Expert Review of Medical Devices

ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20

Biologic matrices in oncologic breast reconstruction after mastectomy Ergun Kocak, Theodore W Nagel, John H Hulsen III, Katherine H Carruthers, Stephen P Povoski, Christopher J Salgado & Albert H Chao To cite this article: Ergun Kocak, Theodore W Nagel, John H Hulsen III, Katherine H Carruthers, Stephen P Povoski, Christopher J Salgado & Albert H Chao (2014) Biologic matrices in oncologic breast reconstruction after mastectomy, Expert Review of Medical Devices, 11:1, 65-75 To link to this article: http://dx.doi.org/10.1586/17434440.2014.864087

Published online: 22 Nov 2013.

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Biologic matrices in oncologic breast reconstruction after mastectomy Downloaded by [York University Libraries] at 13:42 05 November 2015

Expert Rev. Med. Devices 11(1), 65–75 (2014)

Ergun Kocak*1, Theodore W Nagel1, John H Hulsen III1, Katherine H Carruthers2, Stephen P Povoski3, Christopher J Salgado4 and Albert H Chao1 1

Department of Plastic Surgery, The Ohio State University, 915 Olentangy River Road, Suite 2100, Columbus, OH 43212, USA 2 The University of Toledo College of Medicine, 3000 Arlington Ave., Toledo, OH 43614, USA 3 Department of Surgery, Division of Surgical Oncology, The Ohio State University, 410 West 10th Avenue, Columbus, OH 43210, USA 4 Division of Plastic Surgery, University of Miami Hospital, 1321 NW 14th St, Ste 402, Miami, FL 33125, USA *Author for correspondence: Tel.: +1 614 293 8566 [email protected]

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As the demand for post-mastectomy breast reconstruction has continued to rise, options for the implantable soft-tissue replacement products which enhance the aesthetic and reconstructive outcome of these procedures has grown as well. While the most common product used in an alloplastic breast reconstruction is an acellular dermal matrix derived from human sources, many other options are currently available, each offering their own unique properties and benefits. This review presents a concise description of each of the biologic matrices currently available and discusses their use in the context of one-stage and two-stage breast reconstructions. KEYWORDS: acellular dermal matrix • breast reconstruction • small intestine submucosa

Breast cancer is one of the most common cancers with a lifetime risk of 1 in 8 (12%) among women in the USA [101]. While adjunct therapies such as radiation and chemotherapy are sometimes indicated, the primary treatment for most breast cancers involves surgical tumor extirpation. In some cases, a breast conserving approach, which limits the resection to only the tumor and immediately adjacent breast tissues, can be applied. However, when tumors are multifocal or very large, a mastectomy to remove all of the breast tissue, most often including the nipple–areola complex, is indicated. While quite effective in removing tumor masses, mastectomies can be disfiguring and can have a negative psychological impact on affected women. Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment [1]. In general, breast reconstruction can be accomplished using the patient’s own tissues (autologous), implantable prosthetic devices (alloplastic) or a combination of these methods, incorporating both tissue and implanted material. Recent studies indicate that over the last decade, there has been a significant increase in the rate of alloplastic reconstructions compared with autologous tissue reconstructions in the USA [2,3]. 10.1586/17434440.2014.864087

The popularity of implant-based reconstruction has driven the development of new surgical techniques and methods aimed at improving aesthetic outcomes, shortening the time needed to complete the reconstructive process and improving soft tissue coverage over the implant to minimize complications. Of these innovations, one of the advancements that has been the most significant has been the use of biologic matrices [4]. Following this trend, a large array of biologic materials have become commercially available, making it a challenge for the reconstructive surgeon to choose the most appropriate material for a specific patient. Each of these products differs in the biologic source, processing, sterility, polarity and cost. Therefore, this review aims to highlight the available biologic materials, the various distinctions between them, the surgical outcomes associated with each and the evidence supporting their use in single-stage and two-stage breast reconstructions. Search methods

A literature search was performed in PubMed using the MeSH keywords ‘acellular dermal matrix, acellular dermis, porcine submucosa, allomax, cadaveric dermis, prosthetic, alloderm, allo-derm, acellular human dermis, acellular tissue matrix’ combined with ‘breast reconstruction’ using the Boolean operator


2014 Informa UK Ltd

ISSN 1743-4440

65

Review

disinserted caudal edge of pectoralis muscle and anterior chest wall to create an inferolateral sling, essentially extending the pectoralis major muscle to the inframammary fold (IMF) to provide complete implant coverage (FIGURE 1) [11]. Two years later, the first report of ADM in two-stage alloplastic reconstruction appeared, confirming the value of biologic matrices in reconstructive breast surgery [12]. While ADMs are the most commonly employed soft-tissue substitutes in breast reconstruction, a second family of implantable products also exists, which are non-dermis-based-grafts manufactured from the extracellular matrix (ECM) derived from the submucosal layer of porcine small intestine. Also known as porcine small intestine submucosa (SIS), Figure 1. Reconstructive techniques. Schematic depicting (A) placement of traditional expander/implant and (B) inferiolateral placement of acellular dermal matrix for implantthe product was first introduced for use based breast reconstruction. as an aorta replacement in 1992, and has an extensive history in hernia repair, due ‘AND’. Search results were reviewed and articles of relevance to reports that SIS minimized postoperative elasticity when were obtained in full text. The reference sections from these compared with dermis-based grafts [13,14]. Application in plastic articles were used to identify additional studies of interest. surgery has been more recent, with the largest series in Only full-length original articles originally published or 2009 documenting its success in areas such as facial rejuvenaaccepted for publication in the English language were consid- tion, reconstructive and aesthetic breast surgery and body ered for further review. contouring surgery [15]. A

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Kocak, Nagel, Hulsen III et al.

B

History of biologic matrices in plastic surgery

Many different products constitute biologic grafts used in softtissue repair. The most commonly used are the acellular dermal matrices (ADMs) derived from either human or animal sources. The tissue is processed to remove the cells and antigenic components, with the remaining dermal matrix serving as a biologic scaffold composed of collagen, elastin, hyaluronic acid, fibronectin and proteoglycans. This type of allograft dermis has been used for soft-tissue augmentation for over 20 years, with the first report appearing in 1995 in a paper published by Wainwright et al. [5]. In this publication, the author described how ADM had been used successfully as a dermal substitute for burn reconstruction. After this initial publication, applications for ADM were expanded to include abdominal wall reconstruction, static slings for facial reanimation, cleft palate repair and head and neck reconstruction. Six years later, Duncan et al. explored the use of ADM in the breast surgery setting to correct surface irregularities after cosmetic augmentation [6]. There has since been a slow transition in the use of ADM from its initial applications in aesthetic breast surgery to reconstructive breast surgery where it was used in combination with other implantable devices such as tissue expanders and breast implants. In 2005, Breuing and Warren reported the first series of ADM-assisted single-stage breast reconstructions [7–10]. The surgical technique placed ADM between the 66

Biologic matrices in oncologic breast reconstruction after mastectomy

To understand the role of biologic matrices in breast reconstruction, it is necessary to first understand the changes that occur with a mastectomy. A mastectomy entails removal of not only breast tissue, but a portion of overlying skin, generally including the nipple–areola complex. As a result, there is a deficiency of skin and subcutaneous tissue, which increases the tension of wound closure and may even lead to delayed wound healing. In addition, contained within the breast tissue that is removed is a vascular network that gives blood supply to the overlying breast skin and subcutaneous tissue. Therefore, a mastectomy partially devascularizes the skin and soft tissue of the surrounding region, and renders it susceptible to further vascular compromise from factors such as pressure. Both patient and surgical factors direct the manner in which the subsequent breast reconstruction technique is performed [16]. When alloplastic reconstruction is planned, one of the primary considerations is attaining reliable soft tissue coverage over the implant, which is a foreign body, in order to prevent complications such as infection, extrusion and malposition. However, the changes that occur with a mastectomy, as described above, pose a challenge in this regard. For this reason, the traditional approach to alloplastic reconstruction has involved a two-stage procedure. The first stage involves placement of a tissue Expert Rev. Med. Devices 11(1), (2014)

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Biologic matrices in oncologic breast reconstruction after mastectomy

expander, which is a temporary implant whose volume can be adjusted in a clinic setting. The tissue expander is typically placed with a relatively small initial volume and beneath the pectoralis major muscle, in order to minimize tension on the overlying skin and subcutaneous tissue. Following a brief period of postoperative recovery, the tissue expander is then serially inflated with sterile saline until the desired volume is achieved, to which the body responds by stretching the existing skin and soft tissue envelope. At a second stage, the tissue expander is removed and replaced with a permanent implant. This expansion process allows for a larger volume implant to be placed in the mastectomy defect than would otherwise have been possible. While effective in addressing soft tissue coverage of the implant, this two-stage method is not without complicating factors, such as pain during the expansion phase, inability to control the position of key anatomic landmarks (inframammary and lateral mammary folds) and difficulty in controlling expansion vectors which may result in breast flattening or implant malposition [17]. Biologic matrices may serve to remedy many of the deficiencies of traditional alloplastic breast reconstruction. Typically, these materials are surgically placed to span between the disinserted inferior edge of the pectoralis major muscle and the anterior chest wall. After placement, the patient’s blood infiltrates the biological matrix and brings host stem cells that adhere to the matrix and differentiate. This process promotes revascularization and incorporation of the product into the surrounding normal tissue. Over time, the matrix will become completely populated with the host cells and functionally become the patient’s own tissue. The use of biological matrices enhances soft tissue coverage and support by acting as an internal bra or sling. It also allows the plastic surgeon to set key aesthetic breast landmarks, by sewing the inferior and lateral borders of the biologic matrix to the chest wall at specific points. These matrices also create a larger volume of space beneath the pectoralis major muscle to accommodate the tissue expander or, in some cases, the permanent implant. In twostage operations, this increased space can accommodate larger initial tissue expander fill volumes and, consequently, decrease the number of postoperative fills needed to reach a given volume. If adequate skin is spared at the time of the mastectomy, this increase in space can even allow for the direct placement of permanent implants, eliminating the need for two stages all together [18]. As a result, biologic meshes have found utility in both single-stage and two-stage reconstruction methods and represent a paradigm shift in alloplastic breast reconstruction. One-stage implant-based breast reconstruction

The single-stage or ‘direct-to-implant’ reconstruction obviates the need for a lengthy tissue expansion process and an obligatory return to the operating room. The option of a single-stage implant reconstruction has been expanded with the use of biologic meshes in breast surgery [6,19]. Using biologic materials to create a controlled pocket reduces implant migration and www.expert-reviews.com

Review

Figure 2. Acellular dermal matrix placement.

provides additional implant coverage, specifically if there is a tissue deficit at the inferolateral breast pole [20–24]. This allows the surgeon to fully utilize the existing mastectomy skin envelope and better control the lower pole projection and positioning of the IMF, both recognized to be key breast anatomical landmarks [21–24]. Patients with small to medium breasts with moderate ptosis are ideal candidates for direct-to-implant reconstruction with biologic meshes [25]. In these patients, less dissection is required as full muscle or fascial coverage of the implant is unnecessary [23]. However, it is important to note that an accurate assessment of skin quality and viability, both preoperatively and post-mastectomy, is paramount as biologic matrices require well-vascularized tissue for successful incorporation in even the most ideal patients [25]. Two-stage tissue expander/implant-based breast reconstruction

A traditional two-stage tissue expander/implant-based breast reconstruction may either be surgeon preference or mandated by patient factors. The core anatomic consideration is the quantity and quality of the patient’s post-mastectomy skin envelope. A staged tissue expander/implant-based reconstruction (rather than a physiologically aggressive direct-to-implant method) is warranted if there is a paucity of remaining mastectomy skin or if the viability of the skin flap is in question [16]. The benefits of biologic meshes in two-stage tissue expander/ implant reconstruction are similar to single-stage in that these products improve tissue expander positioning, control of the IMF position, and lower pole projection. Additionally, the use of biologic materials in staged reconstructions allow for a faster rate of tissue expansion because of the greater size of the implant pocket and the elasticity of the material itself [17–18]. Choosing a biologic mesh of appropriate thickness is an 67

34.00

26.00

28.00

21.00

1  1 to 20  25

1  1 to 16  20

3  3 to 25  40

2  3 to 20  30

Yes

No

No

No

important consideration in these cases, especially if the mastectomy skin has tenuous perfusion. While it may be tempting to choose a thicker sheet of AMD/ SIS, thicker sheets have inherently more acellular material that must be revascularized, thus requiring more time and a more vascularized bed for success [16]. Biologic matrix options

ADMs are the most commonly employed type of biologic graft used in alloplastic breast reconstruction. However, the more recently developed SIS products are slowly gaining recognition as comparable alternatives with the existing ADM options. TABLE 1 illustrates the range of ADM and SIS products currently available and highlights their individual features. Published clinical studies utilizing these different biologic materials are outlined in TABLE 2.

Soak in saline

Human acellular dermal matrices AlloDerm (LifeCell)

†

Ethylene oxide gas Yes 1.5 Biodesign Surgis Tissue Graft

SIS products: porcine

Price estimates based on cost of 6  16 cm or 4  16 cm sheets of product. Data taken from [45–47,102–110].

3–10

0.5 Ethylene oxide gas Yes 3

2 Radiation Yes 2



Strattice

ADM products: non-human

SurgiMend

Soak in saline Variable No 3 DermaMartix

Soak in saline

Not available 1  2 to 20  25 Yes 3



Neoform

Yes

Radiation

5

Soak in saline

48.00 2  4 to 16  20 No 5 Radiation Yes 5 AlloMax

No 3 FleHD Acellular Hydrated Dermis

Soak in saline

34.00 1  2 to 20  25 Yes None

Soak in saline

32.00 1  1 to 16  20 Yes Yes 2 AlloDerm Ready to Use

No AlloDerm

ADM products: human

2

Radiation

2

Rinse

37.00 1  1 to 16  20 Yes Soak in saline 10–40

Rehydration time (min) Sterilization method Sterile Shelf life (years)

Soak in saline

Approximate cost/sq cm ($)† Size range (cm)

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Polarization Rehydration method 68

Device

Table 1. Implantable devices available for soft tissue augmentation.

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AlloDerm Regenerative Tissue Matrix (RTM) is a donated cadeveric human dermis allograft. It is aseptically processed to remove all cells and freezedried to remove moisture while preserving the biologic components and structure of the dermal matrix. The AlloDerm product instructions state that comprehensive donor screening and testing is performed on all tissue donors according to the US FDA regulations and tissue banking standards. Adherence to these standards minimizes the risk of disease transmission from donor tissue to recipient patient. However, despite these regulations, AlloDerm is not guaranteed to be free of all pathogens [102]. AlloDerm has been studied extensively in various clinical practices and is frequently used with ‘direct-to-implant’ breast reconstructions. Longterm follow-up data, including complication rates, have been reported [25]. However, currently there have been no long-term studies published that evaluate the carcinogenic potential, mutagenic potential or reproductive impact of AlloDerm implantation. AlloDerm is contraindicated for use in any patient who is sensitive to polysorbate 20 or any of the antibiotics listed on the packaging. The product is distributed in an outer package, which seals a nonsterile inner pouch containing a single sheet of AlloDerm. The unopened outer package may be stored at room temperature. Product sizes range from sheets of 1 cm  1 cm to 16 cm  20 cm and are manufactured in four thickness: thin, medium, thick and x-thick (ranging from 0.23 to 3.3 mm). Prior to implantation, AlloDerm requires a 10–40 min two-step rehydration process that Expert Rev. Med. Devices 11(1), (2014)

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Table 2. Existing literature supporting the use of acellular dermal matrices in breast reconstruction. Study (year)

Product(s) used

1- versus 2-stage reconstruction

Sample size (n)

Ref.

Breuing et al. (2005)

AlloDerm

1-Stage

10

[11]

Margulies et al. (2005)

AlloDerm

2-Stage

31

[48]

Gamboa-Bobadilla et al. (2006)

AlloDerm

1-Stage

11

[49]

Parikh et al. (2006)

AlloDerm

2-Stage

43

[50]

Salzberg et al. (2006)

AlloDerm

1-Stage

49

[20]

Bindingnavele et al. (2007)

ADM-Human (non-specified)

2-Stage

41

[12]

Breuing et al. (2007)

AlloDerm

Both

43

[21]

Ashikari et al. (2008)

AlloDerm

1-Stage

65

[51]

Preminger et al. (2008)

AlloDerm

2-Stage

45

[52]

Spear et al. (2008)

AlloDerm

2-Stage

43

[53]

Becker et al. (2009)

AlloDerm, DermaMatrix

2-Stage

30

[24]

Derderian et al. (2009)

AlloDerm

1-Stage

20

[54]

Losken et al. (2009)

AlloDerm, NeoForm

2-Stage

22

[31]

Namnoum et al. (2009)

AlloDerm

2-Stage

20

[55]

Sbitnay et al. (2009)

AlloDerm

2-Stage

50

[56]

Antony et al. (2010)

AlloDerm

2-Stage

96

[57]

Chen et al. (2010)

AlloDerm

2-Stage

13

[58]

Chun et al. (2010)

AlloDerm

Both

135

[59]

Ellsworth et al. (2010)

Alloderm

1-Stage

1

[60]

Lanier et al. (2010)

Alloderm, FlexHD, Strattice

2-Stage

75

[61]

Liu et al. (2011)

AlloDerm

Both

192

[62]

Newman et al. (2011)

AlloDerm, DermaMatrix, FlexHD, NeoForm

Both

395

[63]

Salzberg et al. (2011)

AlloDerm

1-Stage

260

[25]

Weichman et al. (2013)

AlloDerm

Both

228

[43]

Data taken from [45,64].

produces the soft and pliable product. Incomplete rehydration will give AlloDerm an uneven thickness and mottled appearance. Once properly rehydrated, AlloDerm must be used within 4 h [102]. It is important to note that AlloDerm is polarized and consists of a dermal side which contains a vascular network through which revascularization by the host occurs, and a basement membrane side which does not. When used in breast reconstruction it is recommended that the dermal side be placed against the mastectomy flap and not the tissue expander or implant. At times, this polarity is indistinct and requires a careful visual examination. If uncertainty still remains after visual inspection, a ‘blood test’ can be performed which clearly reveals the orientation. The physician should place a drop of blood onto the rehydrated AlloDerm. The dermal side of the sheet absorbs blood and www.expert-reviews.com

will retain a deep red appearance after rinsing while the basement membrane side of the sheet will repel blood and may only appear lightly pink after rinsing. LifeCell recommends suturing AlloDerm under tension to ensure minimal laxity. This technique will increase the surface area of the neutral graft by up to 30–50%. Permanent suture (polypropylene) is recommended. It is further recommended that fluted drains be placed between the breast implant and the AlloDerm, as well as between the AlloDerm and the mastectomy flap [102]. Drains should remain in place until the output is 30 ml or less, per 24-h period, for three consecutive days. AlloDerm Ready to Use (LifeCell)

AlloDerm RTM Ready to Use is similar to traditional AlloDerm RTM in that they are both donated cadeveric human 69

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Table 3. Complication rates reported from meta-analyses. Study (year)

Risk/odds ratio (95% CI)

Ref.

Infection

Seroma

Hematoma

Skin necrosis

Reconstructive failure

Hoppe et al. (2011)

2.33 (1.55, 3.49)

3.00 (1.96, 4.61)

NR

NR

2.41 (1.59, 3.64)

[38]

Ho et al. (2012)

3.52 (2.00, 6.19)

3.89 (2.44, 6.21)

1.99 (0.76, 5.23)

3.15 (1.79, 5.55)

4.00 (2.33, 6.88)

[39]

Kim et al. (2012)

2.47 (1.71, 3.57)

2.73 (1.67, 4.46)

2.06 (0.86, 4.95)

1.56 (0.85, 2.85)

2.80 (1.76, 4.45)

[40]

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All reported meta-analyses only analyzed the use of human ADM products. Kim et al. and Hoppe et al. focused on two-stage reconstructions, and Ho et al. focused on both one-stage and two-stage reconstructions. NR: Data not reported. Data taken from [41].

dermis allografts. However, the dermal allograft in AlloDerm RTM Ready to Use undergoes a proprietary processing technique as well as a terminal sterilization process that includes electron beam irradiation. It is supplied in an outer package which contains a sterile inner pouch with the AlloDerm Ready to Use. For this product, a minimum soak of only 2 min prior to implantation is required. Polarity, implantation technique, expansion and follow-up care are all similar to traditional AlloDerm RTM [103]. FlexHD Acellular Hydrated Dermis (Ethicon; Musculoskeletal Transplant Foundation)

FlexHD is a dermal matrix that is derived from cadevaric human donation through an alliance between Ethicon and the Musculoskeletal Transplant Foundation. It is minimally processed to remove epidermal and dermal cells and ready to use immediately out of the packaging. It is indicated, in part, for reinforcement or supplemental support of soft tissue defects [104]. Prior to tissue donation, the donor’s history and medical record, including infectious disease testing, are reviewed by an Musculoskeletal Transplant Foundation physician to assure donor suitability criteria are met at the time of tissue procurement. Possible adverse effects of using this product include local or systemic infection, wound dehiscence and immune response to the graft [104]. Of note, a recent in vitro study on the resistance of ADM to microbial penetration found rehydrated FlexHD and AlloDerm to be reasonable barriers against microbial infiltration and subsequent infection [26]. In addition, a study comparing complication and infection rates between various ADMs showed that FlexHD was comparable with other products tested and that its use was unlikely to add a significant infection risk to the patient [27]. FlexHD is packaged aseptically in an ethanol solution. While the tissue comes prehydrated, it is not ready for immediate implantation. It is necessary to soak the product in order to remove the packaging solution prior to implantation. FlexHD is not terminally sterilized and should not be subjected to additional sterilization procedures or freezing. The product is packaged in a sterilized foil pouch that is designed to be passed directly onto the sterile field where it can be soaked in a sterile solution [104]. Since the tissue is packaged in ethanol, it is important to note that the pouch and packaging should be discarded away from electrosurgical equipment in order to prevent 70

damage. Once the tissue is exposed, it should be transplanted within 30 min. However, it may be maintained in a sterile saline bath for up to 24 h prior to implantation. FlexHD has an orientation that must be maintained, similar to the AlloDerm products. The previously described ‘blood test’ may be also be employed on the FlexHD to discern the proper tissue orientation. Additionally, the tissue itself has an indicating notch, such that when the tissue is properly oriented, the indicating notch is in the upper left corner of the tissue with the epidermal side facing up [104]. AlloMax (Bard)

AlloMax is a terminally sterilized human acelluar dermal matrix. It is prepared using the proprietary Tutoplast process to remove non-collagenous cellular components. This tissue sterilization process includes osmotic, oxidative and alkaline treatments to break down cell walls, inactivate pathogens and remove bacteria. Solvent dehydration of the tissue allows the implant to be stored at room temperature. Low-dose gamma radiation is applied terminally to achieve a minimum sterility assurance level of 10-6. This process inactivates or removes potential pathogens and unwanted materials, such as cells, antigens and viruses. As a result, AlloMax is unique in that it is the only terminally sterilized human graft currently available on the market. The graft’s sterile barrier is composed of two sealed pouches, with only the inner package being sterile. The manufacturer recommends rehydration in room temperature sterile normal saline for at least 5 min to achieve the proper implant flexibility. The graft is available for purchase in a number of sizes, ranging from 2  4 cm to 16  20 cm [105]. AlloMax was studied with other biologic scaffolds in a comparison of inflammatory responses and mechanical properties under repetitive loading and enzymatic degradation for hernia repairs [28–30]. However, only a single case series describes the use of the graft in conjunction with tissue expander breast reconstruction following mastectomy. This study analyzed 22 patients and reported no significant complications associated with the use of AlloMax [31]. NeoForm (Mentor Corp.)

NeoForm is a processed dermis consisting of human collagen. It is prepared using the same proprietary Tutoplast process as AlloMax and is terminally sterilized by gamma radiation. The Expert Rev. Med. Devices 11(1), (2014)

Biologic matrices in oncologic breast reconstruction after mastectomy

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product has a shelf life of 3 years and must be used before the expiration date printed on the package. The final dehydrated product is packaged in a non-sterile outer package and a sterile inner pouch that may be placed onto the surgical field. The opened product must then be rehydrated by soaking in a bath of sterile, room temperature, saline solution for a period of at least 5 min. Note the some larger sheets may require more time for rehydration, but the maximum soak time should not exceed 30 min to achieve a soft and malleable product. It is also recommended by the manufactures that the NeoForm rehydration bath be supplemented with an appropriate antibiotic solution to prevent against accidental infection. Sheets of the product can be purchased in sizes ranging from 1  2 cm to 20  25 cm depending on the size of the soft-tissue defect [106]. DermaMatrix (Synthes)

DermaMatrix is human allograft skin that has been minimally processed to remove donor cells while preserving the ECM of the dermis, including the collagen and elastin components. The product is not terminally sterilized but strict medical screening measures were used in the selection of tissue donors as per the MFT standard. However, it still remains possible that some infectious diseases could, theoretically, be acquired through the use of DermaMatrix implantation [107]. The dehydrated DermaMatrix product is distributed in a sterilized foil pouch that may be passed directly onto the surgical field in sizes ranging from 1  1 cm to 20  25 cm. It should then be immediately submerged in 100 ml of sterile saline solution until the allograft is sufficiently soft. The actual time required for rehydration will vary greatly depending on the size of the dermal sheet being used. All reconstituted product must be implanted within 24 h or discarded in the appropriate manner. Once the tissue is soft and ready for implantation, the surgeon must determine the proper orientation of the sheet for placement. In some cases, the epidermal side of the graft will have visibly more pigment than the dermal side, but in instances where this is not the case, the sheet has an indicator notch in the upper left corner to assist the surgeon in determining the correct direction for implantation. DermaMatrix is contraindicated only in patients who have exhibited an autoimmune connective tissue disease [107]. Non-human acellular dermal matrices SurgiMend (TEI Biosciences)

SurgiMend is unique among the ADMs as its collagen matrix is derived from fetal and neonatal bovine dermis. It is reported that this source contains up to three-times more type III collagen than ADMs derived from adult human or other animal tissues [32,33]. It is purported that the increased type III collagen in this product may facilitate tissue incorporation upon implantation [108]. In support of this, a case report of a successful staged nipple reconstruction and a retrospective review of implant-based reconstruction both demonstrated decreased time to drain removal with the use of SurgiMend [34,35]. Currently, there are two randomized controlled trials underway comparing the performance, economics and complication rates of SurgiMend and AlloDerm. The results www.expert-reviews.com

Review

of these trials could further illuminate the strengths and limitations of these two similar products and also clarify the indications for when one product should be used over the other. The processing of SurgiMend is a proprietary manufacturing process of TEI Biosciences. The manufacturer states that it is free of chemical crosslinkers and exposure to antibiotics, limiting possible allergic reactions upon implantation. Of note, the product is terminally sterilized with ethylene oxide gas. Since the source is bovine in origin, care is taken by the FDA and international regulatory bodies to assure that the product is free of transmissible spongiform encephalopathy or other possibly transferable pathogens [108]. SurgiMend is stored at room temperature and has a shelf life of 5 years. A large variety of square and rectangular dimensions are available in two thickness ranges (0.75–1.54 mm and 0.40–0.75 mm). Specifically for plastic and reconstructive surgery, SugiMend plastic and reconstructive surgery, has the properties of its parent product but also has the unique feature of fenestrations. In theory, this allows for the egress of fluid from around the implant and prevents seroma formation. The product requires a 60 s rehydration period prior to use. Once rehydrated the material is pliable, compliant and easily conforms to most surgical sites. SurgiMend has no polarity so there is no need to orient the implant in a specific direction at the time of surgery [108]. Strattice (LifeCell)

Strattice is another unique ADM product, since it is produced from porcine skin. The skin is processed, terminally sterilized and stored in a phosphate buffered aqueous solution containing matrix stabilizers. The product is in a double pouch, with only the inner portion being sterilized for use on the surgical field. Because Strattice is derived from a porcine source, it should not be used in patients who have a known allergy to porcine materials. Once opened, the tissue must be rehydrated for a period of approximately 2 min in room-temperate sterile saline or sterile lactated Ringer’s solution before implantation. It may also remain in the soaking solution for up to 4 h before implantation. Sheets of Strattice may be acquired in sizes from 1  1 cm to 16  20 cm [109]. Porcine small intestine submucosa Biodesign Surgisis Tissue Graft (Cook Medical)

Biodesign is an ECM derived from porcine small intestinal submucosa. It is prepared by mechanically removing selected portions of the mucosa and the external muscle layers and lysing resident cells with repeated hypotonic washes. Layers are stacked to create a multilaminate tissue that is available as a 1-layer or 4-layer tissue graft. Unlike acellular dermal matrices, this product is then sterilized using ethylene oxide gas. Because the graft is derived from a porcine source, it should not be used in patients with a known sensitivity to porcine materials. Biodesign is shipped in a dehydrated form and should be stored in a clean, dry location at room temperature. The manufacturer recommends rehydration with room temperature sterile saline or sterile lactated Ringer’s solution, which may require at least 3 min for a 71

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1-layer graft and 10 min for a 4-layer graft. It is dispensed in an inner sterile pouch, which should be removed from its outer bag and placed in the sterile field. Biodesign does not require any further sterilization process on the part of the physician [110]. Biodesign represents the new generation of SIS products, the first of which was Surgisis. Numerous studies have shown this biomaterial is capable of induction of tissue proliferation, remodeling and regeneration of tissue structures. However, the literature also suggests the multilayer technology of submucosal grafts promotes seroma formation and poor integration [36]. Modifications have been made to Biodesign to address these proven disadvantages. Subsequent processing improvements created a more open matrix, and a pure ECM with the removal of lipid and DNA fragments, as well as the introduction of polyglycolic acid stitching and perforations to allow for quicker remodeling and a reduced occurrence of delaminations. SIS has been previously shown to be replete with potent regulatory factors, such as glycosaminoglycans and proteoglycans, and contain multiple growth factors (VEGF, VFG2, TGF-b and CTGF) in addition to the connective tissue scaffold. It has been suggested that these may also assist in tissue ingrowth and neovascularization [37]. However, there are no studies of Biodesign in alloplastic breast reconstruction. Expert commentary

As with many interventions in the practice of medicine, the incorporation of biologic matrices into alloplastic breast reconstruction procedures has associated benefits and risks. As outlined above, biologic meshes, when interposed between the disinserted caudal edge of the pectoralis muscle and the anterior chest wall, can reduce many of the limitations that are encountered during a full sub-pectoralis muscle placement of an expander or other implant device. Of the many potential advantages, the most clinically significant is the increase in the sub-pectoral space and the coincident ability to place larger initial fill volumes into tissue expanders and implants in a single-stage operation. Reducing the number of postoperative tissue expander fills or eliminating them all together by converting the operation to a single-stage holds the potential to make the process of alloplastic reconstruction much more appealing to patients. While the incorporation of biologic meshes may have several advantages, it is not without risk. The initial excitement over the benefits of biologic use was subdued when concerns for seroma and infection were raised. Underlying this concern was the fact that biologic materials, despite their derivation from living sources, did not become vascularized or incorporated for several days or weeks, and sometimes, not at all. Essentially, dermal grafts are a foreign body until they become vascularized and are, therefore, at the same risk as implanted, prosthetic devices for complications such as infection or other foreign body associated reactions. With an overwhelming number of publications focusing on the wide range of complications reported with use of biologic materials in alloplastic reconstruction, there have been several systematic reviews and only a handful of recent meta-analyses to summarize the findings 72

(TABLE 3).

All of these studies indicate that complications such as seroma, infection and overall reconstructive failure are more likely when biologic materials are used in alloplastic reconstruction [38–43]. However, these analyses were based on relatively few studies with lower levels of evidence and mostly consisted of retrospective cohort comparisons. A true, head-to-head prospective analysis to corroborate these findings is desperately needed, but blinding and bias control make such a study difficult in practice. For now, reconstructive surgeons must weigh the potential benefits of increased initial expander fill volume, potential for single-stage implant reconstruction and added control of the expander/implant pocket and IMF position against the several potential complications, including seroma, infection and reconstructive failure when deciding if a biologic mesh should be used during alloplastic breast reconstruction. At our institution, we utilize biologic matrices in the majority of our patients undergoing implant-based breast reconstruction. Given the potential risks of seroma and infection when these materials are used, we believe attention to patient selection and surgical technique is critical to minimize these complications. In general, we avoid use of biologic matrices in patients who may have diminished tissue perfusion (e.g., tobacco use, vascular disease) since this may impair neovascularization, or in patients who are immunocompromised (e.g., diabetes mellitus, connective tissue disease). Despite these constraints, over half of the patients we encounter, who have opted for tissue expanderbased reconstructions, meet our criteria for ADM use. When biologic matrices are surgically placed, judicious use of closed suction drains may help prevent seroma formation. Typically, we place two drains, with one specifically positioned between the native inferior breast skin and the material itself, which may also aid incorporation of the material by maximizing contact between those two surfaces. Measures that we employ during surgery to help reduce the risk of infection include preferential use of monofilament sutures (which are less likely to harbor bacteria than braided sutures), triple antibiotic irrigation (Ancef, bacitracin, gentamicin), and conservative initial fill volumes of tissue expanders in order to minimize pressure and tension on the overlying skin and subcutaneous tissues. Postoperatively, we routinely prescribe prophylactic antibiotics that cover skin flora, and instruct patients on care of drain sites that may act as a potential port of entry for bacteria until drains are removed.

Five-year view

While it is difficult at the present time, especially in the absence of randomized, prospective data, to determine the true risks versus benefits of biologic materials in alloplastic breast reconstruction, the growing number of publications and attention being paid to their use would indicate an increasing acceptance of their use and benefit. With so much concern for cost-control in healthcare, the added cost of biologic materials may prove to be a limiting factor in the future [44]. Yet, while these materials cost several thousands of dollars, their cost may be offset by the potential to eliminate multi-staged procedures by achieving acceptable results in a single operation. However, Expert Rev. Med. Devices 11(1), (2014)

Biologic matrices in oncologic breast reconstruction after mastectomy

the application of single-stage reconstruction is limited to a small subset of patients, and biologic materials are frequently used in the more common two-stage setting, where they only add to the cost of the procedure. Attempts to analyze the cost– effectiveness of biologic meshes have been made, but they have been largely based on retrospective cohorts and datasets, making it difficult to extrapolate their findings into evidence-based practice decisions [45,46]. In general, the purpose of adding a mesh to an alloplastic breast reconstruction is to increase the volume of the subpectoralis muscle pocket and improve control of the position of this expander/implant and IMF. Currently, biologic meshes

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have served to fill this need, but not without added potential for complications and increased cost. Less expensive alternatives, biologic or prosthetic, may emerge as the demand for products to meet this specific need grows. Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in this manuscript. This includes employment, consultations, honoraria, stock ownership or options, expert testimony, grants or patients received or pending or royalties. No writing assistance was utilized in the production of this manuscript.

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Key issues • Alloplastic breast reconstruction utilizes tissue expanders and/or permanent implant devices to create a reconstructed breast after mastectomy. • Alloplastic breast reconstructions are traditionally carried out in a staged fashion, with placement of a tissue expander at the initial operation, followed by filling of the expander over several outpatient visits, and completed with a second operation to remove the expander and place a permanent implant. • More recently, with a growing trend for skin-sparing and even nipple-sparing mastectomies, single-stage alloplastic breast reconstructions have become possible, allowing for the placement of permanent implant devices at the time of the initial operation. • Traditionally, tissue expanders and implants were placed into a total sub-pectoralis muscle pocket to maintain complete muscle coverage of the implanted device. However, more recently biologic meshes have been used as a ‘sling’ between the divided caudal edge of the pectoralis muscle and anterior chest wall to increase the volume of space that is available in this sub-pectoral pocket and to increase the control of where this pocket is positioned on the chest wall. • Many biologic materials are available, with acellular dermal matrices being the most commonly used products in alloplastic breast reconstruction. • While there are many advantages to using biologic materials in alloplastic breast reconstruction, recent systematic reviews of the growing body of literature indicate that they may be associated with increased rates of seroma, infection and overall reconstructive failure. • Most of the current literature is based on retrospective cohort comparisons or descriptive reports of case series. Randomized, prospective trials are needed to better evaluate the true risks and benefits associated with biologic materials in alloplastic breast reconstruction.

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