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Current Bibliographies in Medicine 99-5
Improving Implant Performance through Retrieval Information
January 1990 through October 1999
1412 Citations
Prepared by
Karen Patrias, M.L.S., National Library of Medicine
Harvey S. Borovetz, Ph.D., University of Pittsburgh and National Heart, Lung, and Blood Institute
Christine A. Kelley, Ph.D., National Heart, Lung, and Blood Institute
James S. Panagis, M.D., M.P.H., National Institute of Arthritis and Musculoskeletal and Skin Diseases
1999 December
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Institutes of Health
National Library of Medicine
Reference Section
8600 Rockville Pike
Bethesda, Maryland 20894
- Series Note
- Table of Contents for this bibliography
- Introduction to this bibliography
- Sample Citations
Each bibliography in the Current Bibliographies in Medicine (CBM) series covers a distinct subject area of biomedicine and is intended to fulfill a current awareness function. Citations are usually derived from searching a variety of online databases. NLM databases utilized include MEDLINE®, AVLINE®, BIOETHICSLINE®, CANCERLIT®, CATLINE®, HEALTHSTARtm, POPLINEtm, and TOXLINE®. The only criterion for the inclusion of a particular published work is its relevance to the topic being presented; the format, ownership, or location of the material is not considered.
Other publications in the Current Bibliographies in Medicine series are available at no cost to anyone with Internet access through the Library's World Wide Web site at http://www.nlm.nih.gov/pubs/resources.html.
Comments and suggestions on this series may be addressed to:
Karen Patrias, Editor
Current Bibliographies in Medicine
Reference Section
National Library of Medicine
Bethesda, MD 20894
Phone: 301-496-6097
Fax: 301-402-1384
Internet: ref@nlm.nih.gov
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Return to title page | Return to table of contentsTable of Contents
Series Note
Introduction
Sample Citations
Bibliography:
Reviews/Overviews
Reviews
Implant Retrieval Conferences
Internet Sites
Patient/Health Care Provider Perspectives
Patient Expectations/Organizations
Patient Education
Ethical, Religious, Cultural Factors
Health Personnel Role and Expectations
Implantation and Follow-Up
Methods of Implantation and Analysis
Patient Monitoring and Diagnostics
Risks and Outcome
Risks and Risk Assessment
Outcome Assessment
Implant Failure and Failure Analysis
Adverse Effects
Other
Economic Factors
Costs and Cost Analysis
Payment/Financing/Insurance
Data Collection and Management
Databases and Information Systems
Registries
Other
Controls
Standards and Guidelines
Regulation
Legal Issues
Implant Industry
The Future
New Device Design
Other Trends and Forecasting
Return to title pageImproving Implant Performance through Retrieval Information
Various medical implant devices have been widely used since the 1960s, and it is estimated that eight to ten percent of the American population currently has a permanent medical implant. Yet there has not been any systematic effort developed in the United States for implant retrieval analysis or data banking, even though medical implant retrieval research provides the only true long-term data on host response and the final condition of the implant. Thorough reporting on the performance of implants would allow physicians to evaluate devices, understand the clinical benefit and risks associated with medical implant treatment and prevention of disease, and advance the development of better devices and materials. This will ultimately benefit patients through superior implant technology.
While most medical implants function very well, significant challenges remain associated especially with their intended long-term duration of use. The advance of medical implant science is hampered by a lack of study of implants retrieved after surgery or at autopsy. Much can be learned of clinical end points, implant performance, and design theory, and this information will again lead to superior medical implants that benefit U.S. patients.
To that end the NIH sponsored a Technology Assessment Conference (TAC) titled "Improving Medical Implant Performance through Retrieval Information: Challenges and Opportunities" held on January 10-12, 2000 at the National Institutes of Health in Bethesda, Maryland. The primary sponsors of this conference were the National Heart, Lung, and Blood Institute (NHLBI) and the NIH Office of Medical Applications of Research (OMAR). Additional sponsors were the NIH Biomaterials and Medical Implant Science Coordinating Committee, which represents all of the NIH Institutes and Centers, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Dental and Craniofacial Research, the National Institute of Neurological Disorders and Stroke, the National Library of Medicine, and the National Institute of Standards and Technology. The objective of the conference was to assess the opportunities and challenges to developing a framework for independent research of explanted natural synthetic implants, with the ultimate objective to provide benefits to patients through implant retrieval and analysis. For the purpose of this conference, implants were defined as having a minimum life span of three months, as penetrating living tissue, as having a physiologic interaction, and of being retrievable.
This bibliography was prepared in support of this Technology Assessment Conference. Specific types of implants which were considered for inclusion in the bibliography are:
Absorbable Implants
Arteriovenous Shunt, Surgical
Artificial Limbs
Bioprosthesis
Blood Vessel Prosthesis
Bone Nails
Bone Plates
Bone Screws
Bone Substitutes (Synthetic)
Breast Implants
Catheters, Indwelling (in dialysis only)
Cavopulmonary Shunts
Cerebrospinal Fluid Shunts
Cochlear Implants
Defibrillators, Implantable
Dental Implants
Dental Implants, Single-Tooth
Dental Prosthesis, Implant-Supported
Tooth, Artificial
Dental Prosthesis
Dental Abutments
Electrodes, Implanted
Endolymphatic Shunt
Glaucoma Drainage Implants
Heart, Artificial
Heart Valve Prosthesis
Heart-Assist Devices
Implants, Experimental
Infusion Pumps, Implantable
Internal Fixators
Joint Prosthesis
Larynx, Artificial
Lenses, Intraocular
Mandibular Prosthesis
Neuroprostheses
Orbital Implants
Ossicular Prosthesis
Pacemaker, Artificial
Penile Prosthesis
Peritoneovenous Shunt
Portacaval Shunt, Surgical
Portasystemic Shunt, Surgical
Reconstructive Surgical Procedures
Skin, Artificial
Splenorenal Shunt, Surgical
Stents
Urinary Sphincter, Artificial
Vena Cava Filters
In compiling this bibliography a variety of government-sponsored and commercially available databases were searched for the period from January 1990 through October 1999. From a candidate pool of over 15,000 citations in all languages on the aforementioned types of implants, those references in which implants met the definition given above and which discussed retrieval of these implants in a study population equal to or greater than ten were selected; animal studies were excluded. These references were then arranged into nine broad subject categories: Reviews/Overviews; Patient/Health Care Provider Perspectives; Implantation and Follow-Up; Risks and Outcome; Economic Factors; Data Collection and Management; Controls; Implant Industry; and the Future. A citation may appear in more than one category.
Under the Reviews/Overviews category an Internet Sites list has been included. This list is not meant to be all inclusive, but rather is intended to provide representative government and private sites which will lead the user to additional information.
The compilers wish to thank Martha Glock of the Reference Section, National Library of Medicine, for her invaluable assistance in searching the legal literature for material relevant to this bibliography. Although there have been many court cases arising from device implantation, only a few hundred were identified which actually discussed explantation of the device. Breast, temporomandibular joint, and intraocular lens implants comprised the largest groups found in these cases. A review of these cases, however, found that they contained little scientific content and thus none have been cited here.
Any reproductions of this bibliography, in whole or in part, must include all credits. If you wish to cite this bibliography, the correct format is:
Patrias, Karen; Borovetz, Harvey S.; Kelley, Christine A.; Panagis, James S., compilers. Improving medical implant performance through retrieval information [bibliography online]. Bethesda (MD): National Library of Medicine; 1999 Dec [insert cited year month day in brackets]. [insert no. of screens or lines in brackets]. (Current bibliographies in medicine; no. 99-5). 1412 citations from January 1990 through October 1999. Available from: URL http://www.nlm.nih.gov/pubs/resources.html
Citations are formatted according to the rules established for Index Medicus ®. Sample journal and monograph citations appear below. For journal articles written in a foreign language, the English translation of the title is placed in brackets; for monographs, the title is given in the original language. In both cases the language of publication is shown by a three letter abbreviation appearing at the end of the citation.
Journal Article:
Example:
Dao TT, Mellor A. Sensory disturbances associated with implant surgery. Int J Prosthodont 1998 Sep-Oct;11(5):462-9.
Order, with separating punctuation:
Authors. Article Title. Abbreviated Journal Title Date;Volume(Issue):Pages.
Monograph:
Example:
Braybrook J, editor. Biocompatibility assessment of medical devices and materials. New York: Wiley; 1997. 231 p.
Order, with separating punctuation:
Authors/Editors. Title. Edition. Place of Publication: Publisher; Date. Total No. of Pages.
For details of the formats used for references, see the following publication:
Patrias, Karen. National Library of Medicine recommended formats for bibliographic citation. Bethesda (MD): The Library; 1991 Apr. Available from: NTIS, Springfield, VA; PB91-182030.
Reviews/Overviews
Reviews
Albanese CT, Wiener ES. Venous access in pediatric oncology patients. Semin Surg Oncol 1993 Nov-Dec;9(6):467-77.
Albers FJ. Causes of hemodialysis access failure. Adv Ren Replace Ther 1994 Jul;1(2):107-18.
Aron-Rosa D. [New biomaterials and cataract surgery]. Bull Acad Natl Med 1995 Mar;179(3):557-66; discussion 566-7. (Fre).
Backer CL, Paape K, Zales VR, Weigel TJ, Mavroudis C. Coarctation of the aorta. Repair with polytetrafluoroethylene patch aortoplasty. Circulation 1995 Nov 1;92(9 Suppl):II132-6.
Beasley AM, Auffarth GU, von Recum AF. Intraocular lens implants: a biocompatibility review. J Invest Surg 1996 Nov-Dec;9(6):399-413.
Bergeron E, Denis R, Cartier P. [Peritoneal dialysis: peritonitis and catheter infections]. Ann Chir 1996;50(8):606-12. (Fre).
Biomaterials: Implant tracking, retrieval and analysis, : A worthy investment. Med Device Diagn Ind 1992 Nov;14(11):22, 115.
Black J. Biological performance of materials: fundamentals of biocompatibility. 3rd ed. New York: Dekker; 1999. Clinical performance of biomaterials; p. 425-41.
Bobyn JD, Dujovne AR, Krygier JJ, Young DL. Surface analysis of the taper junctions of retrieved and in vitro tested modular hip prostheses. In: Morrey BF, editor. Biological, material, and mechanical considerations of joint replacement. New York: Raven Press; 1993. p. 287-301.
Bos J, Berner J, Diebold J, Lohrs U. [Histological and morphometric studies of femurs with stable hip joint replacement. An autopsy study with special reference to factors leading to late loosening]. Z Orthop Ihre Grenzgeb 1995 Sep-Oct;133(5):460-6. (Ger).
Boss JH, Shajrawi I, Mendes DG. The nature of the bone-implant interface. The lessons learned from implant retrieval and analysis in man and experimental animal. Med Prog Technol 1994;20(3-4):119-42.
Braybrook J, editor. Biocompatibility assessment of medical devices and materials. New York: Wiley; 1997. 231 p.
Carlson AN, Stewart WC, Tso PC. Intraocular lens complications requiring removal or exchange. Surv Ophthalmol 1998 Mar-Apr;42(5):417-40.
Carlson B, Carlsson GE. Prosthodontic complications in osseointegrated dental implant treatment. Int J Oral Maxillofac Implants 1994 Jan-Feb;9(1):90-4.
Cason L, McKinney RV, Steflik D, Singh B. Implant retrieval diagnostic microspopy and analyses [abstract]. J Dent Res 1991;70 Spec Issue:488. Paper presented at the 69th General Session of the International Association for Dental Research, Acapulco, 1991 Apr 17-21.
Castro FP Jr, Chimento G, Munn BG, Levy RS, Timon S, Barrack RL. An analysis of Food and Drug Administration medical device reports relating to total joint components. J Arthroplasty 1997 Oct;12(7):765-71.
Cranin AN, Klein M, Sirakian A, Russell D, Lee CJ. Implant retrieval from the oral and maxillofacial region [abstract]. I Dent Res 1991;70 Spec Issue:273. Paper presented at the 69th General Session of the International Association for Dental Research, Acapulco, 1991 Apr 17-21.
Dao TT, Mellor A. Sensory disturbances associated with implant surgery. Int J Prosthodont 1998 Sep-Oct;11(5):462-9.
Duncan E. Biomaterials: Implant tracking, surveillance, and retrieval. Med Device Diagn Ind 1991 Apr;13(4):30, 32-4, passim.
el Khader K. [Complications of double J ureteral stents]. J Urol (Paris) 1996;102(4):173-5. (Fre).
Figueroa TE, Martinez CR, Lockhart JL. Retrieval of retained ureteral stents in chldren [abstract]. J Urol 1992;147(4 Suppl):355A. Paper presented at the 87th Annual Meeting of the American Urological Association., Washington, DC, 1991 May 10-14.
Foliart DE. Swanson silicone finger joint implants: a review of the literature regarding long-term complications. J Hand Surg [Am] 1995 May;20(3):445-9.
Freiherr G. Explanting information: Database proposals pose dilemma for implantable device community. Med Device Diagn Ind 1995 May;17(5):92-6, 266.
Gad SC. Safety evaluation of medical devices. New York: Marcel Dekker; 1997. 288 p.
Gladstone HB, McDermott MW, Cooke DD. Implants for cranioplasty. Otolaryngol Clin North Am 1995 Apr;28(2):381-400.
Goodman SB, Lind M, Song Y, Smith RL. In vitro, in vivo, and tissue retrieval studies on particulate debris. Clin Orthop 1998 Jul;(352):25-34.
Gristina AG, Giridhar G, Gabriel BL, Naylor PT, Myrvik QN. Cell biology and molecular mechanisms in artificial device infections. Int J Artif Organs 1993 Nov;16(11):755-63.
Haubold AD. On the durability of pyrolytic carbon in vivo. Med Prog Technol 1994;20(3-4):201-8.
Huschke T, Zermann DH, Schubert J. [Implants in urology]. Z Arztl Fortbild (Jena) 1997 Jan;90(8):725-31. (Ger).
Kadoya Y, Kobayashi A, Ohashi H. Wear and osteolysis in total joint replacements. Acta Orthop Scand Suppl 1998 Feb;278:1-16. Comment in: Acta Orthop Scand 1998 Aug;69(4):435-6.
Kantharia BK, Kutalek SP. Extraction of pacemaker and implantable cardioverter defibrillator leads. Curr Opin Cardiol 1999 Jan;14(1):44-51.
Kaplan SS. Biomaterial-host interactions: consequences, determined by implant retrieval analysis. Med Prog Technol 1994;20(3-4):209-30.
Karatzas S, Dompkowski D, Warbington M, Amar S. Immunolocalization of inflammatory mediators in soft tissues harvested from failing implant lesions. In: Paper presented at: 27th Annual Meeting of the International Association for Dental Research; 1998 Mar 4-8; Minneapolis, MN.
Kastan DJ, Burke TH, Shetty PC, Venugopal C, Sharma RP, Burke MW. Observations regarding the retrieval of metal stents. In: Paper presented at: 84th Annual Meeting of the Scientific Assembly of the Radiological Society of North America; 1998 Nov 29- Dec 4; Chicago.;
Kim H. Stenting therapy for stenosing airway disease. Respirology 1998 Dec;3(4):221-8.
Laxenaire A, Levy J, Blanchard P, Lerondeau JC, Tesnier F, Scheffer P. [Silastic implants and reconstruction of the orbital floor: review of twenty year's experience]. Ann Chir Plast Esthet 1996 Dec;41(6):631-8. (Fre).
Lemons JE. Unanticipated outcomes: dental implants. Implant Dent 1998;7(4):351-4.
Libby ED, Leung JW. Prevention of biliary stent clogging: a clinical review. Am J Gastroenterol 1996 Jul;91(7):1301-8. Comment in: Am J Gastroenterol 1997 Mar;92(3):542-3.
Malcolm AJ/Cooper PN, Mawhinney WH. The pathobiology of autopsy-retrieved hydroxyapatite-coated prostheses [abstract]. J Pathol 1992;167 Suppl:161A. Papr presented at the 64th Meeting of the Pathological Society of Great Britain and Ireland, London, 1992 Jan 8-10.
Marshall B, Steflik DE, McKinney RV, Lake F, Singh B. Diagnostic microbiology of retrieved human dental implants and augmentation biopsies [abstract]. J Dent Res 1990 Mar;69 Spec Issue:233. Paper presented at the 68th General Session of the International Association for Dental Research, Cincinnati, OH, 1990 Mar 7-11.
Mawhinney WM, Adair CG, Gorman SP. Incidence of microbial biofilm on peritoneal catheters removed peritonitis-free CAPD patients following renal transplant [abstract]. Pharmacotherapy 1991;11(3):277. Paper presented at the 12th Annual Meeting of the American College of Clinical Pharmacology, Minneapolis, MN, 1991 Aug 18-21.
Mehta AC, Dasgupta A. Airway stents. Clin Chest Med 1999 Mar;20(1):139-51.
Mercuri LG. Considering total temporomandibular joint replacement. Cranio 1999 Jan;17(1):44-8.
Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont 1998 Sep-Oct;11(5):491-501.
Misch CE. The implant quality scale: a clinical assessment of the health--disease continuum. Oral Health 1998 Jul;88(7):15-20, 23-5; quiz 25-6.
Moss AJ, Hamburger S, Moore RM Jr, Jeng LL, Howie LJ. Use of selected medical device implants in the United States, 1988. Adv Data 1991 Feb 26;(191):1-24.
Nesbitt JC, Carrasco H. Expandable stents. Chest Surg Clin N Am 1996 May;6(2):305-28.
Obstbaum SA. The Binkhorst Medal Lecture. Biologic relationship between poly(methyl methacrylate) intraocular lenses and uveal tissue. J Cataract Refract Surg 1992 May;18(3):219-31. Comment in: J Cataract Refract Surg 1992 May;18(3):217-8.
Ohrloff C. [Comparative evaluation of intracapsular cataract extraction, extracapsular cataract extraction and phacoemulsification]. Fortschr Ophthalmol 1990;87 Suppl:S14-21. (Ger).
Orszulak TA, Schaff HV, DeSmet JM, Danielson GK, Pluth JR, Puga FJ. Late results of valve replacement with the Bjork-Shiley valve (1973 to 1982). J Thorac Cardiovasc Surg 1993 Feb;105(2):302-12. Comment in: J Thorac Cardiovasc Surg 1994 Jul;108(1):177-9.
Pinchuk L. Polyurethane degradation: Effects on mechanical properties and carcinogenicity. Probl Gen Surg 1994;11(2):179-91.
Piraino B. Peritoneal catheter exit-site and tunnel infections. Adv Ren Replace Ther 1996 Jul;3(3):222-7.
Pizzoferrato A, Stea S, Savarino L, Granchi D, Ciapetti G. [Histomorphometric evaluation and pathogenesis of prosthetic loosening]. Chir Organi Mov 1994 Oct-Dec;79(4):245-55. (Ita).
Powe NR, Schein OD, Gieser SC, Tielsch JM, Luthra R, Javitt J, Steinberg EP. Synthesis of the literature on visual acuity and complications following cataract extraction with intraocular lens implantation. Cataract Patient Outcome Research Team . Arch Ophthalmol 1994 Feb;112(2):239-52. Published erratum appears in Arch Ophthalmol 1994 Jul;112(7):889. Comment in: Arch Ophthalmol 1994 Jul;112(7):875.
Prokop A, editor. Bioartificial organs. New York: New York Academy of Sciences; 1997. (Annals of the New York Academy of Sciences; 831).
Rinaldi S, Sera F, Verrina E, Edefonti A, Perfumo F, Sorino P, Zacchello G, Andreetta B, Ardissino G, Bassi S, Capasso G, Caringella DA, Gianoglio B, Gusmano R, Rizzoni G. The Italian Registry of Pediatric Chronic Peritoneal Dialysis: a ten-year experience with chronic peritoneal dialysis catheters. Perit Dial Int 1998 Jan-Feb;18(1):71-4.
Rogers S, Lawford PV, Kenyon C, Black MM. Pathology of explanted bioprosthetic heart valves [abstract]. J Pathol 1992;167 Suppl:115A. Paper presented at the 164th Meeting of the Pathological Society of Great Britain and Ireland, London, 1992 Jan 8-10.
Schmidt M, Weber H, Schon R. Cobalt chromium molybdenum metal combination for modular hip prostheses. Clin Orthop 1996 Aug;(329 Suppl):S35-47.
Schoen FJ, Levy RJ. Pathology of substitute heart valves: new concepts and developments. J Card Surg 1994 Mar;9(2 Suppl):222-7.
Schwartz-Arad D, Chaushu G. The ways and wherefores of immediate placement of implants into fresh extraction sites: a literature review. J Periodontol 1997 Oct;68(10):915-23.
Shelton T, Steflik DE, Singh BB, McKinney RV, Sisk A. Histological analyses of dental implants removed from humans [abstract]. J Dent Res 1992 Mar;71 Spec Issue:289. Paper presented at the 21st Annual Meeting of the American Association for Dental Research, Boston, 1992 Mar 11-14.
Sherwin JR, Sharkey AM, Smith SK. Validation of an endometrial explant culture system for the measurement of cytokines implicated in implantation. In: Paper presented at: IFFS 98: 16th World Congress on Fertility and Sterility and the 54th Annual Meeting of the American Society for Reproductive Medicine; 1998 Oct 3-9; San Francisco, CA.
Solomon KD, Apple DJ, Mamalis N, Gwin TD, Wilbandt TH, Hansen SO, Tetz MR, Letchinger SL, Brown SJ, Legler UFC, Legler C. Complications of intraocular lenses with special reference to an analysis of 2500 explanted intraocular lenses (IOLs). Eur J Implant Refract Surg 1991;3(3):195-200.
Staab ME, Nishimura RA, Dearani JA, Orszulak TA. Aortic valve homografts in adults: a clinical perspective. Mayo Clin Proc 1998 Mar;73(3):231-8.
Stein PD, Dellsperger KC. Summary and recommendations. J Heart Valve Dis 1996 Aug;5 Suppl 2:S246-8.
Sun BC, Catanese KA, Spanier TB, Flannery MR, Gardocki MT, Marcus LS, Levin HR, Rose EA, Oz MC. 100 long-term implantable left ventricular assist devices: the Columbia Presbyterian interim experience. Ann Thorac Surg 1999 Aug;68(2):688-94.
Tanner A, Maiden MF, Lee K, Shulman LB, Weber HP. Dental implant infections. Clin Infect Dis 1997 Sep;25 Suppl 2:S213-7.
Vinard E, Eloy R, Descotes J, Brudon JR, Guidicelli H, Patra P, Huc A. [The Dacron vascular prosthesis in men. Mechanical performance, lesions and molecular stability]. Presse Med 1990 Apr 14;19(15):709-14. (Fre).
Watson A. Self-expanding metal oesophageal endoprostheses: which is best? Eur J Gastroenterol Hepatol 1998 May;10(5):363-5. Comment on: Eur J Gastroenterol Hepatol 1998 May;10(5):371-4.
Weber HP, Cochran DL. The soft tissue response to osseointegrated dental implants. J Prosthet Dent 1998 Jan;79(1):79-89.
Werkmeister JA, White JF, Ramshaw JA. Evaluation of the Omniflow collagen-polymer vascular prosthesis. Med Prog Technol 1994;20(3-4):231-42.
Wieting DW. The Bjork-Shiley Delrin tilting disc heart valve: historical perspective, design and need for scientific analyses after 25 years. J Heart Valve Dis 1996 Aug;5 Suppl 2:S157-68.
Return to table of contentsImplant Retrieval Conferences
Alexander H, Anderson J, Duncan E, editors. Society for Biomaterials Implant Retrieval Symposium Transactions; 1992 Sep 17-20; St. Charles, IL. Minneapolis (MN): Society for Biomaterials; 1992.
Daniels AU, editor. Society for Biomaterials Symposium on Retrieval and Analysis of Surgical Implants and Biomaterials; 1988 Aug 12-14; Snowbird, UT. Minneapolis (MN): Society for Biomaterials; 1988.
IDr3 implant data: record, report, review. Final conference report. Minneapolis (MN): Society for Biomaterials; 1996 Jun 28. Reports of conferences held 1994 Apr 10-11, Hyannis, MA; 1995 Jan 29-30, Melbourne, Australia; 1996 Jun 2-3, Buffalo, NY.
Weinstein A, Gibbons D, Brown S, Ruff W, editors. Proceedings of the Conference on Implant Retrieval: Material and Biological Analysis; 1980 May 1-3. Washington (DC): National Bureau of Standards; 1981 Jan. (NBS special publication; 601).
Weinstein A, Horowitz E, Ruff A, editors. Proceedings of a Symposium on Retrieval and Analysis of Orthopaedic Implants; 1976 Mar 5. Washington (DC): National Bureau of Standards; 1977 Apr. (NBS special publication; 472).
Return to table of contentsInternet Sites
AAMI: Association for the Advancement of Medical Instrumentation [homepage on the Internet]. Arlington (VA): The Association; [updated 1999 Dec 2; cited 1999 Dec 2]. Available from: http://www.aami.org/.
ANSI Online: American National Standards Institute [homepage on the Internet]. New York: The Institute; 1997-1999 [updated 1999 Nov 8; cited 1999 Dec 2]. Available from: http://www.ansi.org/.
ASAIO: American Society for Artificial Internal Organs [homepage on the Internet]. Boca Raton (FL): The Society; [updated 1999 Oct 14; cited 1999 Dec 2]. Available from: http://www.asaio.com/.
ASTM: American Society for Testing and Materials [homepage on the Internet]. West Conshohocken (PA): The Society; 1996-1999 [updated 1999 Aug 3; cited 1999 Dec 2]. Available from: http://www.astm.org/.
Biomaterials and Medical Implant Science Coordinating Committee [homepage on the Internet]. Bethesda (MD): National Institutes of Health (US), Office of Disease Prevention; [updated 1997 Aug 7; cited 1999 Dec 2]. Available from: http://odp.od.nih.gov/biomaterials/.
CDRH: Center for Devices and Radiological Health [homepage on the Internet]. Rockville (MD): Food and Drug Administration (US), Center for Devices and Radiological Health; [updated 1999 Nov 17; cited 1999 Dec 2]. Available from: http://www.fda.gov/cdrh/.
ECRI: A Nonprofit Agency [homepage on the Internet]. Plymouth Meeting (PA): ECRI; 1999 [updated 1999 Aug 27; cited 1999 Dec 2]. Available from: http://www.ecri.org/.
ECRI's Year 2000 Medical Device Knowledgebase [homepage on the Internet]. Plymouth Meeting (PA): ECRI; [updated 1999 Jan 22; cited 1999 Dec 2]. Available from: http://www.ecriy2k.org/.
ESB: The European Society for Biomaterials [homepage on the Internet]. Stuttgart (Germany): The Society; [updated 1999 Mar 9; cited 1999 Dec 2]. Available from: http://esb.itvd.uni-stuttgart.de/.
European Society for Artificial Organs [homepage on the Internet]. Groningen (The Netherlands): The Society; [updated 1998 May 26; cited 1999 Dec 2]. Available from: http://www.esao.donau-uni.ac.at/.
FDLI: The Food and Drug Law Institute [homepage on the Internet]. Washington (DC): The Institute; 1995-1999 [updated 1999 Nov 24; cited 1999 Dec 2]. Available from: http://www.fdli.org/.
HIMA: Health Industry Manufacturers Association [homepage on the Internet]. Washington (DC): The Association; 1999 [cited 1999 Dec 2]. Available from: http://www.himanet.com/.
ISO: International Organization for Standardization [homepage on the Internet]. Geneva: The Organization; [updated 1999 Nov 15; cited 1999 Dec 2]. Available from: http://www.iso.ch/.
JSAO: Japanese Society for Artificial Organs [homepage on the Internet]. Tokyo: The Society; [updated 1997 Aug; cited 1999 Dec 2]. Available from: http://www.abe.ecei.tohoku.ac.jp/~jsao/WelcomeENG.html.
Materials Science & Engineering Laboratory [homepage on the Internet]. Gaithersburg (MD): National Institute of Standards and Technology (US), Materials Science and Engineering Laboratory; [updated 1999 Oct; cited 1999 Dec 2]. Available from: http://www.msel.nist.gov/.
MDA: Medical Devices Agency [homepage on the Internet]. London: The Agency; 1997-1999 [updated 1999 Nov 26; cited 1999 Dec 2]. Available from: http://www.medical-devices.gov.uk/.
MDMA [homepage on the Internet]. Washington (DC): Medical Device Manufacturers Association; [updated 1999 Nov 10; cited 1999 Dec 2]. Available from: http://www.medicaldevices.org/.
medical design online: a professional community [homepage on the Internet]. [Horsham (PA)]: VerticalNet; 1996-1999 [updated 1999 Dec 2; cited 1999 Dec 2]. Available from: http://www.medicaldesignonline.com/.
Medical Device Link [homepage on the Internet]. Los Angeles (CA): Canon Communications; 1999 [updated 1999 Dec 2; cited 1999 Dec 2]. Available from: http://www.devicelink.com/.
National Heart, Lung, and Blood Institute [homepage on the Internet]. Bethesda (MD): The Institute; [updated 1999 Nov 30; cited 1999 Dec 2]. Available from: http://www.nhlbi.nih.gov/.
National Institute of Dental & Craniofacial Research [homepage on the Internet]. Bethesda (MD): The Institute; [updated 1999 Dec 1; cited 1999 Dec 2]. Available from: http://www.nidr.nih.gov/.
National Institute of Neurological Disorders and Stroke [homepage on the Internet]. Bethesda (MD): The Institute; [updated 1999 Nov 10; cited 1999 Dec 2]. Available from: http://www.ninds.nih.gov/.
NIAMS [homepage on the Internet]. Bethesda (MD): National Institute of Arthritis and Musculoskeletal and Skin Diseases (US); [updated 1999 Nov 1; cited 1999 Dec 2]. Available from: http://www.nih.gov/niams/.
The Society for Biomaterials [homepage on the Internet]. Minneapolis (MN): The Society; [updated 1999 Aug 9; cited 1999 Dec 2]. Available from: http://www.biomaterials.org/.
UNITED STATES National Library of Medicine [homepage on the Internet]. Bethesda (MD): The Library; [updated 1999 Nov 12; cited 1999 Dec 2]. Available from: http://www.nlm.nih.gov/.
Return to table of contentsPatient/Health Care Provider Perspectives
Patient Expectations/Organizations
Boerrigter EM, Geertman ME, Van Oort RP, Bouma J, Raghoebar GM, van Waas MA, van't Hof MA, Boering G, Kalk W. Patient satisfaction with implant-retained mandibular overdentures. A comparison with new complete dentures not retained by implants--a multicentre randomized clinical trial. Br J Oral Maxillofac Surg 1995 Oct;33(5):282-8.
Boerrigter EM, Stegenga B, Raghoebar GM, Boering G. Patient satisfaction and chewing ability with implant-retained mandibular overdentures: a comparison with new complete dentures with or without preprosthetic surgery. J Oral Maxillofac Surg 1995 Oct;53(10):1167-73.
De Wijs FL, Cune MS, De Putter C. Delayed implants in the anterior maxilla with the IMZ-implant system. J Oral Rehabil 1995 May;22(5):319-26.
Fee TE, Caffee HH. Predictors of postoperative aesthetics following explantation of the augmented breast. Ann Plast Surg 1997 Mar;38(3):217-22.
George VK, Erkhan S, Dhabuwala CB. Follow-up with Mentor two-piece inflatable penile prosthesis. Int J Impot Res 1995 Mar;7(1):17-21.
Godin MS, Waldman SR, Johnson CM Jr. The use of expanded polytetrafluoroethylene (Gore-Tex) in rhinoplasty. A 6-year experience. Arch Otolaryngol Head Neck Surg 1995 Oct;121(10):1131-6.
Gunay H, Veltmaat A, Schneller T, Neukam FW. [Psychological aspects of post-implant patients]. Dtsch Zahnarztl Z 1991 Oct;46(10):698-701. (Ger).
Gundian JC, Barrett DM, Parulkar BG. Mayo Clinic experience with the AS800 artificial urinary sphincter for urinary incontinence after transurethral resection of prostate or open prostatectomy. Urology 1993 Apr;41(4):318-21.
Gutowski KA, Mesna GT, Cunningham BL. Saline-filled breast implants: a Plastic Surgery Educational Foundation multicenter outcomes study. Plast Reconstr Surg 1997 Sep;100(4):1019-27.
Kaptein ML, Hoogstraten J, de Putter C, de Lange GL, Blijdorp PA. Dental implants in the atrophic maxilla: measurements of patients' satisfaction and treatment experience. Clin Oral Implants Res 1998 Oct;9(5):321-6.
Leder SB, Erskine MC. Voice restoration after laryngectomy: experience with the Blom-Singer extended-wear indwelling tracheoesophageal voice prosthesis. Head Neck 1997 Sep;19(6):487-93.
Lehur PA, Glemain P, Bruley des Varannes S, Buzelin JM, Leborgne J. Outcome of patients with an implanted artificial anal sphincter for severe faecal incontinence. A single institution report. Int J Colorectal Dis 1998;13(2):88-92.
Leo ME, Barrett DM. Success of the narrow-backed cuff design of the AMS800 artificial urinary sphincter: analysis of 144 patients. J Urol 1993 Nov;150(5 Pt 1):1412-4.
Montorsi F, Guazzoni G, Barbieri L, Maga T, Rigatti P, Graziottin A, Pizzini G, Miani A. AMS 700 CX inflatable penile implants for Peyronie's disease: functional results, morbidity and patient-partner satisfaction. Int J Impot Res 1996 Jun;8(2):81-5; discussion 85-6.
Roberts CS, Wells KE, Walden K. Toward understanding women who request removal of silicone breast implants. Breast J 1999;5(4):246-251.
Steinert RF, Aker BL, Trentacost DJ, Smith PJ, Tarantino N. A prospective comparative study of the AMO ARRAY zonal-progressive multifocal silicone intraocular lens and a monofocal intraocular lens. Ophthalmology 1999 Jul;106(7):1243-55.
Svahn JK, Vastine VL, Landon BN, Dobke MK. Outcome of mammary prostheses explantation: a patient perspective. Ann Plast Surg 1996 Jun;36(6):594-600.
Walden KJ, Thompson JK, Wells KE. Body image and psychological sequelae of silicone breast explantation: preliminary findings. Plast Reconstr Surg 1997 Oct;100(5):1299-306.
Walton JN, MacEntee MI. Problems with prostheses on implants: a retrospective study. J Prosthet Dent 1994 Mar;71(3):283-8.
Whalen RK, Merrill DC. Patient satisfaction with Mentor inflatable penile prosthesis. Urology 1991 Jun;37(6):531-9.
Yazigi A, Yazbeck P, Bou Saba R, Antakly MC. [Complications and outcome of implantable infusion pumps: apropos of 60 cases]. Ann Fr Anesth Reanim 1994;13(3):297-300. Comment in: Ann Fr Anesth Reanim 1994;13(6):915-6. (Fre).
Zimmer CM, Zimmer WM, Williams J, Liesener J. Public awareness and acceptance of dental implants. Int J Oral Maxillofac Implants 1992 Summer;7(2):228-32.
Return to table of contentsPatient Education
Gammon J, Mulholland CW. Effect of preparatory information prior to elective total hip replacement on post-operative physical coping outcomes. Int J Nurs Stud 1996 Dec;33(6):589-604.
Gammon J, Mulholland CW. Effect of preparatory information prior to elective total hip replacement on psychological coping outcomes. J Adv Nurs 1996 Aug;24(2):303-8.
Return to table of contentsEthical, Religious, Cultural Factors
Beyleveld D, Howells GG, Longley D. Heart valve ownership: legal, ethical and policy issues. J Heart Valve Dis 1995 Jul;4 Suppl 1:S2-5; discussion S5-6.
Brian G, Cohn G, Cooper RL, Cooper P, Le Mesurier RT, Cochrane GM. Ophthalmic interventions in the Developing World: insights for successful outcomes. Aust N Z J Ophthalmol 1999 Apr;27(2):101-8.
Sharkness CM, Hamburger S, Kaczmarek RG, Hamilton PM, Bright RA, Moore RM Jr. Racial differences in the prevalence of intraocular lens implants in the United States. Am J Ophthalmol 1992 Dec 15;114(6):667-74.
Wilson MG, May DS, Kelly JJ. Racial differences in the use of total knee arthroplasty for osteoarthritis among older Americans. Ethn Dis 1994 Winter;4(1):57-67.
Young NL, Cheah D, Waddell JP, Wright JG. Patient characteristics that affect the outcome of total hip arthroplasty: a review. Can J Surg 1998 Jun;41(3):188-95. Comment in: Can J Surg 1998 Jun;41(3):184-5.
Return to table of contentsHealth Personnel Role and Expectations
Lippert S, Gutschik E. Views of cardiac-valve prosthesis patients and their dentists on anticoagulation therapy. Scand J Dent Res 1994 Jun;102(3):168-71.
Matthew IR, Frame JW. Policy of consultant oral and maxillofacial surgeons towards removal of miniplate components after jaw fracture fixation: pilot study. Br J Oral Maxillofac Surg 1999 Apr;37(2):110-2.
Return to table of contentsImplantation and Follow-Up
Methods of Implantation and Analysis
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Akizuki S, Yasukawa Y, Takizawa T. A new method of hemostasis for cementless total knee arthroplasty. Bull Hosp Jt Dis 1997;56(4):222-4.
Akkin C, Ozler SA, Mentes J. Tilt and decentration of bag-fixated intraocular lenses: a comparative study between capsulorhexis and envelope techniques. Doc Ophthalmol 1994;87(3):199-209.
Alberto PL. Implant reconstruction of the jaws and craniofacial skeleton. Mt Sinai J Med 1998 Oct-Nov;65(5-6):316-21.
Apsner R, Schulenburg A, Sunder-Plassmann G, Muhm M, Keil F, Malzer R, Kalhs P, Druml W. Routine fluoroscopic guidance is not required for placement of Hickman catheters via the supraclavicular route. Bone Marrow Transplant 1998 Jun;21(11):1149-52.
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Arlin M. Immediate placement of dental implants into extraction sockets: surgically-related difficulties. Oral Health 1993 Jul;83(7):23-4, 27-8, 31 passim.
Arlin ML. Applications of guided tissue regeneration with dental implants. Oral Health 1994 Jul;84(7):27, 29, 31 passim; quiz 38.
Arlin ML. Immediate placement of osseointegrated dental implants into extraction sockets: advantages and case reports. Oral Health 1992 Jul;82(7):19-20, 23-4, 26.
Armstrong TA. Refractive effect of capsular bag lens placement with the capsulorhexis technique. J Cataract Refract Surg 1992 Mar;18(2):121-4.
Ashman A, LoPinto J, Rosenlicht J. Ridge augmentation for immediate postextraction implants: eight year retrospective study. Pract Periodontics Aesthet Dent 1995 Mar;7(2):85-94; quiz 95.
Astrand P, Almfeldt I, Brunell G, Hamp SE, Hellem S, Karlsson U. Non-submerged implants in the treatment of the edentulous lower jar. A 2-year longitudinal study. Clin Oral Implants Res 1996 Dec;7(4):337-44. Published erratum appears in Clin Oral Implants Res 1997 Aug;8(4):342.
Auffarth GU, Wesendahl TA, Brown SJ, Apple DJ. [Reasons for the explantation of posterior chamber lenses]. Ophthalmologe 1994 Aug;91(4):507-11. (Ger).
Auffarth GU, Wilcox M, Sims JC, McCabe C, Wesendahl TA, Apple DJ. Analysis of 100 explanted one-piece and three-piece silicone intraocular lenses. Ophthalmology 1995 Aug;102(8):1144-50.
Baikoff G, Arne JL, Bokobza Y, Colin J, George JL, Lagoutte F, Lesure P, Montard M, Saragoussi JJ, Secheyron P. Angle-fixated anterior chamber phakic intraocular lens for myopia of -7 to -19 diopters. J Refract Surg 1998 May-Jun;14(3):282-93. Comment in: J Refract Surg 1998 May-Jun;14(3):272-3; J Refract Surg 1998 May-Jun;14(3):274-6; J Refract Surg 1998 May-Jun;14(3):276-7.
Balshi TJ, Lee HY, Hernandez RE. The use of pterygomaxillary implants in the partially edentulous patient: a preliminary report. Int J Oral Maxillofac Implants 1995 Jan-Feb;10(1):89-98.
Balshi TJ, Wolfinger GJ. Immediate loading of Branemark implants in edentulous mandibles: a preliminary report. Implant Dent 1997 Summer;6(2):83-8.
Balshi TJ, Wolfinger GJ, Balshi SF 2nd. Analysis of 356 pterygomaxillary implants in edentulous arches for fixed prosthesis anchorage. Int J Oral Maxillofac Implants 1999 May-Jun;14(3):398-406.
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Bebawi MA, Moqtaderi F, Vijay V. Giant incisional hernia: staged repair using pneumoperitoneum and expanded polytetrafluoroethylene. Am Surg 1997 May;63(5):375-81.
Becker W, Dahlin C, Becker BE, Lekholm U, van Steenberghe D, Higuchi K, Kultje C. The use of e-PTFE barrier membranes for bone promotion around titanium implants placed into extraction sockets: a prospective multicenter study. Int J Oral Maxillofac Implants 1994 Jan-Feb;9(1):31-40.
Blankensteijn JD, Mali WP, Eikelboom BC. The Utrecht endovascular technologies (EVT) experience. J Mal Vasc 1998 Dec;23(5):381-4.
Borderie VM, Touzeau O, Bourcier T, Carvajal-Gonzalez S, Laroche L. The triple procedure: in the bag placement versus ciliary sulcus placement of the intraocular lens. Br J Ophthalmol 1999 Apr;83(4):458-62.
Borovetz HS, Ramasamy N, Zerbe TR, Portner PM. Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure. Device explant protocol. ASAIO J 1995 Jan-Mar;41(1):42-8.
Bostman OM. Refracture after removal of a condylar plate from the distal third of the femur. J Bone Joint Surg [Am] 1990 Aug;72(7):1013-8. Comment in: J Bone Joint Surg [Am] 1991 Jul;73(6):949-50.
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Buchmann R, Khoury F, Faust C, Lange DE. Peri-implant conditions in periodontally compromised patients following maxillary sinus augmentation. A long-term post-therapy trial. Clin Oral Implants Res 1999 Apr;10(2):103-10.
Buser D, Mericske-Stern R, Bernard JP, Behneke A, Behneke N, Hirt HP, Belser UC, Lang NP. Long-term evaluation of non-submerged ITI implants. Part 1: 8-year life table analysis of a prospective multi-center study with 2359 implants. Clin Oral Implants Res 1997 Jun;8(3):161-72.
Busin M, Meller D, Cusumano A, Spitznas M. [Chronic low grade endophthalmitis. A growing indication for explantation of intraocular lenses]. Ophthalmologe 1994 Aug;91(4):473-8. (Ger).
Carpenter JP, Tomaszewski JE. Immunosuppression for human saphenous vein allograft bypass surgery: a prospective randomized trial. J Vasc Surg 1997 Jul;26(1):32-42.
Caudill CC, Clinch B, Krueger SK, Gard JR, Turk KT, Wilson CS. Percutaneous extraction of a fractured, exposed atrial J lead retention wire. Cathet Cardiovasc Diagn 1996 Mar;37(3):342-6.
Cavina E, Seccia M, Banti P, Zocco G. Anorectal reconstruction after abdominoperineal resection. Experience with double-wrap graciloplasty supported by low-frequency electrostimulation. Dis Colon Rectum 1998 Aug;41(8):1010-6.
Cerfolio RJ, Danielson GK, Warnes CA, Puga FJ, Schaff HV, Anderson BJ, Ilstrup DM. Results of an autologous tissue reconstruction for replacement of obstructed extracardiac conduits. J Thorac Cardiovasc Surg 1995 Nov;110(5):1359-66; discussion 1366-8.
Chan MF, Howell RA, Cawood JI. Prosthetic rehabilitation of the atrophic maxilla using pre-implant surgery and endosseous implants. Br Dent J 1996 Jul 20;181(2):51-8.
Chaudhry NA, Belfort A, Flynn HW Jr, Tabandeh H, Smiddy WE, Murray TG. Combined lensectomy, vitrectomy and scleral fixation of intraocular lens implant after closed-globe injury. Ophthalmic Surg Lasers 1999 May;30(5):375-81.
Chitwood WR Jr, Wixon CL, Elbeery JR, Moran JF, Chapman WH, Lust RM. Video-assisted minimally invasive mitral valve surgery. J Thorac Cardiovasc Surg 1997 Nov;114(5):773-80; discussion 780-2.
Cochran DL, Douglas HB. Augmentation of osseous tissue around nonsubmerged endosseous dental implants. Int J Periodontics Restorative Dent 1993 Dec;13(6):506-19.
Collaert B, De Bruyn H. Comparison of Branemark fixture integration and short-term survival using one-stage or two-stage surgery in completely and partially edentulous mandibles. Clin Oral Implants Res 1998 Apr;9(2):131-5.
Cosci F, Cosci B. A 7-year retrospective study of 423 immediate implants. Compend Contin Educ Dent 1997 Sep;18(9):940-2, 944, 946 passim.
Cranin AN, Heimke G, Gelbman J, Simons A, Klein M, Sirakian A. Clinical trials with a polycrystalline alumina dental implant. J Oral Implantol 1993;19(3):221-7.
D'Angelo F, Ramacciato G, Caramitti A, Aurello P, Lauro S, Bordin F, Della Casa U. [Totally implantable venous access systems. Analysis of complications]. Minerva Chir 1997 Jul-Aug;52(7-8):937-42. (Ita).
D'Angelo FA, Ramacciato G, Aurello P, Lauro S, Caramitti A, Lalle M, Magri M. Alternative insertion sites for permanent central venous access devices. Eur J Surg Oncol 1997 Dec;23(6):547-9.
Dal Ponte DB, Berman SS, Patula VB, Kleinert LB, Williams SK. Anastomotic tissue response associated with expanded polytetrafluoroethylene access grafts constructed by using nonpenetrating clips. J Vasc Surg 1999 Aug;30(2):325-33.
De Amicis V, Ascione R, Iannelli G, Di Tommaso L, Monaco M, Spampinato N. Aortic valve replacement through a minimally invasive approach. Tex Heart Inst J 1997;24(4):353-5.
Dearborn JT, Harris WH. High placement of an acetabular component inserted without cement in a revision total hip arthroplasty. Results after a mean of ten years. J Bone Joint Surg Am 1999 Apr;81(4):469-80.
Deaton DH, Bogey WM, Chiang K, Brigham D, Powell CS. Bifurcated endovascular grafting for abdominal aortic aneurysm. Ann Vasc Surg 1999 Jan;13(1):23-31.
DeWall RA, Ellis RL. Implantation techniques: A primary consideration in valve surgery. Ann Thorac Surg 1989;48(4 Suppl):S59-60.
Dewey TM, Chen JM, Spanier TB, Oz MC. Alternative technique of right-sided outflow cannula insertion for right ventricular support. Ann Thorac Surg 1998 Nov;66(5):1829-30.
Di Salvo C, Walesby RK. Early single centre experience with 192 Sorin Bicarbon valves. J Cardiovasc Surg (Torino) 1996 Dec;37(6 Suppl 1):13-5.
Dick B, Schwenn O, Stoffelns B, Pfeiffer N. [Adhesion of liquid perfluorocarbon to various intraocular lens materials. A light microscopy study]. Ophthalmologe 1998 May;95(5):301-6. (Ger).
Dion YM, Gracia CR. A new technique for laparoscopic aortobifemoral grafting in occlusive aortoiliac disease. J Vasc Surg 1997 Oct;26(4):685-92.
Donatsky O, Hillerup S. Non-submerged osseointegrated dental implants with ball attachments supporting overdentures in patients with mandibular alveolar ridge atrophy. A short-term follow-up. Clin Oral Implants Res 1996 Jun;7(2):170-4.
Doty DB, Cafferty A, Kon ND, Huysmans HA, Krause AH Jr, Westaby S. Medtronic Freestyle aortic root bioprosthesis: Implant techniques. J Card Surg 1998 Sep-Oct;13(5):369-75.
Duncker GI, Westphalen S, Behrendt S. Complications of silicone disc intraocular lenses. J Cataract Refract Surg 1995 Sep;21(5):562-6.
Durquety MC, Guetari MC, Le Rebeller MJ. [Technics of explantation]. Bull Soc Ophtalmol Fr 1990 Mar;90(3):325-7. (Fre).
Edwards WH Jr, Naslund TC, Edwards WH Sr, Jenkins JM, McPherson K. Endovascular grafting of abdominal aortic aneurysms. A preliminary study. Ann Surg 1996 May;223(5):568-73; discussion 573-5.
Ehsani B, Collo D. [Three years experience with ionomer cement in reconstructive middle ear surgery]. Laryngorhinootologie 1994 Jul;73(7):381-4. (Ger).
Ergin MA. Surgical techniques in prosthetic valve endocarditis. Semin Thorac Cardiovasc Surg 1995 Jan;7(1):54-60.
Fisher DA, Trimble SM, Breedlove K. The medial trivector approach in total knee arthroplasty. Orthopedics 1998 Jan;21(1):53-6.
Fitzgerald RH Jr. Post-discharge prevention of deep vein thrombosis following total joint replacement. Orthopedics 1996 Aug;19 Suppl:15-8.
Fleming AE. The Endopore dental implant system: implant treatment simplified. J Can Dent Assoc 1994 Sep;60(9):785-9.
Fontana E, Trisi P, Piattelli A. Freeze-dried dura mater for guided tissue regeneration in post-extraction dental implants: a clinical and histologic study. J Periodontol 1994 Jul;65(7):658-65.
Friedman RA, Moak JP, Garson A Jr. Active fixation of endocardial pacing leads: the preferred method of pediatric pacing. Pacing Clin Electrophysiol 1991 Aug;14(8):1213-6.
Garber DA. The esthetic dental implant: letting restoration be the guide. J Oral Implantol 1996;22(1):45-50.
Garber DA, Belser UC. Restoration-driven implant placement with restoration-generated site development. Compend Contin Educ Dent 1995 Aug;16(8):796, 798-802, 804.
Geha AS, Lee JH. New approach for replacement of degenerated mitral bioprostheses. Eur J Cardiothorac Surg 1996;10(12):1090-6.
Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants 1993;8(4):388-99.
Gher ME, Quintero G, Sandifer JB, Tabacco M, Richardson AC. Combined dental implant and guided tissue regeneration therapy in humans. Int J Periodontics Restorative Dent 1994 Aug;14(4):332-47.
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Goldberg PV. Techniques and criteria for retention of teeth and placement of implants in the partially edentulous maxilla [interview]. Dent Implantol Update 1995 Mar;6(3):21-4 concl.
Golec TS. Technique for press-fit implants. J Am Dent Assoc 1990 Sep;121(3):409-12.
Graves SL, Jansen CE, Siddiqui AA, Beaty KD. Wide diameter implants: indications, considerations and preliminary results over a two-year period. Aust Prosthodont J 1994;8:31-7.
Grunder U, Polizzi G, Goene R, Hatano N, Henry P, Jackson WJ, Kawamura K, Kohler S, Renouard F, Rosenberg R, Triplett G, Werbitt M, Lithner B. A 3-year prospective multicenter follow-up report on the immediate and delayed-immediate placement of implants. Int J Oral Maxillofac Implants 1999 Mar-Apr;14(2):210-6.
Halpern BL, Gallagher SP. Refractive error consequences of reversed-optic AMO SI-40NB intraocular lens. Ophthalmology 1999 May;106(5):901-3.
Hammerle CH, Bragger U, Schmid B, Lang NP. Successful bone formation at immediate transmucosal implants: a clinical report. Int J Oral Maxillofac Implants 1998 Jul-Aug;13(4):522-30.
Hilgers FJ, Ackerstaff AH, Balm AJ, Tan IB, Aaronson NK, Persson JO. Development and clinical evaluation of a second-generation voice prosthesis (Provox 2), designed for anterograde and retrograde insertion. Acta Otolaryngol (Stockh) 1997 Nov;117(6):889-96.
Hoekstra A, Bassot V, Bertoglio S, Bobin JY, Delassus P, Egeli R, Khayat D, Ranchere JY, Santini J, Segol P. Clinical evaluation of the CORDIS vascular access port systems: a multicenter study. Med Oncol Tumor Pharmacother 1993;10(3):131-8.
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Kileny PR, Meiteles LZ, Zwolan TA, Telian SA. Cochlear implant device failure: diagnosis and management. Am J Otol 1995 Mar;16(2):164-71.
Kirsh ER, Garg AK. Postextraction ridge maintenance using the endosseous ridge maintenance implant (ERMI). Compendium 1994 Feb;15(2):234, 236, 238 passim; quiz 244.
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Koch DD, Kohnen T. A retrospective comparison of techniques to prevent secondary cataract formation following posterior chamber intraocular lens implantation in infants and children. Trans Am Ophthalmol Soc 1997;95:351-60; discussion 361-5.
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Krupin eye valve with disk for filtration surgery. The Krupin Eye Valve Filtering Surgery Study Group. Ophthalmology 1994 Apr;101(4):651-8. Comment in: Ophthalmology 1994 Sep;101(9):1477.
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Return to table of contentsRisks and Outcome
Risks and Risk Assessment
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Return to table of contentsImplant Failure and Failure Analysis
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Return to table of contentsEconomic Factors
Costs and Cost Analysis
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Return to table of contentsPayment/Financing/Insurance
Beyleveld D, Howells GG, Longley D. Heart valve ownership: legal, ethical and policy issues. J Heart Valve Dis 1995 Jul;4 Suppl 1:S2-5; discussion S5-6.
Civilian Health and Medical Program of the Department of Veterans Affairs. (CHAMPVA)--VA. Final rule. Fed Regist 1998 Sep 9;63(174):48100-6.
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Return to table of contentsData Collection and Management
Databases and Information Systems
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Walker AM, Funch DP, Bianchi L, Blot WJ. Shop order fracture rate as a risk factor for strut fracture in Bjork- Shiley CC60 degrees heart valves. J Heart Valve Dis 1997 May;6(3):264-7; discussion 268.
Return to table of contentsRegistries
Asimakopoulos G, Edwards MB, Brannan J, Taylor KM. Survival and cause of death after mitral valve replacement in patients aged 80 years and over: collective results from the UK heart valve registry. Eur J Cardiothorac Surg 1997 May;11(5):922-8.
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Cromheecke ME, Overkamp PJ, de Mol BA, van Gaalen GL, Becker AE. Retrieval analysis of mechanical heart valves: impact on design and clinical practice. Artif Organs 1998 Sep;22(9):794-9.
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Langley JM, LeBlanc JC, Drake J, Milner R. Efficacy of antimicrobial prophylaxis in placement of cerebrospinal fluid shunts: meta-analysis. Clin Infect Dis 1993 Jul;17(1):98-103.
Lawford PV, Kenyon C, Rogers S, Black MM. Understanding valve/host interactions through explanted valve analysis. J Med Eng Technol 1992 Jan-Feb;16(1):23-6.
Luca A, D'Amico G, La Galla R, Midiri M, Morabito A, Pagliaro L. TIPS for prevention of recurrent bleeding in patients with cirrhosis: meta-analysis of randomized clinical trials. Radiology 1999 Aug;212(2):411-21.
O'Roark WL. Improving implant survival rates by using a new method of at risk analysis. Int J Oral Implantol 1991;8(1):31-57.
Rinaldi S, Sera F, Verrina E, Edefonti A, Perfumo F, Sorino P, Zacchello G, Andreetta B, Ardissino G, Bassi S, Capasso G, Caringella DA, Gianoglio B, Gusmano R, Rizzoni G. The Italian Registry of Pediatric Chronic Peritoneal Dialysis: a ten-year experience with chronic peritoneal dialysis catheters. Perit Dial Int 1998 Jan-Feb;18(1):71-4.
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WinMDR: the medical device register for windows [computer program]. Version 1.2. Montvale (NJ): Medical Economics Company; 1997. 1 computer optical disc: 4 3/4 in. System Requirements: IBM compatible 486SX or higher PC; 8 MB RAM; 40 MB available hard disk space; Windows 3.1 or later; VGA card/monitor; 3.5" high-density disk drive or CD-ROM drive; MS-DOS 3.1 or later.
Return to table of contentsOther
Esposito M, Hirsch JM, Lekholm U, Thomsen P. Biological factors contributing to failures of osseointegrated oral implants. (I). Success criteria and epidemiology. Eur J Oral Sci 1998 Feb;106(1):527-51.
Kawanishi DT, Brinker JA, Reeves R, Kay GN, Gross J, Pioger G, Petitot JC, Esler A, Grunkemeier G. Spontaneous versus extraction related injuries associated with Accufix J-wire atrial pacemaker lead: tracking changes in patient management. Pacing Clin Electrophysiol 1998 Nov;21(11 Pt 2):2314-7.
Kerner J, Huiskes R, van Lenthe GH, Weinans H, van Rietbergen B, Engh CA, Amis AA. Correlation between pre-operative periprosthetic bone density and post-operative bone loss in THA can be explained by strain-adaptive remodelling. J Biomech 1999 Jul;32(7):695-703.
Olson RJ, Caldwell KD, Crandall AS, Jensen MK, Huang SC. Intraoperative crystallization on the intraocular lens surface. Am J Ophthalmol 1998 Aug;126(2):177-84.
Schaumberg DA, Dana MR, Christen WG, Glynn RJ. A systematic overview of the incidence of posterior capsule opacification. Ophthalmology 1998 Jul;105(7):1213-21.
Return to table of contentsControls
Standards and Guidelines
American Society for Testing and Materials. Practice for retrieval and analysis of implanted medical devices, and associated tissues. West Conshohocken (PA): The Society; 1998 Jun. 14 p. ASTM-F-561-97.
Andreo LK, Wilson ME, Saunders RA. Predictive value of regression and theoretical IOL formulas in pediatric intraocular lens implantation. J Pediatr Ophthalmol Strabismus 1997 Jul-Aug;34(4):240-3.
Borovetz HS, Ramasamy N, Zerbe TR, Portner PM. Evaluation of an implantable ventricular assist system for humans with chronic refractory heart failure. Device explant protocol. ASAIO J 1995 Jan-Mar;41(1):42-8.
Campbell A, Baldwin T, Peterson G, Bryant J, Ryder K. Pitfalls and outcomes from accelerated wear testing of mechanical heart valves. J Heart Valve Dis 1996 Jun;5 Suppl 1:S124-32; discussion 144-8.
Collier JP, Bargmann LS, Currier BH, Mayor MB, Currier JH, Bargmann BC. An analysis of hylamer and polyethylene bearings from retrieved acetabular components. Orthopedics 1998 Aug;21(8):865-71.
Corden J, David T, Fisher J. In vitro determination of the curvatures and bending strains acting on the leaflets of polyurethane trileaflet heart valves during leaflet motion. Proc Inst Mech Eng [H] 1995;209(4):243-53.
Cromheecke ME, Overkamp PJ, de Mol BA, van Gaalen GL, Becker AE. Retrieval analysis of mechanical heart valves: impact on design and clinical practice. Artif Organs 1998 Sep;22(9):794-9.
Elizondo DR, Boland ED, Ambrus JR, Kurk JL. Mechanical cardiac valve prostheses: wear characteristics and magnitudes in three bileaflet valves. J Heart Valve Dis 1996 Jun;5 Suppl 1:S115-23; discussion 144-8.
Furman S, Benedek ZM, Andrews CA, Gross JN, Ritacco R. Long-term follow-up of pacemaker lead systems: establishment of standards of quality. Pacing Clin Electrophysiol 1995 Feb;18(2):271-85.
Gaev JA. The Universal Medical Device Nomenclature System. Stud Health Technol Inform 1996;28:127-30.
Leitch JW, Dear K, Curteis P. Upward bias in estimates of pacemaker reliability: effect of unreported patient mortality. J Am Coll Cardiol 1994 Oct;24(4):1078-81.
Powe NR, Tielsch JM, Schein OD, Luthra R, Steinberg EP. Rigor of research methods in studies of the effectiveness and safety of cataract extraction with intraocular lens implantation. Cataract Patient Outcome Research Team. Arch Ophthalmol 1994 Feb;112(2):228-38. Published errata appear in Arch Ophthalmol 1994 Apr;112(4):479 and 1994 Jul;112(7):889. Comment in: Arch Ophthalmol 1994 Jul;112(7):875.
Riepe G, Loos J, Imig H, Schroder A, Schneider E, Petermann J, Rogge A, Ludwig M, Schenke A, Nassutt R, Chakfe N, Morlock M. Long-term in vivo alterations of polyester vascular grafts in humans. Eur J Vasc Endovasc Surg 1997 Jun;13(6):540-8.
Sasken H. A standard protocol for the evaluation of retrieved breast implants [abstract]. Mod Pathol 1994 Mar 12-18;7(1):21A. Paper presented at the Annual Meeting of the United States and Canadian Academy of Pathology, San Franscisco.
Valente M, Minarini M, Maizza AF, Bortolotti U, Thiene G. Heart valve bioprosthesis durability: a challenge to the new generation of porcine valves. Eur J Cardiothorac Surg 1992;6 Suppl 1:S82-90.
Wieting DW. The Bjork-Shiley Delrin tilting disc heart valve: historical perspective, design and need for scientific analyses after 25 years. J Heart Valve Dis 1996 Aug;5 Suppl 2:S157-68.
Wilke HJ, Wenger K, Claes L. Testing criteria for spinal implants: recommendations for the standardization of in vitro stability testing of spinal implants. Eur Spine J 1998;7(2):148-54.
Return to table of contentsRegulation
Beyleveld D, Howells GG, Longley D. Heart valve ownership: legal, ethical and policy issues. J Heart Valve Dis 1995 Jul;4 Suppl 1:S2-5; discussion S5-6.
Castro FP Jr, Chimento G, Munn BG, Levy RS, Timon S, Barrack RL. An analysis of Food and Drug Administration medical device reports relating to total joint components. J Arthroplasty 1997 Oct;12(7):765-71.
Civilian Health and Medical Program of the Department of Veterans Affairs: (CHAMPVA)--VA. Final rule. Fed Regist 1998 Sep 9;63(174):48100-6.
Gross TP, Kessler LG. Medical device vigilance at FDA. Stud Health Technol Inform 1996;28:17-24.
Lindstrom RL. Food and Drug Administration study update. One-year results from 671 patients with the 3M multifocal intraocular lens. Ophthalmology 1993 Jan;100(1):91-7.
Return to table of contentsLegal Issues
Beyleveld D, Howells GG, Longley D. Heart valve ownership: legal, ethical and policy issues. J Heart Valve Dis 1995 Jul;4 Suppl 1:S2-5; discussion S5-6.
Brick DC. Risk management lessons from a review of 168 cataract surgery claims. Surv Ophthalmol 1999 Jan-Feb;43(4):356-60.
Buchan P. Fighting for civil justice. Trial 1996 Nov;32(11):11.
Higgins M. Mass tort makeover? ABA J 1998 Nov 1;84:53-8. Impact of lessons learned from class action lawsuits over silicone breast implants on chances for tort reform.
Shiffman MA. Silicone breast implant litigation (Part 1). Med Law 1994;13(7-8):681-716.
Shiffman MA. Silicone breast implant litigation (Part 2). Med Law 1995;14(1-2):59-85.
Smith PC. Silicone breast implant litigation update. J Law Med Ethics 1995 Spring;23(1):101-3.
Stine KR. Silicone, science and settlements: breast implants and a search for truth. Defense Couns J 1996 Oct;63(4):491-501.
Return to table of contentsImplant Industry
Beyleveld D, Howells GG, Longley D. Heart valve ownership: legal, ethical and policy issues. J Heart Valve Dis 1995 Jul;4 Suppl 1:S2-5; discussion S5-6.
Blackstone EH, Kirklin JW. Recommendations for prophylactic removal of heart valve prostheses. J Heart Valve Dis 1992 Sep;1(1):3-14. Published erratum appears in J Heart Valve Dis 1993 Mar;2(2):249.
Cromheecke ME, Overkamp PJ, de Mol BA, van Gaalen GL, Becker AE. Retrieval analysis of mechanical heart valves: impact on design and clinical practice. Artif Organs 1998 Sep;22(9):794-9.
Freiherr G. Explanting information: Database proposals pose dilemma for implantable device community. Med Device Diagn Ind 1995 May;17(5):92-6, 266.
Grunkemeier GL, Anderson WN Jr. Passive surveillance of heart valve devices: Bjork-Shiley outlet strut fracture rates. J Long Term Eff Med Implants 1995;5(3):155-60.
Kallewaard M, Algra A, Defauw J, van der Graaf Y. Which manufacturing characteristics are predictors of outlet strut fracture in large sixty-degree Bjork-Shiley convexo-concave mitral valves? The Bjork-Shiley Study Group. J Thorac Cardiovasc Surg 1999 Apr;117(4):766-75.
Kaplan SS. Biomaterial-host interactions: consequences, determined by implant retrieval analysis. Med Prog Technol 1994;20(3-4):209-30.
Ray MS, Matthew IR, Frame JW. Metallic fragments on the surface of miniplates and screws before insertion. Br J Oral Maxillofac Surg 1999 Feb;37(1):14-8.
Walker AM, Funch DP, Bianchi L, Blot WJ. Shop order fracture rate as a risk factor for strut fracture in Bjork-Shiley CC60 degrees heart valves. J Heart Valve Dis 1997 May;6(3):264-7; discussion 268.
Wee AG, Schneider RL, Aquilino SA. Use of low fusing alloy in dentistry. J Prosthet Dent 1998 Nov;80(5):540-5.
Return to table of contentsThe Future
New Device Design
Atala A. Future perspectives in reconstructive surgery using tissue engineering. Urol Clin North Am 1999 Feb;26(1):157-65, ix-x.
Barrett GD. A new hydrogel intraocular lens design. J Cataract Refract Surg 1994 Jan;20(1):18-25.
Bohm P, Holy T. Is there a future for hinged prostheses in primary total knee arthroplasty? A 20-year survivorship analysis of the Blauth prosthesis. J Bone Joint Surg Br 1998 Mar;80(2):302-9.
Brockhurst PJ. A new design for partial denture circumferential clasp arms. Aust Dent J 1996 Oct;41(5):317-23.
Buechel FF, Pappas MJ, Greenwald AS. Use of survivorship and contact stress analyses to predict the long-term efficacy of new generation joint replacement designs. A model for FDA device evaluation. Orthop Rev 1991 Jan;20(1):50-5.
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Deporter DA, Todescan R, Watson PA, Pharoah M, Levy D, Nardini K. Use of the Endopore dental implant to restore single teeth in the maxilla: protocol and early results. Int J Oral Maxillofac Implants 1998 Mar-Apr;13(2):263-72.
Dorr LD, Hilton KR, Wan Z, Markovich GD, Bloebaum R. Modern metal on metal articulation for total hip replacements. Clin Orthop 1996 Dec;(333):108-17.
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Return to table of contentsLast updated: 27 November 2002
First published: 27 November 2002
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