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Plastic & Reconstructive Surgery:
doi: 10.1097/PRS.0000000000000366
Breast: Original Articles

An Algorithmic Approach for Selective Acellular Dermal Matrix Use in Immediate Two-Stage Breast Reconstruction: Indications and Outcomes

Jordan, Sumanas W. M.D., Ph.D.; Khavanin, Nima B.S.; Fine, Neil A. M.D.; Kim, John Y. S. M.D.

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Author Information

Chicago, Ill.

From the Division of Plastic and Reconstructive Surgery, Northwestern University, Feinberg School of Medicine.

Received for publication December 5, 2013; accepted January 30, 2014.

Disclosure: Dr. Kim receives research funding from and is a consultant for the Musculoskeletal Transplant Foundation. Dr. Fine receives research funding from Allergan, Inc. The other authors have no relevant financial relationships to disclose. This particular research received no external funding.

John Y. S. Kim, M.D., Division of Plastic and Reconstructive Surgery, Northwestern University, Feinberg School of Medicine, 675 North St. Clair Street, Galter Suite 19-250, Chicago, Ill. 60611, jokim@nmh.org

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Abstract

Background: Acellular dermal matrix use has gained widespread acceptance—despite higher material costs—because of its ease of use and potential for enhanced cosmesis. The authors developed a resource-sensitive algorithm for selective acellular dermal matrix use with indications and contraindications based on body mass index, breast size, radiation therapy, flap vascularity, and pectoralis anatomy.

Methods: The algorithm incorporates preoperative and intraoperative decision points. Complication rates and aesthetic scores were compared for procedures performed before and after adoption of the algorithm. Multiple logistic regression was used to determine the independent influence of the algorithm on postoperative outcomes.

Results: One hundred ninety-three breasts underwent reconstruction before and 179 underwent reconstruction after implementation of the algorithm. Overall complication rates did not differ between the cohorts (22.8 percent versus 20.7 percent; p = 0.138). After adjusting for potential confounders, the algorithm did not significantly affect the incidence of infection, seroma, flap necrosis, explantation, or overall complications (all p > 0.05). Aesthetic scores were not affected (2.75 of 4 versus 3.03 of 4; p = 0.138). Acellular dermal matrix use decreased from 84 percent to 36 percent, resulting in a materials cost savings of $270,000 over the study period.

Conclusions: This algorithm obviated placement of acellular dermal matrix in an estimated 48 percent of immediate tissue-expander reconstructions. Patients treated after adoption of this algorithm experienced similar complication rates and aesthetic outcomes as those who underwent reconstruction before. The authors’ preliminary outcomes demonstrate that evidence-based measures can be taken to selectively use acellular dermal matrix without a concomitant worsening of patient outcomes.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Over the past decade, acellular dermal matrix–assisted breast reconstruction has emerged as an increasingly popular technique. It is estimated that over 56 percent of prosthetic-based breast reconstructions may now involve acellular dermal matrix.1 For many surgeons—despite higher material costs—acellular dermal matrix use has become routine because of its ease of use and potential for enhanced cosmesis. Since 2005, over 140 publications have discussed acellular dermal matrix–assisted breast reconstruction, yet few have promulgated its selective use.2 Only a handful of studies provide clear indications and contraindications for acellular dermal matrix use and fewer still provide concomitant outcomes associated with such selective use.

It is reasonably well established that acellular dermal matrix placement can provide patch coverage of compromised serratus fascia or inadequate pectoralis muscle.3–6 Advocates of acellular dermal matrix have also reported its positive effect on intraoperative fill volume,7 increased control of the inframammary fold and inferior pole,8–11 and potential reduction of capsular contracture.12,13 However, these potential advantages must be weighed not only against the material cost, but also against the potential added risk—albeit modest—of acellular dermal matrix.1,2,14–19

Given the relative polarity of acellular dermal matrix adoption in breast reconstruction (and paucity of guidelines for use vis-à-vis outcomes), we endeavored to develop an evidence-based, algorithmic approach to its selective use. Indications were generated from the published literature and the senior author’s experience and include a variety of preoperative and intraoperative decision points. These parameters included breast size, body mass index, radiation therapy, sentinel lymph node status, flap vascularity, and pectoralis major anatomy.

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PATIENTS AND METHODS

Acellular Dermal Matrix Indications Algorithm Development

An algorithm for selective use of acellular dermal matrix was developed based on preoperative and postoperative considerations (Fig. 1). Preoperative parameters included breast size, body mass index, preoperative radiation exposure, and potential postoperative radiation therapy (Fig. 1, above). This preoperative screen was corroborated by intraoperative anatomical and surgical findings. With respect to the interplay of breast size and body mass index, the anticipated concordance between the reconstructive outer lamella, or skin envelope, and the reconstructive inner lamella, or pectoralis plane was the salient consideration (Fig. 2). In patients with a normal body mass index and small breasts, the lengths of the outer and inner lamellae are likely to be comparable. In contrast, patients with large, ptotic breasts or high body mass index are likely to have a significant discrepancy between the length of redundant outer skin envelope and the length of the available pectoralis major muscle. In these cases of outer and inner lamellae discordance, acellular dermal matrix can augment the inner lamella to create a better match between planes, increase the volume of the lower pole, improve the vector of expansion, decrease dead space, and thus improve overall outcomes and aesthetics (Fig. 2, above). Patients with a high body mass index may also benefit from adjunctive acellular dermal matrix use to define the prosthetic pocket both inferiorly and laterally and reduce seroma risk. Notably, however, the combination of high body mass index and large breasts results in long skin flaps that are prone to ischemia and poor wound healing. Although the addition of acellular dermal matrix may provide an extra barrier in the event of threatened tissue-expander exposure, delayed reconstruction should also be considered in these high-risk patients.20

Fig. 1
Fig. 1
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Fig. 2
Fig. 2
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Although the literature is limited,20,21 in our practice, preoperative radiation exposure was a contraindication for acellular dermal matrix use given the stigma of poor tissue vascularity and the risk of poor acellular dermal matrix integration. In contrast, in the setting of anticipated postoperative irradiation, acellular dermal matrix use may speed the initial expansion curve before initiation of radiotherapy. In addition, release of the inferior border of the pectoralis major may obviate pectoralis tightness secondary to radiation-induced fibrosis.

Intraoperative decision points included sentinel lymph node status, flap vascularity, and pectoralis major anatomy (Fig. 1, below). Positive sentinel node status increased the possibility of adjuvant radiation therapy and triggered acellular dermal matrix use. Poor flap vascularity, evaluated clinically, was a contraindication for acellular dermal matrix use.20,22 With good flap perfusion, the degree of relative skin excess was appraised and the principle of outer and inner lamellae match as described above was applied. Finally, the integrity and tightness of the pectoralis major was continuously judged. Iatrogenic defects in the pectoralis, serratus fascia, or rectus fascia were managed with the use of acellular dermal matrix as an interpositional graft.6 Similarly, pectoralis tightness caused by narrow muscle width or high origin was released and supplemented with acellular dermal matrix to address the vertical offset between the inferior border of the muscle and the inframammary fold (Fig. 2, below). This allowed for expansion of the inferior pole that would otherwise be restricted.

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Patient Population and Statistical Analysis

A retrospective review of all immediate tissue-expander breast reconstructions performed by the senior author (J.Y.S.K.) before (2008 to 2009) and after (2011 to 2012) implementation of the acellular dermal matrix indications algorithm was performed with institutional review board approval. The primary outcomes of interest were aesthetic scores and postoperative complications, including overall complications, seroma, infection, explantation, and mastectomy flap necrosis. Postoperative aesthetic scores were determined by three independent members of the division not involved in patient care using anterior photographs taken at least 6 months after expander-implant exchange. Breasts were scored using a four-point scale, with 1 representing unacceptable aesthetic results and 4 representing excellent aesthetic results. The scale was developed based on previous studies assessing aesthetic outcomes following breast reconstruction.23–25 The Fleiss kappa was used to judge interrater reliability.

Statistical analyses included Pearson chi-square or Fisher’s exact tests for categorical variables and t tests for quantitative variables. Multiple logistic regression determined the independent influence of the acellular dermal matrix algorithm on postoperative outcomes. All analyses were performed with IBM SPSS Version 21.0 (IBM Corp., Armonk, N.Y.).

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Surgical Technique

The mastectomy was performed by an oncologic surgeon through an incision encompassing the nipple-areola complex with a lateral extension for skin-sparing mastectomy, or through a lateral inframammary fold incision for nipple-sparing mastectomy. For non–acellular dermal matrix cases, the serratus anterior fascia or muscle was elevated to obtain coverage.26 Acellular dermal matrix–assisted reconstruction was performed as described previously.3,6 Briefly, the inferior aspect of the pectoralis major was released toward the inferomedial border. A crescent-shaped piece of acellular dermal matrix [AlloDerm (LifeCell Corp., Branchburg, N.J.) or FlexHD (Musculoskeletal Transplant Foundation, Edison, N.J.)] was affixed to reconstitute the inferior and lateral borders of the breast. Following inset of the tissue expander, the acellular dermal matrix was sewn to the inferior border of the pectoralis, leaving a gap at the superolateral border to allow for egress of fluid from the subpectoral space. The expander was inflated in proportion to skin excess, taking care to avoid tension on the flap. In both acellular dermal matrix and non–acellular dermal matrix cases, two closed suction drains were placed in the prepectoral space, which remained in place until output was less than 20 ml over 24 hours. Oral antibiotic prophylaxis was prescribed until removal of drains.

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RESULTS

One hundred ninety-three breasts undergoing reconstruction between 2008 and 2009 before implementation of the algorithm and 179 breasts undergoing reconstruction from 2011 to 2012 were identified for analysis. Acellular dermal matrix use decreased from 84 percent to 36 percent (Fig. 3).

Fig. 3
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Overall complication rates did not differ before and after implementation of the algorithm (22.8 percent versus 20.7 percent; p = 0.612). Table 1 summarizes complication rates before and after application of the algorithm. After adjusting for potential confounders, including age, body mass index, smoking, hypertension, tissue expander texture, and radiation exposure, the use of the acellular dermal matrix algorithm did not significantly affect the incidence of infection, seroma, mastectomy flap necrosis, explantation, or overall complications (all p > 0.05) (Table 2).

Table 1
Table 1
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Table 2
Table 2
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Aesthetic scores were not affected by the reduction in acellular dermal matrix use. Overall, a nonsignificant increase was noted in aesthetic scores with its implementation, from 2.75 of 4 to 3.03 of 4 (p = 0.138). Similar changes were noticed in reconstructions both with and without acellular dermal matrix (Table 3). Representative preoperative and postoperative photographs are shown in Figure 4.

Table 3
Table 3
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Fig. 4
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Selective use of acellular dermal matrix resulted in approximately 48 percent less use after adoption of the algorithm. This translated to an estimated total cost savings of $270,000 over the 2-year study period (based on a cost of $3100 for a 6 × 16-cm acellular dermal matrix sheet).

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DISCUSSION

Acellular dermal matrix–assisted breast reconstruction has rapidly gained acceptance despite high material costs and reports of increased risks.1,2,14–19 This surge has occurred without a clear consensus on its indications or contraindications, and many surgeons are polarized to always using acellular dermal matrix or to rarely or never using it.5,11,18,20,27 This polarity stems from numerous outcomes studies highlighting complications and actualized benefit without delineating strong selection criteria.1,2,9,14–19,28–31 In fact, the only multicenter, randomized controlled trial performed to date has demonstrated equivalent outcomes.19 The variegated nature of the literature coupled with the reality of heightened cost was the impetus for greater internal scrutiny of our indications for acellular dermal matrix. In efforts to move the discourse of acellular dermal matrix outcomes into the realm of selective, discriminating use, we present a first-generation algorithm for acellular dermal matrix use in breast reconstruction. We demonstrated comparable complication rates and aesthetic outcomes while reducing costs with patient-centered, selective acellular dermal matrix use.

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Breast Size and Body Mass Index

Breast size and body mass index are important determinants of the concordance between the skin envelope and underlying pectoralis plane. Large, ptotic breasts in particular benefit from adjunctive acellular dermal matrix because of its ability to match the reconstructive inner and outer lamellae, or the length of the pectoralis–acellular dermal matrix plane, with that of the overlying skin envelope (Fig. 2). Acellular dermal matrix use facilitates the management of skin redundancy, resulting in increased contact between the skin flap and underlying muscular–acellular dermal matrix plane, decreased seroma, and decreased overall complications. Acellular dermal matrix also allows for the re-creation of more natural inferior pole projection and ptosis similar to the premastectomy state.8,32 In contrast, small, nonptotic breasts on a patient with a low body mass index generally have good match between the muscular plane and the skin envelope, and acellular dermal matrix may not be necessary.

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Pectoralis Major Anatomy

An accepted indication for acellular dermal matrix use in breast reconstruction is compromised or inadequate pectoralis major coverage.18,20,33 Inadequate pectoralis coverage may be caused by an anatomically high origin or a narrow width. Madsen et al.34 found that 72 percent of patients had a high origin or narrow pectoralis origin width–to–breast width ratio. Undoubtedly, many of these patients may be managed with elevation of serratus and rectus fascial flaps. However, without release of the pectoralis and correction of the vertical pectoralis offset with acellular dermal matrix, expansion of the lower pole is restricted, preventing a natural-appearing breast mound. Moreover, acellular dermal matrix use avoids excess elevation of serratus anterior and rectus abdominis fascia that would be required for total muscular coverage, minimizing surgical trauma and the risk of losing control of the inframammary fold and bottoming out.

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Flap Vascularity and Relative Skin Excess

Flap vascularity is affected by the mastectomy skin flap length and thickness, in addition to patient comorbidities such as peripheral vascular disease, hypertension, and, importantly, smoking history.35–37 Intraoperative evaluation of flap vascularity including trimming of any compromised skin edges is essential. The mastectomy skin flap by nature is hypovascular and subject to poor wound healing, incisional breakdown, and prosthetic exposure when additional stresses are present.36 With significantly devascularized or thin mastectomy flaps with disruption of the subdermal plexus, integration of the acellular dermal matrix will likely be compromised and total muscular coverage is recommended.20–22 In this setting, acellular dermal matrix may be contraindicated, as it will essentially act as an additional foreign body.

With good flap vascularity, acellular dermal matrix use should be based on the degree of relative skin excess toward the goal of matching skin flap length to the length of the underlying plane. This optimizes contact between the outer and inner lamellae and minimizes dead space and allows the skin flap to drape without tension. As a general rule, nipple-sparing mastectomy results in a relative excess of skin, which may benefit from acellular dermal matrix use. In a series of expander-based reconstruction following nipple-sparing mastectomy, Gould et al.38 observed a trend toward a lower rate of nipple necrosis with acellular dermal matrix use. They hypothesized that the acellular dermal matrix sling provided additional support for the prosthetic, reducing biomechanical stresses on nipple perfusion.

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Radiation Therapy

Prosthetic-based reconstruction is controversial in the setting of irradiation; however, its feasibility has been demonstrated with the a priori recognition of increased risks compared with the nonirradiated cohort.39,40 Microvascular fibrosis and poor wound healing, even without obvious skin changes, are known sequelae of radiation therapy. Decreased vascularization and fibroblast ingrowth of the acellular dermal matrix preclude its integration. Consequently, the acellular dermal matrix serves as a foreign body, inciting seroma, infection, explantation, and reconstructive failure.30,41,42 Although the literature is sparse, no studies have shown a protective effect of acellular dermal matrix on the preirradiated breast.20,22,43,44 For patients with failed breast conservation therapy and previous irradiation, the risk of poor integration of acellular dermal matrix and its associated sequelae outweigh any potential benefit.

For patients with anticipated adjuvant radiation therapy, based on a preoperative pathologic condition or positive intraoperative sentinel lymph nodes, there is a potential indication for acellular dermal matrix. Postoperative irradiation has not been shown to affect acellular dermal matrix integration; presumably, some revascularization and integration occur before the initiation of radiotherapy.43 Clinically, Spear et al.42 reported lower rates of explantation with acellular dermal matrix use in the setting of irradiation compared with historical controls of irradiated breasts without acellular dermal matrix. Seth et al.45 demonstrated a 2.63-fold increase in complications caused by postmastectomy radiation therapy in the non–acellular dermal matrix group but no significant increase in the acellular dermal matrix cohort. Although definitive conclusions are difficult to draw given our limited collective experiences,21 the data seem to support its use in this setting. Acellular dermal matrix may provide an additional barrier against exposure and increase salvage rates in the event of radiation-associated wound breakdown. Indeed, our flap necrosis rates were higher in the acellular dermal matrix group, but implant exposure and explantation rates were similar. Furthermore, particularly attractive is the early evidence that acellular dermal matrix may be beneficial for reducing radiation-induced capsular contracture.10,12,46

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Aesthetics

Spear et al.8 described the use of acellular dermal matrix secured to the pectoralis major superiorly and inframammary fold inferiorly to function as a “hammock,” supporting the prosthetic and resulting in a naturally ptotic breast with a sharply defined inframammary fold. Vardanian et al.9 focused on the use of acellular dermal matrix for optimization of the inframammary fold and demonstrated decreased mechanical shift, fewer problems associated with the inframammary fold, and superior aesthetic results with acellular dermal matrix use. Recently, Nguyen et al. showed that, compared with non–acellular dermal matrix reconstructions, acellular dermal matrix–assisted reconstructions scored higher with respect to breast mound volume, breast mound placement, and inframammary fold definition.29 Balancing this gain in aesthetic quality, a highly subjective measure, against concrete material costs and complication rates is problematic and therefore not formally considered in our algorithm. We demonstrated no change in aesthetic scores in the postalgorithm cohort.

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Cost Considerations

In this era of rising health care costs and scrutinized resource allocation, we must be prepared to justify the use of high material costs to our institutions and payers. Bank et al.47 performed an economic analysis of acellular dermal matrix use in two-stage breast reconstruction with a focus on direct variable costs associated with expansion visits. The authors found that for large breasts (>500 ml), acellular dermal matrix use reduced the number of expansion visits compared with non–acellular dermal matrix breast reconstructions (3.7 visits for acellular dermal matrix versus 8.3 visits), which translated into an average variable cost savings of only $941. Given the market price of approximately $3100 for a 6 × 16-cm sheet of acellular dermal matrix, justification of acellular dermal matrix use must be based on clinical criteria. Using our resource-sensitive algorithm, we reduced material costs by $270,000 over 2 years without compromising patient outcomes.

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Limitations

The limitations of this study include those inherent in a single-surgeon experience and sequential study design. In addition, despite using standard scoring methodology, we recognize the limitation of a four-point scale as a comparative measure and that aesthetic outcomes are highly subjective and may not correlate with patient satisfaction.48,49 Long-term patient-reported outcomes of aesthetic satisfaction should be incorporated into future studies. Follow-up time in this study was not adequate for assessing the long-term effect of acellular dermal matrix on capsular contracture. Our crude cost analysis included only the material cost of acellular dermal matrix and did not account for all probabilities and utilities of various health states; however, material costs have been shown to be the major determinant in previous acellular dermal matrix cost-utility analyses.47,50

Finally, the present algorithm was based on the senior surgeon’s clinical experience and available published data. We acknowledge that differing opinions and practices may exist. For instance, Nahabedian cautions against the use of acellular dermal matrix in the morbidly obese population because of thick subcutaneous tissue and the potential for poor adhesion of the biomaterial, which can exacerbate the already high risk of complications in these patients.20 This is perfectly reasonable, as is the option of performing a delayed reconstruction, autologous reconstruction or, frankly, no reconstruction in this subpopulation of patients. Weichman et al.18,31 assert that acellular dermal matrix use should be restricted to cases of inadequate muscular coverage given the risk associated with acellular dermal matrix. It is clear that the use of acellular dermal matrix should be decided on a case-by-case rather than an all-or-none basis. Our focus was to implement thoughtful, discriminating use of acellular dermal matrix in immediate two-stage prosthetic reconstruction and transition the dialogue toward the development of judicious patient selection criteria. For surgeons who routinely use acellular dermal matrix, this approach provides some incipient support for using acellular dermal matrix more selectively and saving cost. In a practice with limited to no acellular dermal matrix use, however, our criteria may or may not resonate with the surgeon’s own inclusion criteria. As our collective experience with acellular dermal matrix expands, future iterations of this algorithm-in-process will benefit from refinement of its decision points. Furthermore, we recognize that no single algorithm can address all clinical scenarios. In the presence of both relative indications and contraindications (e.g., thin mastectomy skin flap and a high-riding pectoralis), the surgeon must use clinical judgment in assigning priority to conflicting factors. It should be noted that as a general consideration, flap vascularity should take precedence over other variables when decision elements collide.

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CONCLUSIONS

We present an evidence-based, resource-sensitive algorithm for acellular dermal matrix use in breast reconstruction. Our indications and contraindications resulted in a nearly 50 percent reduction in acellular dermal matrix use, with significant cost savings. Furthermore, patients treated after the adoption of this algorithm experienced similar complication rates and aesthetic outcomes vis-à-vis those undergoing reconstruction before. Although not definitive, this first-generation algorithmic approach allows for a continued dialogue on the relative indications and contraindications for acellular dermal matrix use. As more conclusive, high-quality data become available, the algorithm can be adjusted to reflect the state of the literature. Until then, this acellular dermal matrix algorithm and our preliminary outcomes function as an important proof of concept that judicious measures can be taken to more selectively use acellular dermal matrix without a concomitant worsening of patient outcomes.

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CODING PERSPECTIVE

This information provided by Dr. Raymond Janevicius is intended to provide coding guidance.

19357 Breast reconstruction with tissue expander, including subsequent expansion

15777 Implantation of biologic implant

* Insertion of a tissue expander for breast reconstruction, either immediate or delayed, is reported with code 19357.

* Code 19357 is global and includes creation of the submuscular pocket, insertion of the tissue expander, closure of the wound, and subsequent expansions during the 90-day global period.

* Creation of a submuscular pocket is not a “muscle flap” and is not to be reported with code 15734. All maneuvers necessary to create a submuscular pocket, including elevation of the pectoralis major muscle and serratus anterior muscle, are included in the global code 19357.

* Acellular dermal matrix is a biologic implant and its placement is reported with code 15777.

* Code 15777 is an add-on code, so modifier 51 is not used.

* To report bilateral procedures, append “-50” to the following codes:

19357-50 Breast reconstruction with tissue expander, bilateral

15777-50 Implantation of biologic implant, bilateral

* Some payers prefer listing each procedure:

19357 Breast reconstruction with tissue expander, right

19357-50 Breast reconstruction with tissue expander, left

15777 Implantation of biologic implant, right

15777-50 Implantation of biologic implant, left

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©2014American Society of Plastic Surgeons

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