cosmetic five critical decisions in breast augmentation ... 5 - dec 2005.pdf · implant volume...

Cosmetic

Five Critical Decisions in Breast AugmentationUsing Five Measurements in 5 Minutes: TheHigh Five Decision Support ProcessJohn B. Tebbetts, M.D., and William P. Adams, M.D.Dallas, Texas

Background: Surgeons’ decisions impactpatient outcomes and implant effects ontissues over time. Tissue assessment systemsthat provide quantitative, objective data en-able objective rather than subjective deci-sions. First-generation dimensional systemsfor breast augmentation defined a desiredresult dimensionally and recommended animplant to force tissues to the desired re-sult. A second-generation system, theTEPID system, defines measurements tomatch the implant to the patient’s tissuecharacteristics, instead of forcing tissues toa desired result. This study defines a third-generation decision support process thatprioritizes five critical decisions, identifiesfive key measurements, and completes allpreoperative assessment and operativeplanning decisions in breast augmentationin 5 minutes or less.Methods: Key decision parameters anddata from more than 2300 primary aug-mentations planned using the TEPID sys-tem were analyzed to define the five mostcritical decisions that affect reoperationrates and risks of uncorrectable deformitiesand to define a decision support processusing five critical measurements.Results: In 1664 cases with up to 7 years offollow-up, the overall reoperation rate was3 percent, and the reoperation rate for im-plant size exchange was 0.2 percent. Thejunior author’s (Adams) clinical experi-

ence includes more than 300 augmenta-tions with up to 6 years of follow-up usingthis system, with an overall reoperation rateof 2.8 percent.Conclusion: The High Five decision sup-port process prioritizes five critical deci-sions in breast augmentation and enablessurgeons to address all preoperative assess-ment and operative planning decisions inbreast augmentation in 5 minutes orless. (Plast. Reconstr. Surg. 116: 2005, 2005.)

When planning and performing primarybreast augmentation, surgeons consider im-portant alternatives and variables that deter-mine short- and long-term results and the pa-tient’s risk of future tradeoffs, complications,and reoperations. Preoperative decision mak-ing is equally important compared with anyaspect of surgical technique, because preoper-ative decisions determine the adequacy of soft-tissue coverage over the implant for the pa-tient’s lifetime, determine the weight andpressure that the implant device will exert onthe tissues over time, and determine the posi-tion of the breast on the chest wall.

Identifying critical variables and decisionsthat affect outcomes and codifying those pa-rameters into a simple, efficient, and reliablesystem provides surgeons with a framework forpreoperative assessment and operative plan-ning. Although more than 50 tissue and sur-geon variables occur in every augmentation,1

From the Department of Plastic Surgery, University of Texas Southwestern Medical Center. Received for publication December 13, 2004;revised October 6, 2005.

DOI: 10.1097/01.prs.0000191163.19379.63

2005

any clinically practical and adoptable decisionprocess must focus on the few critical decisionsand parameters that most affect outcomes.

A quantifiable approach to tissue assessment,using measurements in lieu of subjective visualassessment, provides surgeons with quantifi-able data on which to base decisions. How asurgeon uses these data—decision priority, se-quence, and algorithm— determines out-comes, tradeoffs, and reoperation risks. Previ-ous dimensional systems for breastaugmentation define a desired result and sug-gest methods to force tissues to that result.2The previously published TEPID system1 incor-porates quantitative tissue assessment, but in-stead of forcing tissues to a desired result, pri-oritizes soft-tissue coverage over the implant inthe short and long term. The next logical stepwas to provide surgeons with a simple and ef-ficient decision support process that addressesthe five most critical decisions in breast aug-mentation, using only five measurements, withthe entire assessment and planning processrequiring 5 minutes or less—the High FiveProcess.

By integrating quantitative preoperative tis-sue assessment with a systematic approach tofive critical decisions in breast augmentation,surgeons have an opportunity to improve out-comes, reduce reoperation rates, and improvepractice efficiency. This article integrates astepwise approach to five critical decisions inbreast augmentation with a refined and simpli-fied version of an established tissue assessmentsystem for augmentation. The High Five deci-sion support process adds a decision and man-agement component to an established systemfor quantitative tissue assessment.

FIVE CRITICAL DECISIONS IN BREAST

AUGMENTATION PLANNING

Surgeons must make preoperative decisionsin five critical areas when planning a breastaugmentation. Each of these decisions shouldbe based on quantifiable measurements ordata. In order of priority, these decisions de-fine:

1. Optimal soft-tissue coverage/pocket location forthe implant. This determines future risks ofvisible traction rippling, visible or palpa-ble implant edges, and possible risks ofexcessive stretch or extrusion.

2. Implant volume (weight). This determinesimplant effects on tissues over time, risks

of excessive stretch, excessive thinning,visible or palpable implant edges, visibletraction rippling, ptosis, and parenchymalatrophy.

3. Implant type, size, and dimensions. This de-termines control over distribution of fillwithin the breast; adequacy of envelopefill; and risks of excessive stretch, exces-sive thinning, visible or palpable implantedges, visible traction rippling, ptosis, andparenchymal atrophy.

4. Optimal location for the inframammary foldbased on the width of the implant se-lected for augmentation. This determinesthe position of the breast on the chestwall, the critical aesthetic relationship be-tween breast width and nipple-to-fold dis-tance, and distribution of fill (especiallyupper pole fill).

5. Incision location. This determines degreeof trauma to adjacent soft tissues, expo-sure of implant to endogenous bacteria inthe breast tissue, surgeon visibility andcontrol, potential injury to adjacent neu-rovasculature, and potential postoperativemorbidity or tradeoffs.

A comprehensive system for implant selec-tion should address each of these critical deci-sion areas and provide the surgeon with spe-cific, quantifiable data to consider whenmaking decisions and assessing outcomes.

BACKGROUND OF THE TEPID SYSTEM

The TEPID system [tissue characteristics ofthe breast (T), the envelope (E), parenchyma(P), implant (I), and the dimensions (D) anddynamics of the implant relative to the softtissues] for breast implant selection, based onthe patient’s individual tissue characteristicsand breast dimensions, was published in thisJournal in April of 2002.1 The system has beenrefined and simplified to include only five mea-surements that address five prioritized deci-sions in implant selection and operative plan-ning for breast augmentation that surgeonscan complete in 5 minutes. This process isdesigned to address essential parameters thataffect aesthetic results, compromises, compli-cations, and reoperation risks in breast aug-mentation. Additional clinical experience withthe TEPID system has redefined priorities indecision making and created a simpler andmore efficient process for surgeons gaining

2006 PLASTIC AND RECONSTRUCTIVE SURGERY, December 2005

familiarity with quantitative decision making inbreast augmentation—the High Five process.

The TEPID system evolved from the seniorauthor’s (Tebbetts) experience with the firstdimensional system (later licensed by InamedCorporation as the BioDimensional System)for breast augmentation,2 a system that defineda patient’s desired result by dimensions andthen selected an implant to force tissues to thedesired result. The BioDimensional System hasbeen widely used by surgeons in the UnitedStates and internationally, but clinical experi-ence with the system defined specific limita-tions that encouraged the development of theTEPID system.

The first-generation BioDimensional Sys-tem (1) defines implant dimensions and vol-ume that force patient tissues to an arbitraryresult defined by patient and surgeon desiresinstead of quantitatively characterizing thepatient’s tissue dimensions and characteris-tics, and selecting an implant to fit the require-ments and limitations of the tissues; (2) incor-porates no system to limit volume and weightaccording to patient tissue characteristics, al-lowing patients and surgeons to define a de-sired result dimensionally and select im-plants that may be larger or more projectingthan ideal for the patient’s tissues, riskingpotential long-term negative tissue conse-quences that can be irreversible; (3) does notspecifically address the number one priorityin breast augmentation, that is, ensuring op-timal soft-tissue coverage of the implant long-term; and (4) does not address a criticalthird dimension, tissue stretch, which is acritical measurement to estimate volume re-quired for optimal envelope fill.

The TEPID system was designed to specifi-cally address the limitations of the first-generation BioDimensional System by defininga paradigm shift in planning breast augmenta-tion. Instead of forcing tissues to a desiredresult defined by the patient and surgeon, theTEPID system encourages patient and surgeonto prioritize the long-term welfare of the pa-tient’s tissues and ensure optimal soft-tissuecoverage over the implant to minimize nega-tive tissue consequences long term and mini-mize reoperation rates. The TEPID system isdesigned to help patient and surgeons recon-cile wishes with the tissues by quantifying impor-tant tissue characteristics and helping patientsreconcile their preconceived desires for a spe-cific result with the realities of their tissues.

The High Five process presented in this arti-cle further focuses and simplifies an estab-lished system of quantitative patient tissueassessment and adds a defined decision sup-port process.

CLINICAL EXPERIENCE

The senior author’s (Tebbetts) clinical ex-perience with the TEPID system includesmore than 2000 primary breast augmenta-tion cases. In three series reported in thisJournal, with up to 7 years of follow-up of1664 reported cases, the overall reoperationrate was 3 percent, and the reoperation ratefor implant size exchange was 0.2 percent.3–5

The junior author’s (Adams) clinical experi-ence includes more than 300 augmentationswith up to 6 years of follow-up using thissystem, with an overall reoperation rate of2.8 percent.6 Although these rates are from asingle surgeon’s experience, these data pro-vide an interesting comparison with the over-all reoperation rates of 17 percent and ratesfor size exchange or adjustment rates of 8.7percent from the averaged data of Mentorand McGhan submitted for their saline pre-market approval studies in 2000.7,8

Additional experience by the authors andinput from other colleagues and residents fur-ther codified and refined the TEPID system toa comprehensive decision support process thatspecifically addresses five critical decisions inbreast augmentation.

For efficiency, the High Five process doesnot include any parameters that are not essen-tial to one of these decisions, and the processenables surgeons to perform all measurementsand make all implant selection and operativeplanning decisions in 5 minutes or less.

MEASUREMENTS, IMPLANT SELECTION, AND

OPERATIVE PLANNING

With the patient sitting and the High FiveClinical Evaluation and Operative PlanningForm (Fig. 1) resting in the patient’s lap, thesurgeon performs five measurements, recordsthe measurements, and makes five prioritizeddecisions within 5 minutes or less. During theprocess, the surgeon can discuss the measure-ments, decisions, implications, and tradeoffswith the patient.

A copy of the High Five Clinical Evaluationand Operative Planning Form is downloadablefrom the Journal’s Web site at www.plasreconsur-g.org, along with a video file including measure-

Vol. 116, No. 7 / THE HIGH FIVE SYSTEM 2007

ment techniques and the entire decision-makingprocess. Details and illustrations of the requiredmeasurements and estimates are included in theprevious system1 and are abbreviated in this re-port.

Soft-Tissue Coverage and Pocket Selection

The surgeon performs the first two measure-ments and records the measurements on theevaluation sheet (Fig. 1, section 1):

STPTUP: soft-tissue pinch thickness of the up-per pole (skin and subcutaneous tissue supe-rior to the breast parenchyma (Fig. 2, above).

STPTIMF: soft-tissue pinch thickness at the in-framammary fold (Fig. 2, below).

Implant pocket selection is based on quanti-fied soft-tissue coverage to ensure optimallong-term coverage over the implant. If soft-tissue pinch thickness of the upper pole is lessthan 2.0 cm, the surgeon chooses a dual-planeor partial retropectoral pocket location to en-sure optimal soft-tissue coverage. Adding fas-cial coverage (retromammary, subfascialpocket) of less than 1 mm thickness is incon-sequential long term when pectoralis musclecoverage is available and when dual-plane tech-

FIG. 1. High Five Clinical Evaluation and Operative Planning Form.


niques enable surgeons to minimize tradeoffsof traditional retropectoral placement. Whenselecting a dual-plane or partial retropectoralpocket location to optimize coverage, the surgeonnever divides origins of the pectoralis major fromthe sternal notch to the sternal junction with theinframammary fold to ensure optimal coverage inthis critical area, regardless of a patient’s desiredintermammary distance. If soft-tissue pinch thick-ness at the inframammary fold is less than 0.5 cm,the surgeon preserves intact pectoralis muscle ori-gins along the inframammary fold for additionalcoverage, creating a partial retropectoral pocket(compared with a dual-plane pocket in which thesurgeon divides pectoralis origins along the fold).Considering the quantified measurements of soft-tissue thickness, the surgeon chooses either dual-plane 1, 2 , 3, partial retropectoral, or retromam-mary pocket location, and circles the choice on theform.

Implant Volume

Next, the surgeon measures and records thefollowing parameters (Fig. 1, section 2):

Base width (BW) of the existing breast paren-chyma, a linear measurement (Fig. 3).

Anterior pull skin stretch (APSS), a measure-ment of maximal anterior skin stretch bymanual traction comfortably tolerated by anawake patient (Fig. 4).

Nipple-to-inframammary fold distance (N:IMFMaxSt), measured under maximal stretch(Figs. 5 and 6).

Parenchyma to stretched envelope fill (PCSEF),an estimate of the contribution of the pa-tient’s existing breast. To estimate the paren-chyma to stretched envelope fill, the surgeonpulls the periareolar skin maximally anteri-orly (anterior pull skin stretch), then cupsthe hand or envisions the envelope stretched

FIG. 2. (Above) Measure soft-tissue pinch thickness of the upper pole by isolating skin andsubcutaneous tissue superior to the breast parenchyma, pinching firmly, and measuring thethickness with a caliper. (Below) Measure soft-tissue pinch thickness at the inframammary fold byisolating skin and subcutaneous tissue at the inframammary fold, pinching firmly, and measuringthe thickness with a caliper.


this same amount over the entire breast andestimates the amount of fill as a percentagethat the patient’s existing parenchyma willprovide to the maximally stretched enve-lope.

The surgeon then locates the base width thatcorresponds with the patient’s base width inthe row to the right. In the cell immediatelybeneath, the surgeon circles the initial esti-mated desired implant volume for that basewidth breast and transfers this number to theblank space at the far right of the row.

This volume represents an estimated desiredimplant volume based on the breast base width.These volumes were derived from data de-scribed in the initial TEPID report1 and are

adjustable by the surgeon, depending on otherparameters, including patient wishes. Next, thesurgeon adjusts the estimated starting volume,depending on skin stretch.

If anterior pull skin stretch is less than 2 cm(very tight envelope), the surgeon subtracts 30cc (or another increment of the surgeon’s pref-erence) from the estimated starting volume. Ifanterior pull skin stretch is greater than 3 cm,the surgeon adds 30 cc, and if anterior pullskin stretch is greater than 4 cm, the surgeonadds 60 cc to the starting volume, recordingthe appropriate addition or subtraction in thecell at the far right of the APSS row.

If the nipple-to-inframammary fold distanceis greater than 9.5 cm when measured undermaximal stretch, the surgeon adds 30 cc (oranother increment of the surgeon’s prefer-ence) to the starting volume to provide ade-quate additional fill volume for a larger lowerenvelope. If applicable, the surgeon recordsthis additional volume in the far right cell ofthe N:IMFmax stretch row.

The parenchyma fill estimate is necessary toadjust volume for patients whose skin enve-lopes are tighter (anterior pull skin stretch � 2cm) and already filled with parenchyma (pa-renchyma fill � 80 percent), or for patientswith very lax skin envelopes (anterior pull skinstretch � 3 cm) who have very little breastparenchyma (� 20 percent). If parenchyma fillis greater than 80 percent (already full enve-lope), the surgeon subtracts 30 cc from theinitial estimated volume, and if parenchyma fill

FIG. 3. Measure the base width of the breast mound as alinear measurement from the visible medial border of thebreast mound to the visible lateral border of the breastmound in front view.

FIG. 4. (Left) Measure anterior pull skin stretch by grasping the skin of the areola and pullingit maximally anteriorly (while holding a caliper in the same hand), and then mark that point witha fingernail on the opposite hand. (Right) To complete the measurement of anterior pull skinstretch, release the skin and caliper measure from the point marked by the fingernail back to theresting plane of the areola.


FIG. 5. To measure nipple-to-inframammary fold distance under maximal stretch, first placedots at the exact inframammary fold crease near the 6-o’clock position and just medial to themidpoint of the nipple. Place the tip of a flexible tape measure exactly at the dot beside the nipple,lift maximally to place the lower pole skin under maximal stretch, and measure to the dot at theinframammary fold.

FIG. 6. (Above, left and center) To estimate parenchymal contribution to stretched envelope fill, first measure the anterior pullskin stretch by the techniques described previously. (Above, right) Place a pen or envision a line from the point of maximal stretchtapering into the upper pole. (Below, left) Cup the hand or envision a curved line that parallels the lower pole profile of the breastat a distance equal to anterior pull skin stretch. (Below, right) The white dotted line simulates the maximally stretched envelopefor this patient based on the patient’s anterior pull skin stretch. Envision this line, and estimate the percentage of this stretchedenvelope that is filled by the patient’s existing parenchyma. This concept is easy to demonstrate to the patient using the penand cupped hand.


is less than 20 percent (empty envelope), thesurgeon adds 30 cc and records applicable ad-ditions or subtractions in the cell to the farright of the PCSEF row.

If the patient or surgeon desires a greater orlesser volume than the system recommends,the surgeon can add or subtract an additionalvolume increment and record it in the spaceprovided in the far right cell of the PatientRequest row. The High Five System does notreplace patient or surgeon preferences orchoices. The system provides guidelines basedon quantified tissue characteristics of each in-dividual patient. By adding or subtracting in-crements described above from the initial esti-mated volume, the surgeon derives a netestimated volume that is appropriate for the pa-tient’s quantified tissue characteristics andrecords the appropriate number in the cell atthe far right of the Net Estimated Volume row.

Implant Type and Dimensions

The High Five System applies to a wide rangeof implant types, sizes, and dimensions (Fig. 1,section 3). Having derived a net estimated im-plant volume based on quantified tissue param-eters, the surgeon can then consult size anddimension charts for any type of implant, andselect implant dimensions (width, height, pro-jection) that the surgeon feels are most appro-priate.

The surgeon records the implant volume,the base width of the implant selected, the basewidth of the patient’s existing parenchyma(measured previously), and implant projec-tion. For optimal long-term coverage, the base widthof the implant selected should not exceed the basewidth of the patient’s existing parenchyma, except incases of tubular breasts, severely constricted lower polebreasts, or breasts with a base width less than 10.5cm. Implant projection is an important dimen-sion that may affect distribution of fill andtissue consequences postoperatively and is in-cluded only for postoperative reference. Sur-geons should consider potential irreversibleparenchymal atrophy effects when selectinghighly projecting implants.

Inframammary Fold Location

The ideal nipple-to-inframammary fold dis-tance to mark preoperatively and set intraop-eratively depends on the projected width of thepostoperative breast (Fig. 1, section 4). To esti-mate the optimal level of the inframammaryfold, the surgeon first locates the volume clos-

est to the previously calculated net estimatedimplant volume. In the cell immediately be-neath, the system lists a “Recommended newN:IMF distance (cm) under maximal stretch.”The surgeon circles the recommended num-ber and then transfers that number to the cellin the row below labeled “High Five recom-mended N:IMFMaxSt.” Next, the surgeon trans-fers the preoperative N:IMFMaxSt measurementto the cell labeled “Patient’s PreoperativeN:IMFMaxSt” in the same row.

If the recommended intraoperative N:IMFfor the planned volume implant is greater thanthe patient’s preoperative N:IMFMaxSt, the sur-geon should consider lowering the fold to therecommended level. If the recommendedN:IMFMaxSt is the same or longer than the pa-tient’s preoperative N:IMFMaxSt, no lowering ofthe fold is indicated. After comparing the pre-operative N:IMF with the recommendedN:IMF, the surgeon decides whether to lowerthe fold, and circles either “Yes” or “No.” If thechoice is to lower the fold, the surgeon thenrecords the appropriate number of centime-ters to lower the fold in the cell below “Lowerthe Fold.”

Incision Location

Incision location is based on patient prefer-ence, patient considerations of degree of sur-gical control, tissue trauma, and tradeoffs, andsurgeon preferences and skill set. The surgeonrecords the planned incision location in theappropriate space in Figure 1, section 5.

DISCUSSION

An accurate, efficient decision support pro-cess defines priorities and identifies a minimalnumber of essential decisions and providesquantifiable parameters on which to base thosedecisions. When prioritizing soft-tissue coveragein breast augmentation, two pinch thicknessmeasurements are a minimum for making de-cisions regarding muscle coverage and locationof muscle coverage. To estimate an appropri-ate volume for an envelope, minimum parame-ters include base width, skin stretch, nipple-to-inframammary fold measurement, and thecontribution of the patient’s existing breastparenchyma to stretched envelope fill (enve-lope fill equals implant plus parenchyma).

Optimal volume for a breast soft-tissue enve-lope is the least volume that is required toeither (1) achieve the desired result in a pre-viously unstretched breast or (2) adequately fill


a previously stretched envelope and ensure op-timal soft-tissue coverage and minimize nega-tive tissue effects by the implants. When forc-ing tissues to a desired result, surgeons andpatients must carefully consider potential tis-sue consequences and possible uncorrectabledeformities that may occur long term. Insteadof forcing tissues to a desired result, the HighFive process estimates a volume the tissues arelikely to tolerate without selecting an implantthat is wider than the patient’s existing paren-chyma (sacrificing coverage medially and later-ally) and without adding excessive weight thatcan produce irreversible tissue changes.

Having determined an optimal estimatedvolume for an individual patient’s envelope,the surgeon can then select implant type anddimensions to control the distribution of thatvolume within the breast. For any specific vol-ume, implant width, projection, and heightcan vary. Width is the most important param-eter affecting volume because of its range ofvariability and the effect of a change in widthon a change in volume. Height of an implantin vivo depends on many factors, includingoverlying tissue characteristics, implant fill vol-ume relative to mandrel volume, implant fillercharacteristics, and implant shell–filler interac-tions. Because implant height is so variable invivo in non–form stable devices and is difficultto measure accurately, implant width and pro-jection are the most clinically significant pa-rameters.

Refinements to the system address sugges-tions from surgeons and residents who usethe system routinely to assist with augmenta-tion decisions. For resident education, thisdecision support process provides a codified,logical template with priorities and specificmeasurement techniques that allow residentsto make decisions based on quantifiable pa-rameters instead of stuffing test implants intobras or using other arbitrary and subjectivemethods.

The High Five process suggests an initialestimated implant volume based on the basewidth of a patient’s breasts. The volume thissystem recommends is an averaged volume for arange of implant devices that provides maximumvolume without exceeding the base width of thepatient’s existing parenchyma. These volumeswere derived from implant width–volume re-lationships from implant manufacturers’ sizechart publications for all implant types (sa-line and silicone) in the United States. Aver-

aging the dimension–volume relationshipsprovided a range of volumes for implantwidths at half-centimeter increments. Tomake the system easier to use and memorize,the volume increments were rounded to thenearest 25-cc increment.

Surgeons can base decisions of breast im-plant size and implant pocket location on sub-jective and arbitrary patient and surgeon pref-erences or can base decisions on quantifiabledata to characterize individual patient tissuecharacteristics. Scientific analysis and evidence-based outcomes analysis require quantifieddata. Reoperation rates of 15 to 20 percent inmultiple premarket application studies overthe past two decades with silicone and salineimplants9–11 suggest an opportunity for betterdecision-making processes by surgeons and pa-tients. Reoperations for size exchange, visiblerippling or wrinkling, implant malposition, im-plant exposure or extrusion, ptosis, and otherdeformities can relate directly to the conse-quences of decisions that the patient and thesurgeon make preoperatively.

Establishing quantitative criteria for optimalsoft-tissue coverage, implant pocket location, andimplant size can significantly affect overall reop-eration rates.3–6 Comprehensive, staged patienteducation is essential to help patients understandand accept responsibility for the potential long-term implications of their wishes and theirdecisions.12 A process that prioritizes decisions,provides quantified data to assist with decisions,and defines specific criteria for soft-tissue cover-age and implant volume based on individual pa-tient tissue characteristics is an additional tool forsurgeons and patients.

Any system that suggests a volume range rel-ative to the width of breast parenchyma (prior-itizing soft-tissue coverage) mandates a balancebetween implant width, height, and projection.Volume is weight, and weight applied to breastenvelope tissues over time has consequencesthat are obvious to anyone who has observed aD-cup breast at age 18 and the same breast atage 30 or later, and obvious to anyone who hasseen the effects of pregnancy on the breast. Forany base width implant, increasing implantprojection requires an increase in the volume(weight) of the implant. Increased projectionalso can place additional pressure on overlyingtissues—breast parenchyma, subcutaneous tis-sue, and skin. Increasing projection, therefore,has two potentially negative tissue conse-quences: increasing weight effects and in-


creased pressure effects. Weight and pressureover time can cause stretch and thinning of theenvelope, and focal pressure or excess pressureover time can cause atrophy of parenchymaand subcutaneous tissue. Envelope thinningand parenchymal atrophy are irreversible andmay permanently preclude a patient from hav-ing optimal soft-tissue coverage, increasingrisks and decreasing results of any future reop-erations.

Implant manufacturers currently providesurgeons and patients with the widest array ofimplant device dimensions in history, enablingpatients and surgeons to choose a device withdimensions (size and volume) to force tissuesinto virtually any configuration a patient maydesire. Forcing tissues to go where they havenever been (and some might argue, were neverintended to go) has potential short- and long-term tissue consequences, some of which areirreversible. Whether a system of implant selec-tion is purely dimension based, volume based,or a combination of dimension and volume(e.g., the High Five process), negative tissueconsequences are usually the result of excessiveweight (volume), pressure (projection), orboth. What is “excess” weight or projectiondepends on individual patient tissue character-istics, and surgeons must individualize clinicaljudgments in each case.

One important question is whether patientsand surgeons have an inherent right to placeany volume they desire in a breast. The answeris yes, provided both are aware of and willing toaccept responsibility for potential tissue conse-quences. A second important question iswhether a process recommends volumes thatsatisfy patients while protecting tissues. Al-though this is a difficult question to answerscientifically, in published reports of 1664 caseswith up to 7 years of follow-up,3–5 when inte-grated with staged, repetitive patient educa-tion, the volumes recommended by the systemproduced results that resulted in 3 percentoverall reoperation rates and a reoperationrate of 0.2 percent for size exchange. In anindependent review, the junior author has clin-ical experience with over 300 augmentationsover a 6-year period using this system, produc-ing an overall reoperation rate of 2.8 percentand a 0.4 percent reoperation rate for sizeexchange.6 Optimal preoperative patient edu-cation, patient decision support, and informedconsent processes that document patient ac-countability for requests and decisions are crit-

ical. The High Five process does not replace ordefine patient or surgeon preferences orchoices. Instead, it prioritizes decisions, providesguidelines based on quantified tissue character-istics of each individual patient, and provides anopportunity for surgeons to consider patient re-quests during the process and make choices out-side the recommendations of the system.

To ensure optimal, long-term coverage, thebase width of a breast implant should not ex-ceed the base width of the patient’s paren-chyma. In practice, this means that surgeonsmust be willing to explain to patients that nar-rowing the intermammary distance (cleavagegap) surgically requires placing an implantedge medial to existing parenchymal coverage,risking edge visibility, palpability, and tractionrippling long term. Each of these problems islargely uncorrectable, especially if surgeons di-vide medial origins of the pectoralis to narrowthe intermammary distance. These problemsare almost totally preventable by advising pa-tients that narrowing of the cleavage gap ismore safely accomplished by pushing thebreasts with a bra compared with surgicallyplacing an implant under thin, inadequatesoft-tissue coverage, and confirming the pa-tient’s acceptance of these facts in informedconsent documents.

In patients with extremely narrow base widthbreasts (body width � 10 cm) or tubular or se-verely constricted lower pole breasts, achieving asatisfactory aesthetic result may require an im-plant with a base width that exceeds the basewidth of the existing parenchyma. In these cases,patients and their surgeons should thoroughlydiscuss the potential long-term tradeoffs and tis-sue consequences (i.e., thinner areas of tissue,palpable or visible implant edges or shell, andvisible traction rippling) and arrive at a mutuallyacceptable risk–benefit decision.

In aesthetically appealing breasts, the widerthe breast, the longer the nipple-to-inframam-mary fold distance. The inframammary fold isthe only fixed landmark on the breast, anddetermining optimal inframammary fold posi-tion at the time of breast augmentation is amajor factor that affects the aesthetic result.

An excessively short nipple-to-inframammaryfold distance relative to breast width produces awide, boxy appearing breast with inadequatelower pole dimensions and fill. An excessivelylong nipple-to-inframammary fold distance rela-tive to breast width produces a “bottomed out”appearance, with excessive lower pole dimen-


sions and fill often accompanied by upward tiltnipple-areola malposition. The premise that sur-geons should never lower the inframammaryfold ignores the critical aesthetic relationship be-tween breast width (determined largely by im-plant base width) and nipple-to-inframammaryfold distance that defines optimal postoperativeaesthetics. When indicated, lowering of the infra-mammary fold is a critically important maneuverin breast augmentation, and it is accurate andpredictable when surgeons use optimal measure-ments and techniques.

Many factors, including stretch factors thatsurgeons cannot control, can affect inframam-mary fold position long term, but surgeonsneed basic guidelines during operative plan-ning to decide whether repositioning of theinframammary fold may be necessary for opti-mal aesthetics. The High Five guidelines forinframammary fold position are derived frompreoperative and postoperative measurementdata on large numbers of patients1 and can bemodified by surgeons according to specificclinical situations and considerations.

The High Five process is currently beingused not only by surgeons but also by clinicalassistants, patient educators, and by patientswho wish to perform self-assessment as part oftheir educational process. In the senior au-thor’s (Tebbetts) practice, many out-of-townpatients who express an interest receive a spe-cial, condensed version of the High Five Clin-ical Evaluation Form with numbered instruc-tions by e-mail. Interestingly, their self-assessments have been extremely accurate, andthe majority of these patients fully understandthe concepts of the system.

CONCLUSIONS

The refined and simplified TEPID system,evolved into a decision support process, theHigh Five process, defines five critical decisionsin primary breast augmentation and allows sur-geons and patients to quantify individual pa-tient tissue characteristics and to base decisionsabout soft-tissue coverage (implant pocket lo-cation) and implant volume (size, weight, anddimensions) on objective parameters insteadof subjective, arbitrary parameters. The HighFive process is a comprehensive yet simple andefficient decision and management model forprimary breast augmentation.

The process addresses five critical priori-ties and decisions in breast augmentation:optimal soft-tissue coverage, implant size

(volume/weight), implant dimensions, loca-tion of the inframammary fold, and incisionlocation. Although providing volume recom-mendations relative to the base width, stretchcharacteristics, and nipple-to-inframammaryfold distance, the system also allows surgeonsto add or subtract volume based on specificpatient requests, considering possible long-term tissue tradeoffs and consequences.

In conjunction with staged, repetitive patienteducation and decision-making algorithms, theTEPID system has helped minimize reopera-tions for size exchange (0.4 percent versus 8.7percent in premarket application studies) andreduce overall reoperation rates (3 percentversus 17 percent in premarket applicationstudies).3–8

For any process to be effective, surgeonsmust use it. The demands of clinical practicemandate that this process is efficient and com-prehensively addresses essential clinical priori-ties. A comprehensive decision support processmust address a wide range of implant types andprioritize the patient’s tissues long term. TheHigh Five process prioritizes five decision cat-egories, involves only five measurements andfive decisions, and requires less than 5 minutesto perform all measurements and completeclinical planning to optimize patient out-comes.

John B. Tebbetts, M.D.2801 Lemmon Avenue West, Suite 300Dallas, Texas [email protected]

REFERENCES

1. Tebbetts, J. B. Breast implant selection based on pa-tient tissue characteristics and dynamics: The TEPIDapproach. Plast. Reconstr. Surg. 190:1396, 2002.

2. Tebbetts, J. B. Dimensional Augmentation Mammaplasty Us-ing the BioDimensional System. Santa Barbara, Calif.:McGhan Medical Corporation, 1994. Pp. 1–90.

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

4. Tebbetts, J. B. Dual plane (DP) breast augmentation:Optimizing implant-soft tissue relationships in a widerange of breast types. Plast. Reconstr. Surg. 107: 1255,2001.

5. 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.

6. Adams, W. P., Jr., Rios, J. L., and Smith, S. D. Enhancingpatient outcomes in aesthetic and reconstructive breastsurgery using triple antibiotic breast irrigation: 6 yearprospective clinical study. Plast. Reconstr. Surg. (in press).

7. Mentor Corporation. Saline-Filled Breast Implant Surgery:Making an Informed Decision. Santa Barbara, Calif.:Mentor Corporation, 2000. Pp. 11–19.


8. McGhan Medical Corporation. Saline-Filled Breast ImplantSurgery: Making an Informed Decision. Santa Barbara,Calif.: McGhan Medical Corporation, 2000. Pp. 10–18.

9. Mentor Corporation. Saline-Filled Breast Implant Surgery:Making an Informed Decision. Santa Barbara, Calif.:Mentor Corporation, 2000. Pp. 11–19.

10. McGhan Medical Corporation. Saline-Filled Breast ImplantSurgery: Making an Informed Decision. Santa Barbara,

Calif.: McGhan Medical Corporation, 2000. Pp. 11–19.11. Whalen, T. V., et al. Transcript of General and Plastic Surgery

Devices Panel of the FDA Medical Devices Advisory Com-mittee, October 14–15, 2003. Available at: http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.htm.

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


cosmetic five critical decisions in breast augmentation ... 5 - dec 2005.pdf · implant volume...

Documents