaluronic acids. Their clinical signs are fluctuation (sterile abscess), extreme redness, and induration. Cystic granulomas are small and superficial, occur within the first year, and disappear spontaneously within another year. They are surrounded by a significant number of giant cells. 2. Edematous granulomas (synonym: lipogranuloma): these are caused by artificial fluids such as silicone and polyacrylamides. They appear suddenly years after injection with extensive swelling and are surrounded and infiltrated by mononuclear and inflammatory cells. 3. Sclerosing granulomas (synonyms: sarcoidal and xanthelasmic): these are caused by particulate injectables composed of polymethylmethacrylate, polylactic acid, hydroxyethylmethacrylate, calcium-hydroxylapatite, or dextran microspheres. Sclerosing granulomas occur generally 6 months to 3 years after implantation and are visible, often bluish confined nodules. Histologically, the implant is infiltrated by many macrophages and giant cells, fibroblasts, and collagen fibers but few inflammatory cells. Permanent implants are not characterized by a higher rate of foreign body granuloma per se than temporary implants; however, their clinical appearance is more pronounced and their persistence longer if not treated adequately. (Plast.

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“…Nodule formation occurred in 48 cases Not specified/not known [117] Prospective study (n = 102), 36 months follow-up…”

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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Evaluation of a Calcium Hydroxylapatite-Based Implant (Radiesse) for Facial Soft-Tissue Augmentation

Abstract: The calcium hydroxylapatite-based implant is a safe, long-lasting, highly effective, and well-tolerated agent for many areas of facial soft-tissue augmentation.

Cited by 123 publications

References 15 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

Foreign Body Granulomas after All Injectable Dermal Fillers: Part 1. Possible Causes

Clinical data on injectable tissue fillers: a review

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