Cosmetic

Decision and Management Algorithms toAddress Patient and Food and DrugAdministration Concerns Regarding BreastAugmentation and ImplantsWilliam P. Adams, M.D., Bradley P. Bengston, M.D., Caroline A. Glicksman, M.D.,Joe M. Gryskiewicz, M.D., Mark L. Jewell, M.D., Mary H. McGrath, M.D., M.P.H.,Neal R. Reisman, M.D., J.D., Steven A. Teitelbaum, M.D., John B. Tebbetts, M.D., and Terrye Tebbetts, B.S.Dallas and Houston, Texas; Grand Rapids, Mich.; Neptune and Brick, N.J.; Minneapolis, Minn.; Portland, Ore.; Maywood, Ill.; and Los Angeles, Calif.

During the U.S. Food and Drug Administration’s ad-visory panel hearings to evaluate the premarket approvalfor conventional silicone gel implants on October 14 and15, 2003, panel members and patient advocate represen-tatives focused on four specific areas of concern: reop-eration rates in primary breast augmentation; levels,depth, and methods of patient education and informedconsent; modes, frequency, and management of siliconegel implant device failures, including management of “si-lent” ruptures; and methods of monitoring and managingsymptoms or symptom complexes that may or may not beassociated with connective tissue disease or other unde-fined symptom complexes. These concerns, with a re-ported 20 percent reoperation rate for primary augmen-tation within just 3 years, and a lack of concise, definitivemanagement protocols addressing these areas of concernmay have contributed to the Food and Drug Administra-tion’s rejection of the premarket approval, despite thepanel’s recommendation for approval. This article pre-sents decision and management algorithms that havebeen used successfully for 7 years in a busy breast aug-mentation practice (Tebbetts and Tebbetts). The algo-rithms have been further expanded and refined by agroup of surgeons with diverse experiences and expertiseto address the following clinical situations that coincidewith concerns expressed by patients and the Food andDrug Administration: implant size exchange, grade III toIV capsular contracture, infection, stretch deformities(implant bottoming or displacement), silent rupture ofgel implants, and undefined symptom complexes (con-nective tissue disease or other). In one practice (Tebbettsand Tebbetts) that uses the TEPID system (tissue charac-teristics of the envelope, parenchyma, and implant and the

dimensions and fill distribution dynamics of the implant),implant selection is based on quantified patient tissuecharacteristics, pocket selection is based on quantifiedsoft-tissue coverage, and anatomic saline implants have fillvolumes that are designed to minimize shell collapse andfold fatigue; in this practice, the algorithms contributed toa 3 percent overall reoperation rate in 1662 reported caseswith up to 7 years of follow-up, compared with a 20 percentreoperation rate at 3 years in the 2003 premarket approvalstudy. (Plast. Reconstr. Surg. 114: 1252, 2004.)

During the U.S. Food and Drug Administra-tion’s advisory panel hearings on October 14and 15, 2003, the panel members and patientadvocate organization representatives voicedconcerns about four specific areas regardingbreast augmentation and breast implant devices:reoperation rates in primary breast augmenta-tion; levels, depth, and methods of patient edu-cation and informed consent; modes, frequency,and management of silicone gel implant devicefailures, including management of “silent” rup-tures; and methods of monitoring and managingsymptoms or symptom complexes that may ormay not be associated with connective tissue dis-ease or other undefined symptom complexes.1

These four areas of concern and the rates ofreoperation that accompany primary breast

From the Department of Plastic Surgery, University of Texas Southwestern Medical Center; Department of Plastic Surgery, Michigan StateUniversity; Jersey Shore University Medical Center and Ocean Medical Center; Cleft Palate and Craniofacial Clinics, University of MinneapolisAcademic Health Center, and University of Minnesota; Division of Plastic Surgery, Department of Surgery, Oregon Health Science University;Division of Plastic Surgery, Department of Surgery, Loyola University Medical Center; Division of Plastic Surgery, Department of Surgery, BaylorCollege of Medicine; Division of Plastic Surgery, Department of Surgery, David Geffen School of Medicine, University of California at Los Angeles;and private practice. Received for publication January 26, 2004; revised March 30, 2004.

DOI: 10.1097/01.PRS.0000136801.24005.D1

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augmentation in the augmentation core stud-ies (average rate of 20 percent within just 3years) have remained largely unchanged formore than a decade.2,3 Reoperation rates inpremarket approval studies since 1992 haveremained high while devices have changedfrom silicone to saline and back to silicone.Consistently high reoperation rates using dif-ferent devices over more than a decade raiseinteresting questions: (1) To what extent arereoperation rates primarily device related, or(2) to what extent do patient and surgeondecisions and surgical techniques influence re-operation rates? A comparison of reoperationrates and panel concerns from the 1990 Foodand Drug Administration’s advisory panelhearings to those from the 2000 and 2003 hear-ings reveals that while implant devices mayhave changed (e.g., saline versus silicone),overall reoperation rates for primary augmen-tation have not changed appreciably. Under-standably, scientists on the panel and patientadvocacy representatives question why devices,reoperation rates, and outcomes have not im-proved substantially during the past decade.Interestingly, when panel members questionedsurgeons and manufacturer representativesabout the management of specific clinical en-tities that concerned the panel, clearly definedmanagement solutions were not readily avail-able. Testimony during the October 2003panel hearings clearly defined a need for deci-sion and management algorithms for clinicalentities that concerned the advisory panelmembers.

For decades, the world’s most successfulbusinesses have understood and implementedthe concept of “best practices,” or “best” waysto perform business processes derived fromprocesses that have proved effective in use.4 A“best practice” does not necessarily mean thatthe process is literally the “best”; instead, itsuggests that a business practice or process“solution” is a method that has been imple-mented and has delivered consistently positiveresults. A wide range of medical specialties arecurrently deriving best practices for specificclinical situations using evidence-based medi-cine principles, by integrating individual clini-cal experience with the best available clinicalevidence. This article presents decision andmanagement algorithms that have been imple-mented for more 7 years in a busy augmenta-tion practice and that have been further ex-panded and refined by a group of surgeons

with a wide range of experience and expertise.Combined with a staged, repetitive system ofpatient education,5 the TEPID6 system (tissuecharacteristics of the envelope, parenchyma,and implant and the dimensions and fill distri-bution dynamics of the implant) for implantselection and pocket location based on quan-tifiable, individual patient tissue characteris-tics, and anatomic saline implants with fill vol-umes designed to minimize shell collapse andfold fatigue,7 these algorithms have been a ma-jor factor contributing to an overall reopera-tion rate of 3 percent in 1662 patients with upto 7 years of follow-up in peer-reviewed andpublished studies.7–9

A NEED FOR BEST PRACTICES

More than 7 years ago, as we (Tebbetts andTebbetts) focused on expanding and refiningour patient education and informed consentpractices,5 we adopted a best practices ap-proach to help us and our personnel addressspecific clinical issues or problems. Problemsor situations that rarely arise can often be themost challenging for patients, surgeons, andsurgeons’ personnel, because patient interac-tion, management, and clinical “solutions” areless defined compared with everyday clinicalsituations and issues. We realized that whenfaced with an issue or a difficult clinical situa-tion or problem, if we had carefully prospec-tively defined and documented a process ofaddressing and managing the problem, man-agement was much easier, more refined, lesscostly, and more comfortable for us, for ourpatients, and for their families. Having pre-defined management templates (decision andmanagement algorithms) also allows the sur-geon to focus on more sophisticated concernsand innovative solutions instead of having torethink an entire process each time a problemoccurs.

DECISION AND MANAGEMENT ALGORITHM

FLOWCHARTS

As a first step to developing a best practicesapproach to managing issues and problems, wedeveloped decision and management algo-rithms for specific clinical problems or issuesthat we had encountered during the past twodecades. Developing decision and manage-ment algorithms is a stimulating and challeng-ing process. Despite the fact that there existalternative approaches to every clinical prob-lem or issue, a flowchart-documented, algorith-

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mic approach demands a “solution” ratherthan a list of alternatives that stimulate endlessdebate. A decision algorithm flowchart is a vis-ible template that depicts one process that hasproved clinically useful, and it can be easilychanged or adjusted when new facts or databecome available. Graphic representation ofthought processes, decisions, and actions stim-ulates alternative thinking about problems orissues. A graphic algorithm flowchart helps sur-geons define the sequence of decisions and thelogic of management alternatives. In addition,the process stimulates surgeons to reexaminesacrosanct “answers” and develop even bettersolutions.

When issues or problems occur, the patientusually speaks first with the surgeon’s person-nel. The information the patient receives inresponse to his or her problem, concern, orissue can have a critical effect on the patient’scomfort and confidence as the surgeon andthe surgeon’s staff address the problem. Deci-sion and management algorithms are invalu-able in training personnel—not necessarily todeliver definitive answers but to develop a basicknowledge of how problems will be ap-proached when they arise. Consistency in deci-sion-making and management processes buildsconfidence in surgeons’ personnel, and thatconfidence transmits directly to patients whenthey most need confidence to deal with issuesand adversity.

Defined processes to manage issues andproblems are most effective when patients areaware of how an issue or problem will be man-aged before the issue or problem arises. As we(Tebbetts and Tebbetts) implemented our de-cision and management algorithms, welearned that their value increased exponen-tially when we used them to help educate ourpatients preoperatively about how we would man-age each issue or problem postoperatively, of-fering them management alternatives and anopportunity to help make sometimes difficultdecisions.

PATIENT EDUCATION AND INFORMED CONSENT

When a clinical situation or problem arisespostoperatively, the more a patient knows frompreoperative education about the problem,how it will be handled, who is responsible forcosts, and the chances for correction, the morecomfortably the patient can face the chal-lenges. Preoperative informed consent materi-als and documents addressing the most com-

mon potential postoperative problems areavailable online from a previous publication.4When a reoperation may be necessary, patientsare often more stressed and face additionalcosts and risks compared with the primary op-eration. Before any reoperation procedure isundertaken, detailed information and in-formed consent documentation are arguablymore critical and more challenging comparedwith those for the primary operation. Detaileddecision and management algorithms that con-tain essential summary information about thepotential benefits and risks help clarify the re-alistic choices or alternatives. They containspaces for the patient to document his or herunderstanding and acceptance of choices ateach decision-making stage, and they are in-valuable in assuring optimal informed consentand guaranteeing the patient’s involvement inthe decision-making process. According toMark Gorney, M.D., “it is the prerogative of thepatient and not the physician to determine thedirection in which it is believed his or her bestinterests lie,” as the informed consent law man-dates that patients be involved in the decision-making process.10 An integrated documentthat defines alternatives, provides informationon potential risks and benefits, and documentsthe patient’s choices and decisions helps thesurgeon ensure optimal informed consent be-fore a reoperation. More importantly, the doc-uments can sometimes prevent unnecessary re-operations, such as implant size exchangeoperations, by providing patients with moredefinitive information about the risks andtradeoffs. By demanding that patients acceptresponsibility for their decisions, optimal in-formed consent documents sometimes encour-age patients to reconsider their requests anddecisions.

PRACTICAL CLINICAL INTEGRATION AND

IMPLEMENTATION

Currently in our practice (Tebbetts and Teb-betts), each decision and management algo-rithm is integrated with (a) information pro-vided to the patient in preoperative patienteducation and informed consent documentsand (b) more detailed information and alter-natives contained in additional education andinformed consent documents when an issue orproblem occurs. After providing the patientwith detailed information addressing a specificclinical situation or problem, a patient educa-tor and the surgeon review the information

1254 PLASTIC AND RECONSTRUCTIVE SURGERY, October 2004

with the patient in detail. After the surgeondiscusses and answers the patient’s questions,the patient then re-reads and signs the in-formed consent document and defines his orher choices on the decision and managementflowchart to verify his or her understandingand acceptance of the information and thechoices made.

Reality sometimes demands difficult choices,none of which may seem ideal. One of themost difficult challenges in managing issuesand problems is defining choices—translatinga myriad of grey areas, unknowns, questions,wishes, and fears into realistic alternatives fromwhich a patient may choose. A second chal-lenge is helping the patient understand thatthere is no perfect choice, not at the primaryoperation and certainly not at a reoperationfor an issue or problem. There are only differ-ent sets of tradeoffs, benefits, risks, and costsfor each alternative. A clearly defined ap-proach to management of each issue or prob-lem and a practical, efficient system to opti-mize patient education and informed consentare invaluable. On first review, decision andmanagement algorithms may seem complex,but they are only as complex as required todefine the alternatives available to the patientaccording to the informed consent law.

MANAGEMENT AND DECISION ALGORITHM

FLOWCHARTS: OBJECTIVES AND LOGIC

Each of the following flowcharts (Figs. 1through 6) addresses a specific clinical prob-lem or issue. They are not intended to bedefinitive. No “best practice” is ever definitive.Instead, each algorithm is a snapshot in time ofa process that has proved clinically useful andeffective—a template alternative that surgeonscan examine, modify, individualize, and evolveaccording to surgeon and patient preferencesand specific clinical situations. Each algorithmflowchart is a continuous work in progress thatprovides a basic set of alternatives from whichto evolve better solutions.

For efficiency and to provide as much sum-mary information as possible while outliningchoices in flowchart form to help the patientmake decisions, each decision and manage-ment flowchart incorporates two additionalcomponents: (1) a summary of potential ben-efits and tradeoffs associated with each deci-sion and (2) a space for the patient to specifi-cally accept or decline alternatives at each

stage of the decision-making process, docu-mented in writing by the patient’s initials.

Each algorithm flowchart has six specific ob-jectives that coincide with concerns expressedby patients and the Food and Drug Adminis-tration: (1) to minimize reoperations; (2) toprioritize alternatives that are most likely toreduce reoperations; (3) to define realisticchoices for surgeon and patient; (4) to involvethe patient in the decision-making process; (5)to define “out” points for removal without re-placement in specific clinical situations; and(6) to provide thorough documentation ofchoices and assumption of responsibility forthe choices. When examining any decision ormanagement suggestion in the algorithm flow-charts, surgeons should carefully considerthese priorities. In each flowchart, decisionsand management alternatives are prioritized ina specific order to prevent additional reopera-tions with their inevitable risks and costs.

Every reoperation increases costs and risks.Reoperation rates approximating 20 percentare, at the least, highly questionable for medi-cally necessary operations and are logically un-justifiable for any totally elective, primary cos-metic surgical procedure. An implant sizechange procedure, a common reoperationwhich may be a totally elective patient prefer-ence, increases risks and costs. If preoperativepatient education and informed consent areoptimal, and if choice of implant size is basedon quantifiable tissue characteristics, reopera-tions for size change can be virtually eliminat-ed.6–9 A reoperation is a reoperation, regard-less of whether it is medically necessary orrequested by the patient for aesthetic or per-sonal reasons. Reoperations inarguably in-crease costs and risks that would not be presentif the reoperation did not occur. While pa-tients have a right to request the operationsthey choose, limiting medically unnecessary re-operations and reducing overall reoperationrates require that surgeons define and enforcestrict indications for reoperations.

Implant removal without replacement is analternative available to every surgeon and everypatient before any reoperation is performedfollowing breast augmentation, and it is thealternative most certain to minimize additionalrisks and costs of reoperations. If the choice ofimplant size has been based on quantifiabletissue dimensions and characteristics preoper-atively, implant removal without replacement(in the absence of infection or severe inflam-

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mation) usually allows the breast to return to aform that approximates the effects of a preg-nancy on the breast. Few patients or surgeonsever want to remove breast implants after thepatient has experienced their benefits. In spe-cific situations (e.g., multiple reoperations forcapsular contracture, multiple attempts to sal-vage contaminated or infected implants, or se-vere stretching or thinning of overlying tissueswith traction rippling or visible implant edges),implant removal without replacement is medi-cally the best and most logical solution.

Genetic characteristics of patients’ tissuesthat allow excessive stretching with even smallimplants, wound-healing predispositions thatproduce recurrent capsular contractures, andinflammatory processes around an implant areall factors that surgeons cannot predict or con-trol. Patients should understand and docu-ment their acceptance of these facts before theprimary augmentation. Then should any ofthese events occur, surgeons and patients willhave discussed and agreed upon predefined“out” points preoperatively. Out points for im-plant removal without replacement are dis-cussed in detail with patients preoperatively,and patients accept those out points in writteninformed consent documents.11 When patientsor surgeons choose not to define these outpoints, or choose not to remove and not toreplace implants when irreversible tissue con-sequences are present, both the patient andthe surgeon assume responsibility for the riskof deformities that may not be correctable.

DECISION AND MANAGEMENT ALGORITHMS

The six decision and management algorithmflowcharts address the following clinical issuesor problems: implant size exchange (Fig. 1),grade III or IV capsular contracture (Fig. 2),infection (Fig. 3), stretch deformities (implantbottoming or displacement) (Fig. 4), silentrupture of gel implants (Fig. 5), and undefinedsymptom complexes that may be associatedwith connective tissue disease or other unde-fined problems (Fig. 6). Each algorithm hasevolved in our (Tebbetts and Tebbetts) clinicalpractice for the past 7 years and has beeneffective in helping us address these issues,resulting in an overall reoperation rate of 3percent, a deflation or implant failure rate of0.78 percent, and a reoperation rate of 0.24percent for size adjustment or exchange in1662 cases reported in Plastic and ReconstructiveSurgery with up to 7 years of follow-up.7–9 Each

algorithm addresses a specific clinical situationof concern to the Food and Drug Administra-tion’s advisory panel of 2003.

REFINING THE DECISION AND MANAGEMENT

ALGORITHMS: A SURGEONS FOR PATIENTS

INITIATIVE

Additional input from surgeons with a widerange of experiences and expertise could un-doubtedly refine and improve the decision andmanagement algorithms derived in a singlepractice. Ethical issues, medicolegal issues,variations in practice orientation and manage-ment, and issues addressing standards of prac-tice could best be addressed by seeking inputfrom other surgeons with expertise in eachof these areas. Variations in practice occur aspractices evolve. A broad range of innovativeideas, approaches, and expertise from surgeonsin varying types of practices and with differentlevels of experience offers an opportunity to ex-pand and improve decision and managementprocesses, making the ultimate product moreflexible and comprehensive.

To further improve and widen the scope ofthe decision and management algorithms, we(Tebbetts and Tebbetts) sought the input andexpertise of the other authors of this article. Toaddress patient and Food and Drug Adminis-tration concerns, the Breast AugmentationSurgeons for Patients Initiative (BASPI) fo-cused on a single objective: reducing reopera-tion rates in breast augmentation. The partici-pants who coauthored this article eachprepared extensively by developing and sub-mitting alternative decision and managementsolutions for each topic listed. During 2 days ofintensive workgroup sessions and follow-upcommunications to verify revisions, key contri-butions from all participants’ solutions wereintegrated to derive the final algorithms pre-sented in this article.

The effort by this joint workgroup of plasticsurgeons with diverse backgrounds and expe-riences was to develop decision and manage-ment algorithms to assist in reducing reopera-tion rates in breast augmentation and improvepatient outcomes. All templates are optional,additional resources for surgeons to considerwhen addressing the specific clinical topics.

The Surgeons for Patients Initiative materi-als and solutions are designed to codify andpresent information and alternatives to makerepetitive decision-making processes more effi-cient by defining templates for management

1256 PLASTIC AND RECONSTRUCTIVE SURGERY, October 2004

that have proved effective in long-term clinicalexperience. Basic management templates allowsurgeons to focus on more detailed specifics ofeach clinical situation and, it is hoped, improvereoperation rates and outcomes. The Initiativeprovides defined solutions that prove to pa-tients, the Food and Drug Administration, andpatient advocacy groups that defined alterna-tives and solutions exist to address their con-cerns regarding causes of reoperations.

These decision and management algorithmsare not intended to define standards of prac-tice. The templates are intended to delineate aset of options available to patients and sur-geons, not to define or limit surgeons’ or pa-tients’ choices. No component of any algo-rithm is intended to supplant any area of asurgeon’s clinical decision making. These de-cision and management algorithms cannot anddo not address all of the variables that mayexist in any clinical situation, and in every sit-uation they must be adjusted by the surgeon tofit the clinical issues.

All decision and management algorithms as-sume that the surgeon has obtained all perti-nent baseline historical and medical back-ground information pertaining to the clinicalsituation. Addressing the clinical options avail-able to the patient and surgeon for optimaldecision making and the requirements of in-formed consent requires the level of complex-ity presented in the algorithms. To limit com-plexity, the algorithms are not intended toaddress the management of unanticipatedfindings during surgery.

CONCLUSIONS

Defined management algorithms haveproved invaluable to a wide range of businessesand professionals by optimizing business prac-tices and addressing issues and problems. Thedecision and management algorithms pre-sented in this article have been used success-fully for 7 years in a busy breast augmentationpractice, and they have been further expandedand refined by surgeons with a wide range of

experiences and expertise to address the fol-lowing issues and concerns that have beenexpressed by patients and the Food and DrugAdministration: implant size exchange,grade III or IV capsular contracture, infec-tion, stretch deformities (implant bottomingor displacement), silent rupture of gel im-plants, and undefined symptom complexes(connective tissue disease or other).

John B. Tebbetts, M.D.2801 Lemmon Avenue West, Suite 300Dallas, Texas 75204jbt@plastic-surgery.com

REFERENCES

1. U.S. Food and Drug Administration. General and PlasticSurgery Devices Panel of the Medical Devices AdvisoryCommittee meeting transcript. Washington, D.C.:October 14-15, 2003. Available at http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.htm.Accessed January 13, 2004.

2. U.S. Food and Drug Administration. General and Plas-tic Surgery Devices Panel meeting transcript. Wash-ington, D.C., February 18, 1992.

3. U.S. Food and Drug Administration. General and Plas-tic Surgery Devices Panel meeting transcript. Wash-ington, D.C.: March 1-3, 2000.

4. Hiebeler, R., Kelly, T. T., and Ketteman, C. Best Practices:Building Your Business with Customer-Focused Solutions.New York: Simon and Schuster, 1998. Pp. 7-228.

5. Tebbetts, J. B. An approach that integrates patient ed-ucation and informed consent in breast augmenta-tion. Plast. Reconstr. Surg. 110: 971, 2002.

6. Tebbetts, J. B. A system for breast implant selectionbased on patient tissue characteristics and implant–soft-tissue dynamics. Plast. Reconstr. Surg.: 109: 1396,2002.

7. Tebbetts, J. B. Patient acceptance of adequately filledbreast implants. Plast. Reconstr. Surg. 106: 139, 2000.

8. Tebbetts, J. B. Dual plane breast augmentation: Opti-mizing implant–soft-tissue relationships in a widerange of breast types. Plast. Reconstr. Surg. 107: 1255,2001.

9. Tebbetts, J. B. Achieving a predictable 24-hour returnto normal activities after breast augmentation: Part II.Patient preparation, refined surgical techniques, andinstrumentation. Plast. Reconstr. Surg. 109: 293, 2002.

10. Gorney, M. Preventing litigation in breast augmenta-tion. Clin. Plast. Surg. 28: 607, 2001.

11. Tebbetts, J. B. ”Out points” criteria for breast implantremoval without replacement and criteria to minimizereoperations following breast augmentation. Plast.Reconstr. Surg. 114: 1258, 2004.

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