For breast cancer patients, the use of expanders and/or implants is the most common method of breast reconstruction following mastectomy [
As an alternative, acellular dermal matrices (ADMs) are produced by the removal of the epidermal layer from thin slices of skin, leaving the dermal layer and extracellular matrix followed by a decellularization process. The removal of donor cellular material including major histocompatibility complex (MHC) proteins is performed to theoretically minimize immunological response in ADM recipients [
Ten consecutive female breast cancer patients between the ages of 28 and 60 years old were scheduled to undergo mastectomies from August to November 2011. All eligible patients were included with criteria for exclusion being tobacco use (smoking) or a known planned course of postoperative radiation after mastectomy. One patient was excluded prior to beginning the study under the criteria of smoking and two patients did have previously unplanned radiation treatments following ADM implantation due to unanticipated laboratory results and were still included in the series. Procedures for the 9 remaining patients included 8 bilateral mastectomies and 1 unilateral mastectomy for a total of 17 breasts in the study. The final filling volumes of their tissue expanders ranged between 450 and 800 cc. Eight patients totaling 14 breasts advanced to the 2nd stage operation which involved removing the tissue expanders to be replaced with silicone implants. One of the eight patients lost the right expander, presumably due to smoking. Subsequently, this patient received an autologous Transverse Rectus Abdominis Myocutaneous (TRAM) flap on the right and completed the expander to implant exchange on the left. The ninth patient opted for bilateral expander removal after metastatic disease was diagnosed.
The mastectomies were performed by a total of 4 general surgeons. The D-ADM (DermACELL, LifeNet Health, Virginia Beach, VA) is manufactured [
(a) Showing placement of expander. (b) Showing D-ADM and intraoperative expansion. (c) Showing D-ADM incorporation at second stage reconstruction.
A 46-year-old patient received bilateral mastectomies on September 9, 2011 and advanced to the 2nd stage on February 28, 2012. She underwent chemotherapy during expansion and developed DVT in the left leg during this period, which was treated with warfarin sodium (Coumadin, Bristol-Myers Squibb Company, New York, NY). Her expanders were filled to the full 550 cc and replaced with 700 cc silicone implants. She has completed nipple areolar reconstruction.
A 55-year-old patient received a unilateral mastectomy of the right breast and required evacuation of a hematoma on the first postoperative day after placement of the D-ADM. At that time, the D-ADM was intact and was not removed. She advanced to the 2nd stage at 6 weeks and to a 3rd stage nipple reconstruction at 16 weeks. She was expanded to 450 cc and received a 500 cc implant. Her areolar micropigmentation was completed several months later.
A 60-year-old patient received bilateral mastectomies on September 26, 2011, was expanded to 450 cc, and advanced to the 2nd stage on January 24, 2012 with 533 cc implants. She opted not to proceed with nipple areolar reconstruction.
A 52-year-old patient received bilateral mastectomies on October 11, 2011, was expanded to 510 cc, and advanced to the 2nd stage at 19 wks with 600 cc implants. She has completed nipple and areolar reconstruction.
A 43-year-old patient received bilateral mastectomies on October 20, 2011. She received unanticipated radiation therapy to the left side and was eventually expanded to 510 cc after radiation. She advanced to the 2nd stage on April 17, 2012 with 600 cc implants. She has completed nipple and areolar reconstruction.
A 28-year-old patient, former smoker, relapsed postoperatively after receiving bilateral mastectomies. She experienced right expander extrusion at 4 wks, and reconstruction was put on hold until smoking cessation. Her left side was fully expanded to 510 cc, and she was reconstructed with a 533 cc implant on the left and a TRAM flap on the right. She has completed nipple reconstruction and remained nicotine free.
A 54-year-old patient received bilateral mastectomies on August 5, 2011. Her drains fell out 4 days postoperatively and she experienced seromas with incisional dehiscence, which required irrigation and drain replacement. She experienced recurrent incisional reopening in the left breast which required left expander removal and replacement after cultures of the excision showed negative gram stains. She was expanded to 800 cc and successfully underwent stage two on March 6, 2012 with 800 cc implants. She has completed nipple and areolar reconstruction.
A 43-year-old patient received bilateral mastectomies on November 7, 2011 and was expanded to 800 cc, and the 2nd stage was completed on February 23, 2012 with 800 cc implants. She has completed nipple and areolar reconstruction.
A 48-year-old patient received bilateral mastectomies on November 4, 2011 and had shown complete response to neoadjuvant chemotherapy by preoperative imaging. She had a positive margin to the chest wall and received postoperative radiation therapy. Despite complete resolution of radiation dermatitis and expansion, she elected to have her expanders removed and abort reconstruction when she was found to have hepatic metastases.
Of the 9 implant patients, most had acceptable results (Table
Patient overview and results.
Patient number | Age (yrs) | Postop. chemotherapy | Post-ADM implant radiation | Uni- or bilateral | Duration of implant prior to 2nd stage (wks) | Expander size | Implant size | Nipple/Areola reconstruction | Surgical site infection | Seroma |
---|---|---|---|---|---|---|---|---|---|---|
1 | 46 | Yes | No | Bilateral | 16 | 550 cc | 700 cc | Yes | No | — |
2 | 55 | No | No | R only | 6 | 450 cc | 500 cc | Yes | No | — |
3 | 60 | No | No | Bilateral | 16 | 450 cc | 533 cc | No | No | — |
4 | 52 | No | No | Bilateral | 19 | 510 cc | 600 cc | Yes | No | — |
5 | 43 | No | Yes | Bilateral | 16 | 510 cc | 600 cc | Yes | No | — |
6 | 28 | No | No | Bilateral | Right side TRAM* and left implant | 510 cc | 533 cc | Yes | No | — |
7 | 54 | No | No | Bilateral | 7 weeks | 800 cc | 800 cc | Yes | Yes | Yes |
8 | 43 | No | No | Bilateral | 14 weeks | 800 cc | 800 cc | Yes | No | — |
9 | 48 | Neo-adj. | Yes | Bilateral | 11/4/2011 stage 1 | Aborted | Aborted | Aborted | No | — |
10 | Excluded due to smoking | — | — | — | — | — | — | — | — | — |
(a) Preoperative before mastectomy. (b) Postoperative after 700 cc silicone implant placed.
(a) Preoperative before mastectomy. (b) Postoperative after 800 cc silicone implant placed.
(a) Preoperative before mastectomy. (b) Postoperative after left radiation and reconstruction.
Biopsy specimens were obtained from 8 of the 9 patients and submitted in formalin to Dominion Pathology Laborator (Norfolk, VA) for sectioning and staining. Stains included hematoxylin and eosin (H&E) to assess cellularity and general ultrastructure, immunohistochemical stain CD34, an endothelial cell marker, to assess vascularity, and Verhoeff-Van Gieson (VVG) to assess elastic fibers. Histological assessments were made by dermatopathologists Kevaghn Fair, DO (Dominion Pathology Laboratory) and Antoinette Hood, MD (Eastern Virginia Medical School, Norfolk, VA).
General histological observations for all biopsied patients included presence of fibroblasts, vasculature, and intact ultrastructure, including elastin. Occasional foreign body response was noted, localized to polarizable material which was present in a regular pattern consistent with suture material. Little inflammation was noted except in conjunction with this foreign body response. In general, the side of the implant facing the expander exhibited pseudocapsule formation as a benign response to the expander material. When observed, the opposite interface between the implant and the host tissue demonstrated some level of tissue integration with minimal inflammation consistent with normal healing. Compared to the host tissue, the implant material appeared more organized with fewer living cells and less vasculature, a finding expected for a stable material slowly being incorporated and remodeled after a few weeks to a few months following surgery when the specimens were collected. Specific histology samples from patient number 1 are shown in Figure
(a) Hematoxylin and eosin staining of biopsy specimen from patient number 1 following 16 weeks
Two-stage breast reconstruction procedures can be facilitated by the use of a sling under the expander for both support and cosmetic benefits. Among many other factors, the choice of this material is key in ensuring a good outcome. Decellularized human skin (ADM) is often used for these procedures. It is hypothesized that certain complications may arise from these materials as a function of successful cellular removal. One of these materials (D-ADM) is validated to remove ≥97% DNA while maintaining structural integrity. Here, we used this material and assessed its performance through patient follow-up and histological analysis ofbiopsies taken upon expander removal. Overall results weregood. One observation of note is that there were no observed drug effects of warfarin sodium and prednisone on the outcome of the procedure. Warfarin sodium use presents a concern for uncontrolled hemorrhaging in these patients, and this was not noted. Prednisone is a corticosteroid drug used in patients with low steroid levels and also used as an anti-inflammatory medication. Clotting and generating an immune response are key biological processes that stimulate wound healing, which are affected to some degree in the patients taking warfarin sodium and prednisone. These patients had no adverse effects postoperatively. One patient exhibited a hematoma that required evacuation on postoperative day one after placement of the D-ADM. At that time, the D-ADM was intact and was not removed. She went on to complete successful expansion. There are several concerns with postoperative hematomas, one of which being the inherent risk of surgery when needed to correct them. Also, the accumulation of blood from hematomas can lead to increased tension on the surgical area causing local infection that prevents proper wound healing [
D-ADM appears to be an appropriate adjunct to reconstruction with expanders. D-ADM worked well with patients receiving chemotherapy for further cancer treatment and seemed to work well with those who had received postoperative radiation treatments while the D-ADM was in place. As far as other drug effects on the procedure, there appeared to be none with patients in this study taking warfarin sodium and prednisone as they both responded favorably postoperatively. Additionally, the patient experiencing hematoma responded well with D-ADM despite this complication. Overall, healthy patients had the most favorable results, while those with unhealthy lifestyles, particularly smokers, experienced the most complications.
The author has received compensation for data collection and analysis for this case series from LifeNet Health. The author has declared no further conflict of interests.
The author would like to acknowledge Antoinette Hood, MD (Eastern Virginia Medical School, Norfolk, VA) and Kevaghn Fair, DO (Dominion Pathology Laboratory, Norfolk, VA) for histological assessments of biopsies and interpretation of findings.