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Current Materials Science

Editor-in-Chief

ISSN (Print): 2666-1454
ISSN (Online): 2666-1462

Mini-Review Article

Otolaryngology Implants Usage and their Material Adverse Event Profile - A Narrative Review

Author(s): T.Y. Sree Sudha*, K.S.B.S Krishna Sasanka, Harminder Singh, Saurabh Varshney, Pugazhenthan Thangaraju and Prakash Srinivasan Timiri Shanmugam

Volume 17, Issue 1, 2024

Published on: 20 March, 2023

Page: [77 - 87] Pages: 11

DOI: 10.2174/2666145416666230320103910

Price: $65

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Abstract

Objectives: The objective of this study is to review various biomaterials or implants used in ENT and their adverse effects on events that were noticed from the initial days to the present era.

Methods: Relevant articles were searched from the databases. PubMed, Scopus, Web of Science, and Google were used to search for the data.

Results: Cochlear implant (CI) adequacy depends on biocompatibility, anti-inflammatory treatment, and reduction of fibrosis. Silicone is used in the otologic field, and its allergy is a rare cause of CI extrusion. Nitinol pistons are used in stapedotomy, and polyethylene (Teflon) grafts are used in partial ossicular replacement prosthesis (PORP) or total ossicular replacement prosthesis (TORP). Their complications include graft extrusion and residual perforation. Chronic sphenoid sinusitis is associated with Medpor porous polyethylene implants used for sellar reconstruction in skull-based surgeries. In vocal cord paralysis, injectable collagen preparations form submucosal deposits and dysphonia. Montgomery T-tubes are used in subglottic stenosis, and they produce granulation tissue. Metallic tracheostomy tubes cause the formation of secondary foreign bodies, and biofilms appear in double-lumen tracheostomy tubes.

Conclusion: Even though several research studies have been carried out, still a modification of implant design is needed to minimize the complications and to further promote the quality of life of patients.

Keywords: Cochlear implant, nitinol piston, medpor, metallic tracheostomy tube, side effects, ENT.

[1]
Medical devices Frequently asked Questions. 2017. Available from: http://cdsco.gov.in/opencms/export/sites/CDSCO_web/pdf-documents/medical device/digosfaq19.pdf
[2]
Meher BR. Materiovigilance: An Indian perspective. Perspect Clin Res 2018; 9(4): 175-8.
[PMID: 30319948]
[3]
Manufactures of bio-degradable and bio-based polymers for bio-materials in the pharmaceutical field. J Appl Polym Sci 2022; 139(26): 1-21.
[http://dx.doi.org/10.1002/app.52624]
[4]
Ratner BD. Biomaterials Science. An Introduction to Materials in Medicine. (2nd ed.), Amsterdam: Academic Press 2004.
[5]
Yaman H, Yilmaz S, Alkan N, Subasi B, Guclu E, Ozturk O. Shepard grommet tympanostomy tube complications in children with chronic otitis media with effusion. Eur Arch Otorhinolaryngol 2010; 267(8): 1221-4.
[http://dx.doi.org/10.1007/s00405-010-1220-4] [PMID: 20204390]
[6]
Forsen JW. Chronic disorders of the middle ear and mastoid. In: Pediatric otolaryngology: Principles and practice pathways. New York: Thieme 2000; pp. 281-9.
[7]
Karimi GH, Hatfi H. A study of the rejection time and complications of ventilation tube in children with serous otitis who had under-gone a VT placement operation. J Shahid Sadooghi Univ MedSci 2001; 4(9): 43-7.
[8]
Armstrong BW. What your colleagues think of tympanostomy tubes. Laryngoscope 1968; 78(8): 1303-13.
[http://dx.doi.org/10.1288/00005537-196808000-00004] [PMID: 5671358]
[9]
Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg 2001; 124(4): 374-80.
[http://dx.doi.org/10.1067/mhn.2001.113941] [PMID: 11283489]
[10]
Biedlingmaier JF, Samaranayake R, Whelan P. Resistance to biofilm formation on otologic implant materials. Otolaryngol Head Neck Surg 1998; 118(4): 444-51.
[http://dx.doi.org/10.1016/S0194-5998(98)70199-8] [PMID: 9560093]
[11]
Karlan MS, Skobel B, Grizzard M, et al. Myringotomy tube materials: bacterial adhesion and infection. Otolaryngol Head Neck Surg 1980; 88(6): 783-95.
[http://dx.doi.org/10.1177/019459988008800628] [PMID: 7208047]
[12]
Karlan MS, Mufson RA, Grizzard MB, Buscemi PA, Hench L, Goldberg EP. Potentiation of infections by biomaterials: a comparison of three materials. Otolaryngol Head Neck Surg 1981; 89(4): 528-34.
[http://dx.doi.org/10.1177/019459988108900404] [PMID: 6793960]
[13]
Kinnari TJ, Salonen EM, Jero J. New method for coating tympanostomy tubes to prevent tube occlusions. Int J Pediatr Otorhinolaryngol 2001; 58(2): 107-11.
[http://dx.doi.org/10.1016/S0165-5876(01)00413-X] [PMID: 11278018]
[14]
Chole RA, Hubbell RN. Antimicrobial activity of silastic tympanostomy tubes impregnated with silver oxide. A double-blind randomized multicenter trial. Arch Otolaryngol Head Neck Surg 1995; 121(5): 562-5.
[http://dx.doi.org/10.1001/archotol.1995.01890050054010] [PMID: 7727091]
[16]
Lehnhardt E. [Biocompatibility of cochlear implants]. Eur Arch Otorhinolaryngol Suppl 1992; 1: 223-33.
[PMID: 1521072]
[18]
Marcus DM. An analytical review of silicone immunology. Arthritis Rheum 1996; 39(10): 1619-26.
[http://dx.doi.org/10.1002/art.1780391003]
[19]
Rosato DV. Polymers, processes and properties of medicalplastics: Including markets and applications. In: Szycher M, Ed. Biocompatible Polymers, Metals, and Composites. Lancaster, PA: Technomic Publ. 1983; 1019-67.
[20]
Kronenberg J, Wolf M, Migirov L, Shapira Y. Foreign body reaction to cochlear implant. Oto-Rhino-Laryngologia Nova 2001; 11(3-4): 207-9.
[http://dx.doi.org/10.1159/000063002]
[21]
Puri S, Dornhoffer JL, North PE. Contact dermatitis to silicon after cochlear implantation Laryngoscope 2005; 115: 1760Y2.
[22]
Adkinson NF Jr, Yunginger JW, Busse WW, Bochner BS. Middleton’s Allergy: Principles and Practice. (6th ed.), Philadelphia, PA: Mosby 2003.
[23]
Stratigouleas ED, Perry BP, King SM, Syms CA III. Complication rate of minimally invasive cochlear implantation. Otolaryngol Head Neck Surg 2006; 135(3): 383-6.
[http://dx.doi.org/10.1016/j.otohns.2006.03.023] [PMID: 16949968]
[24]
Li PMMC, Somdas MA, Eddington DK, Nadol JB Jr. Analysis of intracochlear new bone and fibrous tissue formation in human subjects with cochlear implants. Ann Otol Rhinol Laryngol 2007; 116(10): 731-8.
[http://dx.doi.org/10.1177/000348940711601004] [PMID: 17987778]
[25]
Anderson JM, Rodriguez A, Chang DT. Foreign body reaction to biomaterials. Semin Immunol 2008; 20(2): 86-100.
[http://dx.doi.org/10.1016/j.smim.2007.11.004] [PMID: 18162407]
[26]
Kamakura T, Nadol JB Jr. Correlation between word recognition score and intracochlear new bone and fibrous tissue after cochlear implantation in the human. Hear Res 2016; 339: 132-41.
[http://dx.doi.org/10.1016/j.heares.2016.06.015] [PMID: 27371868]
[27]
Marsh MA, Jenkins HA, Coker NJ. Histopathology of the temporal bone following multichannel cochlear implantation. Arch Otolaryngol Head Neck Surg 1992; 118(11): 1257-65.
[http://dx.doi.org/10.1001/archotol.1992.01880110125022] [PMID: 1418907]
[28]
Nadol JB Jr, Burgess BJ, Gantz BJ, et al. Histopathology of cochlear implants in humans. Ann Otol Rhinol Laryngol 2001; 110(9): 883-91.
[http://dx.doi.org/10.1177/000348940111000914] [PMID: 11558767]
[29]
Schindler RA, Bjorkroth B. Traumatic intracochlear electrode implantation. Laryngoscope 1979; 89(5 Pt 1): 752-8.
[PMID: 449520]
[30]
Benatti A, Castiglione A, Trevisi P, et al. Endocochlear inflammation in cochlear implant users: Case report and literature review. Int J Pediatr Otorhinolaryngol 2013; 77(6): 885-93.
[http://dx.doi.org/10.1016/j.ijporl.2013.03.016]
[31]
Seyyedi M, Nadol JB Jr. Intracochlear inflammatory response to cochlear implant electrodes in humans. Otol Neurotol 2014; 35(9): 1545-51.
[http://dx.doi.org/10.1097/MAO.0000000000000540] [PMID: 25122600]
[32]
Linthicum FH Jr, Fayad J, Otto SR, Galey FR, House WF. Cochlear implant histopathology. Am J Otol 1991; 12(4): 245-311.
[PMID: 1928309]
[33]
Fayad JN, Makarem AO, Linthicum FH Jr. Histopathologic assessment of fibrosis and new bone formation in implanted human temporal bones using 3D reconstruction. Otolaryngol Head Neck Surg 2009; 141(2): 247-52.
[http://dx.doi.org/10.1016/j.otohns.2009.03.031] [PMID: 19643260]
[34]
Quesnel AM, Nakajima HH, Rosowski JJ, Hansen MR, Gantz BJ, Nadol JB Jr. Delayed loss of hearing after hearing preservation cochlear implantation: Human temporal bone pathology and implications for etiology. Hear Res 2016; 333: 225-34.
[http://dx.doi.org/10.1016/j.heares.2015.08.018] [PMID: 26341474]
[35]
deTorres A, Olszewski RT, Lopez IA, Ishiyama A, Linthicum FH Jr, Hoa M. Supporting cell survival after cochlear implant surgery. Laryngoscope 2019; 129(1): E36-40.
[http://dx.doi.org/10.1002/lary.27539] [PMID: 30325510]
[36]
O’Malley JT, Burgess BJ, Galler D, Nadol JB Jr. Foreign body response to silicone in cochlear implant electrodes in the human. Otol Neurotol 2017; 38(7): 970-7.
[http://dx.doi.org/10.1097/MAO.0000000000001454] [PMID: 28538471]
[37]
Hetrick EM, Prichard HL, Klitzman B, Schoenfisch MH. Reduced foreign body response at nitric oxide-releasing subcutaneous implants. Biomaterials 2007; 28(31): 4571-80.
[http://dx.doi.org/10.1016/j.biomaterials.2007.06.036] [PMID: 17681598]
[38]
Zeplin PH, Larena-Avellaneda A, Jordan M, Laske M, Schmidt K. Phosphorylcholine-coated silicone implants: effect on inflammatory response and fibrous capsule formation. Ann Plast Surg 2010; 65(6): 560-4.
[http://dx.doi.org/10.1097/SAP.0b013e3181d6e326] [PMID: 20948413]
[39]
Joseph J, Mohanty M. Influence of curing agent on fibrosis around silicone implants. J Biomater Sci Polym Ed 2013; 24(9): 1140-51.
[http://dx.doi.org/10.1080/09205063.2012.743060] [PMID: 23683043]
[40]
Moore LB, Sawyer AJ, Charokopos A, Skokos EA, Kyriakides TR. Loss of monocyte chemoattractant protein-1 alters macrophage polarization and reduces NFκB activation in the foreign body response. Acta Biomater 2015; 11: 37-47.
[http://dx.doi.org/10.1016/j.actbio.2014.09.022] [PMID: 25242651]
[41]
Kyle DJT, Oikonomou A, Hill E, Bayat A. Development and functional evaluation of biomimetic silicone surfaces with hierarchical micro/nano-topographical features demonstrates favourable in vitro foreign body response of breast-derived fibroblasts. Biomaterials 2015; 52: 88-102.
[http://dx.doi.org/10.1016/j.biomaterials.2015.02.003] [PMID: 25818416]
[42]
Clark GM, Clark J, Cardamone T, et al. Biomedical studies on temporal bones of the first multi-channel cochlear implant patient at the University of Melbourne. Cochlear Implants Int 2014; 15(sup2)(Suppl. 2): S1-S15.
[http://dx.doi.org/10.1179/1754762814Y.0000000087] [PMID: 24915284]
[43]
Nadol JB Jr, Eddington DK, Burgess BJ. Foreign body or hypersensitivity granuloma of the inner ear after cochlear implantation: one possible cause of a soft failure? Otol Neurotol 2008; 29(8): 1076-84.
[http://dx.doi.org/10.1097/MAO.0b013e31818c33cf] [PMID: 18997635]
[44]
Montgomery WW. T-Tube tracheal stent. Arch Otolaryngol Head Neck Surg 1965; 82(3): 320-1.
[http://dx.doi.org/10.1001/archotol.1965.00760010322023] [PMID: 14327039]
[45]
Kulkarni VR, Kelkar VS, Salunkhe SA. Anaesthetic challenges ofthe Montgomery T-tube insertion in a patient with fascioscapu-lohumeral dystrophy. Indian J Anaesth 2005; 49: 502-4.
[46]
Montgomery WW, Montgomery SK. Manual for use of Montgomery laryngeal, tracheal, and esophageal prostheses. Ann Otol Rhinol Laryngol 1986; 95(4_suppl): 1-16.
[http://dx.doi.org/10.1177/00034894860950S401] [PMID: 3090923]
[47]
Gallo A, Pagliuca A, Greco A, Martellucci S, Mascelli A. Laryngotracheal stenosis treated with multiple surgeries: Experience, results and prognostic factors in 70 patients. Acta Otorhinolaryngol Ital 2012; 32: 182-8.
[48]
Montgomery WW, Montgomery SK. Manual for use of Mont-gomery laryngeal, tracheal and esophageal prostheses: update1990. Ann Otol Rhinol Laryngol Suppl 1990; 150: 2-28.
[49]
Carretta A, Casiraghi M, Casiraghi M, Melloni G, Bandiera A. Montgomery T-tube placement in the treatment of benign tracheal le-sions. Eur J Cardiothorac Surg 2009; 36: 352-6.
[50]
Guha A, Mostafa SM, Kendall JB. The Montgomery T-tube: Anaesthetic problems and solutions. Br J Anaesth 2001; 87(5): 787-90.
[http://dx.doi.org/10.1093/bja/87.5.787] [PMID: 11878535]
[51]
Saghebi SR, Zangi M, Tajali T, Farzanegan R. The role of T-tubes inthe management of airway stenosis. Eur J Cardiothorac Surg 2013; 43: 934.
[52]
Bell RB, Verschueren DS, Dierks EJ. Management of laryngeal trauma. Oral Maxillofac Surg Clin North Am 2008; 20(3): 415-30.
[http://dx.doi.org/10.1016/j.coms.2008.03.004] [PMID: 18603200]
[53]
Arnold GE. Vocal rehabilitation of paralytic dysphonia. VIII. Phoniatric methods of vocal compensation. Arch Otolaryngol Head Neck Surg 1962; 76(1): 76-83.
[http://dx.doi.org/10.1001/archotol.1962.00740050080015] [PMID: 13862422]
[54]
Ellis JC, McCaffrey TV, Desanto LW, Reiman HV. Migration of Teflon after vocal cord injection. Otolaryngol Head Neck Surg 1987; 96(1): 63-6.
[http://dx.doi.org/10.1177/019459988709600111] [PMID: 3118297]
[55]
Rubin HJ. Misadventures with injectable polytef (Teflon). Arch Otolaryngol Head Neck Surg 1975; 101(2): 114-6.
[http://dx.doi.org/10.1001/archotol.1975.00780310036010] [PMID: 1092292]
[56]
Sittel C, Thumfart WF, Pototschnig C, Wittekindt C, Eckel HE. Textured polydimethylsiloxane elastomers in the human larynx: Safety and efficiency of use. J Biomed Mater Res 2000; 53(6): 646-50.
[http://dx.doi.org/10.1002/1097-4636(2000)53:6<646:AID-JBM5>3.0.CO;2-0] [PMID: 11074422]
[57]
Sittel C, Echtemach M, Federspil PA, Plinkert PK. Polydimethylsiloxane particles for permanent injection laryngoplasty. Ann Otol Rhinol Laryngol 2006; 115(2): 103-9.
[http://dx.doi.org/10.1177/000348940611500204] [PMID: 16514791]
[58]
Chan RW, Titze IR. Hyaluronic acid (with fibronectin) as a bioimplant for the vocal fold mucosa. Laryngoscope 1999; 109(7): 1142-9.
[http://dx.doi.org/10.1097/00005537-199907000-00026] [PMID: 10401858]
[59]
Hallén L, Dahlqvist Å, Laurent C. Dextranomeres in hyaluronan (DiHA): a promising substance in treating vocal cord insufficiency. Laryngoscope 1998; 108(3): 393-7.
[http://dx.doi.org/10.1097/00005537-199803000-00015] [PMID: 9504613]
[60]
Friedrich G. Titanium vocal fold medializing implant: introducing a novel implant system for external vocal fold medialization. Ann Otol Rhinol Laryngol 1999; 108(1): 79-86.
[http://dx.doi.org/10.1177/000348949910800112] [PMID: 9930545]
[61]
Rubin AD, Sataloff RT. Vocal fold paresis and paralysis. Otolaryngol Clin North Am 2007; 40(5): 1109-31.
[http://dx.doi.org/10.1016/j.otc.2007.05.012] [PMID: 17765698]
[62]
Brentel AS, Vasconcellos LMR, Oliveira MV, et al. Histomorphometric analysis of pure titanium implants with porous surface versus rough surface. J Appl Oral Sci 2006; 14(3): 213-8.
[http://dx.doi.org/10.1590/S1678-77572006000300013] [PMID: 19089076]
[63]
Stothers L, Goldenberg SL. Delayed hypersensitivity and systemic arthralgia following transurethral collagen injection for stress uri-nary incontinence. J Urol 1998; 159(5): 1507-9.
[http://dx.doi.org/10.1097/00005392-199805000-00025] [PMID: 9554343]
[64]
Varvares MA, Montgomery WW, Hillman RE. Teflon granuloma of the larynx: etiology, pathophysiology, and management. Ann Otol Rhinol Laryngol 1995; 104(7): 511-5.
[http://dx.doi.org/10.1177/000348949510400702] [PMID: 7598361]
[65]
Giovanni A, Gras R, Grini MN, Robert D, Vallicioni JM, Triglia JM. Medialization of the paralyzed vocal cord by an expanded poly-tetrafluoroethylene (Gore-tex) implant. Ann Otolaryngol Chir Cervicofac 1997; 114(5): 158-64.
[PMID: 9686026]
[66]
Abraham MT, Gonen M, Kraus DH. Complications of type I thyroplasty and arytenoid adduction. Laryngoscope 2001; 111(8): 1322-9.
[http://dx.doi.org/10.1097/00005537-200108000-00003] [PMID: 11568563]
[67]
Gorham MM, Avidano MA, Crary MA, Cotter CS, Cassisi NJ. Laryngeal recovery following type I thyroplasty. Arch Otolaryngol Head Neck Surg 1998; 124(7): 739-42.
[http://dx.doi.org/10.1001/archotol.124.7.739] [PMID: 9677106]
[68]
Schneider B, Denk DM, Bigenzahn W. Acoustic assessment of the voice quality before and after medialization thyroplasty using the titanium vocal fold medialization implant (TVFMI). Otolaryngol Head Neck Surg 2003; 128(6): 815-22.
[PMID: 12825032]
[69]
McCulloch TM, Hoffman HT, Andrews BT, Karnell MP. Arytenoid adduction combined with Gore-Tex medialization thyroplasty. Laryngoscope 2000; 110(8): 1306-11.
[http://dx.doi.org/10.1097/00005537-200008000-00015] [PMID: 10942131]
[70]
Nouwen J, Hans S, De Mones E, Brasnu D, Crevier-Buchman L, Laccourreye O. Thyroplasty type I without arytenoid adduction in patients with unilateral laryngeal nerve paralysis: the montgomery implant versus the Gore-Tex implant. Acta Otolaryngol 2004; 124(6): 732-8.
[http://dx.doi.org/10.1080/00016480310016875] [PMID: 15515499]
[72]
[73]
Biomedical Implants. Available from: http://www.bmecentral.com/implants.html
[74]
Sclafani AP. Nasal Implants. Available from: http://emedicine.medscape.com/article/
[75]
Weitzel EK, Wormald PJ. A scientific review of middle meatal packing/stents. Am J Rhinol 2008; 22(3): 302-7.
[http://dx.doi.org/10.2500/ajr.2008.22.3171] [PMID: 18588764]
[76]
Desrosiers M, Evans GA, Keith PK, et al. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. J Otolaryngol Head Neck Surg 2011; 40 (Suppl. 2): S99-S193.
[PMID: 21658337]
[77]
Keyhan SO, Ramezanzade S, Yazdi RG, et al. Prevalence of complications associated with polymer-based alloplastic materials in nasal dorsal augmentation: a systematic review and meta-analysis. Maxillofac Plast Reconstr Surg 2022; 44(1): 17.
[http://dx.doi.org/10.1186/s40902-022-00344-8] [PMID: 35451637]
[78]
Peled ZM, Warren AG, Johnston P, Yaremchuk MJ. The use of alloplastic materials in rhinoplasty surgery: a meta-analysis. Plast Reconstr Surg 2008; 121(3): 85e-92e.
[http://dx.doi.org/10.1097/01.prs.0000299386.73127.a7] [PMID: 18317090]
[79]
Ferril GR, Wudel JM, Winkler AA. Management of complications from alloplastic implants in rhinoplasty. Curr Opin Otolaryngol Head Neck Surg 2013; 21(4): 1.
[http://dx.doi.org/10.1097/MOO.0b013e3283628e40] [PMID: 23838548]
[80]
Jung YG, Kim KH, Dhong HJ. Ultrasonographic monitoring of new expanded polytetrafluoroethylene implant thickness after augmen-tation rhinoplasty. Am J Rhinol Allergy 2012; 26(5): e137-41.
[http://dx.doi.org/10.2500/ajra.2012.26.3801] [PMID: 23168145]
[81]
Deva AK, Merten S, Chang L. Silicone in nasal augmentation rhinoplasty: A decade of clinical experience. Plast Reconstr Surg 1998; 102(4): 1230-7.
[http://dx.doi.org/10.1097/00006534-199809020-00052] [PMID: 9734450]
[82]
Bednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am 2009; 42(5): 857-66. [x.
[http://dx.doi.org/10.1016/j.otc.2009.07.001] [PMID: 19909864]
[83]
Kennedy DW. The PROPEL™ steroid-releasing bioabsorbable implant to improve outcomes of sinus surgery. Expert Rev Respir Med 2012; 6(5): 493-8.
[http://dx.doi.org/10.1586/ers.12.53] [PMID: 23134241]
[84]
Romo T III, Pearson JM. Nasal Implants. Facial Plast Surg Clin North Am 2008; 16(1): 123-32.
[http://dx.doi.org/10.1016/j.fsc.2007.09.004] [PMID: 18063251]
[85]
Lee MR, Unger JG, Rohrich RJ. Management of the nasal dorsum in rhinoplasty: a systematic review of the literature regarding tech-nique, outcomes, and complications. Plast Reconstr Surg 2011; 128(5): 538e-50e.
[http://dx.doi.org/10.1097/PRS.0b013e31822b6a82] [PMID: 22030516]
[86]
Wang TD. Multicenter evaluation of subcutaneous augmentation material implants. Arch Facial Plast Surg 2003; 5(2): 153-4.
[http://dx.doi.org/10.1001/archfaci.5.2.153] [PMID: 12633202]
[87]
Winkler AA, Soler ZM, Leong PL, Murphy A, Wang TD, Cook TA. Complications associated with alloplastic implants in rhinoplasty. Arch Facial Plast Surg 2012; 14(6): 437-41.
[http://dx.doi.org/10.1001/archfaci.2012.583] [PMID: 22928175]
[88]
Ham J, Miller PJ. Expanded polytetrafluoroethylene implants in rhinoplasty: literature review, operative techniques, and outcome. Facial Plast Surg 2003; 19(4): 331-40.
[http://dx.doi.org/10.1055/s-2004-815653] [PMID: 14737702]

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