Breast Reconstructive Surgery

Number: 0185

Policy

Aetna considers reconstructive breast surgery medically necessary after a medically necessary mastectomy or a medically necessary lumpectomy that results in a significant deformity (i.e., mastectomy or lumpectomy for treatment of or prophylaxis for breast cancer and mastectomy or lumpectomy performed for chronic, severe fibrocystic breast disease, also known as cystic mastitis, unresponsive to medical therapy).  Medically necessary procedures include capsulectomy, capsulotomy, implantation of Food and Drug Administration (FDA)-approved internal breast prosthesis, mastopexy, insertion of breast prostheses, the use of tissue expanders, or reconstruction with a latissimus dorsi (LD) myocutaneous flap, Ruben’s flap, superficial inferior epigastric perforator (SIEP) flap, superior or inferior gluteal free flap, transverse upper gracilis (TUG) flap, transverse rectus abdominis myocutaneous (TRAM) flap, deep inferior epigastric perforator (DIEP) flap, superficial inferior epigastric artery (SIEA) flap, superior gluteal artery perforator (SGAP) flap, profunda artery perforator flap, or similar procedures, including skin sparing techniques. 

Aetna considers the body lift perforator flap technique for breast reconstruction experimental and investigational because there is insufficient evidence to support the effectiveness of this approach.

Aetna considers harvesting (via of lipectomy or liposuction) and grafting of autologous fat as a replacement for implants for breast reconstruction, or to fill defects after breast conservation surgery or other reconstructive techniques medically necessary.

Aetna considers the use of the following acellular dermal matrices medically necessary for breast reconstruction:

• Alloderm (LifeCell Corp., Branchburg, NJ)
• Alloderm-RTU (LifeCell Corp., Branchburg, NJ)
• Cortiva (formerly known as AlloMax, NeoForm) (Davol, Inc., Warwick, RI)
• DermACELL (Novadaq Technologies, Bonita Springs, FL) 
• DermaMatrix (Musculoskeletal Transplant Foundation/Synthes CMF, West Chester, PA)
• FlexHD (Musculoskeletal Transplant Foundation/Ethicon, Inc., Somerville, NJ)
• Strattice (LifeCell Corp., Branchburg, NJ)
• SurgiMend (TEI Biosciences, Boston, MA).

Aetna considers associated nipple and areolar reconstruction and tattooing of the nipple area medically necessary.  Reduction (or some cases augmentation) mammoplasty and related reconstructive procedures on the unaffected side for symmetry are also considered medically necessary.

Aetna considers breast reconstructive surgery to correct breast asymmetry cosmetic except for the following conditions:

• Surgical correction of chest wall deformity causing functional deficit in Poland syndrome when criteria are met in CPB 0272 - Pectus Excavatum and Poland’s Syndrome: Surgical Correction; or
• Repair of breast asymmetry due to a medically necessary mastectomy or a medically necessary lumpectomy that results in a significant deformity.  Medically necessary procedures on the non-diseased/unaffected/contralateral breast to produce a symmetrical appearance may include areolar and nipple reconstruction, areolar and nipple tattooing, augmentation mammoplasty, augmentation with implantation of FDA-approved internal breast prosthesis when the unaffected breast is smaller than the smallest available internal prosthesis, breast implant removal and subsequent re-implantation when performed to produce a symmetrical appearance, breast reduction by mammoplasty or mastopexy, capsulectomy, capsulotomy, and reconstructive surgery revisions to produce a symmetrical appearance; or
• Prompt Footnotes^* repair of breast asymmetry due to trauma (

  Footnotes^* Note: See CPB 0031 - Cosmetic Surgery for criteria related to surgical repair of cosmetic disfigurement due to trauma).

Aetna considers Biodesign Nipple Reconstruction Cylinder experimental and investigational becasue its effectiveness has not been established.

See also CPB 0017 - Breast Reduction Surgery and Gynecomastia Surgery, and CPB 0244 - Wound Care.

Background

Breast reconstruction surgery rebuilds a breast's shape after a mastectomy. The surgeon forms a breast mound by using an artificial implant or autologous tissue from the abdomen, back or buttocks. Implants are silicone sacs filled with saline (salt water) or silicone gel. The type of reconstruction performed depends on body type, age, general health status, type of cancer treatment or other reason for reconstruction.  

Breast reconstruction may require multiple surgeries, such as nipple and areola reconstruction and tattoo pigmentation, revision surgery involving the breast and/or donor site, and surgery on the opposite breast to correct asymmetry.

Breast reconstruction may involve insertion of tissue expanders or breast implants, capsulotomy, capsulectomy or removal of breast implants. Examples of breast reconstruction techniques include, but may not be limited to, transverse rectus abdominis muscle (TRAM), deep inferior epigastric perforator (DIEP), latissimus dorsi (LD), superficial inferior epigastric artery (SIEA), transverse upper gracilis (TUG) and superior gluteal artery perforator (SGAP) flap procedures. Procedure names are related to the muscles or blood supplying vessels used and involve surgically removing tissue, typically fat and muscle, from one area of the body to create a breast mound. Pedicled flaps are positioned with their vascular origin intact while free flaps require microsurgery to connect the tiny blood vessels needed to supply the transplanted tissue.

Breast reconstruction using autologous tissue is most commonly performed using the transverse rectus abdominis myocutaneous (TRAM) flap.  This flap has been in use for 20 years and has provided excellent aesthetic results.  However, a drawback of the TRAM flap is related to donor site morbidity of the abdomen.  The pedicle TRAM flap frequently requires use of the entire rectus abdominis muscle, while the free TRAM flap requires use of as little as a postage-stamp size portion of the muscle.  Abdominal complications resulting from a sacrifice of all or a portion of the rectus abdominis muscle include a reduction in abdominal strength (10 to 50 %), abdominal bulge (5 to 20 %), and hernia (less than 5 %).

Perforator flaps have gained increasing attention with the realization that the muscle component of the TRAM flap does not add to the quality of the reconstruction and serves only as a carrier for the blood supply to the flap.  Thus, the concept of separating the flap (skin, fat, artery, and vein) from the muscle was realized as a means of minimizing the morbidity related to the abdominal wall and maintaining the aesthetic quality of the reconstruction. 

The deep inferior epigastric perforator (DIEP) flap was introduced in the early 1990's and is identical to the free TRAM flap except that it contains no muscle or fascia.  Use of this flap has been popular in the Europe for a number of years and is now gaining popularity in the United States.  The DIEP flap has been performed at Johns Hopkins for several years.  Candidates for this operation are similar to those for the free TRAM in that there must be adequate abdominal fat to create a new breast.  However, caution must be exercised in performing this technique in women who require large volume reconstruction to prevent the occurrence of fat necrosis or hardening of the new breast.  The operation can be performed immediately following mastectomy or on a delayed basis.  Performance of this operation is slightly more difficult than the free TRAM flap because it requires meticulous dissection of the perforating vessels from the muscle. Deep inferior epigastric perforator flaps tend to have less robust blood flow than is typical with a standard TRAM reconstruction, so careful patient selection is important.  In patients who are non-smokers, who require no more than 70 % of the TRAM flap skin paddle to make a breast of adequate size, and who have at least 1 perforating vessel greater than 1-mm in diameter with a detectable pulse, the incidence of flap complications reportedly is similar to that seen in standard free TRAM flap reconstruction.

The superficial inferior epigastric artery (SIEA) flap uses the same abdominal tissue as the DIEP flap but different blood supplying vessels.

Superior gluteal artery perforator (SGAP) flap or gluteal free flap procedures use tissue from the buttock to create the breast shape. It is an option for women who cannot or do not wish to use the abdominal sites due to thinness, incisions, failed abdominal flap or other reasons. The method is much like the free TRAM flap mentioned above. The skin, fat, blood vessels  SGAP flaps may be performed on women who are not candidates for a TRAM flap or who have had a failed TRAM flap.  Thin women who may not have much tissue in the lower abdominal area often have an adequate amount of tissue in the gluteal region.  The inferior gluteal artery perforator (IGAP) flap shares the same indications as the superior gluteal flap, namely the inability to use the TRAM flap and an abundance of soft tissue in the gluteal region.

The transverse upper gracilis (TUG) flap uses tissue from the upper posterior thigh and lower buttock area and is an option for women with insufficient lower abdominal fat for breast reconstruction.

The latissimus dorsi (LD) flap is tunneled through the axilla, leaving the blood supplying vessels (the thoracodorsal artery and vein) intact. The LD flap has less tissue volume and is usually used in combination with a saline or silicone implant.

Poland syndrome is an extremely rare developmental disorder that is present at birth (congenital).  It is characterized by absence (agenesis) or under-development (hypoplasia) of certain muscles of the chest (e.g., pectoralis major, pectoralis minor, and/or other nearby muscles), and abnormally short, webbed fingers (symbrachydactyly).  Additional findings may include underdevelopment or absence of 1 nipple (including the darkened area around the nipple [areola]) and/or patchy hair growth under the arm (axilla).  In females, 1 breast may also be under-developed (hypoplastic) or absent (amastia).  In some cases, affected individuals may also exhibit under-developed upper ribs and/or an abnormally short arm with under-developed forearm bones (i.e., ulna and radius) on the affected side.  In most cases, physical abnormalities are confined to one side of the body (unilateral).  In approximately 75 % of the cases, the right side of the body is affected.  The range and severity of symptoms may vary from case to case.  The exact cause of Poland syndrome is not known.

Autologous fat grafting (or lipomodeling) uses the patient's own fat cells to replace volume after breast reconstruction, or to fill defects in the breast following breast-conserving surgery (NICE, 2012). It can be used on its own or as an adjunct to other reconstruction techniques. The procedure aims to restore breast volume and contour without the morbidity of other reconstruction techniques.  With the patient under general or local anesthesia, fat is harvested by aspiration with a syringe and cannula, commonly from the abdomen, outer thigh or flank. The fat is usually washed and centrifuged before being injected into the breast. Patients subsequently undergo repeat treatments (typically 2 to 4 sessions) (NICE, 2012). Autologous fat grafting may be delayed for a variable period of time after mastectomy. Most of the evidence for the use of autologous fat grafting in breast reconstruction is as a technique to repair contour defects and deformities. There is less information about the use of autologous fat grafting for complete breast reconstruction.

Guidance from the National Institute for Health and Clinical Excellence (NICE, 2012) states that current evidence on the efficacy of breast reconstruction using lipomodelling after breast cancer treatment is adequate and the evidence raises no major safety concerns. The guidance noted that there is a theoretical concern about any possible influence of the procedure on recurrence of breast cancer in the long term, although there is no evidence of this in published reports. The guidance notes that a degree of fat resorption is common in the first 6 months and there have been concerns that it may make future mammographic images more difficult to interpret.  

A technology assessment on autologous fat injection for breast reconstruction prepared for the Australian and New Zealand Horizon Scanning Network (Humphreys, 2008) found that the technique has the potential to improve some contour defects; however, the results appear to be highly variable, with 2 case series finding that following autologous fat injection between 21 % and 86.5 % of patients showed substantial improvement at post-operative assessment.  Patient satisfaction with the procedure was not reported.  The assessment stated that longer-term follow-up is needed to determine how much of the injected fat survives and how much is eventually re-absorbed by the body.  There are also important safety issues with the procedure, especially in association with the lipo-necrotic lumps that can form in the breast from the injected fat.  Both case series reported this to occur in approximately 7 % of cases, and there is concern that such lumps will impede future cancer detection.

Hyakusoku et al (2009) reported several cases of complications following fat grafting to the breast.  These investigators retrospectively reviewed 12 patients who had received autologous fat grafts to the breast and required breast surgery and/or reconstruction to repair the damage presenting between 2001 and 2007.  All 12 patients (mean age of 39.3 years) had received fat injections to the breast for augmentation mammaplasty for cosmetic purposes.  They presented with palpable indurations, 3 with pain, 1 with infection, 1 with abnormal breast discharge, and 1 with lymphadenopathy.  Four cases had abnormalities on breast cancer screening.  All patients underwent mammography, computed tomography, and magnetic resonance imaging to evaluate the injected fats.  The authors concluded that autologous fat grafting to the breast is not a simple procedure and should be performed by well-trained and skilled surgeons.  Patients should be informed that it is associated with a risk of calcification, multiple cyst formation, and indurations, and that breast cancer screens will always detect abnormalities.  Patients should also be followed-up over the long-term and imaging analyses (e.g., mammography, echography, computed tomography, and magnetic resonance imaging) should be performed.

The American Society of Plastic Surgeons (ASPS) fat grafting task force (Gutowski, 2009) concluded that autologous fat grafting is a promising and clinically relevant research topic.  The current fat grafting literature is limited primarily to case studies, leaving a tremendous need for high-quality clinical studies.

Mizuno and Hyakusoku (2010) stated that recent technical advances in fat grafting and the development of surgical devices such as liposuction cannulae have made fat grafting a relatively safe and effective procedure.  However, guidelines issued by the ASPS in 2009 announced that fat grafting to the breast is not a strongly recommended procedure, as there are limited scientific data on the safety and efficacy of this particular type of fat transfer.  Recent progress by several groups has revealed that multi-potent adult stem cells are present in human adipose tissue.  This cell population, termed adipose-derived stem cells (ADSC), represents a promising approach to future cell-based therapies, such as tissue engineering and regeneration.  In fact, several reports have shown that ADSC play a pivotal role in graft survival through both adipogenesis and angiogenesis.  Although tissue augmentation by fat grafting does have several advantages in that it is a non-invasive procedure and results in minimal scarring, it is essential that such a procedure be supported by evidence-based medicine and that further research is conducted to ensure that fat grafting is a safe and effective procedure.

Acellular dermal matrices are considered a standard-of-care as an adjunct to breast reconstruction. The clinical literature on acellular dermal matrix product in breast reconstruction primarily consists of single institution case series focusing on surgical technique. Much of the early literature focused on AlloDerm brand of acellular dermal matrix, since this product was first to market, but more recent literature has considered other acellular dermal matrix products. Recent literature has provided comparisons of AlloDerm to certain other acellular dermal matrix products, with the authors concluding that there is no significant difference among products (see, e.g., Ibrahim, et al., 2013; Cheng, et al., 2012). While different acellular dermal matrix products are processed differently, these appear to result in minor differences in performance in breast reconstruction.

The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.  It is supplied sterile and is intended for 1-time use.  There is a lack of evidence regading the clincial value of this product in breast reconstructive surgery.

Llewellyn-Bennett et al (2012) noted that latissimus dorsi (LD) flap procedures comprise 50 % of breast reconstructions in the United Kingdom.  They are frequently complicated by seroma formation.  In a randomized study, these researchers investigated the effect of fibrin sealant (Tisseel(®)) on total seroma volumes from the breast, axilla and back (donor site) after LD breast reconstruction.  Secondary outcomes were specific back seroma volumes together with incidence and severity of wound complications.  Consecutive women undergoing implant-assisted or extended autologous LD flap reconstruction were randomized to either standard care or application of fibrin sealant to the donor-site chest wall.  All participants were blinded for the study duration but assessors were only partially blinded.  Non-parametric methods were used for analysis.  A total of 107 women were included (sealant = 54, control = 53).  Overall, back seroma volumes were high, with no significant differences between control and sealant groups over 3 months.  Fibrin sealant failed to reduce in-situ back drainage volumes in the 10 days after surgery, and did not affect the rate or volume of seromas following drain removal.  The authors concluded that the findings of this randomized study, which was powered for size effect, failed to show any benefit from fibrin sealant in minimizing back seromas after LD procedures.

Allen et al (2012) stated that the use of perforator flaps has allowed for the transfer of large amounts of soft tissue with decreased morbidity.  For breast reconstruction, the DIEP flap, the superior and inferior gluteal artery perforator flaps, and the transverse upper gracilis flap are all options.  These investigators presented an alternative source using posterior thigh soft tissue based on profunda artery perforators, termed the profunda artery perforator flap.  Pre-operative imaging helped identify posterior thigh perforators from the profunda femoris artery.  These are marked, and an elliptical skin paddle, approximately 27 × 7 cm, is designed 1 cm inferior to the gluteal crease.  Dissection proceeded in a supra-fascial plane until nearing the perforator, at which point sub-fascial dissection was performed.  The flap has a long pedicle (approximately 7 to 13 cm), which allowed more options when performing anastomosis at the recipient site.  The long elliptical shape of the flap allowed coning of the tissue to form a more natural breast shape.  All profunda artery perforator flaps have been successful.  The donor site was well-tolerated and scars have been hidden within the gluteal crease.  Long-term follow-up is needed to evaluate for possible fat necrosis of the transferred tissue.  The authors presented a new technique for breast reconstruction with a series of 27 flaps.  They stated that this is an excellent option when the abdomen is not available because of the long pedicle, muscle preservation, ability to cone the tissue, and hidden scar.

Tanna et al (2013) presented the findings of the largest series of microsurgical breast reconstructions following nipple-sparing mastectomies.  All patients undergoing nipple-sparing mastectomy with microsurgical immediate breast reconstruction treated at New York University Medical Center (2007 to 2011) were identified.  Patient demographics, breast cancer history, intraoperative details, complications, and revision operations were examined.  Descriptive statistical analysis, including t-test or regression analysis, was performed.  In 51 patients, 85 free flap breast reconstructions (n = 85) were performed.  The majority of flaps were performed for prophylactic indications [n = 55 (64.7 %)], mostly through vertical incisions [n = 40 (47.0 %)].  Donor sites included abdominally based [n = 66 (77.6 %)], profunda artery perforator [n = 12 (14.1 %)], transverse upper gracilis [n = 6 (7.0 %)], and superior gluteal artery perforator [n = 1 (1.2 %)] flaps.  The most common complications were mastectomy skin flap necrosis [n = 11 (12.7 %)] and nipple necrosis [n = 11 (12.7 %)].  There was no correlation between mastectomy skin flap or nipple necrosis and choice of incision, mastectomy specimen weight, body mass index, or age (p > 0.05).  However, smoking history was associated with nipple necrosis (p < 0.01).  The authors concluded that the findings of this series represented a high-volume experience with nipple-sparing mastectomy followed by immediate microsurgical reconstruction.  When appropriately executed, it can deliver low complication rates.

Levine et al (2013) stated that recent evolutions of oncologic breast surgery and reconstruction now allow surgeons to offer the appropriate patients a single-stage, autologous tissue reconstruction with the least donor-site morbidity.  These investigators presented their series of buried free flaps in nipple-sparing mastectomies as proof of concept, and explored indications, techniques, and early outcomes from their series.  From 2001 to 2011, a total of 2,262 perforator-based free flaps for breast reconstruction were reviewed from the authors' prospectively maintained database.  There were 338 free flaps performed on 215 patients following nipple-sparing mastectomy, including 84 patients who underwent breast reconstruction with 134 buried free flaps.  Ductal carcinoma in-situ and BRCA-positive were the most common diagnoses, in 26 patients (30.9 %) each.  The most common flaps used were the DIEP (77.6 %), transverse upper gracilis (7.5 %), profunda artery perforator (7.5 %), and superficial inferior epigastric artery flaps (3.7 %).  An implantable Cook-Swartz Doppler was used to monitor all buried flaps.  Fat necrosis requiring excision was present in 5.2 %of breast reconstructions, and there were 3 flap losses (2.2 %); 78 flaps (58.2 %) underwent minor revision for improved cosmesis; 56 (41.8 %) needed no further surgery.  The authors concluded that nipple-sparing mastectomy with immediate autologous breast reconstruction can successfully and safely be performed in a single stage; however, the authors are not yet ready to offer this as their standard of care.

Healy and Allen (2014) noted that it is over 20 years since the inaugural DIEP flap breast reconstruction.  These investigators reviewed the type of flap utilized and indications in 2,850 microvascular breast reconstruction over the subsequent 20 years in the senior author's practice (Robert J. Allen).  Data were extracted from a personal logbook of all microsurgical free flap breast reconstructions performed between August 1992 and August 2012.  Indication for surgery; mastectomy pattern in primary reconstruction; flap type, whether unilateral or bilateral; recipient vessels; and adjunctive procedures were recorded.  The DIEP was the most commonly performed flap (66 %), followed by the superior gluteal artery perforator flap (12 %), superficial inferior epigastric artery perforator flap (9 %), inferior gluteal artery perforator flap (6 %), profunda artery perforator flap (3 %), and transverse upper gracilis flap (3 %).  Primary reconstruction accounted for 1,430 flaps (50 %), secondary 992 (35 %), and tertiary 425 (15 %).  As simultaneous bilateral reconstructions, 59 % flaps were performed.  With each flap, there typically ensues a period of enthusiasm which translated into surge in flap numbers.  However, each flap has its own nuances and characteristics that influence patient and physician choice.  Of note, each newly introduced flap, either buttock or thigh, results in a sharp decline in its predecessor.  In this practice, the DIEP flap has remained the first choice in autologous breast reconstruction.

1. those requiring postoperative fat grafting and
2. those not requiring fat grafting. 

Patient demographics, indications for surgery, history of radiation therapy, patient body mass index, mastectomy specimen weight, need for rib resection, flap weight, and complications were analyzed in comparison.  A total of 228 patients underwent 374 microvascular free flaps for breast reconstruction.  One hundred (26.7 %) reconstructed breasts underwent post-operative fat grafting, with an average of 1.12 operative sessions.  Fat was most commonly injected in the medial and superior medial poles of the breast and the average volume injected was 147.8 ml per breast (22 to 564 ml).  The average ratio of fat injected to initial flap weight was 0.59 (0.07 to 1.39).  Patients undergoing fat grafting were more likely to have had DIEP and profunda artery perforator flaps as compared to muscle-sparing transverse rectus abdominis myocutaneous.  Patients additionally were more likely to have a prophylactic indication 58 % (n = 58) versus 42 % (n = 117) (p = 0.0087), rib resection 68 % (n = 68) versus 54 % (n = 148) (p < 0.0153), and acute post-operative complications requiring operative intervention 7 % (n = 7) versus 2.1 % (n = 8) (p < 0.0480).  Additionally, patients undergoing autologous fat grafting had smaller body mass index, mastectomy weight, and flap weight.  The authors concluded that fat grafting is most commonly used in those breasts with rib harvest, DIEP flap reconstructions, and those with acute post-operative complications.  It should be considered a powerful adjunct to improve aesthetic outcomes in volume-deficient autologous breast reconstructions and additionally optimize contour in volume-adequate breast reconstructions.

The “body lift” perforator flap technique allows for a double fat layer in each breast when both breasts are being reconstructed.  This is offered to the thin patient with ample breasts in the setting of bilateral mastectomy when volume preservation and projection are desired, yet the fat deposits in the waist and tummy are minimal.  A body lift incision design in the waist gives both a tummy tuck effect and a lift of the buttocks in the donor site.  There is currently insufficient evidence to support the use of the body lift perforator flap technique for breast reconstruction.

DellaCroce et al (2012) stated that for patients with a desire for autogenous breast reconstruction and insufficient abdominal fat for conventional abdominal flaps, secondary options such as gluteal perforator flaps or latissimus flaps are usually considered.  Patients who also have insufficient soft tissue in the gluteal donor site and preference to avoid an implant, present a vexing problem.  These researchers described an option that allows for incorporation of 4independent perforator flaps for bilateral breast reconstruction when individual donor sites are too thin to provide necessary volume.  They presented their experience with this technique in 25 patients with 100 individual flaps over 5 years.  The “body lift” perforator flap technique, using a layered deep inferior epigastric perforator/gluteal perforator flap combination for each breast, was performed in this patient set with high success rates and quality aesthetic outcomes over several years.  Patient satisfaction was high among the studied population.  The authors concluded that the body lift perforator flap breast reconstruction technique can be a reliable, safe, but technically demanding solution for patients seeking autogenous breast reconstruction with otherwise inadequate individual fatty donor sites.  This sophisticated procedure overcomes a limitation of autogenous breast reconstruction for these patients that otherwise resulted in a breast with poor projection and overall volume insufficiency.  The harvest of truncal fat with a circumferential body lift design gave the potential added benefit of improved body contour as a complement to this powerful breast reconstructive technique.

Also, UpToDate reviews on “Principles of grafts and flaps for reconstructive surgery” (Morris, 2013) and “Breast reconstruction in women with breast cancer” (Nahabedian, 2013) do not mention the body lift perforator flap technique as a management tool for breast reconstruction.

SurgiMend

Butterfield and colleagues (2013) noted that a 2010 nationwide survey of plastic and reconstructive surgeons indicated that approximately 83 % performed predominantly implant-based breast reconstruction, with acellular dermal matrix (ADM) used by approximately 50 % of those practitioners.  Although the medical literature documents well over 2,000 cases of breast reconstruction with matrices, relatively few cases using other than human cadaveric ADMs have been reported.  This investigator compared complications and costs using SurgiMend fetal bovine and AlloDerm human cadaveric ADMs.  A retrospective review of a single surgeon's 5-year experience was performed for consecutive, non-randomized immediate breast reconstructions with ADM from 2005 to 2010.  A total of 281 patients had 440 implant-based reconstructions using SurgiMend [222 patients (79.0 %)] or AlloDerm [59 patients (21.0 %)].  No significant differences in complication rates were observed between SurgiMend and AlloDerm for hematoma, infection, major skin necrosis, or breast implant removal.  Seroma was the most prevalent complication; the seroma rate for AlloDerm (15.7 %) was significantly greater than that for SurgiMend (8.3 %).  Using recent product costs for equivalently sized AlloDerm and SurgiMend units, the cost of SurgiMend was $1,024 less per breast than AlloDerm.  The authors concluded that SurgiMend fetal bovine and AlloDerm human cadaveric ADMs demonstrated similar rates of major early complications in breast reconstruction in this study.  This similarity in complication rates between SurgiMend and AlloDerm and the cost savings observed with the use of SurgiMend were factors for the surgeon to consider in choosing a matrix for breast reconstruction.

Ricci and associates (2016) compared the rates of complications between 2 commonly used products: AlloDerm (human cadaveric) and SurgiMend (fetal bovine) ADMs.  A retrospective review of a single center's 6-year experience was performed for consecutive, immediate breast reconstructions with ADM from 2009 to 2014.  These researchers compared demographics and surgical characteristics between patients receiving AlloDerm versus SurgiMend.  Multi-variate logistic regression was used to determine any association between type of matrix and surgical complications and to identify other clinical predictors for complications.  A total of 640 patients underwent 952 reconstructions using AlloDerm [578 breasts (61 %)] or SurgiMend [374 breasts (39 %)].  The average follow-up was 587 days.  Multi-variate analysis revealed that type of matrix was not an independent risk factor for the development of complications.  However, smoking, age, radiotherapy, and initial tissue expander fill volume were associated with increased risk of post-operative complications.  The authors concluded that both AlloDerm and SurgiMend ADMs demonstrated similar rates of major complications when used in immediate implant-based breast reconstruction.  In contrast, pre-operative radiation therapy, smoking, increasing age, and initial tissue expander fill volume were independent risk factors for post-operative complications.  They stated that reconstructive surgeons should take these findings into consideration when performing implant-based breast reconstruction with a dermal matrix.

Ball and co-workers (2017) noted that ADM assisted implant-based breast reconstruction (IBBR) has grown in popularity over traditional submuscular techniques.  Numerous human, bovine or porcine derived ADMs are available with the type used varying considerably worldwide.  Yet, comparative evidence for the efficacy of different ADMs particularly xenogenic is limited.  In a retrospective study, these researchers compared early outcomes of porcine (Strattice) and bovine (Surgimend) ADMs in IBBR.  Data were collected for patients undergoing ADM assisted IBBR after prophylactic or therapeutic mastectomy in Cambridge (October 2011 to March 2016).  Patient demographics, adjuvant and neoadjuvant therapies, operative details, post-operative management and outcomes were analyzed.  A total of 81 patients underwent IBBR with ADM; 38 bilateral and 43 unilateral (n = 119 breasts). Strattice was used in 30 breasts (25 %) and Surgimend in 89 (75 %).  Analysis of patient specific variables showed statistical significance only for higher mastectomy weight in the Strattice group (367.1 ± 159.3 g versus 296.3 ± 133.4 g; P = 0.0379).  Strattice was associated with higher rates of skin erythema post-operatively (16.7 % versus 4.5 %; p = 0.044).  Analyzed per woman or per breast, there was no statistically significant difference in rates of hematoma, infection, wound dehiscence, skin necrosis or seroma, although there was a trend towards more complications with Strattice.  The authors concluded that this study found significantly higher rates of skin erythema and a trend towards higher complication rates with Strattice in IBBR.

Mazari and associates (2018) stated that Strattice (porcine derivative) and SurgiMend (bovine derivative) are the 2 most common ADMs used in breast reconstruction in the United Kingdom.  In a retrospective study, these researchers compared clinical outcomes in immediate implant-based breast reconstruction patients.  The study, conducted across 3 hospitals, included all patients who underwent immediate implant-based breast reconstruction using Strattice and SurgiMend.  The primary outcome measure was implant loss rate; secondary outcome measures included ADM loss rate, seroma formation, and minor and major complication rates; inter-group comparison was performed.  A total of 82 patients (Strattice, n = 45; SurgiMend, n = 37) underwent 97 immediate implant-based breast reconstructions (Strattice, n = 54; SurgiMend, n = 43).  There were no differences between groups for age, co-morbidities, specimen weight, or implant volume.  Drains were used in all Strattice and 36 (84 %) SurgiMend cases.  The implant loss rate was higher for Strattice (n = 10, 20 %) compared with SurgiMend (n = 3, 7 %); but failed to reach statistical significance (Chi-square test, p = 0.077).  The ADM loss rate was significantly higher (Fisher's exact test, p = 0.014) in the Strattice group (n = 7, 14 %), with no ADM loss with SurgiMend.  The re-operation rate was also significantly higher (Chi-square test, p = 0.002) in the Strattice group (n = 17, 33 %, versus n = 3, 7 %).  The incidence of red breast was significantly higher (Chi-square test, p = 0.022) in the SurgiMend group (n = 9, 21 %t, versus n = 3, 6 %); seroma, wound problems, and infection rates were similar.  The authors concluded that clinical outcomes, including implant loss, ADM loss, and re-operation rates, were significantly better when using SurgiMend in immediate implant-based breast reconstruction compared with Strattice.

Dermacell

Decellularized human skin has been used in a variety of medical applications, primarily involving soft tissue reconstruction, wound healing, and tendon augmentation. Theoretically, decellularization removes potentially immunogenic material and provides a clean scaffold for cellular and vascular in growth. DermACELL acellular dermal matrix offers advanced processing in order to attempt to decrease bio-intolerance and complications in breast reconstruction and other procedures. There are little published data on the use of DermACELL in breast reconstruction.

Bullocks (2014) reported on 10 consecutive patients that presented for breast reconstruction and were candidates for tissue expanders underwent the procedure with the use of an acellular dermal matrix. The patients underwent postoperative expansion/adjuvant cancer therapy, then tissue expander exchange for permanent silicone breast prostheses. Patients were followed through the postoperative course to assess complication outcomes. Histologic evaluation of host integration into the dermal matrix was also assessed. Of the ten patients included in the study, eight completed reconstruction while two patients failed reconstruction. The failures were related to chronic seromas and infection. Histology analysis confirms rapid integration of mesenchymal cells into the matrix compared to other acellular dermal matrices.

Vashi described the use of DermACELL acellular dermal matrix in two-stage postmastectomy breast reconstruction. Ten consecutive breast cancer patients were treated with mastectomies and immediate reconstruction from August to November 2011. There were 8 bilateral and 1 unilateral mastectomies for a total of 17 breasts, with one exclusion for chronic tobacco use. Reconstruction included the use of a new 6 × 16 cm sterile, room temperature acellular dermal matrix patch (DermACELL) soaked in a cefazolin bath. Results. Of the 17 breasts, 15 reconstructions were completed; 14 of them with expander to implant sequence and acellular dermal matrix. Histological analysis of biopsies obtained during trimming of the matrix at the second stage appeared nonremarkable with evidence of normal healing, cellularity, and vascular infiltration.

Zenn and Salzberg (2016) reported on their experience with Dermacell to Alloderm-RTU.. The authors stated that retrospective study draws on the experience of 2 expert surgeons with a history of long-standing use of the Alloderm-RTU (LifeCell Corporation, Branchburg, NJ) product who switched to the DermACELL acellular dermal matrix (LifeNet Health, Virgina Beach, Va) product. The authors stated that the consecutive nature of these data over this change allowed comparison between the 2 products without the confounding effects of patient selection or change in technique. The postoperative complications of seroma, infection, implant loss, and unplanned return to the operating room were studied, and no statistical differences were noted between these 2 products. The overall complications rates  were low, with implant loss and infection less than 2% in 249 cases. The authors recommended use of acellular dermal matrix in breast reconstruction and product selection based on price and availability.

Pittman et al (2017) compared the clinical outcomes between available acellular dermal matrixes DermACELL and AlloDerm RTU. A retrospective chart review was performed on 58 consecutive patients (100 breasts) reconstructed with either DermACELL(n=30 patients; 50 breasts) or AlloDerm RTU (n=28 patients; 50 breasts). The mastectomies were performed by three different breast surgeons. All reconstructions were performed by the same Plastic surgeon (TAP). Statistical analysis was performed by Fisher's exact test. The average age, body mass index (BMI), percent having neo-djuvant/adjuvant chemotherapy or breast irradiation, and numbers of therapeutic and prophylactic mastectomies between the two groups was not statistically significant (p < 0.05). Complications in both cohorts of patients were clinically recorded for 90 days post immediate reconstruction. The authors reported that, when comparing outcomes, patients in the DermACELL group had significantly less incidence of 'red breast' (0 % versus 26 %, p = 0.0001) and fewer days before drain removal (15.8 versus 20.6, p = 0.017). No significant difference was seen in terms of seroma, hematoma, delayed healing, infection, flap necrosis, and explantation.

Expander-Implant Breast Reconstruction

1. exposure to pre-operative XRT (XRT-pre),
2. post-operative XRT (XRT-post), or
3. no XRT (control). 

A subset of XRT patients with bilateral EIBR was assessed using a matched-pair analysis with the patients serving as their own controls.  A total of 76 patients were included in the study.  Major complications were observed in 6 of 8, 26 of 38, and 14 of 30 patients in the XRT-pre, XRT-post, and control groups, respectively, and were not statistically different (p > 0.05).  Failure rates of EIBR were 13.3 % in the control group compared to 50.0 % in the XRT-pre group (p = 0.044) and 26.3 % in the XRT-post group (p > 0.05).  In the matched-pair analysis, 16 of 26 irradiated breasts developed complications compared to only 7 of 26 contralateral non-irradiated breasts (p = 0.043).  The authors detected a significantly increased risk of complications in patients with pre-mastectomy radiotherapy.  Patients with this history of XRT should strongly consider autologous reconstruction instead of EIBR to avoid the high risk of developing complications and subsequently losing their implant.  They stated that increased complications in irradiated breasts when compared to the contralateral non-irradiated breasts in bilateral EIBR patients confirmed the detrimental role of XRT in the setting of EIBR.

Nipple Reconstruction

Winocour and colleagues (2016) stated that many techniques have been described for nipple reconstruction, with the principal limitation being excessive loss of projection.  The ideal reconstructed nipple provides sustained projection, the fewest complications, and high levels of patient satisfaction.  A variety of materials are available for projection augmentation, including autologous, allogeneic, and synthetic materials.  To date, there has been no systematic review to study the efficacy, projection, and complication rates of different materials used in nipple reconstruction.  Medline, Embase, and PubMed databases were searched, from inception to August of 2014, to identify literature reporting on outcomes of autologous, allogeneic, and synthetic grafts in nipple reconstruction.  Retrospective and prospective studies with controlled and uncontrolled conditions were included.  Studies reporting the use of autologous flap techniques without grafts and articles lacking post-operative outcomes were excluded.  Study quality was assessed using the Newcastle-Ottawa Scale.  A total of 31 studies met the inclusion criteria.  After evidence review, 1 study represented 2 of 9 stars on the Newcastle-Ottawa Scale, 2 studies represented 3 stars, 6 studies represented 4 stars, 7 studies represented 5 stars, 11 studies represented 6 stars, and 4 studies represented 7 stars.  The authors concluded that the findings of this review revealed heterogeneity in the type of material used within each category and inconsistent methodology used in outcomes assessment in nipple reconstruction.  Overall, the quality of evidence was low.  Synthetic materials had higher complication rates and allogeneic grafts had nipple projection comparable to that of autologous grafts.  They stated that further investigation with high-level evidence is needed to determine the optimal material for nipple reconstruction.

Impact of Obesity on Outcomes in Breast Reconstruction

Myung and Heo (2017) noted that although many patients who undergo reduction mammaplasty are obese, reports on whether obesity is a risk factor for post-operative complications have been conflicting.  In a systematic review and meta-analysis, these investigators examined the relationship between obesity and surgical complications after reduction mammaplasty.  PubMed, Medline, and Embase databases were searched between 1998 and 2016 using the MeSH terms and keywords “reduction mammoplasty (mammaplasty)”, “breast reduction”, “obesity”, “body weight”, “body mass index” and “risk factor”.  Among 26 studies that reported surgical complication risk and patient body weight, 11 concluded that obesity was not a risk factor and 15 reported that high BMI increases surgical risk.  On comparing obese and non-obese patients, these researchers found that obese patients had a higher relative risk (RR) of surgical complications (1.38, 95 % confidence interval [CI]: 1.13 to 1.69), particularly skin and fat necrosis (2.01, 95 % CI: 1.54 to 2.63).  The pooled risk further increased with an increase in BMI, and it was 1.71 for BMI greater than 35 kg/m2 and 2.05 for BMI greater than 40 kg/m2.  The authors concluded that the findings of this meta-analysis indicated that the risk of surgical complications and tissue necrosis after reduction mammaplasty was higher in obese patients than in non-obese patients and that the risk gradually increased with an increase in the severity of obesity.  They stated that these findings could form a basis for pre-operative patient education, surgical method selection, and determination of the extent of post-operative care.

The authors stated that this study had several drawbacks.  First, this meta-analysis was based on observational studies, and thus, there was a high risk of selection and publication bias.  The calculation of RR would have been more meaningful if the meta-analysis included studies with a randomized control design and a prospective cohort.  Second, potential confounders were not considered.  Study screening and exclusion of other potential confounders was not possible owing to the nature of a meta-analysis.  The major potential confounders, according to previous publications, were active smoking and resection weight or volume of the operated breast.  However, as mentioned earlier, active smoking had been shown to negatively impact surgical outcomes in both in-vivo and experimental studies, and since resection weight was relatively proportional to a patient’s body weight, these variables unlikely influenced the outcome of the present study.  Third, the study did not examine the risks of specific complication types or surgical methods.  While analyzing the rate of complications, rather than analyzing the incidences of specific complication types, such as infection, hematoma, seroma, and wound dehiscence, the data were grouped.  Moreover, there were many surgical options, including liposuction, round-type incision, vertical reduction, and inverted T resection; however, the results of these different procedures could not be reviewed owing to an insufficient number of reports.  Data heterogeneity in the meta-analysis was likely due to subtle differences in the reporting pattern; the range of complications, symptoms, and follow-up periods; and the limitation of pooled data.  Nevertheless, to the authors’ knowledge, this study was the 1st meta-analysis and systematic review to evaluate the surgical risk of obesity in reduction mammaplasty, and as such, it provided objective conclusions on this controversial topic.

Panayi and colleagues (2018) stated that increased rates of both breast cancer and obesity have resulted in more obese women seeking breast reconstruction.  Studies reported that these women are at increased risk for peri-operative complications.  These investigators carried out a systematic review to examine the outcomes in obese women who underwent breast reconstruction following mastectomy.  Cochrane, PubMed, and Embase electronic databases were screened and data were extracted from included studies.  The clinical outcomes evaluated were surgical complications, medical complications, length of post-operative hospital stay, re-operation rate, and patient satisfaction.  A total of 33 studies met the inclusion criteria and 29 provided enough data to be included in the meta-analysis (71,368 patients, 20,061 of whom were obese).  Obese women (BMI greater than 30 kg/m2) were 2.29 times more likely to experience surgical complications (95 % CI: 2.19 to 2.39; p < 0.00001), 2.89 times more likely to have medical complications (95 % CI: 2.50 to 3.35; p < 0.00001), and had a 1.91 times higher risk of re-operation (95 % CI: 1.75 to 2.07; p < 0.00001).  The most common complication, wound dehiscence, was 2.51 times more likely in obese women (95 % CI: 1.80 to 3.52; p < 0.00001).  Sensitivity analysis confirmed that obese women were more likely to experience surgical complications (RR 2.36, 95 % CI: 2.22 to 2.52; p < 0.00001).  The authors concluded that the findings of this study provided evidence that obesity increased the risk of complications in both implant-based and autologous reconstruction.  Moreover, they stated that additional prospective and observational studies are needed to determine if weight reduction before reconstruction reduces the peri-operative risks associated with obesity.

The above policy is based on the following references: