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Breast: Original Article

Complications of Acellular Dermal Matrices in Breast Surgery

Israeli, Ron M.D.

Author Information
Plastic and Reconstructive Surgery: November 2012 - Volume 130 - Issue 5S-2 - p 159S-172S
doi: 10.1097/PRS.0b013e3182634e62
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Abstract

The first reported use of acellular dermal matrix in breast surgery was in 2001 for the correction of implant rippling.1 Over the past decade, the indication for the use of acellular dermal matrices in breast surgery has expanded to include primary implant-based reconstruction, aesthetic breast surgery, revision breast surgery, and nipple reconstruction. Their use is now common practice in implant-based breast reconstruction.2 Despite their popularity, an ongoing concern is the risk of complications, particularly seroma, skin necrosis, infection, and failed reconstruction with expander or implant loss. An increased rate of these complications has been reported in some recent studies that have questioned the net benefit of acellular dermal matrix use.35

This article reviews the incidences and types of complications associated with the use of acellular dermal matrices for the various indications in breast surgery. Risk factors that may influence complications as well as strategies that may help reduce the risk of complications are also discussed.

PRIMARY IMPLANT-BASED BREAST RECONSTRUCTION

Tissue Expander/Implant Breast Reconstruction

In two-stage breast reconstruction, the acellular dermal matrix is often used to cover and support the inferior aspects of the tissue expander (Fig. 1).611 Several advantages have been reported when matrix is used in this capacity, including reducing the need for musculofascial dissection for inferior pole coverage,7 improving lower pole expansion allowing for a more natural looking breast,6,7,12 providing better control of inframammary and lateral mammary folds,6,7 reducing expander or implant migration,6,13 maximizing utilization of mastectomy skin flaps,12,14,15 facilitating greater intraoperative expander fill with a concomitant reduction in the number of expander fills and possibly time to complete expansion,7,16,17 and improved cosmesis.7,13

Fig. 1
Fig. 1:
Schematic representation of lower pole covered with acellular dermal matrix.

There is extensive published literature on acellular dermal matrix use in tissue expander/implant reconstruction. A pooled analysis that included 19 published studies (four of which reported on direct-to-implant reconstruction with acellular dermal matrix) comprising 2037 reconstructions reported an overall complication rate of 15.4 percent with this approach.18 The most frequently reported complications were seroma (4.8 percent), infection (5.3 percent), skin flap necrosis (6.9 percent), and reconstructive failure (3.8 percent). An important question that is widely debated in the current literature is whether these complications are significantly higher when compared with standard submuscular reconstruction without acellular dermal matrix assistance.

In an attempt to answer this question, 11 retrospective reviews have compared the rate of complications with and without the use of acellular dermal matrix in expander/implant breast reconstruction (Table 1).35,8,13,16,17,1922 The results from these studies are inconclusive. While five of the studies did not find an increase in complications with matrix use,8,13,16,19,20 six reported higher complication rates with matrix.35,17,21,22 One study reported overall complications to be significantly lower with matrix use.13

Table 1
Table 1:
Complications Reported in Acellular Dermal Matrix versus Nonmatrix Tissue Expander/Implant Breast Reconstruction

Although Lanier et al. reported a significantly increased rate of infection, expander removal, and total complications with acellular dermal matrix versus nonmatix reconstructions, when breasts were stratified by size (<600 g versus >600 g), rate of infection or skin necrosis were no longer significantly different between the groups.4 They noted that in general, compared with smaller breasts, all complications were higher in larger breasts, with skin necrosis being significantly higher.

Chun et al. found a statistically significant increase in infection, seroma, and skin necrosis in their acellular dermal matrix cohort.5 When native skin flap necrosis was excluded from the analysis, infection was no longer statistically higher in the matrix group. Seroma, however, remained significantly higher. Using multiple logistic regression analysis adjusted for clustering, the authors showed that acellular dermal matrix and body mass index were statistically significant risk factors for developing postoperative seroma and infection. Compared with the nonmatrix group, the matrix group had a statistically higher mean body mass index and mean mastectomy specimen weight. As alluded to earlier, Lanier et al. showed that larger breasts are associated with higher complications.4

Although Nguyen et al. reported significantly higher rates of explantation due to infected fluid collections and extrusion with acellular dermal matrix, they found no differences in rates of readmission for intravenous antibiotics for infection.21

Antony et al. reported a higher incidence of overall complications, seroma, and reconstructive failure with acellular dermal matrix, but statistical results were not provided.3 Using multivariate analysis, higher age, higher body mass index, and presence of axillary dissection were shown to be significant independent risk factors for the development of complications after breast reconstruction using acellular dermal matrix.

Collis et al. and Liu et al. reported significantly higher total complication rates with acellular dermal matrix, but rates of infection, seroma, skin necrosis, and tissue expander explantation were not significantly elevated.17,22 In the study by Liu et al., the use of acellular dermal matrix, smoking, higher body mass index, higher initial volume, and bigger implant size was found to be statistically significantly associated with a higher overall surgical complication rate.22 The matrix group in this study had a significantly higher mean mastectomy specimen weight, mean initial fill volume, and mean final implant volume as well as a significantly higher number of smokers compared with the nonmatrix cohort.

Taken together, the above studies tend to suggest that in patients with comorbid conditions and large breasts, acellular dermal matrix use may be associated with an increased risk of postoperative complications. However, this is not specific to acellular dermal matrix, as these same patient characteristics also appear to increase complications in the absence of matrix. Obesity (body mass index ≥30 kg/m2), large breasts, age (>65 years), smoking, and hypertension have been identified as risk factors for perioperative complications after conventional expander/implant breast reconstruction.23,24 In a large outcome analysis of 1170 expander/implant reconstructions over a 2-year period, patients who were obese and those with hypertension each had a nearly two times greater risk, while those who were smokers had a 2.2 times greater risk, and patients older than 65 years had a 2.5 times greater risk of developing postoperative complications. In addition, reconstructive failure was five times greater in smokers, seven times greater in obese patients, and four times greater in hypertensive patients.23 A retrospective, 6-year, single-institution review of 413 expander/implant reconstructions found a significant association between breast size larger than C cup and infection requiring intravenous antibiotics.24

Preoperative or postoperative radiation is another factor that may increase postoperative complications in implant-based reconstructions. Irrespective of acellular dermal matrix use, wound dehiscence, infection, explantation, and capsular contracture occur at a higher incidence in the setting of radiotherapy.6,7,20,21,2528 For this reason, many surgeons discourage the use of implant-based reconstruction for patients with a history of radiation or if the need for radiotherapy is known preoperatively.

Given the significant impact of these risk factors on postsurgical outcome, preoperative planning should consider these risk factors in the evaluation of procedural risks, informing patients of potential postoperative complications, setting expectations, and individualizing reconstructive options.

Meta-analyses and systematic reviews of the comparative studies have been undertaken in an attempt to determine whether complication rates are higher in acellular dermal matrix versus nonmatrix reconstructions (Table 2).18,29,30 The metaanalysis by Hoppe et al. included seven of the acellular dermal matrix versus nonmatrix comparative studies, reported an increased risk of infection, explantation, and seroma with use of matrix.29 The meta-analysis by Kim et al., which included six of the comparative studies, reported increased risk of total complications, seroma, infection, and reconstructive failure in acellular dermal matrix patients.18 In contrast, the meta-analysis by Sbitany and Serletti, which included six of the comparative studies plus three studies without a control population, reported no significant difference in the incidence of cellulitis or wound infection not requiring surgical intervention, hematoma, infection requiring expander/implant removal, or skin flap necrosis between the matrix group and the nonmatrix group. Seroma was the only complication that was significantly higher in the matrix group.30

Table 2
Table 2:
Complications Reported in Meta-Analyses of Acellular Dermal Matrix versus Nonmatrix Comparator Studies

It should be noted that the meta-analyses are based on nonrandomized trials and as such are limited by selection bias and interstudy methodologic diversity. Further, the absence of a universally accepted definition of infection, skin necrosis, and clinically relevant seroma makes comparisons of complications between studies difficult. A large prospective randomized control study is thus necessary for a definitive answer to the question of whether complication rates are higher in acellular dermal matrix versus nonmatrix-assisted expander/implant reconstructions.

Direct-to-Implant Breast Reconstruction

The use of acellular dermal matrix to extend the reach of the pectoralis major muscle allows one-stage breast reconstruction to be performed when there is sufficient preservation of skin at the time of mastectomy. The benefit of this approach lies in the elimination of the need for tissue expansion, thus simplifying reconstruction while potentially reducing the time to complete reconstruction and minimizing associated costs. Several published reports have attested to the feasibility of this approach.6,12,15,3137

A review of published studies indicates an overall complication rate of 0 percent to 44.7 percent, which included an infection rate of 0 percent to 9 percent, explantation/failure rate of 0 percent to 11 percent, seroma rate of 0 percent to 9 percent, and skin flap necrosis rate of 0 percent to 25 percent with acellular dermal matrix–assisted one-stage reconstruction (Table 3).6,12,15,3137 The 25 percent skin necrosis rate reported in one study was due to minor skin necrosis, which was managed conservatively.15 There were no instances of major skin necrosis in this study. A 44.7 percent total complication rate observed in one study was driven by a 27.7 percent mild nipple-areola skin slough rate among patients who underwent nipple-areola sparing mastectomy and single-stage implant acellular dermal matrix reconstruction through a periareolar incision.37 In the largest of the studies, an 8-year series that included 260 patients (466 reconstructions) followed for a mean period of 28.9 months, the overall complication rate was 3.9 percent, explantation rate was 1.3 percent, skin breakdown/necrosis rate was 1.1 percent, hematoma rate was 1.1 percent, and infection rate was 0.2 percent.35

Table 3
Table 3:
Complications Reported in Acellular Dermal Matrix–Assisted Direct-to-Implant Breast Reconstruction

All of the acellular dermal matrix–assisted one-stage studies were retrospective reviews that did not include reconstructions without matrix for comparative purposes. However, in one study, the authors compared data on their matrix-assisted one-stage reconstructions with that of their two-stage reconstructions without matrix (age, body mass index, and final implant size were similar between the groups) and reported no significant differences in total complications, infection, seroma, hematoma, skin necrosis, or implant loss between the two procedures.36

Although further long-term and controlled studies are needed to assess the incidence of complications associated with acellular dermal matrix use in one-stage reconstruction, the available data appear to indicate an acceptable complication profile.

Capsular Contracture and Acellular Dermal Matrix–Assisted Breast Reconstruction

Capsular contracture is a mid- to long-term complication of implant-based breast reconstruction. The incidence of clinically significant capsular contracture (Baker grade III/IV) in published studies of conventional breast reconstruction range from 10 percent to 17 percent over a 3- to 6-year period.3841 In contrast, acellular dermal matrix–assisted implant-based reconstructions appear to have a lower incidence of capsular contracture; a 0 percent to 4.4 percent rate has been reported over a mean follow-up period of 7.7 to 29 months (0.6 to 2.4 years) (Table 4).4,6,7,13,15,16,27,28,34,35,42 Further, Vardanian et al. used a multivariate logistic regression adjusted for clinical characteristics and postoperative complications to show that matrix use was associated with less capsular contracture (odds ratio, 0.18; 95 percent confidence interval, 0.08 to 0.43) and mechanical shift (odds ratio, 0.23; 95 percent confidence interval, 0.06 to 0.78) compared with conventional reconstruction.13 These results suggest that matrix use may mitigate the risk of capsular contracture in implant-based breast reconstruction. Histologic evidence is in concordance with this clinical observation.4345 Because the incidence of capsular contracture increases with time,46 and most of the studies reporting on capsular contracture with acellular dermal matrix use had a relatively short follow-up period (<2 years), longer-term follow-up is needed to confirm the low incidence of capsular contracture reported with matrix use. Of note, in the longest follow-up reported to date, a mean period of 29 months in two studies, the incidence of capsular contracture in acellular dermal matrix reconstructions was 0.4 percent and 3.8 percent.13,35

Table 4
Table 4:
Rate of Capsular Contracture Reported in Acellular Dermal Matrix–Assisted Implant-Based Reconstruction

Strategies to Minimize Complications with Acellular Dermal Matrix Use

Although the evidence for increased complications with acellular dermal matrix use is equivocal, with the goal of proactively minimizing complications, it would be judicious to incorporate best practices and established proper technique principles when using matrix in implant-based breast reconstruction. Infection is a concern with any implanted material, although the addition of matrix may compound the risk. Strict adherence to protocols that maximize sterility and minimize contamination is thus critical during surgery, including aggressive antibiotic irrigation of breast pockets and rinsing of expanders/implants in antibiotic solution before insertion. In addition, some surgeons advocate the “one-touch technique,” limiting handling of the expander/implant and acellular dermal matrix to the reconstructive surgeon to minimize contamination. Others soak the matrix in antibiotic solution for as long as possible before implantation.

The management of infectious complications requires the administration of oral or intravenous antibiotics depending on the severity of the infection. Expander/implant and/or acellular dermal matrix removal may be necessary if infection does not resolve with antibiotic therapy alone.

During the early postoperative period, erythema may occur over the lower pole of the breast (Fig. 2). Some surgeons believe that in some cases this erythema may be the result of an inflammatory response to the preservatives used in the packaging of the acellular dermal matrix.20 It may also be that erythema, particularly in thin patients, is a manifestation of the revascularization of the implanted matrix because the timing of the erythema coincides with the revascularization period. While the etiology of postoperative lower pole erythema may not always be clear, it is important to determine whether there is an infectious underlying cause or whether it is caused by the development of seroma. If infection is suspected, it is frequently resolved with oral antibiotics, but there should be a low threshold for hospital admission and treatment with intravenous antibiotics. If seroma is suspected, drainage as appropriate may be necessary.

Fig. 2
Fig. 2:
Erythema at the lower pole following acellular dermal matrix–assisted breast reconstruction.

The development of seroma with acellular dermal matrix use may be attributed to two factors: insufficient intraoperative expansion and inadequate drainage of the spaces around the expander. Insufficient intraoperative expansion increases the dead space between the expander and the skin flap, allowing for fluid retention. Ensuring sufficient intraoperative expansion would reduce the dead space and potentially reduce fluid collection. Drain placement in the subcutaneous plane (Fig. 3), with maintenance of drains until there is less than 30 cc of drainage per day, further helps minimize seroma formation. The author's personal experience suggests that mastectomy closure with the pectoralis muscle deep to the incision may help minimize the risk of device exposure in the setting of seroma formation or wound healing problems.

Fig. 3
Fig. 3:
Drain placement in the subcutaneous plane. One drain is placed along the lateral and inframammary fold, and one is placed deep to the superior breast skin.

When seroma does develop after drain removal, management depends on the grade of the seroma. Low-grade seromas may be resolved by serial percutaneous drainage in the office. High-grade seromas are managed using a closed-system drainage procedure (Fig. 4). Two options that are available for this purpose include a blunt catheter system (SeromaCath; Greer Medical, Inc., Santa Barbara, Calif.) that can be utilized by the surgeon for in-office drainage or a pigtail catheter system, which typically is utilized by an interventional radiologist in conjunction with ultrasound. The seroma fluid should be cultured and managed appropriately in the event of infection.

Fig. 4
Fig. 4:
Management of seroma. (Above, left) Patient with a seroma on the lower left outer breast and partial areolar skin slough on the right breast at the 1-month postoperative visit. (Above, right). The SeromaCath (Greer Medical, Inc., Santa Barbara, Calif.). (Below, left) Placement of a SeromaCath for seroma drainage. (Below, right) Resolution of the seroma 3 weeks later; the right areolar skin slough has healed with local care.

Skin necrosis with acellular dermal matrix use may be a consequence of thin mastectomy skin flaps, patient comorbidities, or overexpansion. The use of matrix frequently allows a greater intraoperative expander fill. In this setting, overexpansion may compromise the vascularity of the overlying mastectomy skin flap, resulting in ischemia and other complications.47 Use of new technologies such as fluorescent angiography (e.g., Spy Elite; LifeCell Corp., Branchburg, N.J.) to assess tissue perfusion may help to minimize the incidence of skin necrosis.48,49 Expansion must be performed judiciously to minimize dead space and prevent seroma formation while ensuring maximum adherence of the acellular dermal matrix to the overlying skin flap without placing undue tension on the flap.

If skin necrosis does occur (Fig. 5), the area of ischemia is allowed to demarcate and a complete excision is performed to minimize the risk of expander/implant loss. Deflation of the expander or replacement of the implant may be required during necrosis excision. In some instances, removal of the expander/implant and acellular dermal matrix may be required. In the event of wound dehiscence with expander/implant exposure, removal of the prosthesis and salvage with a flap procedure may be required (Fig. 6).

Fig. 5
Fig. 5:
Skin necrosis at the incision site (left) resolved after full-thickness excision of the devitalized skin (right).
Fig. 6
Fig. 6:
Latissimus flap salvage in the setting of implant exposure. (Above, left) Patient shown with wound dehiscence and implant exposure on the left breast following left mastectomy and implant/acellular dermal matrix reconstruction in the setting of prior radiation. The patient had undergone breast reconstruction at another facility and then presented to the author for management of device exposure. (Above, right) Close-up view of the left breast. (Below, left) Intraoperatively, a well-incorporated acellular dermal matrix was noted; despite this, the patient developed exposure. (Below, right) The patient is shown after staged reconstruction with a latissimus flap and expander, followed by implant exchange and nipple reconstruction.

There is a significant learning curve associated with the acellular dermal matrix use, and surgeons need to be cognizant of this. The incidence of complications noted during an individual surgeon's early experience with matrix in breast reconstruction may be decreased with continued use and strict adherence to established details of proper technique. This was aptly demonstrated by Colwell et al., who reported a significantly higher rate of complications in their combined first year of using acellular dermal matrix for one-stage breast reconstruction compared with their subsequent years (21.4 percent versus 10.9 percent, p< 0.02).36

AESTHETIC BREAST SURGERY

While the use of acellular dermal matrix in revisionary aesthetic breast surgery is increasing, limited data exist on the use of matrix in primary aesthetic breast surgery. Colwell and Breuing used matrix in five mastopexy/reduction mammaplasty patients to circumferentially support and shape the breasts to achieve symmetry.50 No complications were reported in this case series during a follow-up of 6 months to 3 years. In another series of 27 patients who underwent inferior pedicle reduction mammaplasty, acellular dermal matrix was used as an internal sling to support the inferior pedicle and prevent postoperative bottoming out and star-gazing phenomena.51 During a mean follow-up period of 19 months (range, 5 to 29 months), there was one incidence of cellulitis and one incidence of partial skin flap necrosis.

REVISION BREAST RECONSTRUCTION

Implant malposition, capsular contracture, ptosis, rippling, and asymmetry are commonly encountered problems associated with implant-based breast surgery.38,39,46 They are also the most common reasons for revision surgery in reconstruction as well as augmentation patients. There is an emerging trend to use acellular dermal matrix for the management of these implant-associated breast deformities.6,37,5255 A summary of these studies is listed in Table 5.1,6,37,5256 The overall complication rate with the use of acellular dermal matrix in this setting is low, ranging from 0 percent to 9.1 percent. An important observation is the low incidence of postoperative capsular contracture, including recurrent contracture.

Table 5
Table 5:
Complications Reported in Acellular Dermal Matrix–Assisted Revision Breast Surgery

NIPPLE RECONSTRUCTION

In nipple reconstruction, acellular dermal matrix has been used within the core of the newly reconstructed nipple or within a subdermal pocket below the nipple to augment nipple projection, but with limited success due to progressive loss of nipple projection over time.5761 A total of five published studies have reported the use of matrix in nipple reconstruction: three retrospective reviews,5759 one prospective study,60 and one case report.61 Collectively, a total of 114 nipples were reconstructed with assistance from acellular dermal matrix. Minimum follow-up was 6 months, and maximum follow-up was 3 years. No skin flap necrosis, wound dehiscence, or local infection was reported in these studies. Excessive nipple projection was the only complication reported in one study (in 4 reconstructions), which was resolved by debulking.60

COMPLICATIONS IN DIFFERENT ACELLULAR DERMAL MATRICES

AlloDerm (LifeCell Corp., Branchburg, N.J.), the human acellular dermal matrix, is the most extensively used matrix in breast surgery. Most of the published studies discussed in this article have used AlloDerm exclusively or in the majority of reconstructions. Published clinical experience on the use of other matrices available on the market is limited. Studies on initial experience with the use of NeoForm (processed by RTI Biologics, Inc., Alachua, Fla,. for Mentor Corporation, Santa Barbara, Calif.),9 DermaMatrix (processed by MTF, Edison, N.J., for Synthes CMF, West Chester, Pa.),10 FlexHD (processed by MTF, Edison, N.J., for Ethicon, Inc., Somerville, N.J.),11 and Strattice (LifeCell Corp., Branchburg, N.J.)28 in expander/implant reconstruction have reported complication rates that are comparable to those reported with AlloDerm (Table 6).911,28,62 Because the matrix products differ in their source tissue and in their processing, there are likely to be differences in complication rates and outcomes among the different products. Prospective randomized controlled trials are needed to determine whether there are any differences between the products. Such a study [comparing AlloDerm and SurgiMend (TEI Biosciences, Boston, Mass.)] is in progress at M. D. Anderson Cancer Center.63

Table 6
Table 6:
Complications Reported with Various Acellular Dermal Matrix Products Used in Expander/Implant Breast Reconstruction

CONCLUSIONS

The largest experience base for the use of acellular dermal matrix in breast surgery is in tissue expander/implant reconstruction. While some studies have reported an increased risk of infection, seroma, skin flap necrosis, and explantation with matrix use compared with standard reconstruction, others have not. Only prospective, randomized controlled trials can resolve the issue of whether or not these complications are truly elevated. Irrespective of the outcome of such trials, based on the knowledge that certain patient factors and intraoperative technical nuances may lead to increased complications, it would be judicious for surgeons to implement strategies that would reduce the risk of these complications to maximize the benefits that could be derived from using acellular dermal matrices. There is limited experience with the use of acellular dermal matrix for the other indications in breast surgery, and more experience is needed before the risk of complications can be effectively assessed.

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