Pre-pectoral Breast Reconstruction in Nipple Sparing Mastectomy

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1 September 2017 Issue 9 Pre-pectoral Breast Reconstruction in Nipple Sparing Mastectomy Aldona J. Spiegel, MD Director and Founder of the Center for Breast Restoration at the Institute for Reconstructive Surgery Houston Methodist Hospital Houston, TX INTRODUCTION We have been on a quest to obtain a natural appearing reconstructed breast since the beginning of implant based reconstruction, in the simplest way possible with minimal pain for the patient. To that end, the original location of breast implants was the subcutaneous breast pocket. However, this was fraught with problems including implant malposition, rippling and capsular contracture. 1 To improve soft tissue coverage we then ventured under the muscle to achieve complete muscular coverage and attempted to use this tissue to camouflage rippling and minimize contracture. This approach tended to result in a much less natural reconstruction, with poor lower pole definition, and was more painful for the patient. Advancement was then made to the dual plane approach which was then utilized to improve the inferior projection without muscle constriction. Nevertheless, other issues ensued, mainly related to the release of the muscle including window shading and pectoralis animation deformity. With the dual plane technique, patients can achieve very natural results at rest, but with muscle contraction pectoral animation deformity is a significant distressing phenomenon in many patients. Over the last decade, we have seen an exciting evolution in implant based breast reconstruction. The introduction of acellular dermal matrix (ADM)s has enabled the use of implants with improved softtissue support and coverage. Significant progress has also been made in the mastectomy techniques, with Nipple Sparing Mastectomy (NSM) advancing to being able to achieve a virtually unoperated appearing breast, with the incision being hidden inconspicuously in the inframammary fold. Implants have also improved with different round and shaped devices being available. 2 We also have better tools to reliably assess mastectomy skin perfusion, which is crucial to the success of this technique. All these advancements have allowed us to venture back into the pre-pectoral space and avoid the pitfalls that we were initially faced with. The choice of technique in pre-pectoral breast reconstruction can be divided into two categories. The first is the wrapping technique where the implant is totally wrapped in the ADM and then inserted into the breast pocket. 3 The second option is the lining technique, which I prefer, where the ADM is precisely tailored to correspond to the mastectomy skin, forming an anterior lining of the pocket that will reinforce the mastectomy flap. In this method, the ADM conforms to the subcutaneous tissue of the pocket optimizing its incorporation.

2 PATIENT SELECTION Patient selection is key in this technique, therefore careful preoperative evaluation is made for ptosis, soft tissue quality and desired post mastectomy breast size, all predictors of mastectomy skin vascularization. With NSM, skin expansion is not necessary if the patient desires a breast size which is not much larger than their preoperative size. Assessment of the perfusion of the mastectomy skin in NSM dictates how much of the mastectomy skin envelope can be pushed to accommodate an implant, or if an underfilled tissue expander needs to be placed initially. OPERATIVE TECHNIQUE Preoperative markings are made, including a midline vertical mark, breast perimeter, as well as the inframammary fold and its position at the midline mark. The first step in the procedure is to check the mastectomy skin perfusion with the SPY, or other flap perfusion monitoring devices, with an appropriate breast sizer in place. If all areas, especially the nipple areola complex, appear well perfused then direct to implant option is chosen. However, if there are areas that appear to be poorly perfused, the breast sizer is removed and these areas checked to see if the perfusion improves with the skin being on less stretch. If this is the case, then a tissue expander is chosen and underfilled. (Fig. 1) Figure 1: Assessment of mastectomy skin perfusion. The implant sizer is placed into the breast pocket. Vascularization of the skin, especially the nipple is assessed to determine if an implant of the desired volume implant can be placed directly. The image on the lower left shows excellent perfusion, but the image on the right shows lack of perfusion in the nipple, therefore an underfilled tissue expander is planned. A B

3 The second step is to inspect the pocket for hemostasis, especially in the region of the axilla. The inframammary fold needs to be assessed for any malposition and necessity for reinforcement is determined. Correlating the post mastectomy position of the fold with the midline mark that was made preoperatively can help in determining if the fold was dissected during the mastectomy and needs to be supported. The lateral part of the breast pocket also needs to be assessed and any sutures required for reinforcement should be placed at this time. I will typically use 2-0 Ethicon MONOCRYL Suture. After the device is chosen, the ADM is prepared by a triple wash alternating antibiotic solution and betadine irrigation. In my practice, I found that this eliminates issues with red breast syndrome and minimizes infections. There are two options for shaping the ADM. Two FlexHD Pliable Shaped pieces are sewn together as shown in Figure 2. Figure 2: Two FlexHD Pliable Shaped pieces are sutured together as shown An alternative option is to use one large sheet (16cm x 20cm) which introduces some waste as the corners are trimmed, but eliminates the anterior suture line. If a large piece is chosen, it is then draped over the sizer or tissue expander and the perimeter of the device is outlined. A vertical and horizontal axis is also marked with the point zero located at the nipple position. These markings are extremely helpful during inset of the ADM, as one can refer to the nipple position and correlate the horizontal and vertical dimensions of the breast pocket. The perforation markings are then made concentrically centered on the nipple. Usually this involves three sets of variably sized circles as show in Figure 3. The perforations are then made with a blade and the edge excess is excised with scissors. Figure 3: A 16cm x 20cm sheet of ADM is marked with vertical and horizontal lines based on the nipple location and concentric circles indicating the perforations for improved projection and incorporation to the overlying subcutaneous tissue. A B

4 A lighted retractor is then used to expose the pocket up to the top of the pectoralis. Here the top of the breast can be determined by correlating with the preoperative markings. The ADM is then introduced into the breast pocket taking care as not to touch the skin edges. The ADM is then smoothed out and the markings for inset reinforced. 2-0 Ethicon MONOCRYL Suture is used starting at the meridian of the breast at the top of the pectoralis and run medially to the inframammary fold. A second suture is started at the same point at the top of the pectoralis and run continuously to the lateral boarder of the breast down to the inframammary fold. Enough opening needs to be left at the inframammary fold to accommodate placing the implant with an introduction device, or placing a folded Tissue Expander. The opening is then closed carefully with interrupted sutures with the help of a malleable to ensure protection of the implant or tissue expander from the suture needle. Once the device and ADM are in place, any last checks for hemostasis are made. EXPAREL is then injected and two drains are placed laterally, one is directed along the inframammary fold, the other is directed to the axilla. Mastectomy incision edges are evaluated for perfusion and trimmed if necessary. Careful three-layer closure is then performed of the skin using absorbable sutures and covered with Steri-Strips. Figure 4: ADM is sutured starting at the top of the pectoralis as shown. An opening is left at the inframammary fold for easy placement of MENTOR ARTOURA Smooth Breast Tissue Expander and interrupted sutures are then placed carefully to complete the closure.

5 RESULTS The early results with this technique are very promising. Patients have a pleasing breast shape immediately after surgery, without the distortion that is sometimes initially caused by the tight pectoralis muscle. The postoperative pain is also significantly improved. In my experience, infection rates are low, but seromas can occur, and one must be vigilant with late removal of drains and early drainage of any seromas. Long term results are still undetermined, as we need several years to observe for any gravitational bottoming out of the implant and any increased issues with capsular contracture. CONCLUSION D Pre-pectoral breast reconstruction in the nipple sparing mastectomy is a straightforward technique that eliminates side effects related to the pectoralis muscle found in the dual plane approach. With the many advances that have recently occurred, we hope that the complications that were found in the beginnings of breast reconstruction in the subcutaneous plane will Ebe avoided. We still need more long term data to determine if this is the most optimal approach in our pursuit to enhance our breast reconstruction results for our patients. CLINICAL CASES CASE 1: This patient underwent direct to implant reconstruction with High Profile, 300cc MENTOR MemoryGel Breast Implants using a single piece of FlexHD Pliable for her pre-pectoral ADM construct.

6 CLINICAL CASES CASE 2: This patient had a previous mastopexy, but desired a similar breast size, therefore a direct to implant procedure was planned depending on the SPY intra-operative evaluation. Her postmastectomy nipple perfusion was found to be excellent, and she underwent direct to implant reconstruction using a single piece of FlexHD Pliable for her construct with Moderate Plus, 250cc MENTOR MemoryGel Breast Implants. CASE 3: This patient had significant ptosis and was prepared for two stage reconstruction using an air filled expander at the first stage. The intraoperative SPY evaluation confirmed hypoperfusion at the nipple. Therefore, tissue expanders were chosen. 550cc Medium Height, MENTOR CPX 4 Tissue Expanders were filled to 430cc of air. The air fill is lighter, therefore there is less stretch of the nipple areola postoperativley. This patient also had two FlexHD Pliable pieces sutured together for her ADM construct. The air was then exchanged to saline in the office and ultimately was able to undergo conversion to Moderate Plus, 550cc, MENTOR MemoryGel Breast Implants 1 month after her initial procedure.

7 REFERENCES 1. Glasberg SB, Light D., AlloDerm and Strattice in Breast Reconstruction: A comparison and techniques for optimizing outcomes. Plast Reconstr Surg. 2012; 129, Sigalove, S., Maxwell, G. P., Sigalove, N. M., Storm-Dickerson, T. L., Pope, N., Rice, J., & Gabriel, A. (2017). Prepectoral Implant-Based Breast Reconstruction: Rationale, Indications, and Preliminary Results. Plastic and Reconstructive Surgery, 139(2), Raghavan Vidya, Fahad Mujtaba Iqbal. Clinical Breast Cancer. A Guide to Prepectoral Breast Reconstruction: A New Dimension to Implant-based Breast Reconstruction. Volume 17, Issue 4, July 2017, DISCLAIMER: This white paper is brought to you by Mentor Worldwide, LLC and is not certified for continuing medical education. Dr. Aldona Spiegel is compensated by and presenting on behalf of Mentor Worldwide, LLC, and must present information in accordance with applicable Regulatory requirements. This white paper reflects the opinion of Dr. Aldona Spiegel. the materials presented do not necessarily represent the opinion of Mentor Worldwide LLC. This white paper has not been subject to independent peer review. This white paper includes a demonstration of the use of a surgical device; it is not intended to be used as a surgical training guide. Other surgeons may employ different techniques. The steps demonstrated may not be the complete steps of the procedure. Individual surgeon preference and experience, as well as patient needs, may dictate variation in procedure steps. Before using any medical device, including those demonstrated or referenced in this white paper, review all relevant package inserts, with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device. IMPORTANT SAFETY INFORMATION: MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, or who are currently pregnant or nursing. Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation and reconstruction with MemoryGel Implants include any reoperation, capsular contracture, and implant removal with or without replacement. The most common complications with MemoryShape Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and ptosis. The most common complications with MemoryShape Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. A lower risk of complication is rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The most common complications with MENTOR Saline-filled Implants include reoperation, implant removal, capsular contracture, breast pain, and implant deflation. For MemoryGel Implants, patients should receive a copy of Important Information for Augmentation Patients about MENTOR MemoryGel Breast Implants or Important Information for Reconstruction Patients about MENTOR MemoryGel Breast Implants. For MemoryShape Implants, patients should receive a copy of Patient Educational Brochure Breast Augmentation with MENTOR MemoryShape Breast Implants or Patient Educational Brochure Breast Reconstruction with MENTOR MemoryShape Breast Implants, and a copy of Quick Facts about Breast Augmentation & Reconstruction with MENTOR MemoryShape Breast Implants. For MENTOR Saline-filled Implants, patients should receive a copy of Saline-Filled Breast Implants: Making an Informed Decision. Your patient needs to read and understand the information regarding the risks and benefits of breast implants, with an opportunity to consult with you prior to deciding on surgery. The ARTOURA Breast Tissue Expander or CONTOUR PROFILE Breast Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. Do not use the ARTOURA Tissue Expander nor CONTOUR PROFILE Tissue Expander in patients where an MRI may be needed. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas. Possible adverse effects of using human skin include but are not limited to: Local or systemic infection Dehiscence and/or necrosis due to poor revascularization Specific or nonspecific immune response to some component of the graft For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR Implantable Devices, which include MENTOR Salinefilled Implants, MemoryGel Implants, MemoryShape Implants, ARTOURA Expanders, and CONTOUR PROFILE Expanders, please refer to the Product Insert Data Sheet provided with each product or visit Mentor Worldwide LLC