2 VI + TRUNK AND LOWER EXTREMITYFIGURE 118-1. The original Cronin-Gerow silicone implant introduced in 1962 had ananatomic...
4 VI • TRUNK AND LOWER EXTREMITYAlthough the foam was placed on the implant prima-rilyto maintain its position, clinical u...
118 • BREAST AUGMENTATION 5A BcFIGURE 118-2. A, Polyurethane foam gains tissue adherence and delaminates from the implant....
6 VI • TRUNK AND LOWER EXTREMI1YFIGURE 118-3. Style 410 Matrix (INAMED)of enhanced cohesive silicone gel implants offers v...
1 18 • BREAST AUGMENTATION 7Anatomic-shaped saline inflatable implants areavailable in the United States manufactured by b...
8 VI • TRUNK AND LOWER EXTREMITYto make premarket approval for the FDA in April of1991 and withdrew these devices from the...
A(I)(5Q.•..(I)Q.Q.::>.•....c:Ol(j)..c:.•..(J)ctl(I)•...CD118 • BREAST AUGMENTATIONSoft tissue envelopeParenchymaProsthesis...
10 VI • TRUNK AND LOWER EXTREMITYI--IMD--I.FIGURE 118-5. Preoperative mea-sures (taken before breast augmen-tation) includ...
118 • BREAST AUGMENTATION IIImplantwidthOriginalbreast widthFIGURE 118-7. After the width ofthe existing breast is measure...
12 VI • TRUNK AND LOWER EXTREMITYABFIGURE 118-8. A. A typical patient presenting forbreast augmentation. B. Postoperative ...
ARoundimplantB118 • BREAST AUGMENTATION 13AnatomicimplantFIGURE 118-9. A, When the preoperative breast has an acceptable f...
118 • BREAST AUGMENTATION 15Ample soft tissueRetroglandular Inadequate soft tissueRetropectoralA BFIGURE 118-10. A, When a...
16 VI + TRUNK AND LOWER EXTREMllYA Bc oE FFIGURE 118-12. A. The biodimensional approach is demonstrated in this physically...
118 • BREAST AUGMENTATION 17A Bc DE FFIGURE 118-13. A biodimensional approach is demonstrated in this postpartum patient d...
18 VI • TRUNK AND LOWER EXTREMITYABCFIGURE 118-14. Subpectoral implant placement generally involves release or division of...
118 • BREAST AUGMENTATION 21A Bc oFIGURE 118-15. A, Asmall-breasted woman with a soft tissue pinch test result of less tha...
22 VI • TRUNK AND LOWER EXTREMITYA BcEDFIGURE 118-16. A. A small-breasted woman with a sig-nificant upper pole concavity. ...
118 • BREAST AUGMENTATION 23FIGURE 118-17. Theoperatingtableisflexedtoa90-degree angle intraoperatively to allowthe surgeo...
24cVI • TRUNK AND LOWER EXTREMITYBDEbe implanted. Before final implant placement, thepocket is once again checked for hemo...
118 • BREAST AUGMENTATION 25TRANSAXILLARY AUGMENTATIONThe markings for transaxillary breast augmentationare also made with...
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  1. 1. CHAPTER118. _Breast AugmentationC. PATRICK MAXWELL, MD, FACS • R. WINFIELD HARTLEY, Jr., MDEVOLUTIONOF MAMMARYIMPLANTSSilicone Gel ImplantsSaline-Filled ImplantsDouble-Lumen ImplantsTextured-Surface Implants"Alternative Filler Implants"Enhanced Cohesive Silicone Gel ImplantsAnatomic-Shaped ImplantsSAFETYANDREGULATORYISSUESCONCERNINGBREASTIMPLANTSCURRENTSTATUSOF SILICONEGELIMPLANTSFemale glandular hypomastia is a frequently encoun-tered entity that occurs either developmentally or bypostpartum involution. Historically, women have longsought breast enlargement to improve physical pro-portions, to foster a more feminine appearance, or toenhance self-image. Following the introduction of thesilicone gel prosthesis in 1962, breast augmentationhas become the most frequently performed operationin plastic surgery. It is estimated that more than 1%of the adult female population in the United States(between 1 and 2 million) has undergone breast aug-mentation. The women undergoing breast implan-tation have been scientifically scrutinized since itsinception and found to range from outgoing healthyindividuals with a desire for aesthetic improvementto women with depression, low self-esteem, negativebody image, and sexual inhibitions." The popularityof the procedure is thought to be based on the satis-faction of the patients results. Women in generalhave enhanced self-image, increased self-assurance,improved sexual functioning, and better interpersonalrelationships after augmentation.Czerny8 reported the first augmentation mam-maplasty, in which he transferred a lipoma to thebreast, in 1895.Longacre9attempted autogenous"flap"augmentations in the 1950s, and the use of variousinjectable substances such as petroleum jelly,beeswax,shellac, and epoxy resin soon followed.1OUchida 11reported the use of injectable siJicone in 1961. Solidmaterials implanted in the 1950s and early 1960sincluded polyurethane, Teflon, and polyvinyl alcoholformaldehyde (the IvaIon spongeO). Although noneINFORMEDCONSENT/LITIGATIONPREVENTIONSURGICALGOALSSURGICALTREATMENTAssessmentOperative PlanningTechniquePostoperative CareCLINICALISSUESCapsular ContractureComplicationsof these methods proved satisfactory, the introduc-tion of the silicone gel breast implant in 1962 byCronin and Gerow began the modern era of breastaugmentation.EVOLUTION OF MAMMARYIMPLANTSSilicone Gel ImplantsThe silicone gel implants commercially available inthe United States today are a refined and safer devicethan their predecessors. Silicone development evolvedto meet the needs of the aircraft-engineering indus-try during World War II. Because of its softness andinert nature, it attracted interest from the medicalsector and was soon evaluated as an implantablemedical device by plastic surgical researchers."·13The Cronin and Gerow mammary implant of the1960s, which was manufactured by Dow Corning,was composed of a viscous silicone gel containedwithin a thick silicone shell in the shape of a teardrop.Seams were present at the periphery of the device,and Dacron fixation patches were placed on theposterior surfaces to help ensure proper position(Fig. 118-1). These early devices had such a high inci-dence of capsular contracture that a new generationof silicone implants was developed by various man-ufacturers in the mid to late 1970s in an attempt toproduce a more natural result. These implants wereround and characterized by a seamless, thin, smoothsilicone shell. There were no fixation patches, and the
  2. 2. 2 VI + TRUNK AND LOWER EXTREMITYFIGURE 118-1. The original Cronin-Gerow silicone implant introduced in 1962 had ananatomic (teardrop) shape. smooth surface, and posteriorly placed Dacron patches to helpmaintain the implants position. (From Cronin TD,Gerow FJ: Augmentation mammoplasty:a new "natural feel" prosthesis. Transactions of the Third International Congress of PlasticSurgery, October 13-18, 1963. Amsterdam, Excerpta Medica Foundation, 1963:41-49.)silicone gel was less viscous than in first-generationimplants. Whereas the incidence of capsular con-tracture may have been improved somewhat, the inci-dence of silicone gel "bleed" and shell rupture wasenhanced (especially from manufacturers who madevery thin shells"). Gel bleed is a phenomenon wherebylow-molecular-weight particles of silicone gel diffuseor leak through the silicone elastomer shell, giving asticky feel to the surface. It has been theorized thatsilicone bleed could promote capsule contracture.IS,16Whether it is due to silicone bleed or other factors,capsule contracture has been the biggest clinicalproblem with the use of smooth-surfaced silicone gelimplants.The third generation of smooth-surfaced siliconeimplants, developed in the early to mid 1980s, focusedon improving the strength and integrity of the sili-cone shell as well as on minimizing the silicone bleedphenomenon.",18 This generation of implants wascharacterized by two layers of "high-performance"elastomer with a thin fluorosilicone "barrier coat"in between (produced by McGhan Medical, Heyer-Schulte, Dow Corning, and Cox-Uphoff). There aredata to suggest that these improvements enhanced shelllife and lessened capsule contracture. Third-genera-tion silicone gel implants with the application of atextured surface can be considered fourth-generationdevices, and cohesive silicone gel-filled implants canbe considered fifth-generation devices. These are dis-cussed in the following paragraphs (Table 118-1).Saline-Filled ImplantsThe inflatable saline-filled implant was first reportedby Arion" in France in 1965. The impetus for itsdevelopment was to allow smaller incisions throughwhich a non inflated device could be inserted and theninflated with its liquid filler material. Saline implantswere subsequently developed by American manufac-turers and underwent clinical evaluation in the early1970s.o,,, The emphasis for the inception of and inter-est in these devices was focused on their inflatable
  3. 3. 118 • BREAST AUGMENTATION 3TABLE 118-1 + DEVELOPMENT ANDCHARACTERIZATION OFSILICONE GEL BREASTIMPLANTFirst Generation (1962-1970)ThickshellsThickgelDacron patchesTeardrop shapeSecond Generation (1970-1982)Thin shellsThingelNo patches (smooth)Round shapeThird Generation (1982-present)Thicker (stronger) shells"Barrier coat" ("low-bleed") shellsThicker gelNo patchesRound shapeFourth Generation (1986-present)Third-generation technologyTextured silicone surfacesRound and anatomic shapesFifth Generation (1993-present)Enhanced cohesive silicone gelTextured silicone surfaceDiverse anatomic and round shapesnature, allowing smaller incisions, not on the charac-ter or safety of the liquid filler or an attempt to lessenthe rates of capsular contracture.Although it is generally accepted that the contrac-ture rate with saline implants is relatively low,two qual-ities of these devices have plagued their clinical use.The foremost was their deflation rate. The originalFrench implant manufactured by Simaplast was foundto have a deflation rate near 75% at 3 years and waswithdrawn from the market. Heyer-Schulte developedan American saline implant in 1968.Whereas siliconegel implant shells are high-temperature vulcanized(HTV) platinum cured, the shells for saline-filledimplants were made thicker and cured by a room-tem-perature vulcanized (RTV) process. This significantlydecreased the deflation rate, and all American-madesaline implants have since had shells cured by thisprocess."A second factor found to increase deflation rateswas valve failure." The original Heyer-Schulte pros-thesis had a retention (leaflet) valve, which wassubsequently replaced by a diaphragm valve. Salineimplants currently manufactured in the United Statesby Mentor (which purchased Heyer-Schulte) andINAMED (formerly McGhan Medical) have diaphragmvalves and RTV-cured shells.The other characteristic of saline implants that hasbeen a problem relates to the saline itself, which maytransmit visible surface wrinkles and a knuckle-likefeel in volumetrically underfilled devices. When thedevice is overfilled, it may feel and look like a firm balland transmit a peripheral "scalloping" look. For thesereasons, saline implants historically perform betterunder thicker tissue, and surgeons generally fillimplants to the recommended volume or just beyond.Saline implants are also heavier than silicone gelimplants on a volumetric basis and may cause moretissue thinning with inferior displacement of theimplant over time.Double-Lumen ImplantsThe original double-lumen implant was developed byHartley" as a means of countering capsular contrac-ture. It was constructed of an inner silicone gel-filledlumen surrounded by an outer saline inflatable shell.The conceptual use of the device employed the initialinflation of the outer saline shell to make a largerpocket, with subsequent percutaneous deflation toleave the smaller silicone gel-filled shell within a largerpocket. The device became popular without goingthrough these machinations as a fixed-volume, two-chamber device or as a drug delivery device, whichallowed the addition of steroids or antibiotics to theouter saline-filled chamber.Cox-Uphoff developed a "reverse double-lumen"implant," which had an outer silicone gel-filled shellsurrounding an inner inflatable shell. Today, theonly double-lumen device on the U.S. market is theMentor Becker, an expander-implant used primarilyfor reconstruction.· This device was originally devel-oped as a saline device but subsequently converted toa reverse gel and saline double-lumen design to min-imize deflation rates. INAMED (McGhan) makesa similar round design and additionally has ananatomic version in which the postoperative addi-tion of saline selectively enhances only breast projec-tion. The McGhan style 153 anatomic silicone gelimplant is also structurally composed of two lumenswith different shapes to enhance its anatomicform.Textured-Surface ImplantsEarly attempts at augmentation with polyurethanesponge were not successful, but in 1970, Ashley"reported the favorable use of a silicone gel implantcovered with a thin layer of polyurethane foam.
  4. 4. 4 VI • TRUNK AND LOWER EXTREMITYAlthough the foam was placed on the implant prima-rilyto maintain its position, clinical use seemed to showa lessened incidence of capsular contracture.",9Throughout the 1980s, increasing numbers of plasticsurgeons found polyurethane-covered silicone gelimplants to produce aesthetically pleasing results withlow capsular contracture rates.o,,, The polyurethanesurface adhered to the surrounding tissues, subse-quently delaminated, and created a relatively non-contractible capsule." Unlike smooth-surfacedimplants that had to be mobile within their pocket,polyurethane-covered implants could be immobile yetsoft, These devices had reached a zenith of popularityby 1990, when questions of the safety of polyurethanefoam breakdown products caused Bristol-MyersSquibb, which owned Surgitek (the company manu-facturing the implants), to withdraw from the breastimplant market."The favorable clinical outcomes and commercialsuccess of polyurethane-covered implants (Fig. 118-2) led American implant manufacturers to developtextured silicone surfaces in the hope of achievingsimilar results. In 1986, McGhan Medical introducedBiocell textured implants and expanders, and Mentorintroduced Siltex textured implants. These remain thetwo textured surfaces available in the United Statestoday. Dow Corning subsequently introduced its MSI"structured surface" in 1990, but the company with-drew from the market in 1992.Biocell is an aggressive open-pore textured siliconesurface composed of irregular pores having an averagedensity of 3.1 pores/mm with a mean pore size of28911m (range, 3711m to 64811m) (see Fig. 118-2).Created by a lost-salt technique, these interconnectedpores promote adherence to the surrounding, devel-oping capsule through an "adhesive effect.""·" Thistissue adherence, which is clinically similar to that seenwith the polyurethane foam surface, differs in thatthere is no delamination of the texture as occurs withpolyurethane. The adhesive effect and tissue adher-ence are enhanced in Biocell-covered expanders; thesehave the added mechanical advantage of expansionpressure, which pushes the textured surface into thedeveloping capsule and imparts its mirror image intothe surrounding tissue." Whereas adherence may notoccur around the entire device or with all Biocell breastimplants, there is a high friction coefficient aroundthese devices, making them relatively immobile. Thus,similar to the polyurethane implants, "immobility withsoftness" characterizes Biocell-covered implants.Prospective clinical studies have demonstrated thatBiocelltextured implants have a significantly lower inci-dence of capsule contracture than do their smoothcounterparts, whether they are filled with silicone gel9or saline.oSiltex is a less aggressive textured silicone surfacecreated as a negative contact imprint off texturing foam(see Fig. 118-2). It is characterized by a raised, densepattern of irregular nodules ranging in height6 from65 to 150l1m and in width from 60 to 27511m, Siltexdoes not adhere to the surrounding tissue and thus isnot characterized by immobility with softness, as arepolyurethane and BioceiL" Whereas Siltex-coveredimplants thus move within their surrounding pocketsimilar to smooth-walled implants, prospective clin-ical studies have shown a significantly lower incidenceof capsule contracture compared with their smoothcounterparts, whether they are filled with siliconegel"" or saline"Other textured-surface devices that have beenavailable in the past or are currently available outsidethe United States include the MSI pillar-structuredtexture previously manufactured by Dow Corning"and the polyurethane foam-covered implant manu-factured by Silimed in BraziL""Alternative Filler Implants"When safety issues with silicone gel implants becamea concern, investigators looked for alternative fillersubstances. Three actually came to market.Polyvinylpyrrolidone is a low-molecular-weight"bio-oncotic" gel thought to be more radiolucent than sil-icone. It composed the fill material of the Misti Goldimplant introduced in 1991 by Bioplasty6 NovaMedpurchased this company, and the polyvinylpyrrolidoneimplant is currently still available outside the UnitedStates under the name NovaGold.ln December 2000,the British Medical Devices Agency issued a device alertregarding this implant and other alternative fillerdevices, citing the opinion that studies demonstratingthe safety of these devices are lacking,"LipoMatrix manufactured triglyceride-filled im-plants termed Trilucent implants in 1994. Soybean oilcomposed the fill material, which was said to be radi-olucent. Problems with oil bleed," tissue irritation,and a rancid or foul smell9 were reported, and theimplants were withdrawn from the market in 1999.Hydrogel implants are implants filled with anorganic polymer, which is a mixture of polysaccha-ride and water. These implants have been manufac-tured in France by PIP and Arion. There have beenreports of swelling of hydrogel (as well as polyvinyl-pyrrolidone) implants after implantation due toosmotic gradient pressure." The British MedicalDevices Agency alert of 2000 also applied to thesedevices. None of these alternative filler devices isavailable in the United States.Enhanced Cohesive SiliconeCellmplantsAll silicone gel implants are cross-linked to maintaina gel consistency, and thus all silicone gel has cohe-
  5. 5. 118 • BREAST AUGMENTATION 5A BcFIGURE 118-2. A, Polyurethane foam gains tissue adherence and delaminates from the implant. Nolonger available inthe United States, this texture fostered the development of textured silicone surfaces.B, Biocellis an aggressive silicone textured surface that adheres to surrounding tissue by an adhesiveeffect. C, Siltex is a less aggressive silicone textured surface that does not demonstrate any adhesiveeffect and does not gain tissue adherence. (From MaxwellGP, Hammond DC: Breast implants: smoothvs. textured. Adv Plast Reconstr Surg 1993;9:209.)sive properties. As the cross-linking is increased, theconsistency or firmness of the "liquid-feeling" gelchanges to that of a soft cheese. The enhanced cohe-sive nature of these implants makes them "formstable." This refers to the implants maintaining itsshape in all positions (shape maintenance). Theseimplants are designed in various anatomic dimensionsin addition to round shapes and are collectivelyreferred to as cohesive silicone gel implants. Theseform-stable implants are currently popular worldwideand undergoing Food and Drug Administration(FOA)-approved clinical trials in the United States(Fig. 118-3).45Anatomic-Shaped ImplantsThe original Cronin and Gerow silicone gel implantshad a teardrop shape, as did a number of the early
  6. 6. 6 VI • TRUNK AND LOWER EXTREMI1YFIGURE 118-3. Style 410 Matrix (INAMED)of enhanced cohesive silicone gel implants offers varying heights andprojections of shaped devices for breast augmentation and reconstruction. (L,low;M, moderate; F,full;X,extra). (Cour-tesy of INAMEDHealth, Santa Barbara, Calif.)saline- and gel-filled devices. Problems with capsularcontracture, however, led manufacturers to designround, smooth-surfaced low-profile implants, whichwould move within their surgical pockets. Theseround, smooth designs dominated the market for nearly20 years. Only when the phenomenon of immobilitywith softness was appreciated was the creation ofanatomic devices clinically appropriate.38,51The poly-urethane Optimum and Replicon devices (no longeravailable) were early-generation anatomic-shapedimplants popular in the 1980s.28,29 The adherenceof the polyurethane surface, in fact, lent itself to the"stacking" of these implants, one on top of another, toproduce an anatomic shape with enhanced projection.51The tissue adherence observed with tissue expandersthat had the Biocell surface led McGhan to developanatomically shaped expanders and subsequently aninternally stacked style 153 gel anatomic-shapedimplant.J5,38,51," Favorable clinical experience andadvanced product design led to a matrix of variableheight-to-width ratio anatomic expanders andimplants, the Style 133 expanders and Style 410Matrix cohesive implants (see Fig. 118-3). The latterenjoy widespread international use in aestheticsurgery"·55 and have completed their initial FDA clin-ical Investigative Device Exemption study in theUnited States, awaiting longer follow-up.Silimed (Brazil) markets polyurethane-coveredcohesive silicone gel implants in anatomic shapes."These devices also enjoy international popularity, butto date, no clinical investigative studies have taken placein the United States.Mentor introduced a midheight Siltex anatomic-shaped tissue expander in 1997 and other heightoptions in 2003. In the fall of 2002, an InvestigativeDevice Exemption study on a midheight anatomiccohesive gel implant was initiated. These "contour"-shaped devices are covered with the Siltex texture.Because tissue adherence does not generally occur, thepocket must be exact and only minimally larger thanthe footprint of the reduced height device to mini-mize the possibility of implant rotation.s6
  7. 7. 1 18 • BREAST AUGMENTATION 7Anatomic-shaped saline inflatable implants areavailable in the United States manufactured by bothMentor and INAMED (McGhan), and there is debateamong plastic surgeons about the merit of each rela-tive to the resultant breast form.58" This debate seemsconfined to saline-filled implants alone as virtually alltissue expanders marketed for breast reconstructionin the United States are textured and anatomicallyshaped. It is predicted that once cohesive gel anatomicimplants and other gel implants are available in theUnited States, the issue will be of less concern asevidenced by surgeons preferences worldwide.SAFETY AND REGULATORYISSUES CONCERNINGBREAST IMPLANTSIn 1976, the U.S. Congress passed a Medical DeviceAmendment to the Food, Drug, and Cosmetic Act thatgave the FDA authority over medical devices. Implantson the market at the time or those considered "sub-stantially equivalent" to those marketed before 1976were "grandfathered" in and allowed to remain in useuntil the FDA could formally review their safety andefficacy. In 1988, the FDA called for the manufactur-ers of silicone gel-filled implants to submit their Pre-market Approval Applications containing dataadequate to substantiate the safety and efficacy of thedevices they were marketing. In November 1991, theFDA convened an advisory panel of experts to holdpublic hearings and evaluate the manufacturers data.The panel concluded that more research was neces-sary (to establish safety and efficacy) but recommendedcontinued availability of implants while that researchwas carried out. In January 1992, however, the FDACommissioner went against the recommendation ofthe advisory panel and called for a voluntary mora-torium on the use of silicone gel implants. After furtherevaluation of the situation by the advisory panel (whothought there was a public need for the devices), theFDA Commissioner, in April 1992, ruled that althoughsilicone breast implants were not necessarily unsafe,the law required more data to substantiate safety andefficacy than the manufacturers had supplied.62.63Theuse of silicone gel implants was thus restricted to clin-ical trials until the data were produced. This was inter-preted by the media and the public at large that siliconegel implants were "banned" because they were not safe.This effectivelytook silicone gel implants off the marketfor breast augmentation in the United States for thenext 12 years.The "media frenzy" surrounding this issue wasfurther heightened by several lay jury court decisionsthat found silicone implants to be responsible forwomens pathologic conditions. This led to the filingof thousands of product liability lawsuits against theimplant manufacturers. This culminated in a classaction lawsuit involving more than 400,000 women."Unable to withstand the financial pressure to defendthis massive number of cases, Dow Corning filedChapter I I and Bristol-Myers Squibb withdrew fromthe market. Ultimately, a settlement of approximately$4 billion was reached, and Mentor and McGhan wereleft as the only two American manufacturers of salineand silicone breast implants.Concerns relating to the safety of foreign materi-als implanted in the female breast began in Japan in1964 when the term human adjuvant disease wassuggested on speculation of an association betweenparaffin breast injections and connective tissue disease-like symptoms in several women." In the 1980s,severalreports questioned a link between silicone gel breastimplants and various collagen vascular diseases"-6Questions were raised as to whether silicone "leaked"into the body and caused pathologic conditions.Whereas increased levels of silicone were found withinthe surrounding tissue capsule68,6.and axillary lymphnodes, no correlation with symptoms or any diseasecould be established. Likewise, no specific antibodiesto silicone could be found.,o,1Amid this background oflawsuits, public concerns,and implant restrictions, the scientific data began toprevail, demonstrating the safety of silicone gel andthe lack of its correlation with any disease or patho-logic condition. By the late 1990s, approximately 20epidemiologic studies and other important scientificinvestigations found no increased risk for developmentof connective tissue disorders in women with breastimplants." In addition, respected independentscientific groups including the Independent ReviewGroup in England," the Institute of Medicine," andthe National Science Panel" (appointed by the judgeof the class action litigation), after carefully review-ing all scientific data available, found no relationshipbetween silicone gel implants and connective tissuedisease.The other health issue that clouded the breastimplant arena in the early 1990s was the possibility ofa polyurethane foam breakdown product being car-cinogenic. Specifically cited was a National Cancer Insti-tute study in which mice fed extremely high doses of2,4-toluenediamine showed an increased incidence ofbreast cancer." Since the foam used to cover the Sur-gitek implant was produced by a mixture of 2,4- and2,6-toluenediisocyanate, the FDA questioned whetherthe polyurethane itself or one of its biodegradationproducts could be carcinogenic in patients after breastimplantation. Scientific scrutiny of patients in whomthese devices had been implanted found minimal expo-sure to 2,4-toluenediamine,6 and the FDA ultimatelyconcluded that it was unlikely any woman withpolyurethane-covered implants was at increased riskfor development of cancer." Before these scientificfindings of safety, however, Bristol-Myers Squibb failed
  8. 8. 8 VI • TRUNK AND LOWER EXTREMITYto make premarket approval for the FDA in April of1991 and withdrew these devices from the market.Despite this decade of turbulence, the future of sil-icone gel implants looks bright. No fill material hasbeen found to be as safe and as functional as silicone.Saline clinical inadequacies (in certain situations) arewell appreciated by American plastic surgeons. Man-ufacturing practices of silicone gel implants have beenimproved and brought into compliance to ensurebetter-quality products.CURRENT STATUS OF SILICONEGEL IMPLANTSThe Premarket Approval Application for silicone gelbreast implants submitted by [NAMED in December200 I was heard by the FDA expert advising panel inOctober 2003. After intense scrutiny of the data sub-mitted, as well as public testimony, the panel recom-mended approval of the application "with conditions;setting the stage for the return to market of siliconegel implants in the United States. The panel found noevidence to support that silicone gel implants causedisease. They did, however, question the adequacy ofthe length of follow-up on the studies.In January 2004, the Commissioner of the FDAwentagainst the panels recommendation and asked foraddi-tional data with longer follow-up from all manufac-turers on silicone gel implants. * In addition, moreinformation was requested on life expectancy ofimplants, causes and effects of shell failure, and clin-ical evaluation of possible"siIent rupture" of implants.In light of these requests from the FDA, silicone gelimplants will probably not be back on the Americanmarket until 2005. They remain available for clinicaluse (as they have for the last 12 years) under FDA-approved clinical studies.INFORMED CONSENT/LITIGATIONPREVENTIONBecause the breast is historically viewed as a symbol offemale sexuality and the quality of the surgical resultis primarily in the eye of the beholder (and her com-panion) alone, emotional outcome can on occasion besomewhat volatile. The facts are that almost 40% ofaesthetic plastic surgical claims relate to elective breastoperations and half of these to breast augmentation."It is thus incumbent on the surgeon to evaluate thepatients emotional state, timing, and appropriatenessof the desired outcome. It is the surgeons responsibil-ity to listen, educate, and evaluate; this process and thecommunication that takes place between patient andsurgeon are documented in the medical record.. consent isnot simply the signing of a paperor contract but refers to the entire process betweenpatient and physician as well as physician extenders.To be "informed," the patient must be provided withadequate information about risks, benefits, and treat-ment alternatives to the proposed procedure. To"consent; the patient must be an adult (by age), becapable of rational communication, and be able tounderstand the information. The informed consentdocumentation must be thorough and specific to theoperation and preferably the surgeon. A checklist ofspecifics (which must be initialed by the patient) isconsidered advisable. "Before and after" photographsmay be shown but should be realistic. Photographs ofthe patient are a necessary form of documentation,requiring appropriate permission. Their confidential-ity is essential unless permission is given for any useother than medical review documentation. A malesurgeon should be accompanied by a female chaperonduring all breast photography and examinations.Because of the multiple options in breast aug-mentation surgery, a second office visit is advisable.There must be a clear understanding (which is docu-mented in the medical record) between patientand surgeon of the specific desired outcome (size,shape), the alternative ways by which this can beachieved, and the risk-to-benefit ratio of the chosen"pathway."SURGICAL GOALSThe conceptual goal of breast augmentation is toenhance the form and volume of the female breast inthe most predictable manner with the fewest possiblecomplications. The resultant form of the augmentedbreast will be determined by dynamic interaction overtime between the compliance and character of the softtissue envelope; the quality and consistency of the breastparenchyma; and the dimensions, volume, and charac-teristics of the breast prosthesis (Fig. 118_4).9 Toachieve these goals, experience has shown that asurgical approach based on dimensional conceptsrather than on volume alone ispreferable. This"biodi-mensional" approach takes into account the patientsexisting breast dimensions and tissue characteristicsof the form of the patients desired surgical result."o.81A breast implant is then selected of appropriatedimensions, character, and volume to accomplish thisgoal (Table 118-2).SURGICAL TREATMENTEach year, more than 100,000 women in the UnitedStates elect to have surgical enhancement of theirbreasts. Women seeking breast augmentation placeconsiderable emphasis on their physical appearance,and time should be taken to understand their
  9. 9. A(I)(5Q.•..(I)Q.Q.::>.•....c:Ol(j)..c:.•..(J)ctl(I)•...CD118 • BREAST AUGMENTATIONSoft tissue envelopeParenchymaProsthesisB9FIGURE 118-4. A, The aesthetic breast form is composed of measurable parameters. This form can be attained bythe careful planning and surgical performance of a breast augmentation. B, The resultant breast form desired aftersurgical augmentation is determined by the dynamic interaction between the character and compliance of the softtissue envelope; the quality, volume, and consistency of the breast parenchyma; and the dimensions, volume, and char-acteristics of the breast implant.motivations for having surgery. Most patients are prop-erly motivated with realistic goals, but the preopera-tive visit is the time to identify patients who may haveunrealistic expectations or are using surgery as a crutchfor other problems. The patients desires and expec-tations must be weighed against the predictability ofachieving those goals. A high level of satisfaction canbe ensured ifthe patients aesthetic concerns and expec-tations are within a predictable and attainable result.TABLE 118-2 • STEPS IN A BIODIMENSIONALAPPROACH TO BREASTAUGMENTATIONEvaluate existing chest and breast form.Characterize the soft tissue envelope.Plan the resultant breast form desired.Select implant and site location to accomplish this goal.Select incision and approach.Whereas individual preferences will affect opera-tive planning and procedural specifics, the goal of breastaugmentation is to enhance the form and volume ofthe female breast. The form of the female breast isdeter-mined by the quality, volume, and dimensions of thebreast parenchyma and the character and complianceof the soft tissue envelope. The form of the augmentedfemale breast (assuming that capsuJecontracture is notpresent) is based on these in dynamic interaction withthe dimensions, volume, and consistency of the breastprosthesis (see Fig. 118-4).79 There must be mutualunderstanding between the patient and surgeon of thespecific resultant breast form that is desired and thepredictability (and tradeoffs) of achieving that form.AssessmentAfter the patients goals are determined and rea-sonable expectations are established with regardto outcome, a thorough physical assessment is
  10. 10. 10 VI • TRUNK AND LOWER EXTREMITYI--IMD--I.FIGURE 118-5. Preoperative mea-sures (taken before breast augmen-tation) include SSNto N[suprasternalnotch to nipple). N to IMF (nippleto inframammary fOld). BW (breastwidth). BH (breast height). and IMD[intermammary distance).undertaken. The bone and muscle structural founda-tion of each breast must be assessed. Note the shapeof the thorax as well as whether the patient is "long"or "short" chested.The majority of women will have some degree ofasymmetry when the breast and chest wall are criti-cally evaluated." It is imperative to document anddiscuss any amount of nipple-areola complex asym-metry as well as chest wall asymmetry with the patient.Precise measurements must be taken (Fig. 118-5). Keymeasurements include suprasternal notch to nippledistance, nipple to inframammary fold distance, basewidth or diameter, and breast height.The compliance of the soft tissue envelope is thenassessed. Characterize the elasticity of the skin bynoting evidence of poor compliance, such as stretchmarks or thin nonelastic dermis. The soft tissue pinchtest is a useful measurement; the superior pole of thebreast is gathered between the thumb and index finger(skin plus parenchyma), and the distance between thetwo is measured (Fig. 118-6).A rough estimatefortheamount of inherent soft tissue necessary to cover asubglandular implant is 2 cm. A pinch test result ofless than 2cm may lead to subpectoral implant place-ment. Skin redundancy may also be present." Olderpatients or those with a history of weight loss mayexhibit varying degrees of pseudoptosis or true breastptosis. These patients may benefit from a concomi-tant mastopexy.It is also important to characterize the breastparenchyma itself. Determination of the amount,quality, and distribution of the parenchyma may altersurgical techniques; thus, these should be evaluatedand documented. It may be necessary to redistribute,adjust, or reshape the parenchyma to achieve the desiredbreast mound form.Operative PlanningIMPLANT SIZE (DIMENSIONS)The patients request for a particular breast size andshape will largely determine the dimensions of theFIGURE 118-6. Soft tissue pinch test. Assessment ofthe thickness and quality of the soft tissue in the upperpole of the breast preoperatively willhelp the surgeon inconsidering pocket locationoptions for implant placement.
  11. 11. 118 • BREAST AUGMENTATION IIImplantwidthOriginalbreast widthFIGURE 118-7. After the width ofthe existing breast is measured andthe desired resultant breast form isformulated, an implant is selected(generallyjust narrower than the orig-inal breast, shown on the patientsright)that incombination withthe pre-operative breast tissue willachievethedesired postoperative dimensions andform (shown on the patients left).breast implant used. In addition to a thorough dis-cussion with the patient as to her desire for the result-ant form and size, it is often helpful to have the patientbring photographs showing the sizeand shape of breastthat she finds appealing.The most important clinical factor in determiningbreast prosthesis size is the base width or diameter ofthe patients native breast. After measuring the patient,one turns to the manufacturers published data chartsand generally selects an implant slightly less wide thanthe existing breast. Rarely does the selected implantvary significantly more or less than the measured breastwidth to avoid an unnatural postoperative appearance(Fig. lI8-?). In addition to the desired width of theimplant, one also considers height, projection, andvolume before making an implant selection. Anatomic-shaped implants allow implant height and projectionoptions to be much more important operativeconsiderations.SILICONE VERSUS SALINEThe decision between a saline-filled prosthesis and asilicone gel implant is one of the patients preferenceafter the surgeons conveyance of information. Expe-rience has shown the results of silicone gel implantsin primary breast augmentation to be generally softand to have a natural feel and appearance, assumingcapsule contracture is not present. Although theauthors prefer silicone gel implants, saline implantsplaced in the subpectoral posItIOn can producegood results with a low incidence of capsule contrac-ture. The thicker the soft tissue under which a salineimplant is placed, the better it performs. Despiteour preference for silicone gel, some patients willundoubtedly continue to have concerns about silicone-filled devices, and subpectoral saline implants haveproved to be a reasonable alternative (Fig. 118-8).Ultimately, the patient must feel comfortable withthe implant device, so the final decision rests withthe patient.TEXTURED VERSUS SMOOTHThe decision between textured and smooth-walledimplants is only applicable for round implants.Anatomic implants are all textured by design to min-imize malrotation. With round implants, the choicebetween textured and smooth-walled implants isbased primarily on minimizing capsular contracture.For subpectoral augmentation, either implant canprobably be used with comparable results. When thedevice is placed in the subglandular pocket, a smooth-walled implant offers the best protection from visiblerippling and palpability but runs a greater risk for devel-opment of capsular contracture. A textured implantcan be used in the subglandular position, but it shouldbe reserved for those patients with adequate soft tissuecoverage such that it will not be visible or easilypalpable.
  12. 12. 12 VI • TRUNK AND LOWER EXTREMITYABFIGURE 118-8. A. A typical patient presenting forbreast augmentation. B. Postoperative result withsubpectorally positioned, smooth saline implants (275 mLfilled to 300 mL) placed through an inframammaryincision.ANATOMIC VERSUS ROUNDThe decision between anatomic implants and roundimplants is determined by the shape and form of theexisting breast. If a patient has hypovolemic breastswith good natural shape, form, and contour, roundimplants will provide the desired final result with thelowest risk of complications. By augmentation ofvolume while shape is maintained, a natural result isattainable (Fig I I8-9A). In a patient who wouldbenefit from having the form and shape of her breastsimproved in addition to volumetric enhancement, ananatomic implant is preferable. Breast parenchymalmaldistributions can be corrected, with a more aes-thetically pleasing result (Fig. II8-9B).POCKET SELECTIONThe decision of subglandular or subpectoral implantplacement depends on implant selection (fill andtexture) and tissue thickness. In theory, the best posi-tion for a mammary implant is in the subglandularplane. This is the most anatomically correct positionto maintain natural shape and form. The reasons forplacement of implants in the subpectoral plane are tominimize the risk of capsular contracture (primarilyfor gel implants) and to minimize implant visibilityand palpability. Other considerations relate to possi-ble effects on mammography and tissue stretch overtime. There are benefits and tradeoffs to each site (Table118-3). In practice, saline implants are predominantlyplaced in the subpectoral pocket because of their easeof palpability and visibility. Silicone gel implant place-ment is determined largely by soft tissue adequacy. Inpatients with a pinch test result of more than 2 em,the implant can safely be placed in the subglandularplane (Fig. 118-10). Previous data suggest that tex-tured gel implants have a lower rate of capsular con-tracture when they are placed subglandularly. If onechooses smooth gel implants for the subglandularplane, additional measures to prevent capsular con-tracture must be taken. These include larger pocketdissections with displacement exercises or possibledilute steroid pocket irrigation (Fig. !l8-!lA).Anatomic-shaped textured implants are placed in theappropriate pocket as determined by soft tissue thick-ness. Pockets for these implants are made only mini-mally larger than the footprint of the device tominimize displacement or malrotation (Figs. II8-IIB,118-12, and !l8-13).When subpectoral pockets are selected (Fig. 118-14), one generally divides the origin of the pectoralismajor muscle just above the inframammary fold toallow better projection in the lower pole of the aug-mented breast and to maintain a natural inframam-mary fold. This places the superior portion of theimplant in a subpectoral position while the inferiorportion is subglandularly located. In constrictedbreasts (tuberous breasts) or ptotic breasts, for whichmore parenchymal surgical manipulation is necessary,or when there is a greater need for the implant to fillout the lower soft tissue envelope, more dissectionbetween parenchyma and muscle will allow the muscleto cover less of the implant with a resultant greatersubglandular implant coverage. Alternatively, the pec-toral muscle can be divided at a higher level to give asimilar result. These pocket manipulations have beendescribed as dual-plane maneuvers to allow varyingdegrees of subpectoral to subglandular implantcoverage (Table 118-4).8An additional pocket more recently introduced andadvanced by some is the subpectoral fascial pocket.This thin layer of tough tissue is said by some to offerthe advantage of subglandular placement with athicker soft tissue cover.8.Text continued on p, 19
  13. 13. ARoundimplantB118 • BREAST AUGMENTATION 13AnatomicimplantFIGURE 118-9. A, When the preoperative breast has an acceptable form and inadequate volume, a round implantmay be preferable to achieve the desired result. 8. When the breast form and volume are inadequate, an anatomic-shaped implant may be preferable.
  14. 14. 14 VI • TRUNKAND LOWEREXTREMI1YTABLE 118-3 • ALTERNATIVE POCKET LOCATIONS WITH POTENTIAL TRADEOFFSPocketRetromammaryPartial retropectoral(without dividingpectoralis originsalong theinfra mammaryfold)Total submuscularTradeoffsIncreased risk of edge visibility or palpabilityPossible increased interference withmammographyPossible increased incidence of capsularcontractureLateral implant displacement over time,widening the space between the breastsLess control of upper medial fillMore postoperative tenderness and a moreprolonged recoveryDistortion of breast shape with pectoraliscontractionLess precise control of infra mammary foldposition, depth, and configuration. Thispotential tradeoff is minimized oreliminated by division of pectoralis originsalong the inframammary fold in patientswho have adequate soft tissue coverage.Increased risk of superior implant malpositionor displacement (when inferior pectoralisorigins across inframammary fold are notdivided)Longer time required for deepening of theinframammary fold (when pectoralis originsalong the infra mammary fold are not divided)All tradeoffs listed above for partialretropectoral, plus:Highest risk of superior implant displacementor malpositionLonger operative timeLongest postoperative recovery and morbidityLeast accurate and predictable inframammaryfold and longest to achieve depthGreatest risk of inframammary foldirregularities, lateral flattening, and foldlevel inaccuraciesPotential BenefitsIncreased control of breast shapeUsually a more rapid postoperative recoveryMinimal or no distortion with pectoraliscontractionIncreased control of inframammary foldposition and shapeMuscle coverage mandatory if pinchthickness <2 cm above breast parenchymaPossibly more accurate mammogramsLess risk of palpable or visible implant edgesPossible decreased risk of capsularcontracture (small difference with saline-filled implants, greater difference withsilicone gel-filled implants)Possible increased coverage inferolaterallybut clinically no significant additionalcover long termFrom Tebbetts 18: Dual plane breast augmentation: optimizing implant-soft tissue relationships in a wide range of breast types. Plast Reconstr Surg 200 1;107: 1255.
  15. 15. 118 • BREAST AUGMENTATION 15Ample soft tissueRetroglandular Inadequate soft tissueRetropectoralA BFIGURE 118-10. A, When ample soft tissue is present, implants may be placed in the subglandular position.8, When there is soft tissue inadequacy, the subpectoral position is generally preferable.AMobile implant movingwithin larger capsuleBExact pockelFIGURE 118-11. A, Round pocket dissection for smooth-surfaced implants to allow tissue redraping and encour-age implant mobility to minimize capsule contracture. 8, Precise pockets only slightly larger than the base of an anatomictextured implant help maintain implant position. Movement is not desirable when the implant allows immobility withsoftness.
  16. 16. 16 VI + TRUNK AND LOWER EXTREMllYA Bc oE FFIGURE 118-12. A. The biodimensional approach is demonstrated in this physically fit patient wishing no pec-toral flexion distortion. B, Minor chest-breast asymmetries are noted on examination. C, Result with subglandularplacement of smooth, 240-mL (width of 10.5 em) round, silicone gel implants. D, The subglandular pocket selectedbecause of her athleticism requires smooth implant displacement exercises within the large pocket to minimizecapsule contracture. E and F. Oblique preoperative and postoperative appearance.
  17. 17. 118 • BREAST AUGMENTATION 17A Bc DE FFIGURE 118-13. A biodimensional approach is demonstrated in this postpartum patient desiring a natural pro-portionate appearance. A, N-SSN and BW measurements are noted. B, The soft tissue pinch test result is1.5 cm. C and D, Preoperative and postoperative photographs; style 410 MM cohesive gel implants were placed inprecise subpectoral pockets through an inframammary incision. On the patients right, a 245-mL implant [11.5-cmwidth and 1O.6-cm height) was used; on the patients left, a 215-mL implant [11-cm width and 10. 1-cm height) wasused. E and F. Oblique views of preoperative and postoperative appearance.
  18. 18. 18 VI • TRUNK AND LOWER EXTREMITYABCFIGURE 118-14. Subpectoral implant placement generally involves release or division of the pectoralis major muscle,resulting in varying coverage relationships of muscles and parenchyma to implant. A, Muscle division near the infra-mammary fold results in muscle coverage of most of the implant. B, Muscle division (or muscle-parenchymal detach-ment) to the lower areolar level results in muscle coverage of the upper half of the implant. C. Muscle division (ormuscle-parenchymal detachment) to the upper areolar level results in muscle coverage of the upper third of the implant.
  19. 19. 118 + BREAST AUGMENTATION 19TABLE 118-4 • POTENTIAL BENEFITS AND TRADEOFFS OF THE DUAL-PLANE POCKET LOCATIONPocketDual plane (comparedwith retromammary)Dual plane (comparedwith partialretropectoral)TradeoffsPossible increased riskof palpable or visibleimplant edges inferiorlyPotential BenefitsPreserves the potential increased control of lower breastshape with retromammaryWith proper techniques can have similar recovery as withretromammaryReduced risk of edge visibilityor palpability of retromammaryby providing more upper pole coverageReduced interference with mammography by retromammaryReduced possibility of capsular contracture of retromammaryby reducing contact with parenchyma compared withretromammaryProvides same mandatory muscle coverage if pinch thickness<2 cm above breast parenchymaReduced risk of lateral implant dispiacement over time;dividing inferior origins decreases pectoralis pressure onimplantBetter control of upper medial fillwith division of inferiororigins to decrease pectoralis tension and pressure onupper pole of implantReduced postoperative tenderness and recovery period withproper techniqueReduced distortion of breast shape with pectoraliscontractionDecreased risk of superior implant malposition ordisplacement by decreasing pressure of pectoralis on lowerpole of implant by dividing lower pectoralis originsIncreased control of inframammary fold position, depth, andconfiguration by decreasing pressure of pectoralis on lowerpole of implant along inframammary foldRetains possibility of more accurate mammograms,depending on position of musclePossible decreased risk of capsular contracture (small)From Tebbetts J B: Dual plane breast augmentation: optimizing implant-soft tissue relationships in a wide range of breast types. Plast Reconstr Surg 200 I; 107: 1255.INCISIONSFour types of incision are commonly employed inbreast augmentation: transaxillary, inframammary,periareolar, and transumbilical. After implant selec-tion, the decision as to which type of incision is to beused should be made by the patient and surgeon afterthe options, risks, and benefits of each have been thor-oughly explained. Surgeons should offer only the tech-niques that they are comfortable performing. The finalchoice should allow the surgeon optimal controland visualization to deliver the desired outcomefor the specific patient and the specific implant(Table 118-5).The inframammary incision permits completevisualization of either the prepectoral or subglandu-lar pocket and allows precise placement of virtuallyall implants. The technique does leave a visible scarwithin the inframammary fold. Smaller incisions«3 cm) can be used for saline-filled implants, butsilicone gel implants often require incisions up to5.5 cm in length. The incision should be placed inthe projected inframammary fold rather than in theexisting fold to avoid visibility and widening of thesubsequent scar (Fig. 118-15).The periareolar incision is placed at the areolar-cutaneous juncture and generally heals inconspicu-ously. The dissection allows easy adjustment of theinframammary fold and direct access to the lowerparenchyma for scoring and release when a constrictedlower pole is present. Disadvantages include limitedexposure of the surgical field, transection of theparenchymal ducts (which are often colonized withStaphylococcus epidermidis), potentially increased riskof nipple sensitivity changes, and visible scarring onthe breast mound. This technique should not routinelybe used on patients with an areola diameter less than40 mm and may not allow introduction of larger gelor enhanced cohesive gel implants.The transaxillary approach can be performed eitherbluntly or with the aid of an endoscope. The endo-scope allows precise dissection and release of theinferior musculofascial attachments of the pectoralismajor as well as direct visualization for hemostasis.This approach avoids any scarring on the breastmound and can be used with both saline and gel
  20. 20. 20 VI • TRUNK AND LOWER EXTREMI1YTABLE 118-5 + INCISION OPTIONS IN BREASTAUGMENTATIONFactor Axillary Periareolar Inframammary PeriumbilicalImplant planeSubmuscular + + +Subglandular + + +Implant typeSaline round + + + +Saline shaped + +Silicone round/shaped + +Preoperative breast volumeHigh(>200 g) + + + +Low«200g) + + +Preoperative breast base positionHigh + + + +Low + + +Breast shapeTubular +Glandular ptosis + + + +Ptosis (grade I-II) +Areolar characteristicsSmall diameter + + +Light/indistinct + + +Inframammary creaseNone + + +High + + +Low + + + +Secondary procedure + ++ indicates applicable; - indicates not generally recommended .• Included for completeness but not generally recommended.From Hidalgo DA: Breast augmentation: choosing the optimal incision, implant, and pocket plane. Plast Reconstr Surg 2000;105:2202.implants in either a subpectoral or subglandularpocket. Disadvantages include difficulty withparenchymal alterations and the probable need for asecond incision on the breast mound for revisionarysurgery. Precise implant placement can be moredifficult with this incision, and enhanced cohesive geland anatomic implants may be precluded.Transumbilical breast augmentation has theobvious advantage of a single, well-hidden, remote inci-sion. It can be used only with saline implants, however,and precise pocket dissection requires experience. Thepocket is dissected bluntly, and hemostasis can bedifficult from the remote access port. As with thetransaxillary approach, revisions often necessitate asecond incision on the breast mound.TechniqueINFRAMAMMARY INCISIONThe patient is marked preoperatively in the standingor seated position, with shoulders even and armsresting comfortably at her sides. The miclline of thechest is marked as a point of reference from the sternalnotch to the xiphoid process. The existing infra-mammary folds are marked, as are the proposed limitsof the dissection. The incision site is marked along theexpected new inframammary fold after augmentation.Frequently, augmentation mammaplasty will lower theexisting inframammary fold, and this must be takeninto account when the patient is marked. The result-ant location of the inframammary fold is determinedby the dimensions of the selected implant postoper-atively in interaction with the existing tissues. The inci-sion should begin on a straight line dropped from themedial areolar border and extend laterally. For salineimplants, a 3-cm incision is often sufficient, whereassilicone gel implants require incisions 4 cm or morein length; enhanced cohesive implants may require 5.5-to 6-cm incisions (Fig. 118-16).Proper positioning of the patient is important tothe outcome of the procedure. The patient is placedin the supine position, well centered on the operatingroom table. Her arms should be at 90-degree anglesto her torso and well secured to fixed arm boards. Thepatient must be able to flex fully at the waist to 90degrees during the procedure (Fig. 118-17). Finally,the patients shoulders must be visible after steriledraping to ensure symmetry when the intraoperativeappearance is evaluated. The incision sites are injectedwith 2 to 3 mL of 1% lidocaine with 1:1000 dilutionof epinephrine to aid in hemostasis.
  21. 21. 118 • BREAST AUGMENTATION 21A Bc oFIGURE 118-15. A, Asmall-breasted woman with a soft tissue pinch test result of less than 2 cm desirous of full,round result. B, A 340-mL round, smooth, silicone gel implant is selected, which willbe placed in the subpectoralposition after the inframammary fold is lowered 1.5 cm. The inframammary incision will be 4.5 cm in length andplaced in the new lowered inframammary fold location. C and D, The patients postoperative appearance.The incision is made along the proposed markings,and the dissection is continued with an insulated elec-trocautery instrument through Scarpa fascia. Afiberoptic headlight isworn throughout the procedure,or a variety of lighted fiberoptic retractors are avail-able to aid illumination and direct visualization withinthe pocket. If the implant is to be placed in the sub-glandular pocket, the dissection proceeds above thepectoralis major fascia directly beneath the gland.Meticulous hemostasis can be maintained during thecomplete dissection with the use of the electrocautery.Several medial intercostal perforating vessels may beencountered. These should be avoided or coagulatedwith insulated forceps if need be. For smooth-walledimplants, a larger pocket is dissected to allow mobil-ity of the implant. For anatomic implants, the pocketis precisely dissected to snugly accommodate theimplant. Care should be taken to preserve the lateralintercostal cutaneous nerves, especially the fourthintercostal, which contains the primary sensory inner-vation of the nipple-areola complex.If a subpectoral pocket is chosen, the dissection isinitially carried out laterally to identify the lateralborder of the pectoralis major muscle. The muscle edgecan be lifted by forceps to allow easy entry into thesubmusculofascial plane. This plane is readily identifiedby the wispy areolar connective tissue and ease of dis-section. An extended electrocautery instrument is usedto complete the dissection. The inferior origin of thepectoralis major is released from lateral to medial atthe level of the inframammary fold. Various slips oforigin of the pectoralis major muscle are generallyencountered and divided. Division of the pectoraliscontinues medially to the sternal border. Partial deepdivision may selectively be carried out 1to 3 cm abovethe xiphoid, depending on which implant is to be used.
  22. 22. 22 VI • TRUNK AND LOWER EXTREMITYA BcEDFIGURE 118-16. A. A small-breasted woman with a sig-nificant upper pole concavity. She desired strong projec-tion without a convex (round) upper pole shape. B, Breastwidth measured 12 cm and height 12.5 cm; the soft tissuepinch test result was less than 2 cm. A subpectoral pocketwas selected for a cohesive gel style 410 FF implant of290 mL (11.S-cm width and 12-cm height). C,The implantswere placed through a S.B-cm incision at the ievel of thenew infra mammary fold to give this result. D and E, Pre-operative and postoperative appearance demonstrating theenhanced projection with control of the slope of the upperpole.
  23. 23. 118 • BREAST AUGMENTATION 23FIGURE 118-17. Theoperatingtableisflexedtoa90-degree angle intraoperatively to allowthe surgeon to care-fullyevaluate the patient with the sizer or final implantsin position before closure.Lateral dissection can be done bluntly with a fingerto avoid injury to the lateral neurovascular bundles.The nerves can be stretched to accommodate theimplant but should be preserved to minimize post-operative sensory changes. When the pectoralis majormuscle is elevated, care must be taken to leave the pec-toralis minor down on the chest wall. This will min-imize bleeding and allow proper placement of theimplant.Exact implant "sizers" (gel or saline) are used whenavailable to evaluate the pockets and resultant breastform. After the sizers are in place, the patient is placedin a 90-degree upright position and evaluated fromvarious perspectives (see Fig. IIS-17). Any asymme-try or underdissected areas are marked, and thepatient is placed back in the supine position. Onceadequate hemostasis is obtained and pocket dimen-sions are finalized, the pocket is irrigated with an antibi-otic-containing solution, and the implants are carefullyplaced by a minimal-touch technique. The final resultsare assessed, again with the patient in a sitting posi-tion, and a multilayer closure is performed withabsorbable suture. It is important to close off theimplant pocket with a separate layer of suture beforeclosing the skin. Once closure is complete, SteriStripsare applied along the direction of the incisions.PERIAREOLAR AUGMENTATIONThe markings for a periareolar approach are similarto those for an inframammary augmentation. Thepatient is marked in a seated or standing position witheven shoulder position. The sternal midline is markedas reference. The existing inframammary fold ismarked, as are the limits of the dissection and theplanned resultant inframammary fold (if it is to bechanged). The incision is marked along the junctionof the areola and the breast skin. The limits of the inci-sion are the 3-0 clock and 9-0 clock positions.The positioning of the patient is identical to thatfor an inframammary approach. It is imperative thatthe patient be able to fully flex at the waist for evalu-ation of the intraoperative appearance of the implants.With the patient prepared and draped and afterinjection of lidocaine with epinephrine, the preciseincision is made. Wound edges are elevated directlyup from the chest wall with an opposing pair of smallsharp retractors. An insulated electrocautery unit isused to dissect straight down through the breastparenchyma to the pectoralis major fascia. The retrac-tors are repositioned as needed to keep the gland ele-vated into the wound. For subglandular implantplacement, dissection is carried out on top of the pec-toralis major and serratus anterior fasciae. Althoughit is preferable to use a fiberoptic headlight, fiberop-tic retractor illumination can also facilitate the dis-section by aiding visualization. The dissection iscarried out to the extent of the preoperative markingswith use of an extended electrocautery instrument,which allows meticulous hemostasis. If the inferiorpole of the breast is constricted, radial scoring of thegland in the inferior pole can allow proper redrapingof the soft tissue over the implant to correct the defor-mity (Fig. lIS-IS).For subpectoral implant placement, an identicalincision is made, but the dissection is carried downthrough the breast tissue in an oblique plane angledinferiorly, rather than directly through the gland. Whenthe dissection plane approaches the inframammaryfold, it is carried directly down to the pectoralis majorfascia and continued laterally to identify the lateralborder of the muscle. This is an easy area in which tobegin the subpectoral dissection and ensure that thedissection planes are correct. The submuscular dis-section is done under direct vision with use of the elec-trocautery, in a lateral to medial direction. The originof the pectoralis major muscle onto the chest wall canthen be divided. This release is done approximately Icm above the origin of the muscle fibers and proceedsfrom lateral to medial to allow adequate redraping ofthe muscle over the implant. This usually requires divi-sion of several medial slips of muscle that often containperforating vessels. The endpoint of the dissection isadequate release of the pectoralis muscle, usually atthe sternal border. Dual-plane techniques differ slightlydespite which incision is used.When the pocket is dry, sizers are used to evaluatethe dissection and to determine the final prosthesis to
  24. 24. 24cVI • TRUNK AND LOWER EXTREMITYBDEbe implanted. Before final implant placement, thepocket is once again checked for hemostasis and irri-gated with an antibiotic solution. The closure is par-ticularly important with this technique. The gland mustbe precisely reapproximated and closed with severalFIGURE 118-18. A Patient witha severely constrictedlower breast pole and high, tight inframammary fold. B,Round,smooth, siliconegel implantswere selected of 11 .4-em width and 280-mL volume to be positioned in a sub-pectoral (dual-plane) pocket with a significantly loweredinframammary fold, after extensive parenchymal release.e, Thiswas accomplished through a periareolar approachto give this result with an inconspicuous scar. D and E,Preoperative and postoperative appearance.layers of interrupted absorbable sutures to prevent dis-tortion of the nipple-areola complex. The skin is closedwith deep everting dermal sutures and a runningsubcuticular absorbable monofilament. SteriStripsare applied to the closed incision.
  25. 25. 118 • BREAST AUGMENTATION 25TRANSAXILLARY AUGMENTATIONThe markings for transaxillary breast augmentationare also made with the patient in the sitting or uprightposition. The existing and resultant inframammaryfolds are marked, as are the boundaries of the pro-posed dissection. To locate and mark the incision, thepatients arm is placed in complete adduction and themost anterior aspect of the axilla is marked. The inci-sion should not extend beyond this line. The arm isthen abducted approximately 45 degrees, and a promi-nent axillary crease is identified. Any fold may be used,but preference is given to one high in the axilla, whichaids in instrumentation during the procedure. Forsaline-filled implants, the incision should generally be2.5 to 3.5 em. Silicone implants require larger incisions.The patient is placed on the operating table in thesupine position with arms abducted 90 degrees andsecured to arm boards that allow 10- to IS-degree vari-ations in abduction and adduction from 90 degrees.She must be able to flex 90 degrees at the waist duringthe procedure. After sterile preparation and draping,the incision is infiltrated with 1 to 2 mL of 1% lido-caine containing 1:1000 dilution of epinephrine. Thebreast parenchyma is then elevated from the chest wallby manual traction, and the inframammary fold andmedial sternal border are infiltrated with 10 to 15mLof the same lidocaine solution to aid hemostasis duringthe dissection.The incision is made, and small sharp retractors areused to elevate the medial aspect of the incision.Superficial subcutaneous dissection to the lateralborder of the pectoralis major prevents injury to theintercostobrachial nerve. Scissor dissection isemployedwith use of the electrocautery and insulated forceps tocontrol any bleeding. The fascia of the pectoralis majormuscle is visualized at the lateral edge of the muscle,and the dissection is carried deep to this, with caretaken to identify the wispy areolar plane between thepectoralis major and the pectoralis minor. One mustbe certain the correct plane is entered before contin-uing the dissection further.The subpectoral space is developed bluntly witheither an Agris-Dingman breast dissector or a 36 Frenchurethral sound. For a standard transaxillary augmen-tation, the origin of the pectoralis major muscle mustbe avulsed by the dissectors to allow release of themuscle from the chest wall to a point I to 2 em up themedial aspect of the sternum. Complete division of allthe muscle fibers is not always necessary.For an endoscopically assisted augmentation, theendoscope is passed into the transaxillary tunnel, andthe subpectoral space is seen under direct vision. Thisallows a more controlled release of the pectoralis majororigin with a long insulated electrocautery instru-ment. The pectoralis muscle fibers are released approx-imately I em above their origin along the inferior andinferomedial aspects. Meticulous hemostasis can beconfirmed with the electrocautery, and drain tubes areseldom necessary.On completion of the dissection, implant sizers areused to evaluate the pocket and identify any areas thatneed final adjustment. This must be done with thepatient in the sitting position. The pockets are thenirrigated with an antibiotic solution, and the finalimplants are inserted. Before closure, the patient isonceagain placed in the sitting position for a final check ofthe implant position. The pectoralis muscle fascia isrepaired with a single absorbable suture, and the inci-sion isclosed in one or two layers. SteriStrips are appliedto the incision.""TRANSUMBILICAL BREASTAUGMENTATIONThe markings for transumbilical breast augmentationare similar to those for a standard inframammaryfold approach. The patient is marked in the seated orstanding position. The existing inframammary fold ismarked, as are the limits of the proposed dissection.The midline is marked for reference.The patient is placed on the operating table in thesame manner as for an inframammary augmentation.An additional mark is made with the patient supine:a line isdrawn from the umbilicus to the medial borderof the areola bilaterally. An incision is made withinthe umbilicus, large enough to easily accommodatean index finger. An endotube with a blunt obturatoris passed just above the rectus fascia along the linefrom the umbilicus to the areola. Care is taken to con-stantly palpate the progress of the obturator with thesurgeons other hand, always keeping the force up andaway from the abdominal and thoracic cavities. Theendotube is advanced over the costal margin. For sub-glandular implant placement, the force applied to theendo tube isdirected upward at the inframammary foldto prevent the obturator from slipping beneath thepectoralis major. The tunnel ends just cephalad to thenipple. Subpectoral positioning is possible by carefultechnique with use of special instruments to enter thefascial plane high laterally.The obturator is then removed, and an endoscopemay be used to verify correct pocket identification.Hemostasis is also ensured. Both the endotube andendoscope are removed from the tunnel, and anexpander is rolled up and placed within the incision.The expander is "milked" up the tunnel by manualexternal pressure. The expander is filled with saline to150% of the final volume of the implant. Pocket adjust-ments can be made manually during filling.When the expansion is complete, the expander isdrained and removed from the pocket by traction onthe fill tube. The implant is placed and filled in exactlythe same manner as the expander. The endotube isthen