Chemical characterization, adverse effects and potential toxicological effects of medical devices applied in gastrointestinal disease: a review


  • Shoban Babu Varthya Department of Pharmacology, All India institute of medical sciences (AIIMS) Jodhpur, Rajasthan, India
  • Hare Krishna Department of Anatomy, All India institute of medical sciences (AIIMS) Jodhpur, Rajasthan, India



Medical devices, SEMS, Gastrointestinal diseases, Toxicological effects


Medical devices have gained popularity as a therapeutic or diagnostic purpose in gastrointestinal obstructions caused by malignant tumour or benign stricture or any other pre-existing conditions. The problems of stents are like sense of foreign body, migration or incomplete expansion or re obstruction. In this scenarios, self-expandable metallic stents (SEMS), or biodegradable self-expanding stents, wall flex stents, drug eluted stents, etc prevents the obstruction related difficulties. SEMS associated with re-obstruction and migration along with difficulty in removal and chances of leaks due to corrosion.  In case of biodegradable self-expanding stents, which are either made of magnesium-based materials or synthetic polymers, such as polylactide or polyglycolide, or co-polymers, such as polydioxanone. Magnesium-based materials are very biocompatible but due to the property of dissolving in the body by rapid corrosion, degradation can occur before the therapeutic objective is reached. Synthetic polymers associated severe mucosal hyperplastic reaction with overgrowth and/or ingrowth. Wall flex stents, drug eluted stents can be used to prevent complications associated with above variants but their clinical significance and toxicological effects were not evaluated completely. Under this given scenario toxicological evolution of various medical devices used in gastrointestinal disease and their potential toxicological effects are required to understand their tolerability and acceptability.


Maetani I, Isayama H, Mizumoto Y. Palliation in patients with malignant gastric outlet obstruction with a newly designed enteral stent: a multicenter study. Gastrointest Endosc. 2007;66(2):355-60.

Morgan R, Adam A. Use of metallic stents and balloons in the esophagus and gastrointestinal tract. J Vasc Interv Radiol. 2001;12(3):283-97.

Shi. D, Xm. Q, Ty. F. Current Status of Metal Stents for Malignant Gastro-Duodenal Obstruction. J Gastroint Dig Syst. 2013;3(140):1-5.

Bektas H, Gurbulak B, Duzkoylu Y, Colak S, Gurbulak EK, Cakar E et al. Clinical Outcomes of Upper Gastrointestinal Stents and Review of Current Literature. JSLS. 2017;21:4.

Kochar R, Shah N. Enteral stents: from esophagus to colon. Gastrointest Endosc. 2013;78(6):913-8.

Conigliaro R, Battaglia G, Repici A, De Pretis G, Ghezzo L, Bittinger M et al. Polyflex stents for malignant oesophageal and oesophagogastric stricture: a prospective, multicentric study. Eur J Gastroenterol Hepatol. 2007;19(3):195-203.

Cheung DY, Kim JY, Hong SP, Jung MK, Ye BD, Kim SG et al. Outcome and safety of self-expandable metallic stents for malignant colon obstruction: a Korean multicenter randomized prospective study. Surg Endosc. 2012;26(11):3106-13.

Kim CG, Choi IJ, Lee JY, Cho SJ, Park SR, Lee JH et al. Covered versus uncovered self-expandable metallic stents for palliation of malignant pyloric obstruction in gastric cancer patients: a randomized, prospective study. Gastrointest Endosc. 2010;72(1):25-32.

Verschuur EM, Repici A, Kuipers EJ, Steyerberg EW, Siersema PD. New design esophageal stents for the palliation of dysphagia from esophageal or gastric cardia cancer: a randomized trial. Am J Gastroenterol. 2008;103(2):304-12.

Szegedi L, Gal I, Kosa I, Kiss GG. Palliative treatment of esophageal carcinoma with self-expanding plastic stents: a report on 69 cases. Eur J Gastroenterol Hepatol. 2006;18(11):1197-201.

Park J, Kim J-K, Park SA, Lee D-W. Biodegradable polymer material based smart stent: Wireless pressure sensor and 3D printed stent. Microelectron Eng. 2019;206(1):1-5.

Boam AB. Regulatory issues facing the development of drug-eluting stents: a US FDA perspective. Expert Rev Med Devices. 2006;3(3):297-300.

Hansen DC. Metal Corrosion in the Human Body: The Ultimate Bio-Corrosion Scenario. Electrochem Soc Interface. 2008;7(2):31-4.

Pilliar RM. Overview of surface variability of metallic endosseous dental implants: textured and porous surface-structured designs. Implant Dent. 1998;7(4):305-14.

Volenec K, Pohl I. The challenges: Stent materials from the perspective of the manufacturer. Int J Gastrointestinal Intervention. 2016;5(2):98-104.

Duerig T, Stoeckel D, Johnson D. SMA: smart materials for medical applications. European Workshop on Smart Structures. Engineering Technol. 2003;4763.

Stoeckel D. Nitinol Medical Devices and Implants. Minimally Invasive Therapy Allied Technol. 2000;9(2):81-8.

Holm AN, De la Mora Levy JG, Gostout CJ, Topazian MD, Baron TH. Self-expanding plastic stents in treatment of benign esophageal conditions. Gastrointest Endosc. 2008;67(1):20-5.

Lorenzo-Zuniga V, Moreno-de-Vega V, Marin I, Boix J. Biodegradable stents in gastrointestinal endoscopy. World J Gastroenterol. 2014;20(9):2212-7.

Stivaros SM, Williams LR, Senger C, Wilbraham L, Laasch HU. Woven polydioxanone biodegradable stents: a new treatment option for benign and malignant oesophageal strictures. Eur Radiol. 2010;20(5):1069-72.

Tanaka T, Takahashi M, Nitta N, Furukawa A, Andoh A, Saito Y, et al. Newly developed biodegradable stents for benign gastrointestinal tract stenoses: a preliminary clinical trial. Digestion. 2006;74(3-4):199-205.

Škrlová K, Malachová K, Muñoz-Bonilla A, Měřinská D, Rybková Z, Fernández-García M et al. Biocompatible Polymer Materials with Antimicrobial Properties for Preparation of Stents. Nanomaterials (Basel, Switzerland). 2019;9:11.

Guo Q, Guo S, Wang Z. A type of esophageal stent coating composed of one 5-fluorouracil-containing EVA layer and one drug-free protective layer: in vitro release, permeation and mechanical properties. J Control Release. 2007;118(3):318-24.

Hirdes MM, Vleggaar FP, De Beule M, Siersema PD. In vitro evaluation of the radial and axial force of self-expanding esophageal stents. Endoscopy. 2013;45(12):997-1005.

Emre A, Sertkaya M, Akbulut S, Erbil O, Yurttutan N, Kale IT et al. Self-expandable metallic stent application for the management of upper gastrointestinal tract disease. Turk J Surg. 2018;34(2):101-5.

Repici A, Conio M, De Angelis C, Battaglia E, Musso A, Pellicano R et al. Temporary placement of an expandable polyester silicone-covered stent for treatment of refractory benign esophageal strictures. Gastrointest Endosc. 2004;60(4):513-9.

Lin M, Firoozi N, Tsai CT, Wallace MB, Kang Y. 3D-printed flexible polymer stents for potential applications in inoperable esophageal malignancies. Acta Biomater. 2019;83:119-29.

Imaz-Iglesia I, Garcia-Perez S, Nachtnebel A, Martin-Agueda B, Sanchez-Piedra C, Karadayi B et al. Biodegradable stents for the treatment of refractory or recurrent benign esophageal stenosis. Expert Rev Med Devices. 2016;13(6):583-99.

Seo EH, Jung MK, Park MJ, Park KS, Jeon SW, Cho CM et al. Covered expandable nitinol stents for malignant gastroduodenal obstructions. J Gastroenterol Hepatol. 2008;23(7 Pt 1):1056-62.

Woo SM, Kim DH, Lee WJ, Park KW, Park SJ, Han SS et al. Comparison of uncovered and covered stents for the treatment of malignant duodenal obstruction caused by pancreaticobiliary cancer. Surg Endosc. 2013;27(6):2031-9.

Katsanos K, Sabharwal T, Adam A. Stenting of the upper gastrointestinal tract: current status. Cardiovasc Intervent Radiol. 2010;33(4):690-705.

Soehendra N, Reynders-Frederix V. Palliative bile duct drainage - a new endoscopic method of introducing a transpapillary drain. Endoscopy. 1980;12(1):8-11.

Catalano MF, Geenen JE, Lehman GA, Siegel JH, Jacob L, McKinley MJ et al. "Tannenbaum" Teflon stents versus traditional polyethylene stents for treatment of malignant biliary stricture. Gastrointest Endosc. 2002;55(3):354-8.

Donelli G, Guaglianone E, Di Rosa R, Fiocca F, Basoli A. Plastic biliary stent occlusion: factors involved and possible preventive approaches. Clin Med Res. 2007;5(1):53-60.

O'Brien S, Hatfield AR, Craig PI, Williams SP. A three year follow up of self expanding metal stents in the endoscopic palliation of longterm survivors with malignant biliary obstruction. Gut. 1995;36(4):618-21.

Van Berkel AM, Bergman JJ, Waxman I, Andres P, Huibregtse K. Wallstents for metastatic biliary obstruction. Endoscopy. 1996;28(5):418-21.

Tsang TK, Pollack J, Chodash HB. Silicone-covered metal stents: an in vitro evaluation for biofilm formation and patency. Dig Dis Sci. 1999;44(9):1780-5.

Deans GT, Krukowski ZH, Irwin ST. Malignant obstruction of the left colon. Br J Surg. 1994;81(9):1270-6.

Olubaniyi BO, McFaul CD, Yip VS, Abbott G, Johnson M. Stenting for large bowel obstruction-evolution of a service in a district general hospital. Ann R Coll Surg Engl. 2009;91(1):55-8.

Dohmoto. M. New method: endoscopic implantation of rectal stent in palliative treatment of malignant stenosis. Endoscopia Digestiva. 1991;3:1507-12.

Keymling M. Colorectal stenting. Endoscopy. 2003;35(3):234-8.

Chun HJ, Kim ES, Hyun JJ, Kwon YD, Keum B, Kim CD. Gastrointestinal and biliary stents. J Gastroenterol Hepatol. 2010;25(2):234-43.

Gorich J, Rilinger N, Kramer S, Aschoff AJ, Vogel J, Brambs HJ et al. Displaced metallic biliary stents: technique and rationale for interventional radiologic retrieval. AJR Am J Roentgenol. 1997;169(6):1529-33.

Kim JH, Song HY, Shin JH, Choi E, Kim TW, Lee SK et al. Stent collapse as a delayed complication of placement of a covered gastroduodenal stent. AJR Am J Roentgenol. 2007;188(6):1495-9.

Sanyal A, Maskell GF, Hohle R, Murray IA. An unusual complication of oesophageal stent deployment. Br J Radiol. 2006;79(945):e103-5.

Catalano O, De Bellis M, Sandomenico F, De Lutio di Castelguidone E, Delrio P et al. Complications of biliary and gastrointestinal stents: MDCT of the cancer patient. AJR Am J Roentgenol. 2012;199(2):W187-96.

Kullman E, Frozanpor F, Soderlund C, Linder S, Sandstrom P, Lindhoff-Larsson A et al. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc. 2010;72(5):915-23.

Phillips MS, Gosain S, Bonatti H, Friel CM, Ellen K, Northup PG et al. Enteral stents for malignancy: a report of 46 consecutive cases over 10 years, with critical review of complications. J Gastrointest Surg. 2008;12(11):2045-50.

Kim HC, Han JK, Kim TK, Do KH, Kim HB, Park JH et al. Duodenal perforation as a delayed complication of placement of an esophageal stent. J Vasc Interv Radiol. 2000;11(7):902-4.

Li Sol Y, Kim CW, Jeon UB, Lee NK, Kim S, Kang DH et al. Early infectious complications of percutaneous metallic stent insertion for malignant biliary obstruction. AJR Am J Roentgenol. 2010;194(1):261-5.

Anikhindi SA, Ranjan P, Sachdeva M, Kumar M. Self-expanding plastic stent for esophageal leaks and fistulae. Indian J Gastroenterol. 2016;35(4):287-93.

Khara HS, Diehl DL, Gross SA. Esophageal stent fracture: case report and review of the literature. World J Gastroenterol. 2014;20(10):2715-20.

Costa L, Bracco P, Vada S, Trossarelli L, Jacobson K. A chemical analysis of the clogging process of polymeric biliary endoprostheses. Biomaterials. 2001;22(23):3113-9.

Motte S, Deviere J, Dumonceau JM, Serruys E, Thys JP, Cremer M. Risk factors for septicemia following endoscopic biliary stenting. Gastroenterology. 1991;101(5):1374-81.




How to Cite

Varthya, S. B., & Krishna, H. (2021). Chemical characterization, adverse effects and potential toxicological effects of medical devices applied in gastrointestinal disease: a review. International Journal of Basic & Clinical Pharmacology, 10(11), 1317–1323.



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