Abscess formation and local necrosis after treatment with Zyderm or Zyplast Collagen Implant

Hanke, C. William; Higley, Howard R.; Jolivette, Dan M.; Swanson, Neil A.; Stegman, Samuel J.

doi:10.1016/0190-9622(91)70200-l

Cited by 194 publications

(92 citation statements)

References 13 publications

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“…Nonhypersensitive side effects are usually related to the injection site, including bruising, erythema, and swelling. Herpetic or bacterial infections after collagen injection are a possible but rare and more frequently reported when injected at the glabella area [42]. Systemic complications, such as flulike symptoms, paresthesia, or difficulty breathing, also have been reported previously [43].…”

Section: Adverse Events Related To Temporary Fillersmentioning

confidence: 99%

“…The risk for allergic reaction is highly dependent on the filler material itself. Whereas hypersensitivity is rarely reported after injection with hyaluronic acid, the risk increases significantly with bovine collagen and other dermal wrinkle implants [16,42].…”

Section: Material-independent Adverse Eventsmentioning

confidence: 99%

“…Delayed hypersensitivity response or severe anaphylactic shocks due to the collagen product are feared and serious side effects [44]. Rare hypersensitive reactions include the formation of foreign body granulomas at the injection site [45,46], as well as cyst or abscess formation and necrosis [42,47]. Therefore, a skin test is required 4 weeks before injection with bovine collagen [48,49].…”

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%

Section: Material-independent Adverse Eventsmentioning

confidence: 99%

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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“…39 "Necrobiotic granuloma" has also been used to describe the collagen implant, with collagen floating in a sea of neutrophils. [39][40][41][42] Some believe that this form of granuloma is a manifestation of cell-mediated delayed hypersensitivity reaction 39 and that these patients may have elevated collagen antibody titers 43 and a positive reaction at a second test site. 35,40 In our own experience, none of the patients with cystic foreign body granuloma showed positive skin tests against collagen or hyaluronic acid at the time of onset.…”

Section: Cystic Granulomamentioning

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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“…In addition, the collagen is replaced by connective tissue at approximately 2-3 months after implantation. Therefore, an observation period longer than 1 month is needed to accurately assess fibroplasia onset with collagen deposition [35][36][37][38].…”

Section: Discussionmentioning

confidence: 99%

Potential of Migration and Tissue Reactions to Intraperitoneally Implanted Polymethyl Methacrylate in Wistar Rats

Fc¹,

Acl²,

A³

2016

J Clin Exp Dermatol Res

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Objective: This study aimed to evaluate the performance of polymethyl methacrylate (PMMA) when implanted into the peritoneal cavities of Wistar rats, specifically its potential for migration to the examined organs and possible tissue reactions at the implantation site.Methods: Adult male Wistar rats (290-400 g) were distributed randomly into 2 groups: P4 (n=20), to which 0.4 mL of PMMA was administered; and P2 (n= 0), to which was 2 mL of PMMA were administered. These groups were subsequently divided into 4 subgroups according to the day on which euthanasia occurred (day 1, 7, 14, or 28). Results:The changes in animal weight prior to PMMA implantation and after euthanasia were compared. No nodules or signs of PMMA implantation or any other macroscopic alterations were observed in the spleen, kidneys, lungs, or liver. However, mild-to-moderate inflammatory infiltration in which macrophages, lymphocytes, and neutrophils predominated was observed in at least 1 of the 4 organs examined from each animal during the experimental time points. Mild inflammatory responses were observed that were rich in histiocytes and giant cells and featured increased numbers of blood vessels and fibroblasts in the pericapsular regions of the studied organs. In 29 cases, a greyish material compatible with PMMA was identified. There was no migration of PMMA into the parenchyma of the examined organs. The changes in the tissues were the same regardless of the volume of implanted PMMA. Following staining with HE, the PMMA particles in the tissues were a grayish color, measuring approximately 30-40 µm in size, and were found to have stimulated histiocytic reactions in 29 examined organs. Conclusions:The results showed that the most affected tissues were the visceral peritoneum of the spleen and the kidneys from group P2. Our study may contribute to add a new proof of testing implants.

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Abscess formation and local necrosis after treatment with Zyderm or Zyplast Collagen Implant

Cited by 194 publications

References 13 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

Potential of Migration and Tissue Reactions to Intraperitoneally Implanted Polymethyl Methacrylate in Wistar Rats

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