Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy

Burgess, Cheryl; Quiroga, Rafaela M.

doi:10.1016/j.jaad.2004.08.056

Cited by 160 publications

(146 citation statements)

References 18 publications

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“…If left untreated, they remain for 2 to 5 years. The occurrence and description of foreign body granuloma varies from one author to another, 24,72,87,96 and an estimated rate of 0.25 percent appears to reflect the reality ( Table 2). The rate is expected to further diminish because the dilution of the beads has been raised to 5 ml.…”

Section: Polylactic Acid Microspheresmentioning

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

223

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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Section: Polylactic Acid Microspheresmentioning

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

223

243

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“…[46] The results associated with this product therefore are not immediate and are instead gradual, lasting for at least 2 years. [45,47] It is approved in Europe for the treatment of scars and wrinkles, and in the United States for the treatment of facial lipoatrophy in patients diagnosed with human immunodeficiency virus (HIV) lipodystrophy syndrome. The injection technique is of crucial importance given the risk of papule and nodule formation.…”

Section: Poly-l-lactic Acidmentioning

confidence: 99%

“…[43,45,48] This product is overall very advantageous because it provides volume restoration while simultaneously increasing the dermal thickness. [45,47] Other advantages include reduced safety concerns because it provides temporary results, and its very good risk-benefit profile in both HIV+ and cosmetic patients. [42] PLA was first approved for use in Europe in 1999.…”

Section: Poly-l-lactic Acidmentioning

confidence: 99%

“…[51] Although many studies have examined the safety of PLA, its use is continually refined. [46][47][48]51] While the above studies investigated the optimal treatment times and methods of application, additional studies have been conducted regarding injection in the periorbital and perioral regions, [52] the use of conservative injection volumes [53] , and appropriate dilution volumes. [53,54] Calcium hydroxylapatite CaHA and its derivatives are naturally found in human bone and dental enamel.…”

Section: Poly-l-lactic Acidmentioning

confidence: 99%

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Intradermal fillers for minimally invasive treatment of facial aging

Lin¹,

Shah²,

Dhinakar³

et al. 2016

PAR

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The ever-increasing interest in retaining a youthful physical appearance has facilitated the development of various minimally invasive dermatological techniques. The use of intradermal fillers can be incorporated into dermatological practices with minimal overhead costs. This strategy addresses facial volume loss and dynamic lines, which are the main features of facial aging. Moreover, intradermal fillers provide an array of flexible treatment options for a balanced and holistic result to dermatological practitioners. This paper reviews the different intradermal fillers categorized by biodegradable and non-permanent fillers including collagen based materials, hyaluronic acid and autologous fat, semi-permanent fillers including poly methyl methacrylate, poly-L-lactic acid and calcium hydroxyapatite microspheres, and permanent fillers including silicone. A discussion is provided of the commercial products made of these materials and their clinical efficacy in the treatment of facial aging. Key words:Intradermal fillers; facial aging; volumization; biodegradable and non-permanent fillers; semipermanent fillers; permanent fillers Xin Zhao is an associate professor at Xi'an Jiaotong University, China. Prior to starting this appointment, she was a postdoctoral fellow at Medical School and School of Engineering and Applied Sciences at Harvard University. Her research involves engineering the micro-and nanoscale systems for tissue regeneration and drug delivery.

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“…Two patients developed persistent asymptomatic palpable intradermal papules Treatment related [96] Prospective study (n = 20), 7 months follow-up…”

Section: {{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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Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy

Cited by 160 publications

References 18 publications

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

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

Intradermal fillers for minimally invasive treatment of facial aging

Clinical data on injectable tissue fillers: a review

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