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# Current Bibliographies in Medicine 99-5

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# Improving Implant Performance through Retrieval Information

January 1990 through October 1999

1412 Citations

Prepared byKaren Patrias, M.L.S., National Library of MedicineHarvey S. Borovetz, Ph.D., University of Pittsburgh and National Heart, Lung, and Blood InstituteChristine A. Kelley, Ph.D., National Heart, Lung, and Blood InstituteJames 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 SERVICESPublic Health ServiceNational Institutes of Health

National Library of MedicineReference Section8600 Rockville PikeBethesda, Maryland 20894

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      - Series Note
      - Table of Contents for this bibliography
      - Introduction to this bibliography
      - Sample Citations

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**Series Note**

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, EditorCurrent Bibliographies in MedicineReference SectionNational Library of MedicineBethesda, MD 20894Phone: 301-496-6097Fax: 301-402-1384Internet: ref@nlm.nih.gov

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## Table 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

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**Introduction**

Improving 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 ImplantsArteriovenous Shunt, SurgicalArtificial LimbsBioprosthesisBlood Vessel ProsthesisBone NailsBone PlatesBone ScrewsBone Substitutes (Synthetic)Breast ImplantsCatheters, Indwelling (in dialysis only)Cavopulmonary ShuntsCerebrospinal Fluid ShuntsCochlear ImplantsDefibrillators, ImplantableDental ImplantsDental Implants, Single-ToothDental Prosthesis, Implant-SupportedTooth, ArtificialDental ProsthesisDental AbutmentsElectrodes, ImplantedEndolymphatic ShuntGlaucoma Drainage ImplantsHeart, ArtificialHeart Valve ProsthesisHeart-Assist DevicesImplants, ExperimentalInfusion Pumps, ImplantableInternal FixatorsJoint ProsthesisLarynx, ArtificialLenses, IntraocularMandibular ProsthesisNeuroprosthesesOrbital ImplantsOssicular ProsthesisPacemaker, ArtificialPenile ProsthesisPeritoneovenous ShuntPortacaval Shunt, SurgicalPortasystemic Shunt, SurgicalReconstructive Surgical ProceduresSkin, ArtificialSplenorenal Shunt, SurgicalStentsUrinary Sphincter, ArtificialVena 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
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**Sample Citations**

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.
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## Reviews/Overviews

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### Reviews

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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.
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### Implant Retrieval Conferences

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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).
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### Internet Sites

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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/.
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## Patient/Health Care Provider Perspectives

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### Patient Expectations/Organizations

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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.
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### Patient Education

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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.
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### Ethical, Religious, Cultural Factors

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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.
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### Health Personnel Role and Expectations

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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.
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## Implantation and Follow-Up

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### Methods of Implantation and Analysis

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Aagaard J, Andersen UL, Lerbjerg G, Andersen LI. Expanding the use of total mitral valve preservation in combination with implantation of the CarboMedics heart valve prosthesis. J Cardiovasc Surg (Torino) 1999 Apr;40(2):177-81.

Acar C, Tolan M, Berrebi A, Gaer J, Gouezo R, Marchix T, Gerota J, Chauvaud S, Fabiani JN, Deloche A, Carpentier A. Homograft replacement of the mitral valve. Graft selection, technique of implantation, and results in forty-three patients. J Thorac Cardiovasc Surg 1996 Feb;111(2):367-78; discussion 378-80. Comment in: J Thorac Cardiovasc Surg 1996 Dec;112(6):1678-9.

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.

Aris A, Padro JM, Camara ML. [Minimally invasive aortic valve replacement]. Rev Esp Cardiol 1997 Nov;50(11):778-81. (Spa).

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.

Barzilay I. Immediate implants: their current status. Int J Prosthodont 1993 Mar-Apr;6(2):169-75.

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.

Boutault F, Cantaloube D, Testelin S, Gueroult JM, Huet P. [Role of coral blocks in cheek augmentation surgery. Prospective study of 23 patients]. Ann Chir Plast Esthet 1997 Jun;42(3):216-22. (Fre).

Brodell GK, Castle LW, Maloney JD, Wilkoff BL. Chronic transvenous pacemaker lead removal using a unique, sequential transvenous system. Am J Cardiol 1990 Oct 15;66(12):964-6.

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.

Godet F. [Esthetic peri-implant flap]. J Parodontol 1991 May;10(2):197-205. (Fre).

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.

Hofmann GO, Kirschner MH, Gonschorek O, Buhren V. [Allogeneic vascularized transplantation in cases of bone and joint defects]. Unfallchirurg 1999 Jun;102(6):458-65. (Ger).

Hong YJ, Choe CM, Lee YG, Chung HS, Kim HK. The effect of mitomycin-C on postoperative corneal astigmatism in trabeculectomy and a triple procedure. Ophthalmic Surg Lasers 1998 Jun;29(6):484-9.

Huang TT. Breast and subscapular pain following submuscular placement of breast prostheses. Plast Reconstr Surg 1990 Aug;86(2):275-80.

Hvass U, Chatel D, Assayag P, Ouroudji M, Pansard Y, Lenormand C, Laperche T, Depoix JP. The O'Brien-Angell stentless porcine valve: early results with 150 implants. Ann Thorac Surg 1995 Aug;60(2 Suppl):S414-7.

Hvass U, Chatel D, Ouroudji M, Pansard Y, Laperche T, Depoix JP, Lenormand C. The O'Brien-Angell stentless valve. Early results of 100 implants. Eur J Cardiothorac Surg 1994;8(7):384-7.

Ilnitskii VV, Saksonova EO, Gureva NV. [Surgical treatment of retinal detachment with multiple, giant and post-equatorial ruptures]. Vestn talmol 1997 Mar-Apr;113(2):3-5. (Rus).

Ishino K, Stumper O, De Giovanni JJ, Silove ED, Wright JG, Sethia B, Brawn WJ, de Leval M. The modified Norwood procedure for hypoplastic left heart syndrome: early to intermediate results of 120 patients with particular reference to aortic arch repair. J Thorac Cardiovasc Surg 1999 May;117(5):920-30.

Jemt T, Lekholm U. Implant treatment in edentulous maxillae: a 5-year follow-up report on patients with different degrees of jaw resorption. Int J Oral Maxillofac Implants 1995 May-Jun;10(3):303-11.

Jennings KJ, Critchlow HA, Lilly P, Broad MT. The clinical use of ITI transmucosal implants. Br Dent J 1992 Jul 25;173(2):67-71.

Jesus I, Leiria G. [The pocket infection-erosion of permanent pacemakers: the results of a conservative approach without substitution of the components]. Rev Port Cardiol 1995 Oct;14(10):691-5. (Por).

Kahnberg KE, Nystrom E, Bartholdsson L. Combined use of bone graft and Biotes fixtures in the treatment of the severely resorbed upper jaws. Oral Health 1992 Mar;82(3):37-9, 41-2.

Kawano K. Modified corneoscleral incision to reduce postoperative astigmatism after 6 mm diameter intraocular lens implantation. J Cataract Refract Surg 1993 May;19(3):387-92.

Khayat P, Nader N. The use of osseointegrated implants in the maxillary tuberosity. Pract Periodontics Aesthet Dent 1994 May;6(4):53-61; quiz 62.

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.

Kiyama H, Imazeki T, Irie Y, Katayama Y, Murai N, Sato Y, Hata I, Gon S. [Aortic valve operations through an upper partial sternotomy]. Kyobu Geka 1999 Jul;52(7):519-24; discussion 525-7. (Jpn).

Kluge A, Rauber K, Rau WS. [Radiologically implanted subcutaneous tunneled central venous catheters for dialysis: the course and complications]. Ro Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 1997 Mar;166(3):230-2. (Ger).

Kluge A, Stroh H, Wagner D, Rauber K. [The fluoroscopy-guided implantation of subcutaneous venous ports: the complications and long-term results]. Ro Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 1998 Jul;169(1):63-7. (Ger).

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.

Koch FH, Gumbel HO, Hattenbach L-O, Ohrloff Ch. [Intravitreal endoscopic visualization of intraocular ganciclovir devices: Improved long-term treatment of CMV retinitis]. Klin Monatsbl Augenheilkd 1999;214(2):107-11. (Ger).

Kohlhaas M, Walter A, Schulz D. [Primary orbital implant dislocation. A retrospective study]. Ophthalmologe 1998 May;95(5):328-31. (Ger).

Kornmehl EW, Steinert RF, Odrich MG, Stevens JB. Penetrating keratoplasty for pseudophakic bullous keratopathy associated with closed-loop anterior chamber intraocular lenses. Ophthalmology 1990;97(4):407-14.

Koster G, Willert H, Buchhorn GH. Endoscopy of the femoral canal in revision arthroplasty of the hip.A new method for improving the operative technique and analysis of implant failure. Arch Orthop Trauma Surg 1999;119(5-6):245-52.

Kowalik B. [The effect of subvalvular apparatus preservation on the hemodynamic function of the heart in the early postoperative period after prosthetic mitral valve replacement]. Ann Acad Med Stetin 1997;43:181-92. (Pol).

Krasnov MM, Beloglazov VG, Pupis I. [Use of silicone implants in patients with stable epiphora]. Vestn talmol 1992 Mar-Apr;108(2):20-2. (Rus).

Kremmer S, Pflug A, Heiligenhaus A, Fanihagh F, Steuhl KP. [Laser scanning topography and polarimetry with implantation of intraocular lenses before and after cataract surgery]. Klin Monatsbl Augenheilkd 1999 Jun;214(6):378-85. (Ger).

Krump JL, Barnett BG. The immediate implant: a treatment alternative. Int J Oral Maxillofac Implants 1991 Spring;6(1):19-23.

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.

Kubler NR, Will C, Depprich R, Betz T, Reinhart E, Bill JS, Reuther JF. [Comparative studies of sinus floor elevation with autologous or allogeneic bone tissue]. Mund Kiefer Gesichtschir 1999 May;3 Suppl 1:S53-60. (Ger).

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### Patient Monitoring and Diagnostics

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## Risks and Outcome

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### Risks and Risk Assessment

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### Outcome Assessment

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### Implant Failure and Failure Analysis

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### Adverse Effects

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Thomas WO 3rd, Harper LL, Wong SW, Michalski JP, Harris CN, Moore JT, Rodning CB. Explantation of silicone breast implants. Am Surg 1997 May;63(5):421-9.

Tomizawa Y, Takanashi Y, Noishiki Y, Nishida H, Endo M, Koyanagi H. Evaluation of small caliber vascular prostheses implanted in small children: activated angiogenesis and accelerated calcification. ASAIO J 1998 Sep-Oct;44(5):M496-500.

Torgersen S, Gjerdet NR, Erichsen ES, Bang G. Metal particles and tissue changes adjacent to miniplates. A retrieval study. Acta Odontol Scand 1995 Apr;53(2):65-71.

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Tunney MM, Patrick S, Gorman SP, Nixon JR, Anderson N, Davis RI, Hanna D, Ramage G. Improved detection of infection in hip replacements. A currently underestimated problem. J Bone Joint Surg Br 1998 Jul;80(4):568-72.

van der Linde MJ, Tonino AJ. Nerve injury after hip arthroplasty. 5/600 cases after uncemented hip replacement, anterolateral approach versus direct lateral approach. Acta Orthop Scand 1997 Dec;68(6):521-3.

Vanherweghem JL. [Thrombosis and stenosis of central venous access in hemodialysis]. Nephrologie 1994;15(2):117-21. (Fre).

Vinard E, Eloy R, Descotes J, Brudon JR, Guidicelli H, Magne P, Patra P, Streichenberger R, David M. [Diagnosis of bacterial infections on vascular prosthesis. Histological and microbiological analysis]. Presse Med 1992 Feb 22;21(7):293-8. (Fre).

Virden CP, Dobke MK, Stein P, Parsons CL, Frank DH. Subclinical infection of the silicone breast implant surface as a possible cause of capsular contracture. Aesthetic Plast Surg 1992 Spring;16(2):173-9.

Vogt PR, Stallmach T, Niederhauser U, Schneider J, Zund G, Lachat M, Kunzli A, Turina MI. Explanted cryopreserved allografts: a morphological and immunohistochemical comparison between arterial allografts and allograft heart valves from infants and adults. Eur J Cardiothorac Surg 1999 May;15(5):639-44; discussion 644-5.

Walkow T, Anders N, Pham DT, Wollensak J. Causes of severe decentration and subluxation of intraocular lenses. Graefes Arch Clin Exp Ophthalmol 1998 Jan;236(1):9-12.

Wang RC, Parisier SC, Weiss MH, Chute PM, Hellman SA, Sauris E. Cochlear implant flap complications. Ann Otol Rhinol Laryngol 1990 Oct;99(10 Pt 1):791-5.

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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.

Wilhelm MJ, Schmid C, Hammel D, Kerber S, Loick HM, Herrmann M, Scheld HH. Cardiac pacemaker infection: surgical management with and without extracorporeal circulation. Ann Thorac Surg 1997 Dec;64(6):1707-12.

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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).

Zervos EE, McCormick J, Goode SE, Rosemurgy AS. Peritoneovenous shunts in patients with intractable ascites: palliation at what price? Am Surg 1997 Feb;63(2):157-62.

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Zhao P, Wang W, Qiu X. [Causes of intraocular lens removal]. Chung Hua Yen Ko Tsa Chih 1995 Mar;31(2):114-7. (Chi).

Zolog I, Chercota V, Ban C. [Pseudophacos explant: the causes and the functional results]. Oftalmologia 1998;42(1):14-9. (Rum).
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### Other

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Badlani GH, Press SM, Defalco A, Oesterling JE, Smith AD. Urolume endourethral prosthesis for the treatment of urethral stricture disease: long-term results of the North American Multicenter UroLume Trial. Urology 1995 May;45(5):846-56.

Brady KM, Atkinson CS, Kilty LA, Hiles DA. Glaucoma after cataract extraction and posterior chamber lens implantation in children. J Cataract Refract Surg 1997;23 Suppl 1:669-74.

Caimmi PP, Di Summa M, Galloni M, Gastaldi L, Papillo B, Actis Dato GM, Agaccio G, Donegani E, Poletti G, Morea M. Twelve-year follow up with the Sorin Pericarbon bioprosthesis in the mitral position. J Heart Valve Dis 1998 Jul;7(4):400-6.

Calcagno D, Hallett JW Jr, Ballard DJ, Naessens JM, Cherry KJ Jr, Gloviczki P, Pairolero PC. Late iliac artery aneurysms and occlusive disease after aortic tube grafts for abdominal aortic aneurysm repair. A 35-year experience. Ann Surg 1991 Dec;214(6):733-6.

Christie GW, Barratt-Boyes BG. Biaxial mechanical properties of explanted aortic allograft leaflets. Ann Thorac Surg 1995 Aug;60(2 Suppl):S160-4.

Le Franc P, Klug D, Jarwe M, Lacroix D, Delfaut P, Kouakam C, Kacet S. Extraction of endocardial implantable cardioverter-defibrillator leads. Am J Cardiol 1999 Jul 15;84(2):187-91.

Salih V, Graham TR, Berry CL, Coumbe A, Smith SC, Dasse K, Frazier OH. The lining of textured surfaces in implantable left ventricular assist devices. An immunocytochemical and electronmicroscopic study. Am J Cardiovasc Pathol 1993;4(4):317-25.

Shi Q, Wu MH, Onuki Y, Ghali R, Hunter GC, Johansen KH, Sauvage LR. Endothelium on the flow surface of human aortic Dacron vascular grafts. J Vasc Surg 1997 Apr;25(4):736-42.

Thyagarajan K, Conlin C, Milligan HL, Wieting DW. A comparison of wear patterns in vivo and in vitro for Bjork-Shiley Delrin heart valve discs. J Heart Valve Dis 1996 Aug;5 Suppl 2:S206-15.

Thyagarajan K, Conlin CH, Wieting DW. Evaluation of disc retention of Bjork-Shiley Delrin heart valves. J Heart Valve Dis 1996 Aug;5 Suppl 2:S243-5.

Wu L, Weisberg DM, Runt J, Felder G 3rd, Snyder AJ, Rosenberg G. An investigation of the in vivo stability of poly(ether urethaneurea) blood sacs. J Biomed Mater Res 1999 Mar;44(4):371-80.

Youssefzadeh S, Baumgartner W, Dorffner R, Gstottner W, Trattnig S. MR compatibility of Med EL cochlear implants: clinical testing at 1.0 T. J Comput Assist Tomogr 1998 May-Jun;22(3):346-50.

Zak P, Tauchman M, Maisnar V, Podzimek K, Mirova S, Voglova J, Dulicek P, Filip S, Chrobak L. [A fully implantable port system for venous access. Personal experience with 91 patients]. Vnitr Lek 1997 May;43(5):273-8. (Cze).

Zioupos P, Barbenel JC, Fisher J, Wheatley DJ. Changes in the mechanical properties of bioprosthetic valve leaflets made of bovine pericardium, as a result of long-term mechanical conditioning in vitro and implantation in vivo. J Mater Sci Mater Med 1993;4(6):531-7.

Zoltobrocki M. Insulin delivery by implantable pumps. Horm Metab Res Suppl 1992;26:140-5.
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## Economic Factors

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### Costs and Cost Analysis

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Belouet C, Bonnichon P, Douard MC, Maroudy D, Vidal-Trecan G. [Elements for a cost/utility analysis of long term intravenous devices]. Pathol Biol (Paris) 1999 Mar;47(3):282-7. (Fre).

Biffi R, de Braud F, Orsi F, Pozzi S, Mauri S, Goldhirsch A, Nole F, Andreoni B. Totally implantable central venous access ports for long-term chemotherapy. A prospective study analyzing complications and costs of 333 devices with a minimum follow-up of 180 days. Ann Oncol 1998 Jul;9(7):767-73.

Binkert CA, Ledermann H, Jost R, Saurenmann P, Decurtins M, Zollikofer CL. Acute colonic obstruction: clinical aspects and cost-effectiveness of preoperative and palliative treatment with self-expanding metallic stents--a preliminary report. Radiology 1998 Jan;206(1):199-204.

Bostman O. Economic considerations on avoiding implant removals after fracture fixation by using absorbable devices. Scand J Soc Med 1994 Mar;22(1):41-5.

Bostman OM. Metallic or absorbable fracture fixation devices. A cost minimization analysis. Clin Orthop 1996 Aug;(329):233-9.

Braf Z, Chen J, Sofer M, Matzkin H. Intraprostatic metal stents (Prostakath and Urospiral): more than 6 years' clinical experience with 110 patients. J Endourol 1996 Dec;10(6):555-8.

Gregoratos G. Permanent pacemakers in older persons. J Am Geriatr Soc 1999 Sep;47(9):1125-35.

Pettengell R, Davies AJ, Harvey VJ. Experience with an implantable venous access system for chemotherapy. N Z Med J 1991 Jul 10;104(915):284-5.

Quinones-Baldrich WJ. Achieving cost-effective endoluminal aneurysm repair. Semin Vasc Surg 1999 Sep;12(3):220-5.

Ray CD. Threaded fusion cages for lumbar interbody fusions. An economic comparison with 360 degrees fusions. Spine 1997 Mar 15;22(6):681-5.

Sethi KK, Bhargava M, Pandit N, Mohan JC, Arora R, Khanna SK, Khalilullah M. Experience with recycled cardiac pacemakers. Indian Heart J 1992 Mar-Apr;44(2):91-3.

Ververeli PA, Masonis JL, Booth RE, Hozack WJ, Rothman RH. Radiographic cost reduction strategy in total joint arthroplasty. A prospective analysis. J Arthroplasty 1996 Apr;11(3):277-80.

Walton JN, MacEntee MI, Hanvelt R. Cost analysis of fabricating implant prostheses. Int J Prosthodont 1996 May-Jun;9(3):271-6.
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### Payment/Financing/Insurance

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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.

Katz BP, Freund DA, Heck DA, Dittus RS, Paul JE, Wright J, Coyte P, Holleman E, Hawker G. Demographic variation in the rate of knee replacement: a multi-year analysis. Health Serv Res 1996 Jun;31(2):125-40.

Kellie SE, Kelly JT. Medicare Peer Review Organization preprocedure review criteria. An analysis of criteria for three procedures. JAMA 1991 Mar 13;265(10):1265-70. Comment in: JAMA 1991 Mar 13;265(10):1306-7.

Roos LL, Stranc L, James RC, Li J. Complications, comorbidities, and mortality: improving classification and prediction. Health Serv Res 1997 Jun;32(2):229-38; discussion 239-42.

Tomizawa Y, Kitamura M, Koyanagi H. [Planning of implant data system for medical device in Japan]. Jpn J Artif Organs 1998;27(1):92-6. (Jpn).
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## Data Collection and Management

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### Databases and Information Systems

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Embrey M, Adams EE, Cunningham B, Peters W, Young VL, Carlo GL. Factors associated with breast implant rupture: pilot of a retrospective analysis. Aesthetic Plast Surg 1999 May-Jun;23(3):207-12.

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.

Hansen R. [Preoperative calculation of eyeglass lens power after cataract surgery]. Lakartidningen 1990 Aug 29;87(35):2661-2. (Swe).

Jamieson WR, Edwards FH, Schwartz M, Bero JW, Clark RE, Grover FL. Risk stratification for cardiac valve replacement. National Cardiac Surgery Database. Database Committee of The Society of Thoracic Surgeons. Ann Thorac Surg 1999 Apr;67(4):943-51.

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.

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.

Minsk L, Polson AM, Weisgold A, Rose LF, Sanavi F, Baumgarten H, Listgarten MA. Outcome failures of endosseous implants from a clinical training center. Compend Contin Educ Dent 1996 Sep;17(9):848-50, 852-4, 856 passim.

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.

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.

Smith RA, Arvanitis TN, English M, Vincent R. An intranet database for pacemaker patients. Int J Med Inf 1997 Nov;47(1-2):79-82.

Tomizawa Y, Kitamura M, Koyanagi H. [Planning of implant data system for medical device in Japan]. Jpn J Artif Organs 1998;27(1):92-6. (Jpn).

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.
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### Registries

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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.

Asimakopoulos G, Edwards MB, Taylor KM. Aortic valve replacement in patients 80 years of age and older: survival and cause of death based on 1100 cases: collective results from the UK Heart Valve Registry. Circulation 1997 Nov 18;96(10):3403-8.

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.

Edwards MB, Ratnatunga CP, Dore CJ, Taylor KM. Thirty-day mortality and long-term survival following surgery for prosthetic endocarditis: a study from the UK heart valve registry. Eur J Cardiothorac Surg 1998 Aug;14(2):156-64.

Knutson K, Lewold S, Robertsson O, Lidgren L. The Swedish knee arthroplasty register. A nation-wide study of 30,003 knees 1976-1992. Acta Orthop Scand 1994 Aug;65(4):375-86.

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.

Tomizawa Y, Kitamura M, Koyanagi H. [Planning of implant data system for medical device in Japan]. Jpn J Artif Organs 1998;27(1):92-6. (Jpn).

Weyant RJ, Burt BA. An assessment of survival rates and within-patient clustering of failures for endosseous oral implants. J Dent Res 1993 Jan;72(1):2-8.

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.
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### Other

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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.
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## Controls

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### Standards and Guidelines

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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.
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### Regulation

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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.
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### Legal Issues

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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.
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## Implant Industry

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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.
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## The Future

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### New Device Design

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Atala A. Future perspectives in reconstructive surgery using tissue engineering. Urol Clin North Am 1999 Feb;26(1):157-65, ix-x.

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### Other Trends and Forecasting

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**Last updated:** 27 November 2002**First published:**  27 November 2002**Metadata**| **Permanence level****:** Permanent: Dynamic Content

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