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Histological examination of the capsules surrounding Trilucent breast implants
British Journal of Plastic Surgery (2001), 54, 684-686 9 2001 The British Association of Plastic Surgeons doi: 10.1054/bjps.2001.3705
l
BRITISHJOURNAL OF ~
PLASTIC SURGERY
Histological examination of the capsules surrounding Trilucent breast implants E A. McArthur, A. R. Green, K. Hancock and A. R. T. Green*
Mersey Regional Plastic Surgery Centre, Whiston Hospital, Liverpool; and *Department of Histopathology, Wirral Hospitals Trust, Merseyside, UK SUMMARY. Following a statement by the UK Medical Devices Agency (MDA), soya-oil-filled Trilucent implants for breast augmentation were withdrawn from sale in March 1999. The most recent report on the toxicity of the Trilucent implant suggests that one of the breakdown products of the filler is an aldehyde with an explicit risk of genotoxic and teratogenic effects. Explantation of all these prostheses was advised by the MDA in June 2000. No guidance regarding capsulectomy was put forward by any publication. The operation of capsulectomy confers an increased morbidity compared with simple prosthetic replacement. This study looks at the capsules of 18 consecutive patients who had received Trilucent implants for cosmetic breast augmentation, and who had undergone explantation and capsulectomy. The mean duration of implantation was 3 years (range: 2 years to 4 years 9 months). The capsules were examined histologically. The significant features of all the capsules included a florid foreign-body type reaction, synovial metaplasia, a villous hyperplasia and the presence of refractile material within the substance of the capsule. It is postulated that the refractile material is filler material that has bled through the wall of the intact Trilucent implant, and as such would represent a potential genotoxic hazard. Until such time as this potential hazard has been investigated fully and a conclusion reached, we recommend acceptance of the increased morbidity, and the performance of capsulectomies when explanting Trilucent implants. 9 2001 The British Association of Plastic Surgeons
Keywords:breast, implant, Trilucent, capsulectomy, genotoxicity. In the light of the silicone controversy, clinicians, patients and manufacturers identified the need for a more acceptable implant filler. Following the early work of Young et all triglyceride was considered safe for use in breast implants. In 1995 Lipomatrix, an implant manufacturer, produced and marketed the Trilucent breast implant as a 'safe' alternative to silicone-filled implants with the added advantage of radiolucency, thereby reducing the problem of breast-cancer screening of the augmented breast. Following reports of triglyceride bleed from the intact implants, Young et al considered this to be safe, as the filler would simply be taken up by the body and disseminated into the body's lipid pool. 2 Using a rat model they demonstrated the presence of radiolabelled lipid (oleic acid) within the omentum, aortic arch and other visceral organs. 2 In 1999 Davies and Kirkpatrick reported the emulsification of the filler oil on explantation of a ruptured implant. 3 As the number of reported adverse reactions increased, the Medical Devices Agency (MDA), in conjunction with the company, released a voluntary recall of all Trilucent implants in 1999. 4 The following year a Professor of Toxicology at New York Medical College reported to AEI Inc. (the manufacturing parent company) that the risks of carcinogenesis and genotoxicity of the breakdown products of triglyceride filler were of no concern. 5 (The production of aldehydes and other products by peroxidation of fatty acids had raised concerns that the substances could potentially represent a risk to patients.) However, within the report it was suggested
that 'only the immediately adjacent fibrous connective tissue is a candidate target for a carcinogenic effect'. 5 A recent, as yet unpublished, study has demonstrated the concentration of the aldehyde breakdown products of the Trilucent filler to be of the order of milligrams, 6 rather than the micrograms previously reported. 5 The MDA subsequently released a hazard notice and recommended the removal of all Trilucent implants, citing an 'explicit risk from the potential release of genotoxic products as a result of the on-going diffusion of filler material through the implant shell and possible rupture'. 7 However, no advice was offered in respect of capsulectomy. Choudhary et al reported two cases of Trilucent explantation and capsulectomy, s The patients underwent explantation and capsulectomy for a Baker IV capsule in one case and a Baker II capsule in the other. In both cases an intense inflammatory response within the capsule and the presence of 'droplets' of material were reported. Our study was devised to investigate the capsule further, and to compare the findings in a larger group with the case report of Choudhary et al. s
Methods We recruited to the study 18 consecutive patients, with a mean age of 35 years and a mean implantation duration of 3 years. All had been recalled by the surgeons following the issue of the MDA guidelines on explantation of the devices. 7 All patients were healthy and apparently 684
Examination of capsules surrounding breast implants very happy with the results of their augmentation mammalSlasty. The study group confirmed the high levels of satisfaction documented by Armstrong and Jones. 9 All had developed only Baker I or Baker II capsules. All patients underwent explantation of intact implants; seven had a complete capsulectomy and 11 had a partial capsulectomy with excision of macroscopically suspicious areas. Suspicious areas were defined as dark mossy patches of friable tissue seen on the implant surface of the capsule (Fig. 1). All the tissue excised was sent for histological examination. Initial histological examination of formaldehyde-fixed tissue was performed using haematoxylin and eosin stains, and further studies were performed using a fatspecific stain, Oil Red-O. Selected sections were stained using Oil Red-O before and after washing with xylene and turpentine oil. The purpose of washing was to remove endogenous fat from the specimens before staining.
685
Figure 3---The refractile material stains with a fat-specific stain (Oil Red-O stain, high power).
Discussion Results In all 18 cases, four consistent features were reported: synovial metaplasia, villous hyperplasia, intense inflammatory and foreign-body reaction, and the presence of refractile material within the substance of the capsule. Figures 2 and 3 illustrate the histological features of the intense inflammatory response.
Figure 1--The dissected capsule with dark 'suspicious' areas visible.
The histological examination of capsules excised from 18 patients with intact Trilucent breast implants reveals a consistent picture of intense inflammation and the presence of refractile material within the substance of the capsule. Whilst the MDA has recommended the explantation of all Trilucent implants on the grounds that there is the potential for genotoxic material to bleed out of the implant, 7 it has not issued guidelines for the removal of the capsule. Moreover, Williams has suggested that the capsule itself is the only tissue at potential risk of carcinogenesis. 5 It was not the remit of this study to determine the genotoxic potential of material found within the substance of the capsule; however, we feel that the substance found within the capsule was not of endogenous origin. The study does, however, document that in 100% of cases the tissue examined contains material that we consider, by exclusion, to have bled out from the intact Trilucent implant, causing a florid inflammatory response. Kirkpatrick and Jones 6 have demonstrated that the concentrations of aldehyde and breakdown products of the filler are significantly higher than originally thought by Williams. 5 Recognising the concerns raised as to the potential genotoxic nature of this material, 7 and accepting the increased morbidity and complications, we recommend that capsulectomy is performed when explanting Trilucent breast implants, until such time as the true potential for carcinogenesis is understood.
Acknowledgements The authors thank Dr H. D. Zakhour and Dr D. A. Agbamu for the provision of histologyreports for this study, and Dr A. H. Clark for advice.
References
Figure 2--A florid inflammatory response, including foreign-body type giant cells, surrounds refractile material (H & E, low power).
1. YoungVL, Lund H, DestouetJ, Pidgeon L, Ueda K. Biocompatibility of radiolucent breast implants. Plast Reconstr Surg 1991; 88: 462-74. 2. Young VL, Lund H, Ueda K, Pidgeon L, Schorr MW, Kreeger J. Bleed of and biologic response to triglyceride filler used in radiolucent breast implants. Plast Reconstr Surg 1996; 97: 1179-93.
686 3. Davies DM, Kirkpatrick WNA. Lipid emulsification after implant rupture. Br J Plast Surg 1999; 52: 238. 4, Medical Devices Agency. TrilucentT M breast implants: voluntary recall. MDA AN1999(01), 55/27/99020505, March 1999. 5. Williams GM. Assessment of cancer risk associated with exposure to soybean oil filler compounds and peroxidation products potentially released from Trilucent breast implants. Report prepared for AEI Inc, 2000. Trilucent| information: http://www. trilucentinfo.com. 6. Kirkpatrick WN, Jones B. Analysis of 49 consecutively removed TrilucentTM breast implants. Presented at The British Association of Plastic Surgeons Winter Meeting, December 2000, London, UK. 7. Medical Devices Agency. TrilucentTM breast implants: recommendation to remove. MDA HN2000(05), 20000211.011-31, June 2000. 8. Choudhary S, Cadier MAM, Cottrell BJ. Local tissue reactions to oil-based breast implant bleed. Br J Plast Snrg 2000; 53: 317-18. 9. Armstrong AP, Jones BM. Patient satisfaction with TrilucentTM breast implants. Br J Plast Surg 2000; 53: 479-83.
British Journal of Plastic Surgery The Authors E A. McArthur, Specialist Registrar in Plastic Surgery A. R. Green FRCS, Consultant Plastic Surgeon K. Hancock MBBS, FRCSEd, FRCS(Plast), Consultant Plastic Surgeon Mersey Regional Plastic Surgery Centre, Whiston Hospital, Warrington Road, Prescot, Merseyside L35 5DR, UK. A. R. T. Green Department of Histopathology, Wirral Hospitals Trust, Merseyside, UK. Correspondence to Mr E A. McArthur. Paper received 21 May 2001. Accepted l 0 September 2001, after revision.
l
BRITISHJOURNAL OF ~
PLASTIC SURGERY
Histological examination of the capsules surrounding Trilucent breast implants E A. McArthur, A. R. Green, K. Hancock and A. R. T. Green*
Mersey Regional Plastic Surgery Centre, Whiston Hospital, Liverpool; and *Department of Histopathology, Wirral Hospitals Trust, Merseyside, UK SUMMARY. Following a statement by the UK Medical Devices Agency (MDA), soya-oil-filled Trilucent implants for breast augmentation were withdrawn from sale in March 1999. The most recent report on the toxicity of the Trilucent implant suggests that one of the breakdown products of the filler is an aldehyde with an explicit risk of genotoxic and teratogenic effects. Explantation of all these prostheses was advised by the MDA in June 2000. No guidance regarding capsulectomy was put forward by any publication. The operation of capsulectomy confers an increased morbidity compared with simple prosthetic replacement. This study looks at the capsules of 18 consecutive patients who had received Trilucent implants for cosmetic breast augmentation, and who had undergone explantation and capsulectomy. The mean duration of implantation was 3 years (range: 2 years to 4 years 9 months). The capsules were examined histologically. The significant features of all the capsules included a florid foreign-body type reaction, synovial metaplasia, a villous hyperplasia and the presence of refractile material within the substance of the capsule. It is postulated that the refractile material is filler material that has bled through the wall of the intact Trilucent implant, and as such would represent a potential genotoxic hazard. Until such time as this potential hazard has been investigated fully and a conclusion reached, we recommend acceptance of the increased morbidity, and the performance of capsulectomies when explanting Trilucent implants. 9 2001 The British Association of Plastic Surgeons
Keywords:breast, implant, Trilucent, capsulectomy, genotoxicity. In the light of the silicone controversy, clinicians, patients and manufacturers identified the need for a more acceptable implant filler. Following the early work of Young et all triglyceride was considered safe for use in breast implants. In 1995 Lipomatrix, an implant manufacturer, produced and marketed the Trilucent breast implant as a 'safe' alternative to silicone-filled implants with the added advantage of radiolucency, thereby reducing the problem of breast-cancer screening of the augmented breast. Following reports of triglyceride bleed from the intact implants, Young et al considered this to be safe, as the filler would simply be taken up by the body and disseminated into the body's lipid pool. 2 Using a rat model they demonstrated the presence of radiolabelled lipid (oleic acid) within the omentum, aortic arch and other visceral organs. 2 In 1999 Davies and Kirkpatrick reported the emulsification of the filler oil on explantation of a ruptured implant. 3 As the number of reported adverse reactions increased, the Medical Devices Agency (MDA), in conjunction with the company, released a voluntary recall of all Trilucent implants in 1999. 4 The following year a Professor of Toxicology at New York Medical College reported to AEI Inc. (the manufacturing parent company) that the risks of carcinogenesis and genotoxicity of the breakdown products of triglyceride filler were of no concern. 5 (The production of aldehydes and other products by peroxidation of fatty acids had raised concerns that the substances could potentially represent a risk to patients.) However, within the report it was suggested
that 'only the immediately adjacent fibrous connective tissue is a candidate target for a carcinogenic effect'. 5 A recent, as yet unpublished, study has demonstrated the concentration of the aldehyde breakdown products of the Trilucent filler to be of the order of milligrams, 6 rather than the micrograms previously reported. 5 The MDA subsequently released a hazard notice and recommended the removal of all Trilucent implants, citing an 'explicit risk from the potential release of genotoxic products as a result of the on-going diffusion of filler material through the implant shell and possible rupture'. 7 However, no advice was offered in respect of capsulectomy. Choudhary et al reported two cases of Trilucent explantation and capsulectomy, s The patients underwent explantation and capsulectomy for a Baker IV capsule in one case and a Baker II capsule in the other. In both cases an intense inflammatory response within the capsule and the presence of 'droplets' of material were reported. Our study was devised to investigate the capsule further, and to compare the findings in a larger group with the case report of Choudhary et al. s
Methods We recruited to the study 18 consecutive patients, with a mean age of 35 years and a mean implantation duration of 3 years. All had been recalled by the surgeons following the issue of the MDA guidelines on explantation of the devices. 7 All patients were healthy and apparently 684
Examination of capsules surrounding breast implants very happy with the results of their augmentation mammalSlasty. The study group confirmed the high levels of satisfaction documented by Armstrong and Jones. 9 All had developed only Baker I or Baker II capsules. All patients underwent explantation of intact implants; seven had a complete capsulectomy and 11 had a partial capsulectomy with excision of macroscopically suspicious areas. Suspicious areas were defined as dark mossy patches of friable tissue seen on the implant surface of the capsule (Fig. 1). All the tissue excised was sent for histological examination. Initial histological examination of formaldehyde-fixed tissue was performed using haematoxylin and eosin stains, and further studies were performed using a fatspecific stain, Oil Red-O. Selected sections were stained using Oil Red-O before and after washing with xylene and turpentine oil. The purpose of washing was to remove endogenous fat from the specimens before staining.
685
Figure 3---The refractile material stains with a fat-specific stain (Oil Red-O stain, high power).
Discussion Results In all 18 cases, four consistent features were reported: synovial metaplasia, villous hyperplasia, intense inflammatory and foreign-body reaction, and the presence of refractile material within the substance of the capsule. Figures 2 and 3 illustrate the histological features of the intense inflammatory response.
Figure 1--The dissected capsule with dark 'suspicious' areas visible.
The histological examination of capsules excised from 18 patients with intact Trilucent breast implants reveals a consistent picture of intense inflammation and the presence of refractile material within the substance of the capsule. Whilst the MDA has recommended the explantation of all Trilucent implants on the grounds that there is the potential for genotoxic material to bleed out of the implant, 7 it has not issued guidelines for the removal of the capsule. Moreover, Williams has suggested that the capsule itself is the only tissue at potential risk of carcinogenesis. 5 It was not the remit of this study to determine the genotoxic potential of material found within the substance of the capsule; however, we feel that the substance found within the capsule was not of endogenous origin. The study does, however, document that in 100% of cases the tissue examined contains material that we consider, by exclusion, to have bled out from the intact Trilucent implant, causing a florid inflammatory response. Kirkpatrick and Jones 6 have demonstrated that the concentrations of aldehyde and breakdown products of the filler are significantly higher than originally thought by Williams. 5 Recognising the concerns raised as to the potential genotoxic nature of this material, 7 and accepting the increased morbidity and complications, we recommend that capsulectomy is performed when explanting Trilucent breast implants, until such time as the true potential for carcinogenesis is understood.
Acknowledgements The authors thank Dr H. D. Zakhour and Dr D. A. Agbamu for the provision of histologyreports for this study, and Dr A. H. Clark for advice.
References
Figure 2--A florid inflammatory response, including foreign-body type giant cells, surrounds refractile material (H & E, low power).
1. YoungVL, Lund H, DestouetJ, Pidgeon L, Ueda K. Biocompatibility of radiolucent breast implants. Plast Reconstr Surg 1991; 88: 462-74. 2. Young VL, Lund H, Ueda K, Pidgeon L, Schorr MW, Kreeger J. Bleed of and biologic response to triglyceride filler used in radiolucent breast implants. Plast Reconstr Surg 1996; 97: 1179-93.
686 3. Davies DM, Kirkpatrick WNA. Lipid emulsification after implant rupture. Br J Plast Surg 1999; 52: 238. 4, Medical Devices Agency. TrilucentT M breast implants: voluntary recall. MDA AN1999(01), 55/27/99020505, March 1999. 5. Williams GM. Assessment of cancer risk associated with exposure to soybean oil filler compounds and peroxidation products potentially released from Trilucent breast implants. Report prepared for AEI Inc, 2000. Trilucent| information: http://www. trilucentinfo.com. 6. Kirkpatrick WN, Jones B. Analysis of 49 consecutively removed TrilucentTM breast implants. Presented at The British Association of Plastic Surgeons Winter Meeting, December 2000, London, UK. 7. Medical Devices Agency. TrilucentTM breast implants: recommendation to remove. MDA HN2000(05), 20000211.011-31, June 2000. 8. Choudhary S, Cadier MAM, Cottrell BJ. Local tissue reactions to oil-based breast implant bleed. Br J Plast Snrg 2000; 53: 317-18. 9. Armstrong AP, Jones BM. Patient satisfaction with TrilucentTM breast implants. Br J Plast Surg 2000; 53: 479-83.
British Journal of Plastic Surgery The Authors E A. McArthur, Specialist Registrar in Plastic Surgery A. R. Green FRCS, Consultant Plastic Surgeon K. Hancock MBBS, FRCSEd, FRCS(Plast), Consultant Plastic Surgeon Mersey Regional Plastic Surgery Centre, Whiston Hospital, Warrington Road, Prescot, Merseyside L35 5DR, UK. A. R. T. Green Department of Histopathology, Wirral Hospitals Trust, Merseyside, UK. Correspondence to Mr E A. McArthur. Paper received 21 May 2001. Accepted l 0 September 2001, after revision.