TEPID Breast Augmentation

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Cosmetic Five Critical Decisions in Breast Augmentation Using Five Measurements in 5 Minutes: The High Five System John B. Tebbetts, M.D., and William P. Adams, M.D. Dallas, Texas Background: Surgeons can select alterna- tives and control variables that affect long- term results and implant effects on tissues over time. Tissue assessment systems that provide quantitative, objective data enable objective rather than subjective decisions. First-generation dimensional systems for breast augmentation define a desired result dimensionally and recommend an implant to force tissues to the desired result. A sec- ond-generation dimensional system, the TEPID system, defines measurements to fit the implant to the patient’s tissue charac- teristics, instead of forcing tissues to a de- sired result. This study defines a simpler, more focused third-generation system that prioritizes five critical decisions, identifies five key measurements, and completes all preoperative assessment and operative planning decisions in breast augmentation in 5 minutes or less. Methods: Key decision parameters and data from more than 2300 primary aug- mentations planned using the TEPID sys- tem were analyzed to define the five most critical decisions that affect reoperation rates and risks of uncorrectable deformities and to define five critical measurements that affect those decisions. Results: In 1664 cases with up to 7 years of follow-up, the overall reoperation rate was 3 percent, and the reoperation rate for im- plant size exchange was 0.2 percent. The junior author’s (Adams) clinical experi- ence includes more than 300 augmenta- tions with up to 6 years of follow-up using this system, with an overall reoperation rate of 2.5 percent. Conclusion: The High Five System priori- tizes five critical decisions in breast aug- mentation and defines five measurements that enable surgeons to address all preoper- ative assessment and operative planning de- cisions in breast augmentation in 5 minutes or less. (Plast. Reconstr. Surg. 116: 1, 2005.) When planning and performing primary breast 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 any aspect 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 and pressure that the implant device will exert on the tissues over time, and determine the posi- tion of the breast on the chest wall. Surgeon and patient preoperative decisions determine potential consequences to a patient’s breast tissues over her lifetime with breast implants. Identifying critical variables and decisions that affect outcomes and codifying those pa- rameters into a simple, efficient, and reliable From the Department of Plastic Surgery, University of Texas Health Sciences Center. Received for publication December 13, 2004; revised October 6, 2005. DOI: 10.1097/01.prs.0000191163.19379.63 1 balt5/zpr-prs/zpr-prs/zpr01405/zpr9574-05a martines S6 11/2/05 19:03 4/Color Figure(s): 1-5 Art: PRS170846 Input-nlm Foot Foot

Transcript of TEPID Breast Augmentation

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Cosmetic

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

Background: Surgeons can select alterna-tives and control variables that affect long-term results and implant effects on tissuesover time. Tissue assessment systems thatprovide quantitative, objective data enableobjective rather than subjective decisions.First-generation dimensional systems forbreast augmentation define a desired resultdimensionally and recommend an implantto force tissues to the desired result. A sec-ond-generation dimensional system, theTEPID system, defines measurements to fitthe implant to the patient’s tissue charac-teristics, instead of forcing tissues to a de-sired result. This study defines a simpler,more focused third-generation system 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 five critical measurementsthat affect those decisions.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. The

junior 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 2.5 percent.Conclusion: The High Five System priori-tizes five critical decisions in breast aug-mentation and defines five measurementsthat enable surgeons to address all preoper-ative assessment and operative planning de-cisions in breast augmentation in 5 minutesor less. (Plast. Reconstr. Surg. 116: 1, 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. Surgeonand patient preoperative decisions determinepotential consequences to a patient’s breasttissues over her lifetime with breast implants.

Identifying critical variables and decisionsthat affect outcomes and codifying those pa-rameters into a simple, efficient, and reliable

From the Department of Plastic Surgery, University of Texas Health Sciences Center. Received for publication December 13, 2004; revisedOctober 6, 2005.

DOI: 10.1097/01.prs.0000191163.19379.63

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system provides surgeons with a framework forpreoperative assessment and operative plan-ning. Although more than 50 tissue and sur-geon variables occur in every augmentation,1any clinically practical and adoptable systemmust focus on the most important 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, reoperation risks, and tissueconsequences. Previous dimensional systemsfor breast augmentation define a desired resultand suggest methods to force tissues to thatresult.2 The previously published TEPIDsystem1 introduced quantitative tissue assess-ment to select an implant to fit individual pa-tient tissue characteristics, and instead of forc-ing tissues to a desired result, prioritized soft-tissue coverage over the implant in the shortand long term. The next logical step was toprovide surgeons with a simple and efficientdecision-making process that addresses five ofthe most critical decisions in breast augmenta-tion, using only five measurements, with theentire assessment and planning process requir-ing 5 minutes or less—the High Five System.

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 Sys-tem adds a decision and management compo-nent to an established system for quantitativetissue assessment.

FIVE CRITICAL DECISIONS IN BREAST

AUGMENTATION PLANNING

Surgeons must make decisions in five criticalareas when planning a breast augmentation.Each of these decisions should be based onquantifiable measurements or data. In order ofpriority, these decisions define:

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, risksof 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, and potential injury to adjacentneurovasculature.

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.

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 system is de-signed to address essential parameters that af-fect aesthetic results, compromises, complica-tions, and reoperation risks in breastaugmentation. Additional clinical experiencewith the TEPID system has redefined priorities

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in decision making and created a simpler andmore efficient version for surgeons gaining fa-miliarity with quantitative decision making inbreast augmentation—the High Five System.

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 produce the de-sired 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 System(1) defines implant dimensions and volumethat force patient tissues to an arbitrary result de-fined by patient and surgeon desires instead ofcharacterizing the patient’s tissue dimensionsand characteristics, and selecting an implant to fitthe requirements and limitations of the tissues; (2)incorporates no system to limit volume andweight according to patient tissue characteris-tics, allowing patients and surgeons to define adesired result dimensionally and select im-plants that may be larger than ideal for thepatient’s tissues, risking potential long-termnegative tissue consequences that can be irre-versible and uncorrectable; (3) does not spe-cifically address the number one priority inbreast augmentation, that is, ensuring optimalsoft-tissue coverage of the implant long-term;and (4) does not address a critical third dimen-sion, tissue stretch, which is one of two criticalmeasurements to estimate volume required foroptimal 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 System presented in this articlefurther focuses and simplifies an establishedsystem of patient tissue assessment and deci-sion priorities by prioritizing five critical deci-sions and quantitative parameters that mostaffect those decisions.

CLINICAL EXPERIENCE

The senior author’s (Tebbetts) clinical expe-rience with the TEPID system includes morethan 2000 primary breast augmentation cases.In three series reported in this Journal, with upto 7 years of follow-up of 1664 reported cases,the overall reoperation rate was 3 percent, andthe reoperation rate for implant size exchangewas 0.2 percent.3–5 The junior author’s (Ad-ams) clinical experience includes more than300 augmentations with up to 6 years of fol-low-up using this system, with an overall reop-eration rate of 2.5 percent.6 Although theserates are from a single surgeon’s experience,these data provide an interesting comparisonwith the overall reoperation rates of 17 percentand rates for size exchange or adjustment ratesof 8.7 percent from the averaged data of Men-tor and 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 tospecifically address five critical decision areasin breast augmentation, enabling surgeons toperform five measurements, make implant se-lection and operative planning decisions in fiveprioritized areas, and perform all steps in mea-surement and operative planning in less than 5minutes. For efficiency, the High Five Systemdoes not include any parameters that are notessential to one of these decisions, and thesystem enables surgeons to perform all mea-surements and make all implant selection andoperative planning decisions in 5 minutes orless.

MEASUREMENTS, IMPLANT SELECTION, AND

OPERATIVE PLANNING

With the patient sitting and the High FiveClinical Evaluation and Operative PlanningForm (Table I) resting in the patient’s lap, thesurgeon performs five measurements, recordsthe measurements, and makes five prioritizeddecisions within 5 minutes or less. During the

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process, 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.plasreconsurg.

org, along with a video file including measure-ment techniques and the entire decision-makingprocess. Details and illustrations of the requiredmeasurements and estimates are included in theoriginal report of the system1 and are abbreviatedin this report.

TABLE ITEPID Clinical Evaluation and Operative Planning Form

TEPID Tissue Analysis and Operative Planning

Patient Name: Date:1. Coverage: Selecting pocket location to optimize soft-tissue coverage short and long termSTPTUP If �2.0 cm., consider dual plane (DP) or partial retropectoral (PRP,

pectoralis origins intact across IMF)DP PRP RM

STPTIMF If STPTIMF �0.5 cm, consider subpectoral pocket and leave pectoralisorigins intact along IMF

Pocket location selected based on thickness of tissue coverage2. Implant Volume: Selecting an estimated implant volume for optimal envelope fillEstimating Desired Breast Implant Volume Based on Breast Measurements and Tissue CharacteristicsBase width Parenchyma

(cm)10.5 11.0 11.5 12.0 12.5 13.0 13.5 14.0 14.5 15.0

Initialvolume (cc)

200 250 275 300 300 325 350 375 375 400

APSSMaxStr2If � 2.0, –30 cc; if � 3.0, �30cc; if � 4.0, �60cc. Place appropriate number in blank at right.

N:IMFMaxSt If � 9.5, �30 cc. Place appropriate number in blank at right.PCSEF% If � 20%, �30cc; if � 80%, –30 cc. Place appropriate number in blank at right.Pt. request7 Net estimated volume to fill envelope based on patient tissue characterisitics3. Implant Dimensions, Type, and Manufacturer: Selecting specific implant characteristicsManufacturer Style/Shape/Shell/Filler

MaterialImplant Volume (cc) Implant

BaseWidth*(cm)

Breast Base Width(cm)

Implant Projection(cm)

*For optimal long-term coverage, implant base width should not exceed base width of patient’s existing parenchyma, even if widerIMD results.

4. Inframammary Fold Location: Estimating desired postoperative inframammary fold position(Circle volume closest to net estimated implant volume calculated above, and circle suggested N:IMF in the cell beneath that volume)

Volume closestto calculated“totalestimatedimplantvolume”above

200 250 275 300 325 350 375 400

Recommendednew N:IMFdistance (cm)undermaximalstretch ¡

7.0 7.0 7.5 8 8 8.5 9.0 9.5

Planning level ofnewinframammaryfold*

Transfer the patient’s N:IMFMaxSt

measurement and TEPIDrecommended new N:IMF from aboveto corresponding cells at right. If thepreoperative N:IMF is shorter than theTEPID recommended new N:IMF,considering lowering the fold. If it isequal to or greater than the TEPIDrecommended new N:IMF, no changein IMF position is indicated.

Preop N:IMFMaxSt

TEPID N:IMFMaxSt Change in foldposition

Lower fold

cm cm Yes/no cm*Other factors may affect optimal IMF level and require surgeons to modify the TEPID System recommendations for N:IMF.5. Incisions Location: Selecting desired incision locationInframmary Axillary Periareolar Umbilical

The five decisions: 1, soft-tissue coverage measurements and implant pocket selection; 2, selecting an estimated implant volume for optimal envelope fill; 3, selectingspecific implant characteristics; 4, estimating desired postoperative inframammary fold position; 5, selecting desired incision location.

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Soft-Tissue Coverage and Pocket Selection

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

STPTUP: soft-tissue pinch thickness of the up-per pole (skin and subcutaneous tissue supe-rior to the breast parenchyma (Fig. 1, left andcenter).

STPTIMF: soft-tissue pinch thickness at the in-framammary fold (Fig. 1, right).

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 muscle

coverage is available for medial and upper polecoverage long term. When selecting a dual-plane or partial retropectoral pocket locationto optimize coverage, the surgeon never dividesorigins of the pectoralis major from the sternalnotch to the sternal junction with the infra-mammary fold to ensure optimal coverage inthis critical area, regardless of a patient’s de-sired intermammary distance. If soft-tissuepinch thickness at the inframammary fold isless than 0.5 cm, pectoralis muscle originsalong the inframammary fold are preserved foradditional coverage, creating a partial retr-opectoral pocket (compared with a dual-planepocket where the surgeon divides pectoralisorigins along the fold). Considering the quan-tified measurements of soft-tissue thickness,the surgeon chooses either dual-plane 1, 2 , 3,partial retropectoral, or retromammary pocketlocation, and circles the choice on the form.

FIG. 1. (Left and center) Measure soft-tissue pinch thickness of the upper pole by isolating skinand subcutaneous tissue superior to the breast parenchyma, pinching firmly, and measuring thethickness with a caliper. (Right) 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.

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Implant Volume

Next, the surgeon measures and records thefollowing parameters (Table I, section 2):

Base width (BW) of the existing breast paren-chyma, a linear measurement (Fig. 2).

Anterior pull skin stretch (APSS), a measure-ment of maximal anterior skin stretch bymanual traction comfortably tolerated by anawake patient (Fig. 3).

Nipple-to-inframammary fold distance (N:IMFMaxSt), measured under maximal stretch(Figs. 4 and 5).

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 surgeon

pulls the periareolar skin maximally anteri-orly (anterior pull skin stretch), then cupsthe hand or envisions the envelope stretchedthis 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 base width of thepatient’s existing breast parenchyma. Thesevolumes were derived from data described inthe initial TEPID report1 and are adjustable bythe surgeon, depending on other parameters,including patient wishes. Next, the surgeonadjusts the estimated starting volume, depend-ing 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, recording

FIG. 2. 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. 3. (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.

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FIG. 4. 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. 5. (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.

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the 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 to stretched envelope fillestimate is necessary to adjust volume for pa-tients whose skin envelopes are tighter (ante-rior pull skin stretch � 2 cm) and already filledwith parenchyma (parenchyma to stretchedenvelope fill � 80 percent), or for patients withvery lax skin envelopes (anterior pull skinstretch � 3 cm) who have very little breastparenchyma. If parenchyma to stretched enve-lope fill is greater than 80 percent (tight, al-ready full envelope), the surgeon subtracts 30cc from the initial estimated volume, and ifparenchyma to stretched envelope fill is lessthan 20 percent (loose, 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 is applicable to a widerange of implant types, sizes, and dimensions(Table I, section 3). Having derived a net esti-mated implant volume based on quantified tis-sue parameters, the surgeon can then consultsize and dimension charts for any type of im-plant, and select implant dimensions (width,height, projection) that the surgeon feels aremost appropriate.

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, constricted lower pole breasts,or breasts with a base width less than 10.5 cm.Implant projection is an important dimensionthat may affect distribution of fill and tissueconsequences postoperatively and is includedonly for postoperative reference.

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 (Table I, section 4). Toestimate the optimal level of the inframam-mary fold, the surgeon first locates the volumeclosest to the previously calculated net esti-mated implant volume. In the cell immediatelybeneath, 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 can 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 Table I, section 5.

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DISCUSSION

An accurate, efficient decision support sys-tem 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 measurements, and theexisting parenchyma’s contribution to fill ofthe stretched envelope (resulting fill equalsimplant plus parenchyma).

Optimal volume for a breast soft-tissue en-velope is the least volume that is required toeither (1) achieve the desired result in apreviously unstretched breast or (2) ade-quately fill a previously stretched envelopeand ensure optimal soft-tissue coverage andminimize negative tissue effects by the im-plants. When forcing tissues to a desired re-sult, surgeons and patients must carefullyconsider potential tissue consequences andpossible uncorrectable deformities that mayoccur long term. Instead of forcing tissues toa desired result, the High Five System esti-mates a volume the tissues are likely to toler-ate without selecting an implant that is widerthan the patient’s existing parenchyma (sac-rificing coverage medially and laterally) andwithout adding excessive weight that can pro-duce irreversible tissue changes by stretchingand thinning soft tissues covering the im-plant and causing parenchymal atrophy.

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 specificvolume, implant width, projection, andheight can vary. Width is the most importantparameter affecting volume because of itsrange of variability and the effect of a changein width on a change in volume. Height of animplant in vivo depends on many factors,including overlying tissue characteristics, im-plant fill volume relative to mandrel volume,implant filler characteristics, and implantshell–filler interactions. Because implantheight is so variable and difficult to measureaccurately in vivo, implant width and projec-

tion are the most clinically significant param-eters.

Refinements to the system directly addresssuggestions from surgeons and residents whoroutinely use the TEPID system to assist withaugmentation decisions. For resident educa-tion, the system provides a codified, logicaltemplate with priorities and specific mea-surement techniques that allow residents tomake decisions based on quantifiable param-eters instead of stuffing test implants intobras or using other arbitrary and subjectivemethods.

The High Five System is a dimensionalsystem based on the base width of the breastthat specifies an initial estimated volume foreach base width. The volume this system rec-ommends is an averaged volume for a range ofimplant devices that provides maximum volumewithout exceeding the base width of the patient’sexisting parenchyma. These volumes were de-rived from implant width–volume relation-ships from implant manufacturers’ size chartpublications for all implant types (saline andsilicone) in the United States. Averaging thedimension–volume relationships provided arange of volumes for implant widths at half-centimeter increments. To make the systemeasier to use and memorize, the volume in-crements were rounded to the nearest 25-ccincrement.

Decisions of breast implant size and implantpocket location can be based on subjective andarbitrary patient and surgeon preferences orcan use quantifiable data to characterize indi-vidual patient tissue characteristics. Scientificanalysis and evidence-based outcomes analysisrequire quantified data. Reoperation rates of15 to 20 percent in multiple premarket appli-cation studies over the past two decades withsilicone and saline implants9–11 suggest an op-portunity for better decision-making processesby surgeons and patients. Reoperations for sizeexchange, visible rippling or wrinkling, im-plant malposition, implant exposure or extru-sion, ptosis, and other deformities can relatedirectly to the consequences of decisions thatthe patient and the surgeon make preopera-tively.

Establishing quantitative criteria for opti-mal soft-tissue coverage, implant pocket loca-tion, and implant size can significantly im-pact overall reoperation rates.3–5

Comprehensive, staged patient education isessential to help patients understand and ac-

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cept responsibility for the potential long-term implications of their wishes and theirdecisions.12 A system that prioritizes deci-sions, provides quantified data to assist withdecisions, and defines specific criteria forsoft-tissue coverage and implant volumebased on individual patient tissue character-istics is an additional tool for surgeons andpatients.

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 stretch effects of pregnancy on thebreast. For any base width implant, increasingimplant projection requires an increase in thevolume (weight) of the implant. Increased pro-jection also can place additional pressure onoverlying tissues—breast parenchyma, subcuta-neous tissue, and skin. Increasing projection,therefore, has two potentially negative tissueconsequences: increasing weight effects and in-creased pressure effects. Weight and pressureover time can cause stretch and thinning of theenvelope, and focal pressure or excess pressureof high-profile implants over time can causeatrophy of parenchyma and subcutaneous tis-sue. Envelope thinning and parenchymal atro-phy are irreversible and may permanently pre-clude a patient from having optimal soft-tissuecoverage, increasing risks and compromisingresults of any future reoperations.

Implant manufacturers currently providesurgeons and patients with the widest arrayof implant device dimensions in history, en-abling patients and surgeons to choose a de-vice with dimensions (size and volume) toforce tissues into virtually any configurationa patient may desire. Forcing tissues to gowhere they have never been (and some mightargue, were never intended to go) has poten-tial short- and long-term tissue conse-quences, some of which are irreversible.Whether a system of implant selection ispurely dimension based, volume based, or acombination of dimension and volume (e.g.,the High Five System), negative tissue conse-quences are usually the result of excessiveweight (volume), pressure (projection), orboth. What is “excess” weight or projection

depends on individual patient tissue charac-teristics, and surgeons must individualizeclinical judgments in each case.

One important question is whether pa-tients and surgeons have an inherent right toplace any volume they desire in a breast. Theanswer is yes, provided both are aware of andwilling to accept responsibility for potentialtissue consequences. A second importantquestion is whether the TEPID system recom-mends volumes that satisfy patients whileprotecting tissues. Although this is a difficultquestion to answer scientifically, in pub-lished reports of 1664 cases with up to 7 yearsof follow-up,3–5 when integrated with staged,repetitive patient education, the volumes rec-ommended by the system produced resultsthat resulted in 3 percent overall reoperationrates and a reoperation rate of 0.2 percentfor size exchange. In an independent review,the junior author (Adams) has clinical expe-rience with over 300 augmentations over a6-year period using this system, producing anoverall reoperation rate of 2.5 percent and a0.5 percent reoperation rate for sizeexchange.6 The High Five System does notreplace or define patient or surgeon prefer-ences or choices. Instead, the system priori-tizes decisions and provides guidelines basedon quantified tissue characteristics of eachindividual patient and provides an opportu-nity for surgeons to consider patient requestsduring the process and make choices outsidethe 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.

In patients with extremely narrow base widthbreasts (body width � 10 cm) or tubular or se-

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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, documentingsurgeon and patient acceptance of responsibilityfor potential long-term tradeoffs in informedconsent documents.

In aesthetically appealing breasts, the widerthe breast, the longer the nipple-to-inframam-mary fold distance. Determining optimal infra-mammary fold position at the time of breastaugmentation is a major factor that affects theaesthetic result.

An excessively short nipple-to-inframammaryfold distance relative to breast width producesa wide, boxy appearing breast with inadequatelower pole dimensions and fill. An excessivelylong nipple-to-inframammary fold distance rel-ative to breast width produces a “bottomedout” appearance, with excessive lower pole di-mensions and fill, often accompanied by up-ward tilted nipple-areola malposition. Thepremise that surgeons should never lower theinframammary fold ignores the critical aes-thetic relationship between breast width (de-termined largely by implant base width) andnipple-to-inframammary fold distance that de-fines optimal postoperative aesthetics. Whenindicated, lowering of the inframammary foldis a critically important maneuver in breastaugmentation, and it is accurate and predict-able when surgeons use optimal measurementsand 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 System guide-lines for inframammary fold position are de-rived from preoperative and postoperativemeasurement data on large numbers ofpatients1 and can be modified by surgeons ac-cording to specific clinical situations and con-siderations.

The High Five System is currently beingused not only by surgeons but also by clinicalassistants, patient educators, and patients

who wish to perform self-assessment as partof their educational process. In the seniorauthor’s (Tebbetts) practice, many out-of-town patients who express an interest receivea special, condensed version of the High FiveClinical Evaluation Form with numbered in-structions by e-mail. Interestingly, their self-assessments have been accurate in more than90 percent of cases, and the majority of thesepatients fully understand the concepts of thesystem.

CONCLUSIONS

The refined and simplified TEPID system,renamed the High Five System, defines fivecritical decisions in primary breast augmen-tation, allows surgeons and patients to quan-tify individual patient tissue characteristics,and base decisions about soft-tissue coverage(implant pocket location) and implant vol-ume (size, weight, and dimensions) on ob-jective parameters instead of subjective, arbi-trary parameters. The High Five System is acomprehensive yet simple and efficient deci-sion and management model for primarybreast augmentation.

The system addresses five critical prioritiesand decisions in breast augmentation: opti-mal soft-tissue coverage, implant size (vol-ume/weight), implant dimensions, locationof the inframammary fold, and incision loca-tion. Although providing volume recommen-dations 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 (0.2 percent versus 8.7percent in premarket application studies) andreduce overall reoperation rates (3 percentversus 17 percent in premarket applicationstudies).3–5,7,8

For any system to be effective, surgeons mustuse it. The demands of clinical practice man-date a system that is efficient and comprehen-sively addresses essential clinical priorities. Acomprehensive system must address a widerange of implant types and prioritize the pa-tient’s tissues long term. This refined and sim-plified version of the TEPID system focuses onthose requirements. The High Five System pri-

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oritizes five decision categories, involves onlyfive measurements and five decisions, and re-quires less than 5 minutes to perform all mea-surements and make all operative planning de-cisions.

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. AdamsJr.,W. P., Rios, J. L., and Smith, S. D. Enhancingpatient outcomes in aesthetic and reconstructivebreast surgery using triple antibiotic breast irrigation:6 year prospective clinical study. Plast. Reconstr. Surg.

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. WhalenT. V.,et al. Transcript of General and Plastic Sur-gery Devices Panel of the FDA Medical Devices AdvisoryCommittee., 14 and 15 October 2003. Available at:http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.htm.

12. Tebbetts, J. B. An approach that integrates patienteducation and informed consent in breast augmen-tation. Plast. Reconstr. Surg. 110: 971, 2002.

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AQ1: AUTHOR—PMA spelled out correctly as “premarket approval”?

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