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O RI G I N A L A R T I C LE EXPERIMENTAL/SPECIAL TOPICS

Economic Analysis and Review of the Literature on Implant-Based Breast Reconstruction With and Without the Useof the Acellular Dermal Matrix

Jonathan Bank Nicole A. Phillips

Julie E. Park David H. Song

Received: 1 May 2013 / Accepted: 29 August 2013/ Published online: 3 October 2013 Springer Science+Business Media New York and International Society of Aesthetic Plastic Surgery 2013

Abstract Background Use of the acellular dermal matrix (ADM) intwo-stage implant-based breast reconstruction has beenwidely adopted. Despite an increasing focus on health carecosts, few reports have addressed the nancial implicationsof ADM use. This study sought to examine the costs of thetwo-stage technique with and without ADM, concentratingon the direct variable costs of patient care during theexpansion process. Methods A retrospective review of a prospectivelymaintained database was conducted. Data were collectedon 132 cases resulting in a second-stage exchange for apermanent implant. The ndings showed that AlloDermwas used in 61 reconstructions and Strattice in 23 recon-structions. The primary outcome was the number of llsrequired to achieve the nal expander ll volume. The costof subsequent patient encounters for expansion was esti-mated using institutional cost data. Results The number of lls required to achieve the nalvolume was higher in the non-ADM group (6.5 1.7) thanin the ADM group (3.6 1.4) ( p \ 0.0001). No signicantdifference was found in the small ll volumes ( \ 350 ml;5.3 vs. 3.7; p [ 0.05). The difference was signicant in thelarger ll volumes ( [ 500 ml; 8.3 vs. 3.7; p \ 0.05). Rel-ative to non-ADM reconstruction, with AlloDerm at

current prices, the cost increase ranged from $2,727.75 forlarge reconstructions to $3,290.25 for small reconstructions($2,167.75$2,739.25 with Strattice).Conclusion The use of ADM in two-stage reconstructionreduces the number of visits required for reconstructionswith 350 ml or more. However, at current pricings, thedirect cost of ADM use does not offset the cost savingsfrom the reduced number of visits. Level of Evidence IV This journal requires that authorsassign a level of evidence to each article. For a fulldescription of these Evidence-Based Medicine ratings,please refer to the Table of Contents or the onlineInstructions to Authors www.springer.com/00266 .

Keywords Economics Breast reconstruction Acellulardermal matrix

Implant-based breast reconstruction is the most commonform of breast reconstruction after mastectomy. Of 96,277breast reconstructions in the United States in 2011, 69,916(72.6 %) were performed in two stages, with initial tissueexpander placement followed by exchange for a permanentimplant [ 1]. This two-stage approach has undergone revi-sions in recent years, including dual-plane positioning[24] over total submuscular prosthetic placement, theadvent of the acellular dermal matrix (ADM), and theincorporation of ADM into the initial stage of alloplasticbreast reconstruction. These techniques have been widelyadopted by many reconstructive surgeons [ 3, 59].

The use of ADM provides support for the prosthesis andits coverage, limiting muscle dissection and resulting indecreased postoperative pain [ 10]. Further benets includereduced migration of the pectoralis major and stabilizationof the prosthetic device itself [ 3, 11]. In addition,

J. Bank J. E. Park D. H. Song (& )Department of Surgery, Section of Plastic and ReconstructiveSurgery, University of Chicago Medical Center, 5841 SouthMaryland Avenue, Chicago, IL 60637, USAe-mail: [email protected]; [email protected]

N. A. PhillipsDivision of Plastic Surgery, Department of Surgery, Brighamand Womens Hospital, Boston, MA, USA

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Aesth Plast Surg (2013) 37:11941201DOI 10.1007/s00266-013-0213-2
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our institution, and since 2010, all patients have undergonereconstruction using ADM as part of a standard protocol.

The study excluded 11 cases that failed to meet theinclusion criteria or to achieve adequate follow-up evalu-ation. Subsequently, 33 cases that involved somethingother than a normal exchange were excluded from theanalyses to allow accurate comparison of a single set of variable costs.

The primary outcome examined was the number of tissue expander lls required to achieve the nal expanderll volume, a proxy for the number of clinic visits requiredto achieve this volume. All lls were via 50-ml incrementsin both study groups. Expander size, shape, and type wereconsistent throughout the entire study period for bothgroups. Additional variables assessed were patient age,percentage of bilateral cases, and initial and nal ll vol-umes of the tissue expander.

Variables were analyzed two ways. First, the cases weredivided into three study arms (AlloDerm, Strattice, andnon-ADM). Analyses comparing age, number of bilateralcases, initial ll volume, number of lls, and nal llvolume showed no signicant differences between Allo-Derm and Strattice ( p [ 0.05 for all comparisons). There-fore, it was deemed appropriate to combine these cases(AlloDerm and Strattice) into one study arm (ADM). Asecond set of analyses involving the same variables thenwas performed using two study arms (ADM vs. non-ADM).

In addition, the primary outcome was studied with ref-erence to the nal ll volume, subdivided arbitrarily intosmall-(\ 350 ml), medium-(350500 ml), and large-([ 500 ml) volume reconstructions. Again, this was per-formed for both the three-armed study (AlloDerm vs.Strattice vs. non-ADM) and the two-armed analysis (ADMvs. non-ADM).

Statistical analyses of patient age, initial ll volume,number of lls required to achieve the nal ll volume, andthe average ll volume per clinic visit were carried outusing analysis of variance (ANOVA). Post hoc compari-sons among the study arm means used the Tukey procedureto control for the family-wise error rate of 0.05. Compar-ison of the percentage of bilateral cases and the nal llvolume distribution among the study arms was carried outusing Chi square tests. A p value lower than 0.05 wasconsidered statistically signicant.

Previously published analyses on this topic have usedpresumed Medicare reimbursement rates and projectedcosts associated with expected complication rates to studythe nancial implications of ADM use [ 13, 14]. For thepurposes of our study, the total cost of each clinicencounter was estimated using expenditure data from ourown institution. Calculations encompassed facility fees,labor costs, and miscellaneous variable costs (e.g., material

costs) associated with each clinic visit. The net presentvalue calculation at the time of manuscript preparation was$187.50 per clinic visit. For the purposes of limiting con-founding variable costs, including physician professionaltime, our methodology focused on the variable costsassociated with expansion and held xed costs of healthcare delivery the same for these visits.

Results

No statistically signicant differences were found betweenthe study group arms when patient age or percentageof bilateral reconstructions was compared ( p [ 0.05)(Tables 1, 2). When initial ll volume was examined, Al-loDerm was found to have a mean initial ll volume of 235.7 ml, whereas Strattice had a mean ll volume of 278.3 ml. These initial ll volumes, although not signi-cantly different from one another ( p [ 0.05), were eachsignicantly higher than the mean initial ll volume for thenon-ADM group (84.2 ml). We therefore combined thesetwo sets of patients into one study arm (ADM). ComparingADM with non-ADM, we found that the ADM group had a

Table 1 Statistics by age in year of surgery

n Mean SD p valuea

Three armsNon-ADM 48 44.4 9.5 0.1617

AlloDerm 61 47.9 11.1Strattice 23 44.7 9.1

Two armsNon-ADM 48 44.4 9.5 0.1603ADM 84 47.0 10.6

SD standard deviation, ADM acellular dermal matrixa Analysis of variance comparing study arm means

Table 2 Percentage of bilateral cases

n (%) p value a

Three armsNon-ADM 22 (45.8) 0.9804AlloDerm 61 (47.5)Strattice 11 (47.8)

Two armsNon-ADM 22 (45.8) 0.8434ADM 40 (47.6)

ADM acellular dermal matrixa Chi square test comparing percentages of bilateral cases among thestudy arms

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signicantly higher initial ll mean (247.3 ml) than thenon-ADM group (84.2 ml) ( p \ 0.0001) (Table 3).

A comparison of nal ll volumes between the threecategories of size stratication showed no signicant dif-ference in the nal ll volume distribution between theAlloDerm and Strattice groups ( p [ 0.05), thus permittinga comparison between the combined non-ADM group andthe ADM group. This showed a signicant difference in thenal ll volume distributions ( p = 0.0137) (Table 4).

In analyzing our primary outcome (the mean number of lls required to achieve nal ll volume), we found asignicant difference between the study group arms( p \ 0.0001) (Table 5). AlloDerm and Strattice, althoughnot signicantly different from each other ( p [ 0.05), eachhad a signicantly lower mean number of lls than the non-

ADM group. After these patient sets were combined intoone study arm (ADM), comparison with the non-ADMgroup showed a signicantly lower mean number of lls( p \ 0.0001).

The nal ll volume differed signicantly from themean number of required lls in the comparison of non-ADM and ADM within the size stratication ( p = 0.0132)(Table 6). Among the patients whose nal ll volumeswere considered medium (350500 ml) or large([ 500 ml), the number of lls required to achieve the nalexpander ll volume differed signicantly between theADM and non-ADM groups ( p \ 0.05). This difference

Table 3 Statistics on the initial ll (in ml)

n Mean SD p valuea

Three armsNon-ADM 48 84.2 65.9b \ 0.0001 b

AlloDerm 61 235.7 89.5a

Strattice 23 278.3 118.5 a

Two arms n Average p valuea

Non-ADM 48 84.2 65.9b \ 0.0001 b

ADM 84 247.3 99.4a

SD standard deviation; ADM acellular dermal matrixa Analysis of variance comparing mean initial ll among the studyarmsb Indicates that at least one study arm has a signicantly differentmean initial ll ( p \ 0.05)a,b Post hoc pairwise comparisons of means were carried out usingthe Tukey adjustment procedure with control for the family-wise errorrate at 0.05. The study arms connected with the same letter do notdiffer signicantly

Table 4 Final ll volume distribution

Small(\ 350 ml)n (%)

Medium(350500 ml)n (%)

Large([ 500 ml)n (%)

p valuea

Three armsNon-ADM 9 (18.8) 31 (64.6) 8 (16.7) 0.0156 b

AlloDerm 3 (4.9) 50 (82.0) 8 (13.1)Strattice 0 (0) 16 (69.6) 7 (30.4)

Two armsNon-ADM 9 (18.8) 31 (64.6) 8 (16.7) 0.0137 b

ADM 3 (3.6) 66 (78.6) 15 (17.9)

ADM acellular dermal matrixa Chi square test comparing the nal ll volume distributions amongthe study armsb Indicates a signicant difference in the nal ll volume distribu-tions among the study arms

Table 5 Primary outcome: Statistics on the no. of lls

n Mean SD p valuea

Three armsNon-ADM 48 6.5 1.7 c \ 0.0001 b

AlloDerm 61 3.7 1.4d

Strattice 23 3.3 1.3 d

Two arms n Average p valuea

Non-ADM 48 6.5 1.7 c \ 0.0001 b

ADM 84 3.6 1.4 d

SD standard deviation, ADM acellular dermal matrixa Analysis of varianceb Indicates a signicant difference in the nal ll volume distribu-tions among the study armsc,d The letter designations ( a,b ) are assigned to denote differences.The study arms connected with the same letter do not differ signi-cantly ( p [ 0.05)

Table 6 Average number of lls per case by nal ll volumecategory

Average of number of lls

Small(\ 350 ml)

Medium(350500 ml)

Large([ 500 ml)

Total

Three armsNon-ADM 5.3 b 6.3c 8.3c 6.5c

AlloDerm 3.7 b 3.6b 4.1b 3.7b

Strattice NA 3.4 b 3.1b 3.3b

Two arms TotalNon-ADM 5.3 b 6.3c 8.3c 6.5c

ADM 3.7 b 3.5b 3.7b 3.6b

ADM acellular dermal matrixa This table should be read vertically. No statistical comparisons havebeen made among the nal ll volume categories within a study arm.Statistical comparisons among the study arms are made within eachnal ll volume category onlyb,c The letter designations ( a,b ) are assigned to denote differences.The study arms connected with the same letter do not differ signi-cantly ( p [ 0.05)

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was not seen among the patients whose nal ll volumewas considered small ( \ 350 ml).

Overall, the non-ADM cases required 6.5 1.7 visits,whereas the ADM cases required 3.6 1.4 visits to com-plete the expansion (Table 5). This difference was accen-tuated in the cases with a larger nal ll volume (8.3 fornon-ADM vs. 3.7 for ADM) (Table 6). The smaller nalll volumes showed a smaller difference in the number of visits (5.3 vs. 3.7).

More patients in the ADM group achieved higher llvolumes (15 in the ADM group vs. 8 in the non-ADMgroup), and fewer cases in the ADM group had smallvolumes (3 vs. 9). Therefore, to normalize for nal llvolume distribution, we calculated the number of addi-tional visits expected for non-ADM patients to achieve acomparable nal ll distribution.

On the average, non-ADM patients would be expected toreturn an additional 0.42 times (95 % condence interval,0.1780.655) to achieve the nal ll volume reected in thedistribution seen in ADM cases. Accordingly, 40 % of non-ADM patients would have one or more additional visits if thenal ll volume were normalized to the comparator group(ADM) using our standard 50-ml ll per visit.

Table 7 shows the direct variable costs incurred by thevisits required to achieve the nal ll volumes for the non-ADM and ADM cases. Small nal ll volumes requiredfewer visits to achieve the nal ll, and there was lessdifference in the number of visits between the non-ADM

and ADM groups. Concordantly, the corrected cost dif-ferential was lower than that of the higher nal ll volumegroups ($378.75). The higher the nal ll volume, the morell visits were required, raising the variable cost per case.Relatively more visits were required for the non-ADMgroup than for the ADM group, resulting in an averageadditional cost of $941.25 to achieve the nal ll volume(Table 7).

The market price of a 6 9 16-cm piece of thick Allo-Derm in 2012 was $3,669. The price of a pliable 6 9 16-cm piece of Strattice in 2012 was $3,109. The correctedcosts for additional visits (0.42 additional visits per non-ADM case) to normalize the nal ll volume distributionare shown as well. The nal corrected cost difference ishighlighted.

Discussion

An estimated 230,480 new cases of breast cancer werediagnosed in the United States in 2011 [ 15], and morewomen are electing to proceed with prophylactic mastec-tomies [ 16]. With the multitude of reconstructive optionsavailable, the number of patients affected by breast cancer,and the current economic climate, it is imperative thatreconstructive surgeons be aware of the costs incurred bythese procedures. However, as noted by de Blacam et al.[13], the balance between aesthetic outcome and nancialburden is not necessarily determined easily.

Multiple authors have documented the aesthetic benetsof two-stage breast reconstruction incorporating ADM,most notably the greater denition of the inframammaryand lateral mammary folds achieved with ADM use [ 3, 59]. A recent systematic review by Jansen and Macadam[10] compared outcomes in studies examining the use of ADM in two-stage breast reconstruction with those instudies surveying non-ADM alloplastic reconstruction.Minor acute complication rates were determined to becomparable between the two groups, and lower rates of capsular contracture have been reported for reconstructionsperformed with ADM [ 7, 10].

Previous analyses determining the nancial impact of ADM use have calculated expenses based on direct healthcare costs incurred by procedures and hospital staysincluding operating room cost, anesthesia time, hospitalfees, and stafng costs [ 1214]. Furthermore, they havecalculated expected complication rates based on previouslypublished reports, applying these costs to their overallanalyses [ 13, 14]. De Blacam et al. [ 13] conducted a costanalysis of breast reconstruction comparing traditionaltwo-stage implant-based reconstruction with two-stagereconstruction using ADM and with single-stage (direct-to-implant) reconstruction also using ADM. This study

Table 7 Cost of ll visits per case by nal ll volume category (in $)

Small(\ 350 ml)

Medium(350500 ml)

Large([ 500 ml)

Total

Three armsNon-ADM 993.75 1,181.25 1,556.25 1,218.75AlloDerm 693.75 675 768.75 693.75Strattice NA 637.5 581.25 618.75Difference 300 506.25 787.5 525

Two armsNon-ADM 993.75 1,181.25 1,556.25 1,218.75Corrected cost 1072.5 1,260 1,635 1,297.5ADM 693.75 656.25 693.75 675

Difference - 300 - 525 - 862.5 -543.75

Correcteddifference

- 378.75 - 603.75 - 941.25 - 622.5

DifferenceincludingAlloDerm

3,290.25 3,065.25 2,727.75 3,046.5

DifferenceincludingStrattice

2,730.25 2,505.25 2,167.75 2,486.5

ADM acellular dermal matrix, NA not available

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calculated Medicare reimbursement for each procedure andincorporated probable additional costs incurred by com-plications. Presumed complication rates were based on aliterature review examining reported outcomes per proce-dure. The most expensive procedure at baseline was foundto be tissue expander/implant (TE/I) reconstruction withADM ($11,255.78) followed by TE/I alone ($10,934.18)and SSI with ADM ($5,423.02). Higher complication rateswere expected for procedures involving ADM, leading toan incremental rise in the cost of those procedures. Theadditional cost associated with ADM use was attributed toextended operating room time and greater material costs. Intheir calculations, these authors did not use the wholesalecost of ADM or the hospital fee charged for its use becauseof institutional and national variability, assuming that therelative difference in procedure cost incurred by the use of ADM would be similar if actual costs were used.

Jansen and Macadam [ 14] published a similar cost ana-lysis using a decision analytic model, calculating baselineand expected costs using assigned outcomes probabilities.These authors compared two-stage TE/I non-ADM recon-struction with SSI using ADM. Expected costs were calcu-lated based on the Canadian payer structure and includeddirect medical costs associated with the procedures. A6 9 16-cm sheet of AlloDerm was presumed to be the ADMgraft material. The ndings showed that SSI with ADM wasless expensive than the two-stage non-ADM procedure inboth baseline noncomplicated cases (in Canadian dollars,$10,240 vs. $10,584) and in expected cost incorporatingpotential complications ($10,734 vs. $11,251). With asmaller ADM sheet (6 9 12 cm), the expected cost of SSIdecreased to $9,673. However, these calculations assumedsimilar operative times for both methods. When a longeroperative time for the single-stage technique was taken intoaccount, the expected cost of SSI with ADM rose to $11,784.The investigators also performed a sensitivity analysis toexamine the effect of presumed capsular contracture ratesbut found that changing these rates had little effect on theoverall cost of either procedure.

In focusing the discussion on direct costs and expecteddirect costs associated with complication probabilities,these studies underestimated the broader scope of thenancial burden covered in other analyses such as thatrecently published by Damen et al. [ 17]. These investiga-tors in Holland performed a medium-term cost analysis of breast reconstruction options encompassing medical costsbeyond the scope of the procedure itself, including con-sultations with other physicians, in-home nursing care, andphysical therapy costs. Whereas these factors may not bepertinent to each type of reconstruction, other incorporatedcosts such as patient travel and productivity burdens arebroadly applicable and can have a deep impact on theoverall nancial burden of a chosen reconstructive option.

Costs associated with the expansion process have beenlargely excluded from previously published economicanalyses of ADM use in breast reconstruction, except for abrief mention by Colwell et al. [ 12], who noted that theinclusion of extramural factors such as patient time off work would have resulted in a cost savings for SSIreconstruction.

We began with the hypothesis that the direct and indirectcosts incurred during theexpansionprocess play a signicantrole in the overall economics of alloplastic breast recon-struction. This hypothesis was not borne out by our results.Among thepatients whose nal ll volumes were consideredmedium (350500 ml) or large ( [ 500 ml), the ndingsshowed a statistically signicant difference in the number of lls required to achieve the nal expander ll volumebetween the ADM and non-ADM groups (Table 6). How-ever, an average cost difference of roughly $3,000 remainedif AlloDerm was used in the reconstruction ($2,500 withStrattice). The cost differences were lower when the recon-structions were larger (more expansion visits required).

It should be noted that the calculations performed werebased on general pricings of LifeCell products and not onspecic contract pricings with any particular surgicalpractice. In theory, break-even calculations could bederived from the data presented in Table 7.

No signicant difference was found between the studyarms in terms of patient age, percentage of bilateral cases,or average ll volume achieved per outpatient clinic visit.However, statistically signicant differences were notedregarding initial ll volume and nal ll volume betweenthe ADM and non-ADM group (Tables 3, 4). The differ-ence in initial ll volume was expected because one pri-mary advantage of the ADM technique over the traditionaltwo-stage method is the greater initial expansion allowabledue to the larger pocket.

The higher percentage of patients in the non-ADMgroup who had a small nal ll volume ( \ 350 ml; 18.8 vs.3.6 % in the ADM group; p = 0.0137) could have beendue to several factors. Because most reconstructions aim torestore the original breast size and shape, it is likely thatthese patients were expected to need less volume expansionand less prosthetic coverage. Therefore, they may havebeen selected for non-ADM reconstruction due to theiranatomy. It also is possible that greater volume expansionwas not appropriate for some patients, although 64.6 % of the patients in the non-ADM group achieved a mediumnal ll volume (350500 ml), and 16.7 % achieved alarge nal ll volume ( [ 500 ml).

The limitations of this study included those inherent to asingle-center, single-surgeon study. The patient populationfactors in this study may not be applicable to all practicesettings, and the gain of experience over time may inu-ence the results achieved with the same procedure.

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Time as an independent variable also is specicallyrelevant to this study. No patients in our study had recon-struction with ADM before March 2005. Because thematerials and techniques associated with ADM use inbreast reconstruction gained popularity and became morefamiliar, more patients in our study underwent this type of reconstruction. Currently, it is the standard of care in ourinstitution, and the patients who underwent reconstructionin the later period of the study had reconstruction withADM as part of a standard protocol.

Based on our study, no cost advantage is associated withthe use of ADM. Therefore, our continued decision to offertwo-stage reconstruction using ADM is based on clinicalcriteria, and all patients are offered this form of reconstruc-tion unless it is contraindicated or deemedunnecessary in thesetting of ample soft tissue and muscular coverage.

Prior studies [ 13, 14] have highlighted the fact that thecosts associated with complications not only add to theoverall cost associated with each type of reconstruction;they also complicate cost calculations. This study was asmall, nonrandomized, retrospective investigation. Wepurposefully excluded from our study cases that involvedanything other than a normal exchange of tissue expanderfor a permanent implant, designing our study to comparecost differences in noncomplicated cases so we would havean accurate comparison of a single set of variable costs.

We recognize that costs incurred by the complicationsassociated with each reconstructive option can be signi-cant. A prospective, randomized casecontrol study isindicated to address not only the economic burden of thesereconstructive options but also the aesthetic and functionalbenets of ADM use and its associated complication andrevision rates.

Our study was specically designed to address the var-iable costs associated with the expansion process as itapplies to two-stage reconstruction, currently the mostcommon form of alloplastic breast reconstruction per-formed. However, because previous studies examining thenancial burden of ADM use in breast reconstruction haveincluded single-stage reconstructions in their analyses [ 1214], it would be interesting to compare all reconstructiveoptions while taking the costs of the expansion process intoaccount. Other factors to be considered in future economicstudies analyzing the use of ADM in alloplastic breastreconstruction include the lower revision and capsularcontracture rates reported in several studies [ 7, 10].

Conclusion

The use of ADM in two-stage reconstruction reduces thenumber of clinic visits required between the initial opera-tion and the second operation for tissue expander exchange

for women expected to reach nal ll volumes of at least350 ml. However, the cost savings of reduced clinic visitsdo not offset the direct cost of ADM at the current pricingsof the products used in this study. The economics of theexpansion process should be included in further discussionson the nancial implications of ADM use in alloplasticbreast reconstruction.

Acknowledgments This study was conducted with an unrestrictededucational grant from LifeCell Corporation. The senior author was apaid consultant for LifeCell.

Conicts of interest The remaining authors have no conicts of interest to disclose.

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