cosmetic - cohesive breast implantscosmetic five critical decisions in breast augmentation using...

COSMETIC

Five Critical Decisions in Breast AugmentationUsing Five Measurements in 5 Minutes: TheHigh Five Decision Support Process

John B. Tebbetts, M.D.William P. Adams, M.D.

Dallas, Texas

Background: Surgeons’ decisions impact patient outcomes and implant effectson tissues over time. Tissue assessment systems that provide quantitative, ob-jective data enable objective rather than subjective decisions. First-generationdimensional systems for breast augmentation defined a desired result dimen-sionally and recommended an implant to force tissues to the desired result. Asecond-generation system, the TEPID system, defines measurements to matchthe implant to the patient’s tissue characteristics, instead of forcing tissues to adesired result. This study defines a third-generation decision support processthat prioritizes five critical decisions, identifies five key measurements, andcompletes all preoperative assessment and operative planning decisions inbreast augmentation in 5 minutes or less.Methods: Key decision parameters and data from more than 2300 primary aug-mentations planned using the TEPID system were analyzed to define the five mostcritical decisions that affect reoperation rates and risks of uncorrectable deformitiesand to define a decision support process using five critical measurements.Results: In 1664 cases with up to 7 years of follow-up, the overall reoperationrate was 3 percent, and the reoperation rate for implant size exchange was 0.2percent. The junior author’s (Adams) clinical experience includes more than300 augmentations with up to 6 years of follow-up using this system, with anoverall reoperation rate of 2.8 percent.Conclusion: The High Five decision support process prioritizes five criticaldecisions in breast augmentation and enables surgeons to address all pre-operative assessment and operative planning decisions in breast augmenta-tion in 5 minutes or less. (Plast. Reconstr. Surg. 118 (Suppl.): 35S, 2006.)[Reprinted from Plast. Reconstr. Surg. 116(7): 2005, 2005.]

When planning and performing primarybreast augmentation, surgeons considerimportant alternatives and variables that

determine short- and long-term results and thepatient’s risk of future tradeoffs, complications,and reoperations. Preoperative decision making isequally important compared with any aspect ofsurgical technique, because preoperative decisionsdetermine the adequacy of soft-tissue coverageover the implant for the patient’s lifetime, deter-mine the weight and pressure that the implantdevice will exert on the tissues over time, and de-termine the position 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

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 quantifiabledata on which to base decisions.

Please go to the online version of the Journalat www.PRSJournal.com to see the onlinestreaming video associated with this article.

From the Department of Plastic Surgery, University of TexasSouthwestern Medical Center.Received for publication December 13, 2004; revised October6, 2005.Copyright ©2006 by the American Society of Plastic SurgeonsDOI: 10.1097/01.prs.0000191163.19379.63

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How a surgeon uses these data—decision prior-ity, sequence, and algorithm—determines out-comes, tradeoffs, and reoperation risks. Previousdimensional systems for breast augmentation de-fine a desired result and suggest methods toforce tissues to that result.2 The previously pub-lished TEPID system1 incorporates quantitativetissue assessment, but instead of forcing tissuesto a desired result, prioritizes soft-tissue coverageover the implant in the short and long term. Thenext logical step was to provide surgeons with asimple and efficient decision support processthat addresses the five most critical decisions inbreast augmentation, using only five measure-ments, with the entire assessment and planningprocess requiring 5 minutes or less—the HighFive Process.

By integrating quantitative preoperative tissueassessment with a systematic approach to fivecritical decisions in breast augmentation, sur-geons have an opportunity to improve outcomes,reduce reoperation rates, and improve practiceefficiency. This article integrates a stepwise ap-proach to five critical decisions in breast aug-mentation with a refined and simplified versionof an established tissue assessment system foraugmentation. The High Five decision supportprocess adds a decision and management com-ponent to an established system for quantitativetissue assessment.

FIVE CRITICAL DECISIONS IN BREASTAUGMENTATION PLANNING

Surgeons must make preoperative decisions infive critical areas when planning a breast augmen-tation. Each of these decisions should be based onquantifiable measurements or data. In order ofpriority, these decisions define:

1. Optimal soft-tissue coverage/pocket location for theimplant. This determines future risks of visi-ble traction rippling, visible or palpable im-plant edges, and possible risks of excessivestretch or extrusion.

2. Implant volume (weight). This determines im-plant effects on tissues over time, risks ofexcessive stretch, excessive thinning, visibleor palpable implant edges, visible tractionrippling, ptosis, and parenchymal atrophy.

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

4. Optimal location for the inframammary foldbased on the width of the implant selectedfor augmentation. This determines the posi-tion of the breast on the chest wall, thecritical aesthetic relationship between breastwidth and nipple-to-fold distance, and distri-bution of fill (especially upper pole fill).

5. Incision location. This determines degree oftrauma to adjacent soft tissues, exposure ofimplant to endogenous bacteria in thebreast tissue, surgeon visibility and control,potential injury to adjacent neurovascula-ture, and potential postoperative morbidityor tradeoffs.

A comprehensive system for implant selectionshould address each of these critical decision areasand provide the surgeon with specific, quantifi-able data to consider when making decisions andassessing outcomes.

BACKGROUND OF THE TEPID SYSTEMThe TEPID system [tissue characteristics of

the breast (T), the envelope (E), parenchyma (P),implant (I), and the dimensions (D) and dynamicsof the implant relative to the soft tissues] for breastimplant selection, based on the patient’s individ-ual tissue characteristics and breast dimensions,was published in this Journal in April of 2002.1 Thesystem has been refined and simplified to includeonly five measurements that address five priori-tized decisions in implant selection and operativeplanning for breast augmentation that surgeonscan complete in 5 minutes. This process is de-signed to address essential parameters that affectaesthetic results, compromises, complications,and reoperation risks in breast augmentation. Ad-ditional clinical experience with the TEPID systemhas redefined priorities in decision making andcreated a simpler and more efficient process forsurgeons gaining familiarity with quantitative de-cision making in breast augmentation—the HighFive process.

The TEPID system evolved from the seniorauthor’s (Tebbetts) experience with the first di-mensional system (later licensed by Inamed Cor-poration as the BioDimensional System) for breastaugmentation,2 a system that defined a patient’sdesired result by dimensions and then selected animplant to force tissues to the desired result. TheBioDimensional System has been widely used bysurgeons in the United States and internationally,but clinical experience with the system definedspecific limitations that encouraged the develop-ment of the TEPID system.

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The first-generation BioDimensional Sys-tem (1) defines implant dimensions and vol-ume that force patient tissues to an arbitrary resultdefined by patient and surgeon desires insteadof quantitatively characterizing the patient’s tis-sue dimensions and characteristics, and selectingan implant to fit the requirements and limitations ofthe tissues; (2) incorporates no system to limitvolume and weight according to patient tissuecharacteristics, allowing patients and surgeonsto define a desired result dimensionally andselect implants that may be larger or more pro-jecting than ideal for the patient’s tissues, risk-ing potential long-term negative tissue conse-quences that can be irreversible; (3) does notspecifically 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 a critical measure-ment to estimate volume required for optimalenvelope fill.

The TEPID system was designed to specificallyaddress the limitations of the first-generationBioDimensional System by defining a paradigmshift in planning breast augmentation. Instead offorcing tissues to a desired result defined by thepatient and surgeon, the TEPID system encour-ages patient and surgeon to prioritize the long-term welfare of the patient’s tissues and ensureoptimal soft-tissue coverage over the implant tominimize negative tissue consequences long termand minimize reoperation rates. The TEPID sys-tem is designed to help patient and surgeons rec-oncile wishes with the tissues by quantifying impor-tant tissue characteristics and helping patientsreconcile their preconceived desires for a specificresult with the realities of their tissues. The HighFive process presented in this article furtherfocuses and simplifies an established system ofquantitative patient tissue assessment and addsa defined decision support process.

CLINICAL EXPERIENCEThe senior author’s (Tebbetts) clinical ex-

perience 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 (Adams)clinical experience includes more than 300augmentations with up to 6 years of follow-upusing this system, with an overall reoperation

rate of 2.8 percent.6 Although these rates arefrom a single surgeon’s experience, these dataprovide an interesting comparison with theoverall reoperation rates of 17 percent andrates for size exchange or adjustment rates of8.7 percent from the averaged data of Mentorand McGhan submitted for their saline premar-ket approval studies in 2000.7,8

Additional experience by the authors and in-put from other colleagues and residents furthercodified and refined the TEPID system to a com-prehensive decision support process that specifi-cally addresses five critical decisions in breast aug-mentation.

For efficiency, the High Five process does notinclude any parameters that are not essential toone of these decisions, and the process enablessurgeons to perform all measurements and makeall implant selection and operative planning de-cisions in 5 minutes or less.

MEASUREMENTS, IMPLANTSELECTION, AND OPERATIVE

PLANNINGWith the patient sitting and the High Five Clin-

ical Evaluation and Operative Planning Form (Fig.1) resting in the patient’s lap, the surgeon per-forms five measurements, records the measure-ments, and makes five prioritized decisions within5 minutes or less. During the process, the surgeoncan discuss the measurements, decisions, implica-tions, and tradeoffs with the patient.

A copy of the High Five Clinical Evaluation andOperative Planning Form is downloadable from theJournal’s Web site at www.plasreconsurg.org, alongwith a video file including measurement techniquesand the entire decision-making process. Details andillustrations of the required measurements and es-timates are included in the previous system1 and areabbreviated in this report.

Soft-Tissue Coverage and Pocket SelectionThe surgeon performs the first two measure-

ments and records the measurements on the eval-uation sheet (Fig. 1, section 1):

STPTUP: soft-tissue pinch thickness of the upperpole (skin and subcutaneous tissue superior tothe breast parenchyma (Fig. 2, above).

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

Implant pocket selection is based on quan-tified soft-tissue coverage to ensure optimallong-term coverage over the implant. If soft-tissue pinch thickness of the upper pole is less

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than 2.0 cm, the surgeon chooses a dual-planeor partial retropectoral pocket location to en-sure optimal soft-tissue coverage. Adding fascialcoverage (retromammary, subfascial pocket) ofless than 1 mm thickness is inconsequential longterm when pectoralis muscle coverage is avail-able and when dual-plane techniques enablesurgeons to minimize tradeoffs of traditionalretropectoral placement. When selecting a dual-plane or partial retropectoral pocket location to opti-mize coverage, the surgeon never divides origins of thepectoralis major from the sternal notch to the sternaljunction with the inframammary fold to ensure

optimal coverage in this critical area, regardlessof a patient’s desired intermammary distance. Ifsoft-tissue pinch thickness at the inframammaryfold is less than 0.5 cm, the surgeon preservesintact pectoralis muscle origins along the infra-mammary fold for additional coverage, creating apartial retropectoral pocket (compared with adual-plane pocket in which the surgeon dividespectoralis origins along the fold). Consideringthe quantified measurements of soft-tissue thick-ness, the surgeon chooses either dual-plane 1, 2 ,3, partial retropectoral, or retromammary pocketlocation, and circles the choice on the form.

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


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Implant VolumeNext, the surgeon measures and records the

following 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 measurement ofmaximal anterior skin stretch by manual tractioncomfortably tolerated by an awake 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 patient’sexisting breast. To estimate the parenchyma tostretched envelope fill, the surgeon pulls theperiareolar skin maximally anteriorly (anteriorpull skin stretch), then cups the hand or envi-sions the envelope stretched this same amountover the entire breast and estimates the

amount of fill as a percentage that the patient’sexisting parenchyma will provide to the maxi-mally stretched envelope.

The surgeon then locates the base width thatcorresponds with the patient’s base width in therow to the right. In the cell immediately beneath,the surgeon circles the initial estimated desiredimplant volume for that base width breast andtransfers this number to the blank space at the farright 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 ad-justable by the surgeon, depending on otherparameters, including patient wishes. Next, thesurgeon adjusts the estimated starting volume,depending on skin stretch.

Fig. 2. (Above) Measure soft-tissue pinch thickness of the upper pole by isolating skin and subcu-taneous tissue superior to the breast parenchyma, pinching firmly, and measuring the thickness witha caliper. (Below) Measure soft-tissue pinch thickness at the inframammary fold by isolating skin andsubcutaneous tissue at the inframammary fold, pinching firmly, and measuring the thickness with acaliper.


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If anterior pull skin stretch is less than 2 cm(very tight envelope), the surgeon subtracts 30 cc(or another increment of the surgeon’s prefer-ence) from the estimated starting volume. If an-terior pull skin stretch is greater than 3 cm, thesurgeon adds 30 cc, and if anterior pull skinstretch is greater than 4 cm, the surgeon adds 60cc to the starting volume, recording the appro-priate addition or subtraction in the cell at the farright of the APSS row.

If the nipple-to-inframammary fold distance isgreater than 9.5 cm when measured under max-imal stretch, the surgeon adds 30 cc (or anotherincrement of the surgeon’s preference) to the

starting volume to provide adequate additional fillvolume for a larger lower envelope. If applicable,the surgeon records this additional volume in thefar right cell of the N:IMFmax stretch row.

The parenchyma fill estimate is necessary to ad-just volume for patients whose skin envelopes aretighter (anterior pull skin stretch � 2 cm) and al-ready filled with parenchyma (parenchyma fill � 80percent), or for patients with very lax skin envelopes(anterior pull skin stretch � 3 cm) who have verylittle breast parenchyma (� 20 percent). If paren-chyma fill is greater than 80 percent (already fullenvelope), the surgeon subtracts 30 cc from theinitial estimated volume, and if parenchyma fill is lessthan 20 percent (empty envelope), the surgeon adds30 cc and records applicable additions or subtrac-tions in the cell to the far right of the PCSEF row.

If the patient or surgeon desires a greater orlesser volume than the system recommends, thesurgeon can add or subtract an additional volumeincrement and record it in the space provided inthe far right cell of the Patient Request row. TheHigh Five System does not replace patient or sur-geon preferences or choices. The system providesguidelines based on quantified tissue characteris-tics of each individual patient. By adding or sub-tracting increments described above from the ini-tial estimated 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 at thefar right of the Net Estimated Volume row.

Fig. 3. Measure the base width of the breast mound as a linearmeasurement from the visible medial border of the breastmound to the visible lateral border of the breast mound in frontview.

Fig. 4. (Left) Measure anterior pull skin stretch by grasping the skin of the areola and pulling itmaximally anteriorly (while holding a caliper in the same hand), and then mark that point with afingernail on the opposite hand. (Right) To complete the measurement of anterior pull skin stretch,release the skin and caliper measure from the point marked by the fingernail back to the resting planeof the areola.


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

Fig. 6. (Above, left and center) To estimate parenchymal contribution to stretched envelope fill, first measure the anterior pull skinstretch by the techniques described previously. (Above, right) Place a pen or envision a line from the point of maximal stretch taperinginto the upper pole. (Below, left) Cup the hand or envision a curved line that parallels the lower pole profile of the breast at a distanceequal to anterior pull skin stretch. (Below, right) The white dotted line simulates the maximally stretched envelope for this patient basedon the patient’s anterior pull skin stretch. Envision this line, and estimate the percentage of this stretched envelope that is filled by thepatient’s existing parenchyma. This concept is easy to demonstrate to the patient using the pen and cupped hand.


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Implant Type and DimensionsThe High Five System applies to a wide range

of implant types, sizes, and dimensions (Fig. 1,section 3). Having derived a net estimated implantvolume based on quantified tissue parameters, thesurgeon can then consult size and dimensioncharts for any type of implant, and select implantdimensions (width, height, projection) that thesurgeon feels are most appropriate.

The surgeon records the implant volume, thebase width of the implant selected, the base widthof the patient’s existing parenchyma (measuredpreviously), and implant projection. For optimallong-term coverage, the base width of the implant selectedshould not exceed the base width of the patient’s existingparenchyma, except in cases of tubular breasts, severelyconstricted lower pole breasts, or breasts with a base widthless than 10.5 cm. Implant projection is an impor-tant dimension that may affect distribution of filland tissue consequences postoperatively and is in-cluded only for postoperative reference. Surgeonsshould consider potential irreversible parenchy-mal atrophy effects when selecting highly project-ing implants.

Inframammary Fold LocationThe ideal nipple-to-inframammary fold dis-

tance to mark preoperatively and set intraopera-tively depends on the projected width of the post-operative breast (Fig. 1, section 4). To estimate theoptimal level of the inframammary fold, the sur-geon first locates the volume closest to the previ-ously calculated net estimated implant volume. Inthe cell immediately beneath, the system lists a“Recommended new N:IMF distance (cm) undermaximal stretch.” The surgeon circles the recom-mended number and then transfers that numberto the cell in the row below labeled “High Fiverecommended N:IMFMaxSt.” Next, the surgeontransfers the preoperative N:IMFMaxSt measure-ment to the cell labeled “Patient’s PreoperativeN:IMFMaxSt” in the same row.

If the recommended intraoperative N:IMF forthe planned volume implant is greater than thepatient’s preoperative N:IMFMaxSt, the surgeonshould consider lowering the fold to the recom-mended level. If the recommended N:IMFMaxSt isthe same or longer than the patient’s preoperativeN:IMFMaxSt, no lowering of the fold is indicated.After comparing the preoperative N:IMF with therecommended N:IMF, the surgeon decideswhether to lower the fold, and circles either “Yes”or “No.” If the choice is to lower the fold, thesurgeon then records the appropriate number of

centimeters to lower the fold in the cell below“Lower the Fold.”

Incision LocationIncision location is based on patient prefer-

ence, patient considerations of degree of surgicalcontrol, tissue trauma, and tradeoffs, and surgeonpreferences and skill set. The surgeon records theplanned incision location in the appropriate spacein Figure 1, section 5.

DISCUSSIONAn accurate, efficient decision support pro-

cess defines priorities and identifies a minimalnumber of essential decisions and provides quan-tifiable parameters on which to base those deci-sions. When prioritizing soft-tissue coverage inbreast augmentation, two pinch thickness mea-surements are a minimum for making decisionsregarding muscle coverage and location of musclecoverage. To estimate an appropriate volume foran envelope, minimum parameters include basewidth, skin stretch, nipple-to-inframammary foldmeasurement, and the contribution of the pa-tient’s existing breast parenchyma to stretchedenvelope fill (envelope fill equals implant plusparenchyma).

Optimal volume for a breast soft-tissue enve-lope is the least volume that is required to either(1) achieve the desired result in a previously un-stretched breast or (2) adequately fill a previouslystretched envelope and ensure optimal soft-tissuecoverage and minimize negative tissue effects bythe implants. When forcing tissues to a desiredresult, surgeons and patients must carefully con-sider potential tissue consequences and possibleuncorrectable deformities that may occur longterm. Instead of forcing tissues to a desired result,the High Five process estimates a volume the tis-sues are likely to tolerate without selecting an im-plant that is wider than the patient’s existing pa-renchyma (sacrificing coverage medially andlaterally) and without adding excessive weight thatcan produce irreversible tissue changes.

Having determined an optimal estimated vol-ume for an individual patient’s envelope, the sur-geon can then select implant type and dimensionsto control the distribution of that volume withinthe breast. For any specific volume, implant width,projection, and height can vary. Width is the mostimportant parameter affecting volume because ofits range of variability and the effect of a changein width on a change in volume. Height of animplant in vivo depends on many factors, includ-


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ing overlying tissue characteristics, implant fill vol-ume relative to mandrel volume, implant fillercharacteristics, and implant shell–filler interac-tions. Because implant height is so variable in vivoin non–form stable devices and is difficult to mea-sure accurately, implant width and projection arethe most clinically significant parameters.

Refinements to the system address sugges-tions from surgeons and residents who use thesystem routinely to assist with augmentation de-cisions. For resident education, this decisionsupport process provides a codified, logical tem-plate with priorities and specific measurementtechniques that allow residents to make deci-sions based on quantifiable parameters insteadof stuffing test implants into bras or using otherarbitrary and subjective methods.

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 maximum vol-ume without exceeding the base width of the patient’sexisting parenchyma. These volumes were derivedfrom implant width–volume relationships fromimplant manufacturers’ size chart publicationsfor all implant types (saline and silicone) in theUnited States. Averaging the dimension–volumerelationships provided a range of volumes forimplant widths at half-centimeter increments.To make the system easier to use and memorize,the volume increments were rounded to thenearest 25-cc increment.

Surgeons can base decisions of breast implantsize and implant pocket location on subjective andarbitrary patient and surgeon preferences or canbase decisions on quantifiable data to characterizeindividual patient tissue characteristics. Scientificanalysis and evidence-based outcomes analysis re-quire quantified data. Reoperation rates of 15 to20 percent in multiple premarket applicationstudies over the past two decades with silicone andsaline implants9–11 suggest an opportunity for bet-ter decision-making processes by surgeons and pa-tients. Reoperations for size exchange, visible rip-pling or wrinkling, implant malposition, implantexposure or extrusion, ptosis, and other deformi-ties can relate directly to the consequences of de-cisions that the patient and the surgeon makepreoperatively.

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 understand

and 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 (priori-tizing soft-tissue coverage) mandates a balance be-tween implant width, height, and projection.Volume is weight, and weight applied to breastenvelope tissues over time has consequences thatare obvious to anyone who has observed a D-cupbreast at age 18 and the same breast at age 30 orlater, and obvious to anyone who has seen theeffects of pregnancy on the breast. For any basewidth implant, increasing implant projection re-quires an increase in the volume (weight) of theimplant. Increased projection also can place ad-ditional pressure on overlying tissues—breast pa-renchyma, subcutaneous tissue, and skin. Increas-ing projection, therefore, has two potentiallynegative tissue consequences: increasing weighteffects and increased pressure effects. Weight andpressure over time can cause stretch and thinningof the envelope, and focal pressure or excess pres-sure over time can cause atrophy of parenchymaand subcutaneous tissue. Envelope thinning andparenchymal atrophy are irreversible and may per-manently preclude a patient from having optimalsoft-tissue coverage, increasing risks and decreas-ing results of any future reoperations.

Implant manufacturers currently provide sur-geons and patients with the widest array of implantdevice dimensions in history, enabling patientsand surgeons to choose a device with dimensions(size and volume) to force tissues into virtually anyconfiguration a patient may desire. Forcing tissuesto go where they have never been (and somemight argue, were never intended to go) has po-tential short- and long-term tissue consequences,some of which are irreversible. Whether a systemof implant selection is purely dimension based,volume based, or a combination of dimension andvolume (e.g., the High Five process), negative tis-sue consequences are usually the result of exces-sive weight (volume), pressure (projection), orboth. What is “excess” weight or projection de-pends on individual patient tissue characteristics,and surgeons must individualize clinical judg-ments in each case.

One important question is whether patientsand surgeons have an inherent right to place any


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volume they desire in a breast. The answer is yes,provided both are aware of and willing to acceptresponsibility for potential tissue consequences. Asecond important question is whether a processrecommends volumes that satisfy patients whileprotecting tissues. Although this is a difficult ques-tion to answer scientifically, in published reportsof 1664 cases with up to 7 years of follow-up,3–5

when integrated with staged, repetitive patient ed-ucation, the volumes recommended by the systemproduced results that resulted in 3 percent overallreoperation rates and a reoperation rate of 0.2percent for size exchange. In an independent re-view, the junior author has clinical experiencewith over 300 augmentations over a 6-year periodusing this system, producing an overall reopera-tion rate of 2.8 percent and a 0.4 percent reop-eration rate for size exchange.6 Optimal preoper-ative patient education, patient decision support,and informed consent processes that documentpatient accountability for requests and decisionsare critical. The High Five process does not re-place or define patient or surgeon preferences orchoices. Instead, it prioritizes decisions, providesguidelines based on quantified tissue characteris-tics 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 exceedthe base width of the patient’s parenchyma. Inpractice, this means that surgeons must be will-ing to explain to patients that narrowing theintermammary distance (cleavage gap) surgi-cally requires placing an implant edge medial toexisting parenchymal coverage, risking edge vis-ibility, palpability, and traction rippling longterm. Each of these problems is largely uncor-rectable, especially if surgeons divide medial or-igins of the pectoralis to narrow the intermam-mary distance. These problems are almosttotally preventable by advising patients that nar-rowing of the cleavage gap is more safely ac-complished by pushing the breasts with a bracompared with surgically placing an implant un-der thin, inadequate soft-tissue coverage, andconfirming the patient’s acceptance of thesefacts in informed consent 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 base widthof the existing parenchyma. In these cases, pa-

tients and their surgeons should thoroughly dis-cuss the potential long-term tradeoffs and tissueconsequences (i.e., thinner areas of tissue, palpa-ble or visible implant edges or shell, and visibletraction rippling) and arrive at a mutually accept-able risk–benefit decision.

In aesthetically appealing breasts, the widerthe breast, the longer the nipple-to-inframammaryfold distance. The inframammary fold is the onlyfixed landmark on the breast, and determiningoptimal inframammary fold position at the time ofbreast augmentation is a major factor that affectsthe 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 dimensionsand fill often accompanied by upward tilt nipple-areola malposition. The premise that surgeonsshould never lower the inframammary fold ig-nores the critical aesthetic relationship betweenbreast width (determined largely by implant basewidth) and nipple-to-inframammary fold distancethat defines optimal postoperative aesthetics.When indicated, lowering of the inframammaryfold is a critically important maneuver in breastaugmentation, and it is accurate and predictablewhen surgeons use optimal measurements andtechniques.

Many factors, including stretch factors thatsurgeons cannot control, can affect inframam-mary fold position long term, but surgeons needbasic guidelines during operative planning to de-cide whether repositioning of the inframammaryfold may be necessary for optimal aesthetics. TheHigh Five guidelines for inframammary fold po-sition are derived from preoperative and postop-erative measurement data on large numbers ofpatients1 and can be modified by surgeons accord-ing to specific clinical situations and consider-ations.

The High Five process is currently being usednot only by surgeons but also by clinical assistants,patient educators, and by patients who wish toperform self-assessment as part of their educa-tional process. In the senior author’s (Tebbetts)practice, many out-of-town patients who expressan interest receive a special, condensed version ofthe High Five Clinical Evaluation Form with num-bered instructions by e-mail. Interestingly, theirself-assessments have been extremely accurate,


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and the majority of these patients fully understandthe concepts of the system.

CONCLUSIONSThe refined and simplified TEPID system,

evolved into a decision support process, the HighFive process, defines five critical decisions in pri-mary breast augmentation and allows surgeonsand patients to quantify individual patient tissuecharacteristics and to base decisions about soft-tissue coverage (implant pocket location) and im-plant volume (size, weight, and dimensions) onobjective parameters instead of subjective, arbi-trary parameters. The High Five process is a com-prehensive yet simple and efficient decision andmanagement model for primary breast augmen-tation.

The process addresses five critical prioritiesand decisions in breast augmentation: optimalsoft-tissue coverage, implant size (volume/weight), implant dimensions, location of the in-framammary fold, and incision location. Al-though providing volume recommendationsrelative to the base width, stretch characteristics,and nipple-to-inframammary fold distance, thesystem also allows surgeons to add or subtractvolume based on specific patient requests, con-sidering possible long-term tissue tradeoffs andconsequences.

In conjunction with staged, repetitive patienteducation and decision-making algorithms, theTEPID system has helped minimize reoperationsfor size exchange (0.4 percent versus 8.7 percentin premarket application studies) and reduceoverall reoperation rates (3 percent versus 17 per-cent in premarket application studies).3–8

For any process to be effective, surgeons mustuse it. The demands of clinical practice mandatethat this process is efficient and comprehensivelyaddresses essential clinical priorities. A compre-hensive decision support process must address awide range of implant types and prioritize thepatient’s tissues long term. The High Five process

prioritizes five decision categories, involves onlyfive measurements and five decisions, and re-quires less than 5 minutes to perform all measure-ments and complete clinical planning to optimizepatient outcomes.

John B. Tebbetts, M.D.2801 Lemmon Avenue West, Suite 300

Dallas, Texas [email protected]

REFERENCES

1. Tebbetts, J. B. Breast implant selection based on patienttissue characteristics and dynamics: The TEPID approach.Plast. Reconstr. Surg. 190:1396, 2002.

2. Tebbetts, J. B. Dimensional Augmentation Mammaplasty Usingthe BioDimensional System. Santa Barbara, Calif.: McGhanMedical Corporation, 1994. Pp. 1–90.

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

4. Tebbetts, J. B. Dual plane (DP) breast augmentation: Op-timizing implant-soft tissue relationships in a wide range ofbreast types. Plast. Reconstr. Surg. 107: 1255, 2001.

5. Tebbetts, J. B. Achieving a predictable 24 hour return tonormal activities after breast augmentation: Part II. Patientpreparation, refined surgical techniques and instrumenta-tion. 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 year pro-spective clinical study. Plast. Reconstr. Surg. (in press).

7. Mentor Corporation. Saline-Filled Breast Implant Surgery:Making an Informed Decision. Santa Barbara, Calif.: MentorCorporation, 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.: MentorCorporation, 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 SurgeryDevices Panel of the FDA Medical Devices Advisory Committee,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 educa-tion and informed consent in breast augmentation. Plast.Reconstr. Surg. 110: 971, 2002.


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