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Evolution of the Surgical Technique for “Breast in a Day” Direct-to-Implant Breast Reconstruction: Transitioning from Dual-Plane to Prepectoral Implant Placement

Antony, Anuja K. M.D., M.P.H., M.B.A.; Poirier, Jennifer Ph.D.; Madrigrano, Andrea M.D.; Kopkash, Katherine A. M.D.; Robinson, Emilie C. M.D.

Plastic and Reconstructive Surgery: June 2019 - Volume 143 - Issue 6 - p 1547-1556
doi: 10.1097/PRS.0000000000005627
Breast: Original Articles
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Background: Direct-to-implant breast reconstruction offers the intuitive advantages of shortening the reconstructive process and reducing costs. In the authors’ practice, direct-to-implant breast reconstruction has evolved from dual-plane to prepectoral implant placement. The authors sought to understand postoperative complications and aesthetic outcomes and identify differences in the dual-plane and prepectoral direct-to-implant subcohorts.

Methods: A retrospective review of a prospectively maintained database was conducted from November of 2014 to March of 2018. Postoperative complication data, reoperation, and aesthetic outcomes were reviewed. Aesthetic outcomes were evaluated by a blinded panel of practitioners using standardized photographs.

Results: One hundred thirty-four direct-to-implant reconstructions were performed in 81 women: 42.5 percent were dual-plane (n = 57) and 57.5 percent were prepectoral (n = 77). Statistical analysis was limited to patients with at least 1 year of follow-up. Total complications were low overall (8 percent), although the incidence of prepectoral complications [n = 1 (2 percent)] was lower than the incidence of dual-plane complications [n = 7 (12 percent)], with the difference approaching statistical significance (p = 0.07). Panel evaluation for aesthetic outcomes favored prepectoral reconstruction. Pectoralis animation deformity was completely eliminated in the prepectoral cohort.

Conclusions: The authors present the largest comparative direct-to-implant series using acellular dermal matrix to date. Transition to prepectoral direct-to-implant reconstruction has not resulted in increased complications, degradation of aesthetic results, or an increase in revision procedures. Prepectoral reconstruction is a viable reconstructive option with elimination of animation deformity and potential for enhanced aesthetic results.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

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Chicago and Evanston, Ill.

From Plastic and Reconstructive Surgery, Research Design and Statistics, and Surgical Oncology, Department of Surgery, Rush University Medical Center; and Surgical Oncology, Department of Surgery, Northshore University Health System.

Received for publication March 27, 2018; accepted September 27, 2018.

Presented at Plastic Surgery The Meeting 2017, Annual Meeting of American Society of Plastic Surgeons, in Orlando, Florida, October 6 through 10, 2017, and awarded Outstanding Paper Presentation in the Breast Track.

Disclosure:Dr. Antony has a consultant agreement with Allergan Medical, Inc. She received no compensation or support for this study. The authors have no financial interest or disclosures to declare related to the content of this article.

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Anuja K. Antony, M.D., M.P.H., M.B.A., Division of Plastic and Reconstructive Surgery, Rush University Medical Center, 1725 West Harrison Street, Suite 425, Chicago, Ill. 60601, anuja_k_antony@rush.edu, Instagram: @Chicagoplasticsurgeon, Twitter: @AnuAntonyMD

“Breast in a day” direct-to-implant breast reconstruction represents an emerging technique in the field of postmastectomy reconstruction and holds appeal, as it shortens the reconstructive process, eliminates the expansion period, and avoids a second operation. The direct-to-implant technique is routinely performed using the dual-plane space, incorporating acellular dermal matrix as an inferior sling.1,2 Recent studies have indicated that direct-to-implant reconstruction may result in reduction of medical costs and improved patient satisfaction and sexual well-being.3–5 Despite this, direct-to-implant reconstruction remains relatively uncommon, and the two-stage tissue expander/implant method still constitutes 85 to 90 percent of implant-based reconstructions.6

Device placement in the prepectoral space is the newest evolution of prosthesis-based breast reconstruction. This technique is gaining interest among reconstructive surgeons because it eliminates breast animation deformity and may reduce postoperative pain associated with elevation and expansion of the pectoralis muscles.7–10 The prepectoral technique has also been described to revise previous augmentations or reconstructions and correct unwanted dynamic deformity by moving the implant from the subpectoral or dual-plane position to the prepectoral location.11,12 Widespread adoption of prepectoral reconstruction is limited by concerns regarding device failure in the absence of the pectoralis muscle, and compromise of postoperative aesthetics, including visibility of the implant.7,13–17

At our institution, direct-to-implant breast reconstruction constitutes almost 50 percent of our practice and is now performed preferentially in the prepectoral space using an acellular dermal matrix overlay technique, as we have observed enhanced aesthetics postoperatively. This approach amalgamates the benefits of both direct-to-implant reconstruction and prepectoral device placement, but has the potential for a magnified incidence of complication, as each method presents unique technical challenges resulting from the respective steep learning curves. A paucity of data exist in this regard, as few surgeons currently use this combined approach. Recent articles demonstrate renewed interest in prepectoral breast reconstruction, predominantly in two-stage tissue expander–based reconstruction.7–10,14–22 Prepectoral direct-to-implant reconstruction may confer additional benefits, including lower pain intensity and upper limb functional advantages with economic superiority compared with submuscular device placement (tissue expander or implant).9

In this study, we sought to evaluate our direct-to-implant reconstructive outcomes and investigate potential differences between our dual-plane and prepectoral cohorts with regard to postoperative complications, aesthetics, postoperative pain, and length of stay. Limited data on the prepectoral compared to dual-plane direct-to-implant approach are available, as we are aware of only two other comparative cohort studies presenting results between dual-plane and prepectoral direct-to-implant reconstructions.9,14,15 Our current experience constitutes the largest direct-to-implant only comparative patient series in the literature and adds to the growing body of research on this novel technique.

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PATIENTS AND METHODS

This study was conducted through retrospective review of a prospectively maintained database and was approved by the Rush University Medical Center Institutional Review Board. All women undergoing mastectomy followed by direct-to-implant breast reconstruction from November of 2014 to March of 2018 were identified and divided into two cohorts: dual-plane and prepectoral. All cases were performed by a single reconstructive plastic surgeon (A.K.A.) and two extirpative breast surgeons (A.M. and K.A.K.). Demographic, oncologic, and reconstructive characteristics were reviewed. Data were collected on the incidence of postoperative complications (including infection, seroma, hematoma, mastectomy flap necrosis, and exposure) along with rates of reoperation and implant loss. The incidence of capsular contracture was also investigated. Patient length of stay and pain scores for 24 hours postoperatively were reviewed and analyzed.

An objective aesthetic evaluation was conducted by means of a scoring system of standardized photographs by a blinded panel of four physicians: a general surgeon and a plastic surgeon (neither of whom operated on the patients), a medical oncologist, and a mammographic radiologist. The results assessed by the panel included only final reconstructions with completed nipple-areola complex reconstructions or contralateral symmetry procedures when indicated. Evaluators were asked to rate the overall reconstructive result (on a scale of 1 to 10) and the degree of rippling or visibility of the implant, which was assessed by the statement “the result has no evidence of rippling” or “no evidence of a visible implant,” with 1 indicating strong disagreement and 10 indicating strong agreement. Statistical analysis was performed using R 3.3.223; t tests were conducted to compare the cohorts with regard to continuous variables, and Fisher’s exact tests were conducted for categorical variables.

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Surgical Technique

Dual-plane direct-to-implant reconstructions were performed with a standard technique similar to the placement of a tissue expander. After elevation and inferior release of the pectoralis, the implant is positioned behind the muscle and the inferior pole is supported by a sling fashioned from acellular dermal matrix (AlloDerm; Allergan/LifeCell Corp., Branchburg, N.J.). The final implant is then placed into the dual-plane pocket. Prepectoral direct-to-implant reconstructions were performed with an overlay tenting technique, with the implant positioned behind a tailored, perforated 16 × 20-cm piece of acellular dermal matrix (AlloDerm), sutured to the chest wall circumferentially around the implant.

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RESULTS

One-hundred thirty-four direct-to-implant reconstructions were performed in 81 women: 42.5 percent were dual-plane (n = 57) and 57.5 percent were prepectoral (n = 77). Data collection and statistical analysis were limited to patients with follow-up of greater than 1 year, which constituted 79 percent of patients. Mean follow-up was 30.4 months for dual-plane and 16.5 months for prepectoral (p < 0.001) reconstruction. Mean age, body mass index, racial distribution, insurance status, smoking status, and presence of comorbidities were not significantly different between the two cohorts (Table 1).

Table 1.

Table 1.

The two cohorts were similar with regard to oncologic characteristics, including prior breast surgery, indication for mastectomy, mastectomy operation performed, chemotherapy, and radiation therapy before or after mastectomy (Table 2). Implant profile use was primarily anatomical (Style 410; Allergan, Inc., Dublin, Ireland) for dual-plane (anatomical, 75 percent; round, 25 percent), and the majority were round, high-fill cohesive gel (Style SRX/SSX/SCX; Allergan) for prepectoral (round, 53 percent; anatomical, 47 percent). Implant volume was comparable between cohorts (dual-plane, 506 cc; prepectoral, 462 cc; p = 0.16) (Table 3).

Table 2.

Table 2.

Table 3.

Table 3.

The overall incidence of complications, including infection, hematoma, seroma, mastectomy flap necrosis, implant exposure, and capsular contracture, was 12 percent (n = 7) for dual-plane and 2 percent (n = 1) for prepectoral (p = 0.07). There were no cases of complete device loss, although three implants (dual-plane, n = 2; prepectoral, n = 1) required removal and downsizing to placement of a tissue expander (Table 4). In the case of the two dual-plane reconstructions, a patient undergoing bilateral reconstruction experienced an anaphylactic reaction to the isosulfan blue dye, received intraoperative epinephrine, and subsequently had bilateral partial mastectomy flap necrosis with unilateral exposure, necessitating excision of the demarcated flaps and downsizing to a tissue expander. In the case of the prepectoral reconstruction, a patient undergoing bilateral reconstruction, with a history of augmentation and cardiac surgery with subpectoral pacemaker leads, experienced a 2-mm area of persistent poor wound healing of her mastectomy flap with concern for exposure. The patient was returned to the operating room, her implant was removed, and downsizing to a tissue expander with placement of a latissimus dorsi flap to reinforce the thin mastectomy flap was carried out. Both patients have completed exchange operations and have stable implant constructs.

Table 4.

Table 4.

One case (1.7 percent) of capsular contracture was identified in the dual-plane cohort that required operative revision and implant exchange. Thus far, there have been no cases of capsular contracture among prepectoral reconstructions.

Mean pain scores for the first 24 hours postoperatively were low for both cohorts (dual-plane, 3.62; prepectoral, 3.55; p = 0.86) and length of stay was similar (dual-plane, 1.77 days; prepectoral, 1.79 days; p = 0.90). Dual-plane and prepectoral reconstructions were equally likely to undergo reoperation for aesthetic revision [dual-plane, n = 10 (18 percent); prepectoral, n = 9 (19 percent); p = 0.42), including lipofilling, implant exchange, and mastopexy of the reconstructed breast(s). Pectoralis animation deformity was completely eliminated in the prepectoral cohort.

Blinded panel evaluation determined that overall reconstruction scores were highest for prepectoral reconstruction compared with dual-plane reconstructions independent of laterality (bilateral prepectoral, 8.1; unilateral prepectoral, 6.3; bilateral dual-plane, 6.1; and unilateral dual-plane, 5.3). The panel also favored prepectoral with regard to lack of rippling (prepectoral, 8.2; dual-plane, 6.9) and lack of visibility of the implant (prepectoral, 7.6; dual-plane, 6.2).

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DISCUSSION

Direct-to-implant breast reconstruction is at the forefront of advancements in postmastectomy breast reconstruction and presents distinct advantages compared with tissue expander and implant reconstruction through a shorter, more efficient reconstructive process and potential for reduced cost, improved patient satisfaction, and quality of life.3–5,24 Although some authors have demonstrated similar rates of complications between direct-to-implant and tissue expander/implant reconstructions,4,25 other studies highlight the technical challenges and potential pitfalls of the direct-to-implant approach. A recent meta-analysis in 2014 found direct-to-implant reconstruction to result in a higher incidence of flap necrosis, reoperation, and implant loss compared to tissue expander/implant reconstruction, and a large National Surgical Quality Improvement Program study corroborated these findings with higher rates of implant loss.26,27 There is additional evidence to suggest that direct-to-implant reconstructions may be more likely to require operative revision, as high as 87 percent3; however, early outcomes may be related to the steep learning curve, as Colwell et al. demonstrated that complication rates were reduced by half after the initial year performing the direct-to-implant technique.2

Prepectoral implant placement represents another step toward advancing postmastectomy reconstruction and has been described with both tissue expander and direct-to-implant methods, although studies are only now emerging. Prepectoral breast reconstruction eliminates dynamic deformity of the implant and has the potential to reduce postoperative pain and narcotic use, expediting recovery for postmastectomy patients compared to submuscular implant placement.8,9 In addition, prepectoral reconstruction, although associated with increased additional cost of the acellular dermal matrix, may ultimately prove cost-effective through avoidance of secondary operations, decreased use of health care resources (e.g., physical therapy, decreased narcotic use, and length of stay), and faster return to work.24 Prepectoral implant placement may also confer aesthetic benefits, resulting in a natural appearance to the reconstructed breast.7,17 When combined with a direct-to-implant operation, prepectoral reconstruction capitalizes on the advantages of both methods and may amplify benefits to the patient. Historically high complication rates, concern regarding the cosmetic results, and a steep learning curve have resulted in relatively few reconstructive surgeons who routinely use this technique.28 However, the advent of acellular dermal matrix, improved implant designs, and the evolution of mastectomy operations with greater conservation of the breast envelope have all contributed to renewed interest in prepectoral reconstruction.7–10,14–22

In our prepectoral patients, we experienced a low incidence of complications, with only one case (2.1 percent) of persistent delayed wound healing requiring excision and downsizing to a tissue expander. Aggressive management is recommended for any mastectomy flap necrosis to avoid loss of the reconstructive domain. Complication rate in the dual-plane reconstruction cohort was also low at 12.3 percent, although this difference approached significance (p = 0.07), despite similar patient demographics and oncologic history. We feel that both techniques are viable and that this difference may be attributable to acceleration along the learning curve, as the majority of the dual-plane cohort precedes the prepectoral cohort temporally. It is notable, however, that the incidence of complications was not increased in the prepectoral cohort even though the implant is placed in the more vulnerable, superficial position.

In the small body of literature on prepectoral direct-to-implant reconstruction, reported rates of partial or total mastectomy flap necrosis range from 0 to 28 percent and implant loss ranges from 0 to 18 percent, with higher rates occurring in smokers and women with previous radiation therapy, highlighting the need for judicious patient selection when considering a prepectoral direct-to-implant reconstruction.7–10,13–15,26 We corroborate the need for careful patient selection and consider smoking and poorly controlled medical comorbidities to be absolute contraindications.

In our practice, typical candidates for prepectoral direct-to-implant reconstruction are women with small or medium-size breasts who desire a reconstruction similar to the size of their native breast. We have expanded our indications and found that patients with mild ptosis or postpregnancy volume loss can achieve a lifted appearance to the reconstructed breast with conservative implant upsizing in the pliable envelope. Patients with previous breast irradiation require careful evaluation, and the breast tissue and skin must exhibit minimal radiation-induced changes to accommodate the implant in a prepectoral direct-to-implant reconstruction. Radiation therapy is not an absolute contraindication. We have found that in the properly selected patient, prepectoral direct-to-implant reconstruction may provide a reasonable alternative, as it avoids expansion of the previously irradiated mastectomy flaps and donor-site morbidity of autologous tissue. Similarly, we do not consider previous breast surgery to be a contraindication; however, increased vigilance is necessary, as prior augmentation may lead to thinner and vascularly compromised mastectomy flaps and may contribute to an increased risk of flap complications.

Other considerations, highlighted by Sigalove et al. and others, include oncologic features.18,19,29 For example, patients with tumors located in close proximity to the chest wall may be better served by a submuscular reconstruction, to allow for enhanced surveillance for recurrence in the pectoralis muscle. Other factors, such as inflammatory breast cancer or the need for axillary lymph node dissections, should also be considered.18,19 Some surgeons prefer to limit prepectoral reconstruction to patients undergoing nipple-sparing mastectomies; however, in our practice, we have used this technique after skin-sparing and modified radical mastectomies as well. Further studies and longer follow-up are necessary to determine any long-term oncologic ramifications of this approach given the recent reemergence of the prepectoral approach although, arguably, logic for alloplastic reconstruction in the native breast space might be derived from the robust data on free flap reconstruction performed in the prepectoral space.

Reconstructive surgeons may be hesitant to use prepectoral direct-to-implant reconstruction because of concern for jeopardizing cosmetic outcomes in the form of rippling or visibility of the implant. At our institution, direct-to-implant reconstruction constitutes nearly half of our current device-based breast reconstruction practice and is now performed preferentially in the prepectoral space, as we have observed favorable aesthetics with this approach. Contrary to prior studies, results from this study indicate that prepectoral direct-to-implant reconstructions are not more likely to undergo reoperation for aesthetic reasons, including lipofilling, implant exchange, and mastopexy of the reconstructed breast [dual-plane, n = 10 (18 percent); prepectoral, n = 9 (19 percent); p = 0.42]. Enhanced aesthetics in the prepectoral cohort were corroborated through objective panel evaluation by blinded physicians, with higher overall reconstruction scores for prepectoral (bilateral, 8.1; unilateral, 6.25) compared to dual-plane cases (bilateral, 6.1; unilateral, 5.25). A series of representative outcomes are demonstrated with preoperative and postoperative photographs in Figures 1 through 4. (See Video, Supplemental Digital Content 1, which demonstrates postoperative results with absence of dynamic deformity with pectoralis muscle contraction, http://links.lww.com/PRS/D457.)

Fig. 1.

Fig. 1.

Fig. 2.

Fig. 2.

Fig. 3.

Fig. 3.

Fig. 4.

Fig. 4.

Video.

Video.

We believe several factors contribute to the favorable cosmetic results of prepectoral reconstructions. Placement of the implant in the submuscular position is often limited by the medial insertion of the pectoralis fibers. With the implant superficial to the muscle, the reconstructive surgeon is not restricted and is able to properly position the implant to attain medial cleavage of the reconstructed breasts. In addition, we have found that in the subcutaneous position, the implant settles into the mastectomy envelope to create a subtle and natural ptosis, and the contour of the implant is allowed to transmit more readily through the mastectomy flap without the overlying pectoralis muscle. In this regard, the prepectoral technique capitalizes on the perceived benefits of a subglandular augmentation with correction of mild ptosis, the appearance of natural contours, and absence of animation deformity. In addition, the prosthesis is placed into the same anatomical space from which the native breast tissue was removed, contributing to a more natural appearance; this opinion is shared by other authors who perform prepectoral tissue expander and implant reconstruction.15,16,18–20

In prepectoral reconstruction, proper implant selection is critical. Both round and anatomical implants have been used in our practice with good cosmetic outcome. We have found high-fill “Extra-full profile” cohesive gel implants (SCX, SSX, SRX; Allergan) are useful to counteract rippling potential when performing a prepectoral direct-to-implant reconstruction, and as such, there is a higher proportion of this implant type in the prepectoral cohort. The equivalent low revision rate in the prepectoral cohort (follow-up ≥1 year) reinforces the reduced need for significant subsequent lipofilling, as the implant shell characteristics are less visible. The natural appearance is further enhanced by the absence of pectoralis animation deformity; which was completely eliminated in the prepectoral cohort in this study. Although the differing length of follow-up is a consideration, both cohorts had follow-up of at least 1 year, with mean follow-up of 30.4 and 16.5 months. Furthermore, blinded panel evaluation also demonstrated higher scores among the prepectoral reconstructions with regard to lack of rippling (dual-plane, 6.9; prepectoral, 8.2) and lack of implant visibility (dual-plane, 6.2; prepectoral, 7.6).

Although this is the largest direct-to-implant–only comparative study to date (using acellular dermal matrix overlay tent), Casella et al. and Bernini et al. have published their early and late results with retropectoral and subcutaneous direct-to-implant reconstruction using titanium-coated polypropylene mesh. These authors similarly experienced no difference in implant rippling or visibility between prepectoral and dual-plane reconstruction and found objective cosmetic evaluation to favor prepectoral reconstruction.14,15 Another recent article by Cattelani et al. demonstrated increased patient satisfaction following prepectoral direct-to-implant reconstructions compared to dual-plane direct-to-implant and tissue expander/implant reconstructions (using acellular dermal matrix wrap).9 Patient satisfaction is an important consideration and will be a critical component of future directions.

Proponents of the prepectoral approach have described techniques to reduce the incidence of implant rippling and visibility. For example, Sigalove et al. routinely perform fat grafting anterior to the implant to thicken the mastectomy flap and enhance gliding movement within the subcutaneous pocket.18 In our practice, we do not perform fat grafting to the fresh mastectomy flaps but will consider subsequent grafting. Some surgeons feel that prepectoral reconstruction results in increased visibility of the superior implant border. To mitigate this in prepectoral tissue expander reconstructions, Sbitany et al. perform lipofilling to the upper pole at the time of exchange to permanent implant.19 Pittman et al. describe the P1 method, which uses a partial-thickness slip of pectoralis muscle to mask the upper pole.17 In our experience, we find that use of an initial tight construction of the acellular dermal matrix pocket and the aforementioned use of high-fill cohesive gel implants reduce the potential for rippling and upper pole visibility. Lipofilling remains an available option as a revision procedure if needed. We have more recently used higher cohesivity implants as an additional preventative measure. We did note that the lipofilling performed secondarily for prepectoral direct-to-implant reconstruction appeared to be for more minor defects.

Advocates of the prepectoral technique are encouraged by the potential to reduce postoperative pain and shorten recovery by avoiding dissection and expansion of the pectoralis muscle. Some surgeons report an observation of reduced narcotic requirements and decreased postoperative pain with prepectoral reconstruction, in addition to superior upper limb function.8–10 In our study, no significant difference was seen between the dual-plane and prepectoral cohorts with regard to pain scores (dual-plane, 3.62; prepectoral, 3.55; p = 0.86) or length of stay (dual-plane, 1.77 days; prepectoral, 1.79 days; p = 0.90); however, standardized postoperative management and recent implementation of an enhanced recovery after surgery protocol at our institution may better delineate differences.

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CONCLUSIONS

Prepectoral direct-to-implant reconstruction is an innovative approach that offers several unique advantages, including the benefits of a single-stage operation and elimination of breast animation deformity. Transition from dual-plane to prepectoral direct-to-implant reconstruction has not resulted in increased complications or degradation of aesthetic results; interestingly, prepectoral reconstructions did not require an increased number of revision procedures and achieved higher aesthetic scores from our blinded panel. We have found the evolution from dual-plane to prepectoral direct-to-implant reconstruction to be a natural progression toward advancing the field of postmastectomy breast reconstruction, amalgamating the advantages of both prepectoral and direct-to-implant techniques to achieve enhanced aesthetic outcomes and a shortened reconstructive process.

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ACKNOWLEDGMENTS

The authors give special thanks to Vicky Kang, M.D., Andrea McNab, M.D., Gene R. Solmos, M.D., Norman L. Wool, M.D., Melody A. Cobleigh, M.D., and Mark A. Grevious, M.D.

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REFERENCES

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13. Downs RK, Hedges K. An alternative technique for immediate direct-to-implant breast reconstruction: A case series. Plast Reconstr Surg Glob Open 2016;4:e821.
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15. Bernini M, Calabrese C, Cecconi L, et al. Subcutaneous direct-to-implant breast reconstruction: Surgical, functional, and aesthetic results after long-term follow-up. Plast Reconstr Surg Glob Open 2015;3:e574.
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17. Pittman TA, Abbate OA, Economides JM. The P1 method: Prepectoral breast reconstruction to minimize the palpable implant edge and upper pole rippling. Ann Plast Surg. 2018;80:487–492.
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20. Nahabedian MY, Cocilovo C. Two-stage prosthetic breast reconstruction: A comparison between prepectoral and partial subpectoral techniques. Plast Reconstr Surg. 2017;140(6S Prepectoral Breast Reconstruction):22S–30S.
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