- Email: [email protected]
Early and late complications of polyalkylimide gel (Bio-Alcamid)®
Journal of Plastic, Reconstructive & Aesthetic Surgery (2011) 64, 401e405
CASE REPORT
Early and late complications of polyalkylimide gel (Bio-Alcamid) Lisa Nelson *, Kenneth J. Stewart Edinburgh Plastic Surgery Unit, St Johns Hospital, Livingston, Howden Road, West Lothian EH56 6PP, Scotland, UK Received 23 February 2010; accepted 23 April 2010
KEYWORDS Polyalkylimide gel; Complications; HIV lipodystrophy
Summary This case report summarises early and late of complications that have developed inpatients treated with Bio-Alcamid for HIV-associated facial lipoatrophy and describes the management strategy employed to treat the most serious of these cases. ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Bio-Alcamid (Polymekon, Milan, Italy) is a non-biodegradable hydrogel polymer that has gained widespread use in cosmetic and reconstructive practise since obtaining the CE (Conformite European) certificate in 2001. The product is an alkylic resin containing 96% pyrogen-free water and 4% alkylimide-amide groups, and is considered to be a permanent filler due to the stability of its chemical properties and resistance to hydrolysis.1 Once injected, Bio-Alcamid becomes enclosed within a thin (0.02 mm) collagen capsule.2 The process commences within a few days of injection and is completed by 6 weeks. Bio-Alcamid is thus considered to be an endoprosthesis due to the encapsulation process which isolates the injected material from surrounding host tissues. This is reported to contribute to the safety of the product and prevent migration of injected material.3 Several authors have reported success of Bio-Alcamid for the treatment of patients with HIV-associated lipoatrophy * Corresponding author. Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary, 84 Castle Street, Glasgow G4 0SF, UK. Tel.: þ44 141 211 4000. E-mail address: [email protected] (L. Nelson).
with minimal side-effects.2,4-6 However, reports of long-term complications following injection the product are beginning to emerge.7-9 We report a summary of complications that have developed in seven HIV patients treated with Bio-Alcamid for HIV-associated facial lipoatrophy and describe the management strategy employed to treat some of these cases.
Complications with Bio-Alcamid Eighteen patients with HIV-associated facial lipoatrophy underwent treatment using Bio-Alcamid within a clinical trial in the Edinburgh Unit between September 2005 and September 2007. A summary of complications is provided in table one. The onset of complications following injection of Bio-Alcamid ranged from 2 months to 3 years and six patients developed more than one type of complication. Nine patients required minor revision procedures to correct areas of asymmetry or irregularity. All primary procedures and revisions were performed in the operating theatre under general or local anaesthesia using aseptic technique and prophylactic co-amoxiclav. Infection occurred in four patients necessitating surgical removal in one patient. A
1748-6815/$ - see front matter ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2010.04.039
402
L. Nelson, K.J. Stewart
minor revision procedure preceded infection in 2 of these patients but no precipitating event occurred in the other 2 patients. Inferior migration of the product from the malar region to the jowls occurred in three patients and excessive capsule formation was observed in two patients. All patients had stable HIV haematological parameters throughout treatment and follow-up (Table 1).
Case reports Case 1 A 45-year-old man underwent injection of 37 cc BioAlcamid to each cheek and temple. Fourteen months later, he developed of chronic swelling of the left temple. Viscous fluid was present surrounding the capsule suggesting low-grade infection, although pus was subsequently aspirated from this region and both cheeks. Two months later, the patient presented with an acute abscess of the right cheek requiring incision and drainage. Microbiological assessment isolated clostridium perfringens and the patient was commenced on a prolonged course of oral metronidazole. At follow-up assessment, pus discharging from a sinus tract at the right cheek was discovered (Figure 1). Therefore, all remaining Bio-Alcamid was removed from the right cheek and temple via stab incisions, curettage and irrigation. The patient refused removal of the product from the left side of his face and long-term oral metronidazole therapy was continued. Four months later, the areas of inflammation remained quiescent but resulted in undesirable facial scarring (Figure 2). In addition, the patient also developed problematic metronidazole-induced paraesthesia. Table 1
Case 2 A 52-year-old man underwent injection of 39 cc BioAlcamid to the cheek and temple region bilaterally. Two revision procedures to correct minor asymmetry were performed via needle puncture of the capsule. Six months later, the patient developed extrusion of Bio-Alcamid to the buccal mucosa of the right cheek (Figure 3). Manual expression of Bio-Alcamid via the fistula tract combined with antibiotic prophylaxis was attempted on two occasions. However, the patient subsequently required removal of all remaining product via stab incisions and curettage.
Case 4 A 56-year-old man who underwent injection of 30 cc BioAlcamid to both cheeks presented 3 years later with significant inferior migration to the jowls bilaterally (Figure 4). Further surgery to remove the product via stab incisions is planned.
Discussion For patients with severe facial lipoatrophy, Bio-Alcamid has been advocated as an effective treatment option. When compared to other fillers, polyalkylimide gel can be used in large quantities and a permanent correction can be achieved in one or two sessions. Several authors have reported high patient and surgeon satisfaction with minimal side effects2, 4e6 and improved quality of life.10,11 An early, multicentre study of 2000 patients reported excellent cosmetic results with only 12 complications of S. aureus
Summary of complications associated with the use of Bio-Alcamid in the Edinburgh Unit
Case Sex Age Complication Onset
Treatment
1.
M
51
Infection
2 months Oral augmentin
2.
M
47
Infection
6 months Oral augmentin
3.
M
52
Asymmetry
1month
4.
M
45
Asymmetry
5.
M
41
Asymmetry
6.
M
39
Asymmetry
7.
M
59
Inferior migration
2 attempts at removal via needle puncture. 1 month Revision by further injection of Bio-Alcamid.
Co-complication(s)
Onset
Capsule formation/ Inferior migration
12 months
Treatment
Expression of Bio-Alcamid via stab incision. Inferior migration 16 months Removal Bio-Alcamid & Coleman fat transfer. Intra-oral extrusion 12 months Surgical removal by stab incisions/ curettage. Chronic inflammation/ 2 years Surgical removal by acute stab incsions, abscesses at 3 sites. curettage & irrigation. I.V. antibiotics & long-term oral antibiotics. Infection 1 week I.V. flucloxicillin & post-revision benzlypenecillin
1 month Revision by aspiration & further injection of Bio-Alcamid. 1 month Revision by aspiration & Excess capsule further injection of formation Bio-Alcamid 3 years Removal of Bio-Alcamid.
3 months
None
Early and late complications of polyalkylimide gel
Figure 1
Sinus of the right cheek.
infection. This study also reported no observed cases of migration, dislocation, granulomas, allergic response or intolerance of the implant.12 More recently, reports have emerged from plastic surgery units which have become referral centres for complications relating Bio-Alcamid. Schelke et al conducted a retrospective review of 3196 patients treated with polyalkylimide in the Netherlands and have reported a patient complication rate of 4.8%.13 The most common complication was inflammation (2%), followed by accumulation of the product (1%), hardening of the capsule (1%) and migration (0.7%). The greatest concern with the use of Bio-Alcamid, particularly in HIV positive individuals, is the potential for infection. Indeed, Schelke et al have also reported a higher incidence of inflammation in this patient group (3.3%). Although a number of safety studies have shown Bio-Alcamid to be non-toxic, non-allergenic,
Figure 2 Post-operative result following removal of BioAlcamid.
403
Figure 3
Extrusion of Bio-Alcamid.
non-reactive, biocompatible and non-biodegradable,1,3,14 it still carries the risk associated with implants to provide a favourable environment to harbour bacteria. Several authors have emphasised the late appearance of abscesses months to years after injection of the material. In some cases, the onset of infection was triggered by additional revision procedures at or near the site of previous injections.8 However, complications may also arise spontaneously without any history of trauma or local infection. In most published cases, microbacterial cultures have demonstrated streptococcal or staphylococcal bacteria. Interestingly, Clostridium perfringens, an anaerobic bacteria commonly associated with food borne illness, was isolated in one of our patients. Management of infection by antibiotic therapy or attempted aspiration is often unsuccessful. Surgical incision and drainage is usually required to remove all infected material resulting in undesirable facial scarring. A technique of drainage
Figure 4
Inferior migration of Bio-Alcamid.
404 utilising an irrigation system has been described by one institution to minimise skin incisions.9 The potential for infection-related complications is a disastrous and unacceptable result for patients seeking cosmetic enhancement. Because spontaneous inflammatory reactions are possible years after injection, it has been suggested that Bio-Alcamid may lead to chronic interference with surrounding tissues and enhanced susceptibility to infections. Thus, immunocompromised patients with HIV infection may represent an even more vulnerable patient group. Although, warnings against the use of Bio-Alcamid for cosmetic indications have been published,8 Bio-Alcamid is still considered to have a role in the management of severe reconstructive deficits such as HIV lipodystrophy. However, we would caution against the use of this product even more so in this patient group. Bio-Alcamid is also prone to other risks associated with prostheses such as migration and capsule contraction. Capsule formation around the implant is suggested to prevent migration by providing anchorage with surrounding tissues.3 However, gravitational migration was evident in 3 of our patients and is perhaps associated with injection of large volumes of the material into mobile areas. It has been suggested that filler migration may occur after manipulation of the product with disruption of the surrounding capsule.15 However, we have also observed marked migration of Bio-Alcamid in patients who have not undergone revision procedures. Areas of excessive capsule formation can also be unpredictable and difficult to treat. The economic burden of complications relating to BioAlcamid must also be considered. The requirement for in patient admission, intravenous antibiotic therapy, surgical drainage and further corrective procedures may incur significant costs to health trusts. Although private cosmetic practitioners carry out many of these procedures, patients with complications often present via acute hospital settings seeking treatment. In addition, some cosmetic practitioners lack the facilities or skill to address complications requiring surgical removal. As these serious long-term complications of BioAlcamid emerge, several practitioners who previously advocated its use now strongly caution against it. Letters of concern regarding the use of Bio-Alcamid have been submitted to the National Institute of Clinical Excellence (NICE) in the UK although no recommendations have been published. The Dutch Society of Cosmetic Medicine considers the overall complication rate of polyalkylimide too high risk for cosmetic treatment and now advises against its use.13 Our early published results using BioAlcamid to treat HIV-associated lipoatrophy were also favourable.16 However, extended follow-up of these patients within a clinical trial has led us to discontinue Bio-Alcamid injections. We hope our series of complications will add to the growing body of evidence that BioAlcamid may have significant long-term problems and that its use should be restricted or discontinued entirely.
Conflict of interest statement None of the authors have any conflict of interest in the research or products reported in this article.
L. Nelson, K.J. Stewart
Product The case report describes complications with the use of Bio-Alcamid (Polymekon, Milan, Italy). This research was funded by the following charities: 1. The Henry Smith Charity, 6th Floor, 65 Leadenhall Street, London EC3A 2AD 2. The Sick Kids Foundation, Edinburgh 3. The William Rooney Plastic and Reconstructive Surgery Fund, Edinburgh 4. NHS Lothian Endownments Fund, Edinburgh This research has received full ethical approval from the Multi-Centre Research Ethics Committee for Scotland
References 1. Ramires PA, Miccoli MA, Panzarini L, et al. In vitro and in vivo biocompatibility of a polyalkylimide hydrogel for soft tissue augmentation. J of Biomed Materials Research. 2005;72:230e8. 2. Protopapa C, Sito G, Caporale, et al. Bio-alcamid in druginduced lipodystrophy. J Cosmetic & Laser Ther 2003;5:226e30. 3. Formigli L, Zecchi S, Protopapa C, et al. Bio-Alcamid: an electron microscopic study after skin implantation. Plas Recon Surg. 2004;113:1104e6. 4. Honig JF. Cheek augmentation with Bio-alcamid in facial lipoatrophy in HIV seropositive patients. J of Craniofacial Surg 2008; 19:1085e8. 5. Lahiri A, Waters R. Experience with Bio-alcamid, a new soft tissue endoprosthesis. JPRAS 2007;60:663e7. 6. Ramon Y, Lucian F, Ullman Y. Preliminary experiences with Bioalcamid in HIV facial lipoatrophy. Dermatology 2007;214:151e4. 7. Jones DH, Carruthers A, Fitzgerald R, et al. Late-appearing abscesses after injections of nonabsorbable hydrogel polymer for HIV-associated facial lipoatrophy. Dermatol Surg 2007;33: 193e8. 8. Karim RB, Hage JJ, van Rozelaar L, et al. Complications of polyalkylimide 4% injections (Bio-alcamid): a report of 18 cases. JPRAS 2006;59:1409e14. 9. Goldan O, Georgiou I, Grabov-Nardini G, et al. Early and late complications after a nonabsorbable hydrogel polymer injection: a series of 14 patients and novel management. Dermatol Surg 2007;33:199e206. 10. Loufty MR, Raboud JM, Antoniou T, et al. Immediate versus delayed polyalkylimide gel injections to correct facial lipoatrophy in HIV-positive patients. AIDS 2007;21:1147e55. 11. Karim RB, de Lint CA, van Galen SR, et al. Long-term effect of polyalkylimide gel injections on severity of lipoatrophy and quality of life. Aesthetic Plastic Surgery. 2008;32:873e8. 12. Pacini S, Ruggiero M, Morucci G, et al. Bio-alcamid: a novelty for reconstructive and cosmetic surgery. Ital J Anat Embryol. 2002;107:209e14. 13. Schelke LW, Van Del Elzen HJ, Canninga M, et al. Complications after treatment with polyalkylimide. Dermatol Surg 2009;35: 1625e8. 14. Pacini S, Ruggiero M, Cammarota N, et al. Bio-alcamid, a novel prosthetic polymer, does not interfere with morphological and functional characteristics of human skin fibroblasts. Plas Recon Surg. 2003;111:489e91. 15. Adam RH, Malhotra R. Long-term complications orbitofacial of Polyalykylimide 4% (Bio-alcamid). Ophth Plast & Recon Surg 2009;25:394e7. 16. Nelson L, Stewart KJ. Experience in the treatment of HIV-associated lipodystrophy. JPRAS 2008;61:366e71.
CASE REPORT
Early and late complications of polyalkylimide gel (Bio-Alcamid) Lisa Nelson *, Kenneth J. Stewart Edinburgh Plastic Surgery Unit, St Johns Hospital, Livingston, Howden Road, West Lothian EH56 6PP, Scotland, UK Received 23 February 2010; accepted 23 April 2010
KEYWORDS Polyalkylimide gel; Complications; HIV lipodystrophy
Summary This case report summarises early and late of complications that have developed inpatients treated with Bio-Alcamid for HIV-associated facial lipoatrophy and describes the management strategy employed to treat the most serious of these cases. ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
Bio-Alcamid (Polymekon, Milan, Italy) is a non-biodegradable hydrogel polymer that has gained widespread use in cosmetic and reconstructive practise since obtaining the CE (Conformite European) certificate in 2001. The product is an alkylic resin containing 96% pyrogen-free water and 4% alkylimide-amide groups, and is considered to be a permanent filler due to the stability of its chemical properties and resistance to hydrolysis.1 Once injected, Bio-Alcamid becomes enclosed within a thin (0.02 mm) collagen capsule.2 The process commences within a few days of injection and is completed by 6 weeks. Bio-Alcamid is thus considered to be an endoprosthesis due to the encapsulation process which isolates the injected material from surrounding host tissues. This is reported to contribute to the safety of the product and prevent migration of injected material.3 Several authors have reported success of Bio-Alcamid for the treatment of patients with HIV-associated lipoatrophy * Corresponding author. Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary, 84 Castle Street, Glasgow G4 0SF, UK. Tel.: þ44 141 211 4000. E-mail address: [email protected] (L. Nelson).
with minimal side-effects.2,4-6 However, reports of long-term complications following injection the product are beginning to emerge.7-9 We report a summary of complications that have developed in seven HIV patients treated with Bio-Alcamid for HIV-associated facial lipoatrophy and describe the management strategy employed to treat some of these cases.
Complications with Bio-Alcamid Eighteen patients with HIV-associated facial lipoatrophy underwent treatment using Bio-Alcamid within a clinical trial in the Edinburgh Unit between September 2005 and September 2007. A summary of complications is provided in table one. The onset of complications following injection of Bio-Alcamid ranged from 2 months to 3 years and six patients developed more than one type of complication. Nine patients required minor revision procedures to correct areas of asymmetry or irregularity. All primary procedures and revisions were performed in the operating theatre under general or local anaesthesia using aseptic technique and prophylactic co-amoxiclav. Infection occurred in four patients necessitating surgical removal in one patient. A
1748-6815/$ - see front matter ª 2010 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2010.04.039
402
L. Nelson, K.J. Stewart
minor revision procedure preceded infection in 2 of these patients but no precipitating event occurred in the other 2 patients. Inferior migration of the product from the malar region to the jowls occurred in three patients and excessive capsule formation was observed in two patients. All patients had stable HIV haematological parameters throughout treatment and follow-up (Table 1).
Case reports Case 1 A 45-year-old man underwent injection of 37 cc BioAlcamid to each cheek and temple. Fourteen months later, he developed of chronic swelling of the left temple. Viscous fluid was present surrounding the capsule suggesting low-grade infection, although pus was subsequently aspirated from this region and both cheeks. Two months later, the patient presented with an acute abscess of the right cheek requiring incision and drainage. Microbiological assessment isolated clostridium perfringens and the patient was commenced on a prolonged course of oral metronidazole. At follow-up assessment, pus discharging from a sinus tract at the right cheek was discovered (Figure 1). Therefore, all remaining Bio-Alcamid was removed from the right cheek and temple via stab incisions, curettage and irrigation. The patient refused removal of the product from the left side of his face and long-term oral metronidazole therapy was continued. Four months later, the areas of inflammation remained quiescent but resulted in undesirable facial scarring (Figure 2). In addition, the patient also developed problematic metronidazole-induced paraesthesia. Table 1
Case 2 A 52-year-old man underwent injection of 39 cc BioAlcamid to the cheek and temple region bilaterally. Two revision procedures to correct minor asymmetry were performed via needle puncture of the capsule. Six months later, the patient developed extrusion of Bio-Alcamid to the buccal mucosa of the right cheek (Figure 3). Manual expression of Bio-Alcamid via the fistula tract combined with antibiotic prophylaxis was attempted on two occasions. However, the patient subsequently required removal of all remaining product via stab incisions and curettage.
Case 4 A 56-year-old man who underwent injection of 30 cc BioAlcamid to both cheeks presented 3 years later with significant inferior migration to the jowls bilaterally (Figure 4). Further surgery to remove the product via stab incisions is planned.
Discussion For patients with severe facial lipoatrophy, Bio-Alcamid has been advocated as an effective treatment option. When compared to other fillers, polyalkylimide gel can be used in large quantities and a permanent correction can be achieved in one or two sessions. Several authors have reported high patient and surgeon satisfaction with minimal side effects2, 4e6 and improved quality of life.10,11 An early, multicentre study of 2000 patients reported excellent cosmetic results with only 12 complications of S. aureus
Summary of complications associated with the use of Bio-Alcamid in the Edinburgh Unit
Case Sex Age Complication Onset
Treatment
1.
M
51
Infection
2 months Oral augmentin
2.
M
47
Infection
6 months Oral augmentin
3.
M
52
Asymmetry
1month
4.
M
45
Asymmetry
5.
M
41
Asymmetry
6.
M
39
Asymmetry
7.
M
59
Inferior migration
2 attempts at removal via needle puncture. 1 month Revision by further injection of Bio-Alcamid.
Co-complication(s)
Onset
Capsule formation/ Inferior migration
12 months
Treatment
Expression of Bio-Alcamid via stab incision. Inferior migration 16 months Removal Bio-Alcamid & Coleman fat transfer. Intra-oral extrusion 12 months Surgical removal by stab incisions/ curettage. Chronic inflammation/ 2 years Surgical removal by acute stab incsions, abscesses at 3 sites. curettage & irrigation. I.V. antibiotics & long-term oral antibiotics. Infection 1 week I.V. flucloxicillin & post-revision benzlypenecillin
1 month Revision by aspiration & further injection of Bio-Alcamid. 1 month Revision by aspiration & Excess capsule further injection of formation Bio-Alcamid 3 years Removal of Bio-Alcamid.
3 months
None
Early and late complications of polyalkylimide gel
Figure 1
Sinus of the right cheek.
infection. This study also reported no observed cases of migration, dislocation, granulomas, allergic response or intolerance of the implant.12 More recently, reports have emerged from plastic surgery units which have become referral centres for complications relating Bio-Alcamid. Schelke et al conducted a retrospective review of 3196 patients treated with polyalkylimide in the Netherlands and have reported a patient complication rate of 4.8%.13 The most common complication was inflammation (2%), followed by accumulation of the product (1%), hardening of the capsule (1%) and migration (0.7%). The greatest concern with the use of Bio-Alcamid, particularly in HIV positive individuals, is the potential for infection. Indeed, Schelke et al have also reported a higher incidence of inflammation in this patient group (3.3%). Although a number of safety studies have shown Bio-Alcamid to be non-toxic, non-allergenic,
Figure 2 Post-operative result following removal of BioAlcamid.
403
Figure 3
Extrusion of Bio-Alcamid.
non-reactive, biocompatible and non-biodegradable,1,3,14 it still carries the risk associated with implants to provide a favourable environment to harbour bacteria. Several authors have emphasised the late appearance of abscesses months to years after injection of the material. In some cases, the onset of infection was triggered by additional revision procedures at or near the site of previous injections.8 However, complications may also arise spontaneously without any history of trauma or local infection. In most published cases, microbacterial cultures have demonstrated streptococcal or staphylococcal bacteria. Interestingly, Clostridium perfringens, an anaerobic bacteria commonly associated with food borne illness, was isolated in one of our patients. Management of infection by antibiotic therapy or attempted aspiration is often unsuccessful. Surgical incision and drainage is usually required to remove all infected material resulting in undesirable facial scarring. A technique of drainage
Figure 4
Inferior migration of Bio-Alcamid.
404 utilising an irrigation system has been described by one institution to minimise skin incisions.9 The potential for infection-related complications is a disastrous and unacceptable result for patients seeking cosmetic enhancement. Because spontaneous inflammatory reactions are possible years after injection, it has been suggested that Bio-Alcamid may lead to chronic interference with surrounding tissues and enhanced susceptibility to infections. Thus, immunocompromised patients with HIV infection may represent an even more vulnerable patient group. Although, warnings against the use of Bio-Alcamid for cosmetic indications have been published,8 Bio-Alcamid is still considered to have a role in the management of severe reconstructive deficits such as HIV lipodystrophy. However, we would caution against the use of this product even more so in this patient group. Bio-Alcamid is also prone to other risks associated with prostheses such as migration and capsule contraction. Capsule formation around the implant is suggested to prevent migration by providing anchorage with surrounding tissues.3 However, gravitational migration was evident in 3 of our patients and is perhaps associated with injection of large volumes of the material into mobile areas. It has been suggested that filler migration may occur after manipulation of the product with disruption of the surrounding capsule.15 However, we have also observed marked migration of Bio-Alcamid in patients who have not undergone revision procedures. Areas of excessive capsule formation can also be unpredictable and difficult to treat. The economic burden of complications relating to BioAlcamid must also be considered. The requirement for in patient admission, intravenous antibiotic therapy, surgical drainage and further corrective procedures may incur significant costs to health trusts. Although private cosmetic practitioners carry out many of these procedures, patients with complications often present via acute hospital settings seeking treatment. In addition, some cosmetic practitioners lack the facilities or skill to address complications requiring surgical removal. As these serious long-term complications of BioAlcamid emerge, several practitioners who previously advocated its use now strongly caution against it. Letters of concern regarding the use of Bio-Alcamid have been submitted to the National Institute of Clinical Excellence (NICE) in the UK although no recommendations have been published. The Dutch Society of Cosmetic Medicine considers the overall complication rate of polyalkylimide too high risk for cosmetic treatment and now advises against its use.13 Our early published results using BioAlcamid to treat HIV-associated lipoatrophy were also favourable.16 However, extended follow-up of these patients within a clinical trial has led us to discontinue Bio-Alcamid injections. We hope our series of complications will add to the growing body of evidence that BioAlcamid may have significant long-term problems and that its use should be restricted or discontinued entirely.
Conflict of interest statement None of the authors have any conflict of interest in the research or products reported in this article.
L. Nelson, K.J. Stewart
Product The case report describes complications with the use of Bio-Alcamid (Polymekon, Milan, Italy). This research was funded by the following charities: 1. The Henry Smith Charity, 6th Floor, 65 Leadenhall Street, London EC3A 2AD 2. The Sick Kids Foundation, Edinburgh 3. The William Rooney Plastic and Reconstructive Surgery Fund, Edinburgh 4. NHS Lothian Endownments Fund, Edinburgh This research has received full ethical approval from the Multi-Centre Research Ethics Committee for Scotland
References 1. Ramires PA, Miccoli MA, Panzarini L, et al. In vitro and in vivo biocompatibility of a polyalkylimide hydrogel for soft tissue augmentation. J of Biomed Materials Research. 2005;72:230e8. 2. Protopapa C, Sito G, Caporale, et al. Bio-alcamid in druginduced lipodystrophy. J Cosmetic & Laser Ther 2003;5:226e30. 3. Formigli L, Zecchi S, Protopapa C, et al. Bio-Alcamid: an electron microscopic study after skin implantation. Plas Recon Surg. 2004;113:1104e6. 4. Honig JF. Cheek augmentation with Bio-alcamid in facial lipoatrophy in HIV seropositive patients. J of Craniofacial Surg 2008; 19:1085e8. 5. Lahiri A, Waters R. Experience with Bio-alcamid, a new soft tissue endoprosthesis. JPRAS 2007;60:663e7. 6. Ramon Y, Lucian F, Ullman Y. Preliminary experiences with Bioalcamid in HIV facial lipoatrophy. Dermatology 2007;214:151e4. 7. Jones DH, Carruthers A, Fitzgerald R, et al. Late-appearing abscesses after injections of nonabsorbable hydrogel polymer for HIV-associated facial lipoatrophy. Dermatol Surg 2007;33: 193e8. 8. Karim RB, Hage JJ, van Rozelaar L, et al. Complications of polyalkylimide 4% injections (Bio-alcamid): a report of 18 cases. JPRAS 2006;59:1409e14. 9. Goldan O, Georgiou I, Grabov-Nardini G, et al. Early and late complications after a nonabsorbable hydrogel polymer injection: a series of 14 patients and novel management. Dermatol Surg 2007;33:199e206. 10. Loufty MR, Raboud JM, Antoniou T, et al. Immediate versus delayed polyalkylimide gel injections to correct facial lipoatrophy in HIV-positive patients. AIDS 2007;21:1147e55. 11. Karim RB, de Lint CA, van Galen SR, et al. Long-term effect of polyalkylimide gel injections on severity of lipoatrophy and quality of life. Aesthetic Plastic Surgery. 2008;32:873e8. 12. Pacini S, Ruggiero M, Morucci G, et al. Bio-alcamid: a novelty for reconstructive and cosmetic surgery. Ital J Anat Embryol. 2002;107:209e14. 13. Schelke LW, Van Del Elzen HJ, Canninga M, et al. Complications after treatment with polyalkylimide. Dermatol Surg 2009;35: 1625e8. 14. Pacini S, Ruggiero M, Cammarota N, et al. Bio-alcamid, a novel prosthetic polymer, does not interfere with morphological and functional characteristics of human skin fibroblasts. Plas Recon Surg. 2003;111:489e91. 15. Adam RH, Malhotra R. Long-term complications orbitofacial of Polyalykylimide 4% (Bio-alcamid). Ophth Plast & Recon Surg 2009;25:394e7. 16. Nelson L, Stewart KJ. Experience in the treatment of HIV-associated lipodystrophy. JPRAS 2008;61:366e71.