Complications of polyalkylimide 4% injections (Bio-Alcamid™): a report of 18 cases

Karim, Refaat B.; Hage, J. Joris; Rozelaar, Leo van; Lange, Céulne; Raaijmakers, J. A. M.

doi:10.1016/j.bjps.2006.01.049

Cited by 54 publications

(32 citation statements)

References 16 publications

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“…19,20 Skin induration, nodules, and pseudo-abscesses have been reported with polyalkylimide. 1,7,14,15 Unlike other implant fillers, specific histologic granulomas related to PAIs have not yet been described. [19][20][21] Since becoming available in 2001, polyalkylimide is increasingly one of the most commonly used fillers in Europe.…”

Section: Commentmentioning

confidence: 99%

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Delayed Immune-Mediated Adverse Effects of Polyalkylimide Dermal Fillers

Alijotas‐Reig

Garcia-Gimenez²,

Miró-Mur³

et al. 2008

Arch Dermatol

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Section: Commentmentioning

confidence: 99%

“…[9][10][11][12][13] However, more recent evidence refutes these statements, and so the complete safety of PAI gels can no longer be assured. 1,7,14,15 We describe a cohort of patients with delayed adverse reactions to PAI fillers.…”

mentioning

confidence: 99%

Delayed Immune-Mediated Adverse Effects of Polyalkylimide Dermal Fillers

Alijotas‐Reig

Garcia-Gimenez²,

Miró-Mur³

et al. 2008

Arch Dermatol

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“…113 The onset of 10 infections and eight granulomas after polyalkylimide (Bio-Alcamid) injections ranged from 1 month to 3 years. 114 The Chinese articles mention an overall complication rate of 1.4 to 18.2 percent, [115][116][117] among which palpable indurations and aseptic inflammations are the most frequent. The total incidence of complications was 12 percent among 800 patients treated in Foshan, China.…”

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

218

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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“…This is in accordance with previous studies that demonstrated pathological changes in the retina in vivo, primarily in parts more likely to have been in direct contact with the gel [37], suggesting at least in part a toxic or immunological response. Recently, clinical use of Bio-Alcamid® in reconstructive surgery has become increasingly controversial due to late complications such as inflammation, infection and excessive capsule formation [45][46][47][48].…”

Section: Our Previous Results and Our Hypothesismentioning

confidence: 99%

A new model for in vitro testing of vitreous substitute candidates

Barth

Crafoord

O’Shea

et al. 2014

Graefes Arch Clin Exp Ophthalmol

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Purpose To describe a new model for in vitro assessment of novel vitreous substitute candidates. Methods The biological impact of three vitreous substitute candidates was explored in a retinal explant culture model; a polyalkylimide hydrogel (Bio-Alcamid®), a two component hydrogel of 20 wt.% poly (ethylene glycol) in phosphate buffered saline (PEG) and a cross-linked sodium hyaluronic acid hydrogel (Healaflow®). The gels where applied to explanted adult rat retinas and then kept in culture for 2, 5 and 10 days. Gel-exposed explants were compared with explants incubated under standard tissue culture conditions. Cryosections of the specimens were stained with hematoxylin and eosin, immunohistochemical markers (GFAP, Vimentin, Neurofilament 160, PKC, Rhodopsin) and TUNEL. Results Explants kept under standard conditions as well as PEG-exposed explants displayed disruption of retinal layers with moderate pyknosis of all neurons. They also displayed moderate labeling of apoptotic cells. Bio-Alcamid®-exposed explants displayed severe thinning and disruption of retinal layers with massive cell death. Healaflow®-treated explants displayed normal retinal lamination with significantly better preservation of retinal neurons compared with control specimens, and almost no signs of apoptosis. Retinas exposed to Healaflow® and retinas kept under standard conditions showed variable labeling of GFAP with generally low expression and some areas of upregulation. PEG-exposed retinas showed increased GFAP labeling and Bio-Alcamid®-exposed retinas showed sparse labeling of GFAP. Conclusions Research into novel vitreous substitutes has important implications for both medical and surgical vitreoretinal disease. The in vitro model presented here provides a method of biocompatibility testing prior to more costly and cumbersome in vivo experiments. The explant culture system imposes reactions within the retina including disruption of layers, cell death and gliosis, and the progression of these reactions can be used for comparison of vitreous substitute candidates. Bio-Alcamid® had strong adverse effects on the retina which is consistent with results of prior in vivo trials. PEG gel elicits reactions similar to the control retinas whereas Healaflow® shows protection from culture-induced trauma indicating favorable biocompatibility.

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Complications of polyalkylimide 4% injections (Bio-Alcamid™): a report of 18 cases

Cited by 54 publications

References 16 publications

Delayed Immune-Mediated Adverse Effects of Polyalkylimide Dermal Fillers

Delayed Immune-Mediated Adverse Effects of Polyalkylimide Dermal Fillers

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

A new model for in vitro testing of vitreous substitute candidates

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