8
Preliminary report on the use of the Spectraä implant for the correction of hypoplastic breasts with small-volume asymmetry Marco Mazzocchi a, *, Luca Andrea Dessy b , Davide Gagliardi b , Alessandra Martano b , Nicolo ` Scuderi b a Department of Plastic Surgery, University of Perugia, Perugia, Italy b Department of Plastic Surgery, “La Sapienza” University of Rome, Rome, Italy Received 25 April 2011; accepted 21 August 2011 KEYWORDS Hypoplastic breast; Small-volume asymmetry; Breast asymmetry; Breast implant Summary Background: Small-volume breast asymmetry is a challenging problem. In 2008, an intra-operative volume-adjustable breast implant, consisting of a round textured implant with an outer chamber filled with cohesive silicone gel and inner chamber filled with varying amounts of saline solution was marketed in Europe. We describe our experience in the correc- tion of hypoplastic breasts with small-volume asymmetry using this device. Methods: From May 2008 on, female patients presenting small-volume breast asymmetry were enrolled in the study. Standard pictures were taken before surgery and during follow-up visits over 1 year; standardised objective measurements of breast and chest were also taken. Statis- tical significance of value variation was assessed by Wilcoxon’s rank sum test. A Visual Analogue Scale (VAS) was used to evaluate patients’ and external physicians’ judgement of breast symmetry achievement at the end of follow-up. The development of capsular contrac- ture was assessed by measuring mammary compliance. Results: A total of 38 females were treated. The implant pocket was subglandular in 14 cases, subpectoral in 14 and dual plane in 10. The adjustable implant was positioned in the smaller breast. A textured round implant, whose diameter was the same as the adjustable one, was positioned in the contralateral breast. Thirty-five patients were fully satisfied; three were partially satisfied. Good aesthetic and functional breast symmetry results were achieved in all patients, as demonstrated by the objective measurement statistical analysis. We observed one case of delayed wound healing, one of bleeding and one of seroma, with no major late complications. Baker’s classification grade III capsular contracture was detected in one patient. Both implants maintained their initial volume. Conclusions: The possibility of intra-operatively modifying implant volume according to breast volume differences provides a reliable corrective option for hypoplastic breasts with * Corresponding author. Via Portuense 331, 00149 Rome, Italy. Tel./fax: þ39 065581815. E-mail address: [email protected] (M. Mazzocchi). 1748-6815/$ - see front matter ª 2011 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.bjps.2011.08.047 Journal of Plastic, Reconstructive & Aesthetic Surgery (2012) 65, 312e320

Preliminary report on the use of the Spectra™ implant for the correction of hypoplastic breasts with small-volume asymmetry

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Page 1: Preliminary report on the use of the Spectra™ implant for the correction of hypoplastic breasts with small-volume asymmetry

Preliminary report on the use of the Spectra�implant for the correction of hypoplastic breastswith small-volume asymmetry

Marco Mazzocchi a,*, Luca Andrea Dessy b, Davide Gagliardi b,Alessandra Martano b, Nicolo Scuderi b

aDepartment of Plastic Surgery, University of Perugia, Perugia, ItalybDepartment of Plastic Surgery, “La Sapienza” University of Rome, Rome, Italy

Received 25 April 2011; accepted 21 August 2011

KEYWORDSHypoplastic breast;Small-volumeasymmetry;Breast asymmetry;Breast implant

Summary Background: Small-volume breast asymmetry is a challenging problem. In 2008, anintra-operative volume-adjustable breast implant, consisting of a round textured implant withan outer chamber filled with cohesive silicone gel and inner chamber filled with varyingamounts of saline solution was marketed in Europe. We describe our experience in the correc-tion of hypoplastic breasts with small-volume asymmetry using this device.Methods: From May 2008 on, female patients presenting small-volume breast asymmetry wereenrolled in the study. Standard pictures were taken before surgery and during follow-up visitsover 1 year; standardised objective measurements of breast and chest were also taken. Statis-tical significance of value variation was assessed by Wilcoxon’s rank sum test. A VisualAnalogue Scale (VAS) was used to evaluate patients’ and external physicians’ judgement ofbreast symmetry achievement at the end of follow-up. The development of capsular contrac-ture was assessed by measuring mammary compliance.Results: A total of 38 females were treated. The implant pocket was subglandular in 14 cases,subpectoral in 14 and dual plane in 10. The adjustable implant was positioned in the smallerbreast. A textured round implant, whose diameter was the same as the adjustable one, waspositioned in the contralateral breast. Thirty-five patients were fully satisfied; three werepartially satisfied. Good aesthetic and functional breast symmetry results were achieved inall patients, as demonstrated by the objective measurement statistical analysis. We observedone case of delayed wound healing, one of bleeding and one of seroma, with no major latecomplications. Baker’s classification grade III capsular contracture was detected in onepatient. Both implants maintained their initial volume.Conclusions: The possibility of intra-operatively modifying implant volume according to breastvolume differences provides a reliable corrective option for hypoplastic breasts with

* Corresponding author. Via Portuense 331, 00149 Rome, Italy. Tel./fax: þ39 065581815.E-mail address: [email protected] (M. Mazzocchi).

1748-6815/$-seefrontmatterª2011BritishAssociationofPlastic,ReconstructiveandAestheticSurgeons.PublishedbyElsevierLtd.All rightsreserved.doi:10.1016/j.bjps.2011.08.047

Journal of Plastic, Reconstructive & Aesthetic Surgery (2012) 65, 312e320

Page 2: Preliminary report on the use of the Spectra™ implant for the correction of hypoplastic breasts with small-volume asymmetry

small-volume asymmetry. Although these results are encouraging, a longer follow-up isrequired to evaluate implant ageing and long-term outcome.ª 2011 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published byElsevier Ltd. All rights reserved.

Breast asymmetry is present in over two-thirds of females1e5;this problem, which is generally congenital and has no knownaetiopathogenesis, represents one of the most difficult chal-lenges in the field of cosmetic breast surgery. Several authorshave proposed various surgical procedures for the manage-ment of breast asymmetry, even by using a different tech-nique on each breast,1,6e10 although no definitive solutionhas yet been found, particularly in cases in which there islittle difference in volume between the breasts.

Early signs may be observed in prepubertal and pubertalages, when hormonal factors stimulate the gland and theentire breast growth, resulting in the anterior projection ofthe nipple-areola complex (NAC) and peripheral expansionof breast base.6 This phase is critical in the genesis of allmammary malformations. According to Rees and Dupuis,3

the left breast is usually wider and more ptotic than theright breast, though with no difference in the areola ornipple; indeed, a certain degree of breast asymmetry ismore common than the number of diagnosed casessuggests.2,10 Although breast asymmetry is very frequent,the degree of difference between the breasts rarelyjustifies or leads to surgical correction, as the highfrequency of breast asymmetry in the normal populationsuggests.11 According to surgeons’ estimates, breast asym-metry is present in 80% of the female population, thoughthis figure rises to 100% when appropriate measuring toolsare used.3,11 The presence of any difference betweenbreasts in volume and shape, even if minimal, may never-theless create a psychological concern that results in thepatient consulting a plastic surgeon. However, when theinitial asymmetry is minimal, it is more difficult to achievea satisfactory and stable correction.9,10 Although a widerange of classifications and related surgical strategies areavailable,12,13 minor breast asymmetry has as yet receivedlittle clinical interest due to the negligible entity of thedefect, on the one hand, and the extreme difficulty thatis encountered in achieving an aesthetic result that satisfiesboth the surgeon and the patient, on the other.

An intra-operative volume-adjustable breast implant,named Spectra� (Mentor Corporation, Santa Barbara, CA,USA), has recently been introduced in the European market.It can have a textured or a smooth surface as round implants.This implant has a low bleed, cohesive silicone gel-filledouter lumen and an adjustable saline-fillable inner lumen.The inner lumen can gradually be filled with saline intra-operatively through the fill tube by injecting saline into theinjection dome. Once filled to the desired volume, the filltube and the injection dome are removed, and the prosthesisremains in position as a fixed-volume breast implant.Alternatively, the fill tube and the injection dome are keptin place by bringing the injection port through the skin in thesame way as a drain and the implant volume can be adjustedpostoperatively. In thisway, the patient can then be involvedin deciding on minor volume adjustments.

The purpose of this implant is to provide volume flexibilityand projection adjustability. We considered the possibility oftreating small-volume breast asymmetry by means of thisdevice in combination with a conventional non-adjustableround implant, with the same base size as the adjustableimplant. We thus performed a prospective open-label studyto assess the effectiveness of this new prosthesis in thecorrection of small-volume breast asymmetry.

Materials and methods

From May 2008 to March 2009, patients affected bya hypoplastic breast with small-volume asymmetry weretreated in our Institution. All the patients were informedabout the indications for surgical correction and possiblecomplications. Before enrolment, all the patients signed aninformed consent form.

All the patients underwent a mammary ultrasoundassessment or mammography, or both, depending on ageand the quality of mammary tissue.

To correct the deformity, patients underwent a standardbilateral augmentation mammaplasty with a prosthesis; themost appropriate implant pocket (subglandular, subpec-toral or dual plane) was selected after evaluating soft-tissue coverage and degree of breast ptosis.14,18 A texturedfixed-volume round cohesive I implant (Mentor Corporation,Santa Barbara, CA, USA) was positioned in the larger breast,while a volume-adjustable Spectra� implant witha textured surface was positioned in the smaller breast.Implant diameter was the same in both breasts.

Before starting the intra-operative filling with salinesolution, the patient was placed in the sitting-position.Once the adjustable implant was filled to the desiredvolume, breast symmetry achievement was assessed byperforming intra-operative breast-specific objectivemeasurements, and then the fill tube was removed.

In those patients affected by tuberous breast deformity,Muti’s technique was used to correct it following a two-stepprocedure19: first, disepithelialisation of both periareolarand inferior poles was performed according to preoperativemarkings; subsequently, a glandular flap was overturned onthe glandular lower pole as a finger flexes on its proximalinterphalangeal join; normal dimension of the breast basewas restored. With respect to volume adjustment, thesecond surgical step was characterised by a bilateralaugmentation mammaplasty with two different implants,as in the other forms of small-volume breast asymmetry.

All the surgical procedureswere performed under generalanaesthesia; intravenous cephalosporin was administered toall the patients and suction drains were used routinely.

The cost in our country of the textured Spectra� implantis V 700.00 plus 4% value-added tax (VAT), the cost of theintra-operative sizer is V170.00 plus 20% VAT and the cost of

Reports of Spectra� implant for the correction of hypoplastic breasts 313

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the round-textured fixed-volume implant is V620.00 plus 4%VAT.

Before surgery and during follow-up visits (scheduled at 1,4 and 12 months after surgery), standard digital photograms(frontal, oblique and lateral views, with arms down and up)and standard objective measurements of the breast and ofthe chest were taken. Breast-specific objective measure-ments were based on the jugular-to-nipple, mid-clavicular-to-nipple, sternum-to-nipple,mid-armpit-to-nipple and sub-mammary fold-to-nipple distances on each breast. Valuedifferences between breasts were calculated in each patientto evaluate the degree of symmetry achievement. Chest-specific circumferencesweremeasuredat theNACandat theinframammary fold (IMF), with the lungs both full and empty.These measurements were used to detect any change in thesize of the prostheses themselves over time. In fact, bothcircumferences can modify initially after surgery for post-operative oedema and subsequently for variation of soft-tissue thickness whilst the NAC circumference can modifyalso in caseof change in the size of theprostheses themselvesat any time. The stability of the IMF circumference assuresthe absence of soft-tissue thickness modifications.

Differences of specific breast and chest measurementstaken before surgery and during follow-up visits werestatistically analysed by means of Wilcoxon’s matched pairssigned rank sum test; statistical significance was set atp< 0.05.

Breast appearance was subjectively evaluated by thepatients 1 year after surgery. The subjects’ global impres-sion of clinical improvement was recorded using a visualanalogue scale (VAS), based on a score from 1 to 10(1Z no correction of breast asymmetry, 10Z no residualdifference between breasts). In addition, the degree ofbreast symmetry achievement was evaluated by anexternal panel of physicians 1 year after surgery based ona subjective impression, using the same VAS, by comparingpreoperative and postoperative pictures.

Capsular contracture was assessed at follow-up visits bymeans of the palpation method according to the Bakerclassification20,21 and by measuring the mammary compli-ance scores by means of the Anton Paar Mammacompliancesystem.22,23

Before surgery and at the 1-year follow-up visit,patients were asked to fill out a questionnaire designedto examine progress over time in their psychological state.

Results

During the study period, 38 patients, whose age rangedfrom 18 to 36 years (mean 27 years and 3 months; median:24 years), were treated. Twelve patients (31.5%) presentedbilateral developmental hypoplasia with small-volumeasymmetry, 10 patients (26.4%) presented small-volume

Figure 1 Above e preoperative frontal and oblique views. Below e one year postoperative frontal and oblique views of the samepatient. Right: Siltex� Round High Profile, Cohesive I� e 350 cc, diameter 11.7 cm, projection 4.9 cm. Left: Siltex� RoundSpectra� Adjustable Gel Breast Implant e 335 cc, diameter 11.7 cm, projection 4.9 cm. Volume of saline added: 50 cc (Totalvolume: 385 cc). Visual analogical scale (VAS) expressing judgments on breast symmetry e Patients’ judgment: 9 e Physicians’judgment: 9.

314 M. Mazzocchi et al.

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breast asymmetry with mild ptosis, eight patients (21%)presented unilateral iatrogenic hypoplasia as a result ofprevious surgical interventions (benign mass ablation),seven (18.5%) presented a tuberous breast deformity,while one patient (2.6%) was affected by a simple formof Poland’s disease, characterised by the presence ofpectoral muscle, breast atrophy and a slight breastasymmetry with ‘pectus excavatum’. The implantpocket used was subglandular in 14 cases, subpectoralin 14 and dual plane in 10. The size of the textured roundimplants positioned in the larger breast ranged from 275to 375 cc. The size of the adjustable volume implantsranged from 250 to 355 cc, while the saline load usedto achieve symmetry ranged from 35 to 50 cc (mean:47 cc).

Good aesthetic and functional breast symmetry resultswere achieved in all the patients (Figures 1e4).

Immediate complications comprised delayedwound heal-ing in one case (2.63%), which occurred on the adjustablebreast implant side, one case of haematoma (2.63%) and onecase of seroma (2.63%), the last two occurring on the fixed-volume prosthesis side. None of the above complications hada negative effect on the ultimate achievement of breastsymmetry. The mean length of hospital stay was 1.65 days(range: 1e3 days).

No major late complications occurred during the 1-yearfollow-up period.

According to the Baker classification, the degree ofcapsular contracture at the 1-year follow-up on the adjust-able implant side was grade I in 19 cases (50%), grade II in18 cases (47.3%) and grade III in one case (2.63%). In thecontralateral breast, it was grade I in 18 cases (47.3%),grade II in 19 cases (50%) and grade III in one case (2.63%).

The mean value of mammary compliance obtained atthe 1-year follow-up was 45.81 (range 35.6e54.4) in theadjustable breast implant side and 45.50 (range 34.7e52.6)in the contralateral side.

No differences were found in relation to the type ofimplant pocket.

Mean values and standard deviations of the differencesof specific breast measurements and their statisticalsignificance are summarised in Table 1, whereas those ofspecific chest circumferences are summarised in Table 2.

According to the VAS, good-to-high patient satisfactionwas observed (Table 3). In addition, the assessment ofbreast symmetry achievement conducted by the externalpanel of physicians yielded comparable results (Table 3).

The patient questionnaire did not reveal any majorchanges in the patients’ psychological state, with allremaining stable.

Figure 2 Above e preoperative frontal and oblique views. Below e One year postoperative frontal and oblique views of thesame patient. Right: Siltex� Round Spectra� Adjustable Gel Breast Implant e 240 cc, diameter 10.5 cm, projection 4.3 cm.Volume of saline added: 35 cc (Total volume: 275 cc) Left: Siltex� Round High Profile, Cohesive I� e 250 cc, diameter10.5 cm, projection 4.5 cm. Visual analogical scale (VAS) expressing judgments on breast symmetry e Patients’ judgment: 10e Physicians’ judgment: 10.

Reports of Spectra� implant for the correction of hypoplastic breasts 315

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Figure 3 Above e preoperative frontal, oblique and lateral views. Below e One year postoperative frontal, oblique and lateralviews of the same patient. Right: Siltex� Round Spectra� Adjustable Gel Breast Implant e 310 cc, diameter 11.4 cm, projection4.6 cm. Volume of saline added: 50 cc (Total volume: 360 cc). Left: Siltex� Round High Profile, Cohesive I� e 325 cc, diameter11.4 cm, projection 4.6 cm. Visual analogical scale (VAS) expressing judgments on breast symmetry e Patients’ judgment:10 e Physicians’ judgment: 8.

Figure 4 Above e preoperative frontal, lateral and oblique views. Below e One year postoperative frontal, lateral and obliqueviews of the same patient. Right: Siltex� Round High Profile, Cohesive I� e 275 cc, diameter 10.8 cm, projection 4.4 cm. Left:Siltex� Round Spectra� Adjustable Gel Breast Implant e 260 cc, diameter 10.8 cm, projection 4.4 cm. Volume of saline added:25 cc (Total volume: 285 cc). Visual analogical scale (VAS) expressing judgments on breast symmetry e Patients’ judgment:9 e Physicians’ judgment: 10.

316 M. Mazzocchi et al.

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Discussion

Although breast asymmetry is present in over 80% of thefemale population,10,13 the number of cases that ultimatelyundergo surgery is relatively low, probably owing to thefact that this problem is of minor psychological concernto the majority of women; however, another reason maybe that minor forms of breast asymmetry are extremelydifficult to correct and the final aesthetic outcome is notalways satisfactory.8

The technique we present in this study for the correctionof small-volume breast asymmetries has indubitable advan-tages. In particular, the insertion of an implant in eachbreast means that both the mammary glands ‘grow old’ inthe same manner while maintaining the same degree ofptosis over the years.

Volume-asymmetry correction was achieved in all thepatients by means of implants of the same diameter withminimal differences in volume, with the fixed-volume pros-thesis being positioned in the larger breast. The use ofimplants with the same base size contributed to the achieve-ment of symmetry by allowing both breasts to be modelledaccording to a similar final base. The simultaneous use of twodifferent breast implants in the samepatient also allowedus,when we examined the overall follow-up data, to detect anydifference in implant biocompatibility and duration.

The volume difference was easily corrected duringsurgery by altering the volume of the expandable pros-thesis. Indeed, the surgeon was able to increase the volumeof saline both gently and safely, thereby adjusting thebreast size during the intervention. When optimalsymmetry was obtained, the surgeon simply extracted the

Table 1 Mean values, standard deviations of differences of specific breast measurements (evaluated before surgery andduring follow-up visits) and their statistical significance assessed by means of Wilcoxon’s matched pairs signed rank sum test.

Nipple-jugular Mid-clavicular to nipple Sternum to nipple Mid-armpit to nipple Inframammary fold to nipple

M� SD M� SD M� SD M� SD M� SD

T0 0.574� 0.2048 0.650� 0.2137 0.539� 0.2601 0.374� 0.2446 0.760� 0.6499T1 0.044� 0.0714 0.044� 0.0593 0.052� 0.0595 0.053� 0.0716 0.089� 0.1187T2 0.053� 0.0678 0.052� 0.0678 0.058� 0.0633 0.055� 0.0784 0.092� 0.1178T3 0.055� 0.0676 0.055� 0.0676 0.060� 0.0629 0.063� 0.0840 0.094� 0.1218

p p p p pT0eT1 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001T0eT2 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001T0eT3 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001T1eT2 >0.05 >0.05 >0.05 >0.05 >0.05T1eT3 >0.05 >0.05 >0.05 >0.05 >0.05T2eT3 >0.05 >0.05 >0.05 >0.05 >0.05

M: mean; SD: standard deviation; p: probability; T0: preoperative; T1: 1 month after surgery; T2: 4 month after surgery; T3: 1 year aftersurgery.

Table 2 Mean values, standard deviations of differences of specific chest measurements (evaluated before surgery and duringfollow-up visits) and their statistical significance assessed by means of Wilcoxon’s matched pairs signed rank sum test.

Nipple-Areola complex Inframammary fold

Maximum inspiration Maximum expiration Maximum inspiration Maximum expiration

M� SD M� SD M� SD M� SD

T0 83.93� 2.251 79.95� 2.166 76.68� 2.231 71.78� 2.131T1 91.44� 2.649 87.89� 2.248 77.06� 2.228 71.96� 2.104T2 90.88� 2.665 87.37� 2.288 76.64� 2.222 71.71� 2.151T3 90.87� 2.657 87.37� 2.286 76.70� 2.203 71.81� 2.121

p p p pT0eT1 <0.0001 <0.0001 <0.0001 <0.0001T0eT2 <0.0001 <0.0001 >0.05 >0.05T0eT3 <0.0001 <0.0001 >0.05 >0.05T1eT2 <0.0001 <0.0001 <0.0001 <0.0001T1eT3 <0.0001 <0.0001 <0.0001 <0.0001T2eT3 >0.05 >0.05 >0.05 >0.05

M: mean; SD: standard deviation; p: probability; T0: preoperative; T1: 1 month after surgery; T2: 4 month after surgery; T3: 1 year aftersurgery.

Reports of Spectra� implant for the correction of hypoplastic breasts 317

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fill tube and completed the wound/skin closure. In this way,we combined the benefits of breast gel implants withvolume flexibility and the typical projection of an implantfilled with saline.

Furthermore, the implant pockets were created usingthe same technique on each side. The surgical techniqueswe used are fairly standardised owing to their widespreaduse in breast augmentation procedures.14e17 Either theperiareolar or inframammary access was used, as appro-priate; the pocket for the insertion of the prosthesis wassubmuscular, subglandular or dual plane, depending onthe thickness and position of the soft tissue available tocover the implant.14,18 When bilateral tuberous breastcorrection was required, the technique described byMuti19 was executed on each side, and then the twodifferent implants were positioned after pocket creation,following the previous described modalities.

If we consider the potential pros and cons of inserting anadjustable implant in one breast, some concerns may beraised. An alternative method to correct hypoplastic breastwith small-volume asymmetry would be to choose the sameimplant base dimension and use a different projection asthe means of correcting for volume discrepancies, but thismethod allows only fixed-volume corrections and, depend-ing on the dimension of the implant, these fixed volumesrange from 25 to 165 cc. Thus, this method does not allowsmaller volume corrections. In addition, although thevolume of the Spectra implant can be adjusted eitherintra-operatively or postoperatively, we preferred tomodify implant volume only intra-operatively for severalreasons: first, postoperative tissue swelling can behavedifferently on each breast, thus altering the final result;second, we did not want to increase the probability ofimplant infection by keeping a direct communicationbetween the implant and the external environment; third,we wanted to avoid an additional scar; and lastly, we didnot want to negatively influence patient comfort for severaldays in the case of having an eternal tube and valve tomanage with. Besides, the cost of the Spectra� implantcompared with an intra-operative sizer and then a fixed-volume implant is not significant. In fact, the cost of usingthe first time a fixed-volume reusable sizer plus a fixed-volume implant is higher; but considering that sizers canbe re-sterilized for a maximum of 10 times, costs becomecomparable.

Evaluation of capsular contracture did not reveal anydifference between the fixed-volume and variable-volumeimplants.

In our study, the correction of the asymmetry wasconfirmed by the reduction of the differences betweenleft and right values for each specific breast measurement;they decreased after surgery and subsequently remained

stable over the 1-year follow-up, proving the maintenanceof breast symmetry (Table 1).

We did not observe any reduction in implant volumeduring follow-up. This finding was confirmed by the stabilityof both specific chest measurements (Table 2). Thesemeasurements were used to detect any change in the sizeof the prostheses themselves over time. In fact, bothcircumferences can modify initially after surgery for post-operative tissue swelling and subsequently for variation ofthe soft-tissue thickness related to body weight modifica-tions, whilst the NAC circumference can modify also incase of change in the size of the prostheses themselves atany time. The stability of IMF circumferences proved theabsence of relevant body weight modifications in thestudied group, whilst the stability of postoperative NACcircumferences proved the maintenance of implantvolumes.

The objective data and statistical evidence of breastasymmetry correction were confirmed by the subjectiveevaluations. The VAS scores based on the patients’ andphysicians’ judgements yielded almost total satisfactionas regards the aesthetic and functional outcomes.

In our experience, the use of the adjustable implant hasso far proved to be effective, to be free of any specific risksor complications and to yield good aesthetic results.

Although the resistance of the housing and the efficiencyof the valve for the adjustable implant remainedunchanged in the 1-year follow-up period covered by ourstudy, this volume-adjustable device warrants longerfollow-up clinical trials designed to assess its durabilityover time.

Conclusions

Recent statistics have shown that in the course of theirprofessional activity, plastic surgeons deal with four to fivecases of true breast asymmetry every year. This means thatsuch surgeons need to be aware of new diagnostic methodsand innovative surgical techniques, which go hand in handwith a surgeon’s technical skill and experience gained inthe operating theatre. Therefore, the biggest challengea surgeon faces in cases of mild asymmetry is finding thecourage to recommend the most appropriate treatmenteven when the aesthetic results may not be satisfactory.The surgical strategy proposed in our study providesa comparative and temporal assessment of two differentprostheses that are implanted in the same patient at thesame time, thereby offering us the possibility to evaluatethe durability of the adjustable implant.

The results of this study highlight the efficacy, thereproducibility and the ease of the surgical strategy wepropose to correct small-volume breast asymmetry. Themain advantage of the Spectra� implant is that it allowsthe surgeon to make very fine intra-operative adjustmentsto balance breast size, with all the benefits and productquality of gel implants.

Using the satisfying results of this preliminary report asa starting point, we plan to continue our evaluation of thetechnique we have presented through a longer follow-up,focussing on the maintenance of the initial volume of theseadjustable implants over time.

Table 3 Visual analogical scale (VAS) of patients andphysicians expressing their global judgments on breastsymmetry (1: no improvement; 10 maximum improvement).

VAS value 1 2 3 4 5 6 7 8 9 10

Patients’ judgment 1 1 1 14 16 5Physicians’ judgment 1 1 2 15 13 6

318 M. Mazzocchi et al.

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Conflict of interest/funding

None.

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Invited commentary

Marc D. Pacifico *

Department of Plastic Surgery, Queen Victoria Hospital, Holtye Road, East Grinstead, West Sussex RH193DZ, UK

Received 2 September 2011; accepted 17 September 2011

In this well-written paper, Mazzocchi and his co-authorspresent their initial impression of the use of Mentor’sSpectra implants. These are adjustable implants that arepredominantly silicone, but with a small inner lumen toallow volume (mainly projection) adjustment of theimplant.

Breast asymmetry surgery, especially when mild, as inthe theme of this paper, can be a considerable aestheticchallenge. The Spectra implants seem ideally designed forthis situation. Although presenting some very goodoutcomes, my one reservation about Mazzocchi et al.’s

approach is that they appear to have only capitalised onthe adjustable nature of Spectra intra-operatively. Whynot, then, just use a cheaper inflatable breast sizer, ora range of two or three fixed volume reusable sizers offixed base dimensions (see Figure 1)? My rationale forusing the Spectra is to allow the patient to gain ownershipof the final fineetuning decision-making process post-operatively. This is possible in two ways e either theport can be exteriorised (in the same way as a surgicaldrain) and adjusted the day after surgery. Alternatively,it can be placed subcutaneously, to be adjusted in the

DOI of original article: 10.1016/j.bjps.2011.08.047.

Invited commentary 319