Are patients most satisfied with a synthetic or a biological mesh in dual-plane immediate breast reconstruction after 5 years? A randomized controlled trial comparing the two meshes in the same patient.

Biological or synthetic meshes are commonly used in implant-based immediate breast reconstruction (IBR). The aim of this study was to compare patient-reported outcome measurements (PROMs) after IBR with a synthetic mesh and a biological mesh, in a single-blinded randomized controlled trial, using the compared materials in the same patient, thereby eliminating patient-related confounders. Twenty-four patients were recruited, and all patients had a prophylactic bilateral mastectomy and a dual-plane reconstruction using anatomical breast implants. The patients' two breasts were randomized preoperatively to a biological or a synthetic mesh, using a simple approach with a parallel design. PROMs were measured with BREAST-Q. Twenty-one patients answered (88%). Most participants were equally satisfied/dissatisfied with the synthetic and the biological mesh sides regarding size of bra, softness, feel to touch, natural part of body, appearance compared with preoperatively, and palpable wrinkles, and about half of the patients regarding shape of bra, natural appearance, and visible wrinkles. The frequency of capsular contracture rate was zero in both groups at 5 years. One mesh type was not clearly superior to the other regarding PROMs, but biological and synthetic meshes seem to give rise to different types of reconstructed breasts, and more studies are needed regarding whether knowledge about the effects of different meshes can be used to tailor breast reconstructions to individual patients' wishes. The rate of complications and corrections in the biological mesh breasts was higher, and this must be considered when the type of mesh is chosen. Trial registration number: ClinicalTrials.Gov identifier NCT02985073.

A systematic review and meta-analysis of risks and benefits with breast reduction in the public healthcare system: priorities for further research.

BACKGROUND: There is no consensus for when publicly funded breast reduction is indicated and recommendations in guidelines vary greatly, indicating a lack of evidence and unequal access. The primary aim of this review was to examine risks and benefits of breast reduction to treat breast hypertrophy. Secondary aims were to examine how the studies defined breast hypertrophy and indications for a breast reduction. METHODS: A systematic literature search was conducted in PubMed, MEDLINE All, Embase, the Cochrane Library, and PsycInfo. The included articles were critically appraised, and certainty of evidence was assessed using the GRADE approach. Meta-analyses were performed when possible. RESULTS: Fifteen articles were included; eight reporting findings from four randomised controlled trials, three non-randomised controlled studies, three case series, and one qualitative study. Most studies had serious study limitations and problems with directness. Few of the studies defined breast hypertrophy. The studies showed significantly improved health-related quality of life and sexuality-related outcomes in patients who had undergone breast reduction compared with controls, as well as reduced depressive symptoms, levels of anxiety and pain. Most effect sizes exceeded the reported minimal important difference for the scale. Certainty of evidence for the outcomes above is low (GRADE ⊕ ⊕). Although four studies reported significantly improved physical function, the effect is uncertain (very low certainty of evidence, GRADE ⊕). None of the included studies reported data regarding work ability or sick leave. Three case series reported a 30-day mortality of zero. Reported major complications after breast reduction ranged from 2.4 to 14% and minor complications from 2.4 to 69%. CONCLUSION: There is a lack of high-quality studies evaluating the results of breast reduction. A breast reduction may have positive psychological and physical effects for women, but it is unclear which women benefit the most and which women should be offered a breast reduction in the public healthcare system. Several priorities for further research have been identified. PRE-REGISTRATION: The study is based on a Health Technology Assessment report, pre-registered and then published on the website of The Regional HTA Centre of Region Västra Götaland, Sweden.

First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study.

BACKGROUND: Even though meshes and matrices are widely used in breast reconstruction, there is little high-quality scientific evidence for their risks and benefits. The aim of this study was to compare first-year surgical complication rates in implant-based immediate breast reconstruction with a biological mesh with that of a synthetic mesh, in the same patient. METHODS: This study is a clinical, randomized, prospective trial. Patients operated on with bilateral mastectomy and immediate breast reconstruction were randomized to biological mesh on one side and synthetic mesh on the other side. RESULTS: A total of 48 breasts were randomized. As the synthetically and the biologically reconstructed breasts that were compared belonged to the same woman, systemic factors were exactly the same in the two groups. The most common complication was seroma formation with a frequency of 38% in the biological group and 3.8% in the synthetical group (p = .011). A higher frequency of total implant loss could be seen in the biologic mesh group (8.5% vs. 2%), albeit not statistically significant (p = .083). CONCLUSIONS: In the same patient, a synthetic mesh seems to yield a lower risk for serious complications, such as implant loss, than a biological mesh.

Drain secretion and seroma formation after immediate breast reconstruction with a biological and a synthetic mesh, respectively: A randomized controlled study.

The aim of this study was to compare seroma production in breast reconstruction with a biological mesh with that of a synthetic mesh, in the same patient. The patients were randomized to biological mesh in one breast and synthetical in the other. Twenty-four breasts were included. The total drain production and the daily drain production were similar in the two groups. After drain removal, there were more seroma aspirations in the biological group. During the exchange to a permanent implant, there was significantly more seroma in the biological group. Seroma formation is different in synthetic and biological meshes.

Should immediate breast reconstruction be performed in the setting of radiotherapy? An ethical analysis.

Immediate breast reconstruction (IBR) combined with post-mastectomy radiotherapy (PMRT) is associated with an increased risk for complications. Here, we analyse whether IBR combined with PMRT is ethically acceptable. We employ normative analysis following reflective equilibrium and the principles of Beauchamp and Childress: non-maleficence, beneficence, autonomy, and justice. From the perspective of beneficence and non-maleficence, we can choose either IBR or PMRT according to documented risks and complications, delayed autologous breast reconstruction with corresponding benefits but less risk for complications, or even no reconstruction, which for some women, might be equally beneficial. In such a situation, given the level of severity associated with lacking a breast after mastectomy, IBR violates the principles of beneficence and non-maleficence. To deny an IBR in the context of PMRT does not violate the principle of autonomy as it is normally interpreted in the healthcare system, not even when patient-centred care is taken into consideration. Moreover, there is a risk that the decision of the patient will be affected by heuristics, optimism bias, and surgeon bias. IBR in the context of PMRT could be in conflict with the principle of justice, as it could lead to displacement of care for other patient groups. Furthermore, an acceptable level of cost effectiveness should be low, given that living without a breast is a condition of moderate severity. In conclusion, given the current knowledgebase and established ethical norms within the healthcare system, we find strong ethical reasons not to offer IBR when PMRT is expected.

Comparison of inflammatory response and synovial metaplasia in immediate breast reconstruction with a synthetic and a biological mesh: a randomized controlled clinical trial.

The aim of this study was to compare inflammatory response and synovial metaplasia in implant-based immediate breast reconstruction with a biological mesh (Veritas®) with that of a synthetic mesh (TIGR® Matrix Surgical Mesh). We hypothesize that the inflammatory response and formation of synovial metaplasia might be different and the rate of capsular contracture therefore different. The patients were recruited from the Gothenburg TIGR®/Veritas® Study (ClinicalTrials.Gov identifier NCT02985073). All referrals for bilateral immediate breast reconstruction were assessed for inclusions. During the operation, the patients were randomized to which sides the biological and the synthetic mesh were going to be applied. During the implant exchange biopsies were taken. Biopsies were taken from 30 breasts in 15 patients. There seem to be more myofibroblast and neovascularization in the biological meshes than in the synthetic and the collagen fibers seem to be aligned in an irregular pattern with both parallel and vertical fibers. In the synthetic meshes, there were more giant cells and foreign body reaction and the collagen fibers were loosely and well aligned, oriented parallel to the surface of the implant. Synovial metaplasia was seen in the majority of both the biological and the synthetic meshes. The histological patterns in early capsules from biological and synthetic meshes vary considerably. Nonetheless, it is unknown what role different cell types have in capsular formation in the long run and there was no difference in clinical capsular contracture at the clinical follow-up in this study.

A biological or a synthetic mesh in immediate breast reconstruction? A cohort-study of long-term Health related Quality of Life (HrQoL).

OBJECTIVES: Meshes/matrices are commonly used in immediate breast reconstruction. There are few studies comparing biological and synthetic meshes and it is unknown what type of mesh gives the best long-term results. The aim of this study was to compare long-term health-related quality of life (HrQoL) and patient satisfaction in implant-based immediate breast reconstruction with a biological mesh (Surgisis®) with that of patients reconstructed with a synthetic mesh (TIGR ® Matrix Surgical Mesh). MATERIAL AND METHODS: Both cohorts were prospectively included and consecutively operated. Clinical data was collected. HrQoL was evaluated with EuroQoL-5 dimension - 3 levels questionnaire (EQ-5D-3L) and the Hospital Anxiety and Depression Scale (HADS) and the Breast-Q. RESULTS AND CONCLUSION: Seventy-one patients were operated on in the biological group and 49 in the synthetic group. The response rates were 75 and 84 per cent, respectively. Mean follow-up time was 74 months and 23 months, respectively. There were no statistical differences in satisfaction and quality of life between the two groups. Complications and radiation seem to lead to a lower satisfaction. Our findings could indicate that biological and synthetic meshes give an equal long-term result as regards patients' perceived quality of life.

Complications, patient-reported outcomes, and aesthetic results in immediate breast reconstruction with a dermal sling: A systematic review and meta-analysis.

An inferior dermal flap ("sling") can be used to cover an implant with two layers of tissue following Wise pattern skin-reducing mastectomies. Here, we performed a systematic review of the risks and benefits of this technique, specifically regarding complications, patient-reported outcomes, and aesthetic outcomes. PubMed and other relevant databases were searched using specific key words, with inclusion criteria comprising studies of dermal sling use involving ≥ 5 patients and performance according to the PICO framework. A meta-analysis was performed using a random-effects model involving a binomial distribution with logit-link function. For each study, the 95% confidence interval (CI) was obtained based on exact limits from a binomial distribution, and heterogeneity testing was performed using a chi-squared test. A total of 428 abstracts were retrieved, with 24 studies meeting the inclusion criteria and including a total of 879 patients and 1184 reconstructed breasts. The mean complication rate was 21.6% (95% CI: 16.9-27.2%), with the most common complication involving wound-healing problems (mean, 11.4%; 95% CI: 8.5-15.2%), and the frequency of implant loss (< 3 months) varied from 0% to 14% (mean, 2.2%; 95% CI: 1.1-4.4%). Seven articles reported patient-reported outcomes, and four reported aesthetic outcomes, with the quality of evidence classified as low for complications and very low for patient-reported outcomes and aesthetic outcomes. Our findings showed that although implant-based reconstruction with a dermal sling is widely used, there is little scientific evidence supporting the method.

Breast reconstruction with a dermal sling: a systematic review of surgical modifications.

A dermal sling (DS) is used to cover the implant with two layers of tissue when immediate breast reconstruction is performed in women with large and ptotic breasts. It works as an autologous acellular dermal matrix/mesh that can be used to control the implant pocket and inframammary fold, without inferring an extra foreign material and higher costs. There is relatively little published about the DS technique. The primary aim of this study was to systematically review published surgical modifications to the dermal sling (DS). The secondary aim was to investigate what implants have been used. Relevant databases were searched for articles and abstracts published between January 1990 and September 2018. Inclusion criteria were studied and case reports on DS meeting the criteria defined in a PICO. Review articles were excluded. Total evidence for the different types of DSs was graded according to GRADE. A total of 428 abstracts were retrieved. Of these 373 abstracts did not meet the inclusion criteria and were excluded, leaving 54 abstracts. Nine categories of surgical modifications could be identified: classic dermal sling (DS) with minor modifications, non Wise-pattern mastectomy DS, nipple areola complex bearing DS, DS in combination with a matrix/mesh, DS as a suture line protection technique, DS with a modified circulatory basis, DS without an implant, DS as an immediate-delayed technique and pre-pectoral DS. The evidence for DS as a surgical technique is very low (GRADE ⊕). The DS can be used with both permanent implants and tissue expanders (GRADE ⊕).

Immediate breast reconstruction with a wise pattern mastectomy and NAC-sparing McKissock vertical bipedicle dermal flap.

Preservation of the nipple-areola complex (NAC) in immediate reconstruction of ptotic and large breasts is surgically challenging. This article presents a modification of the inferior dermal flap ("dermal sling") to a vertical bipedicle flap with NAC preservation. This flap is well described in breast reductions but has never been described in a mastectomy setting. The study reviews data for a case series of 17 breasts in 11 women who underwent breast reconstruction with the new technique. The complication rate was 12%, thus indicating that the vertical bipedicle NAC-sparing flap should be considered a feasible option for breast reconstruction in women with ptotic and/or large breasts.

TIGR® matrix surgical mesh - a two-year follow-up study and complication analysis in 65 immediate breast reconstructions.

In recent years, it has become increasingly popular to use matrices, such as acellular dermal matrices, in implant-based breast reconstruction. To lower the cost and to avoid implanting biological material, the use of synthetic meshes has been proposed. This is the first study examining TIGR® Mesh in a larger series of immediate breast reconstruction. The aims of the study were to examine complications and predictors for complications. All consecutive patients operated on with breast reconstruction with TIGR® Matrix Surgical Mesh and tissue expanders (TEs) or permanent implant between March 2015 and September 2016 in our department were prospectively included. Exclusion criteria were ongoing smoking, BMI (kg/m2) > 30, planned postoperative radiation, and inability to leave informed consent. Fifteen breasts (23%) were affected by complications within 30 d: four (6.2%) major complications and eleven (17%) minor complications. The major complications included two implant losses and one pulmonary embolism (PE). Predictors for a complication were age over 51 years, BMI over 24.5 kg/m2, large resection weight, and the need for a wise pattern excision of skin. Four minor surgical complications occurred after 30 d (minimum follow-up 17 months). There were no implant losses. In addition, minor aesthetic corrections, such as dog-ear resection, were performed in 10 breasts. In conclusion, breast reconstruction with a TE in combination with TIGR® Matrix Surgical Mesh can be performed with a low complication rate.

Benefits and risks with acellular dermal matrix (ADM) and mesh support in immediate breast reconstruction: a systematic review and meta-analysis.

In modern implant-based immediate breast reconstruction, it has become common to use biological acellular dermal and synthetic matrices in combination with a tissue expander or an implant. The aim of this systematic review was to examine differences in recurrence of cancer, impact on oncological treatment, health related quality of life, complications and aesthetic outcome between matrix and no matrix in immediate breast reconstruction. Systematic searches, data extraction and assessment of methodological quality were performed according to predetermined criteria. Fifty-one studies were eligible and included in the review. The certainty of evidence for overall complication rate and implant loss is low (GRADE ⊕⊕□ □). The certainty of evidence for delay of adjuvant treatment, implant loss, infection, capsular contraction and aesthetic outcome is very low (GRADE ⊕□ □ □). No study reported data on recurrence of cancer or health related quality of life. In conclusion, there is a lack of high quality studies that compare the use of matrix with no matrix in immediate breast reconstruction. Specifically, there are no data on risk of recurrence of cancer, delay of adjuvant treatment and Health related quality of life (HRQoL). In addition, there is a risk of bias in many studies. It is often unclear what complications have been included and how they have been diagnosed, and how and when capsular contracture and aesthetic outcome have been evaluated. Controlled trials that further analyse the impact of radiotherapy, type of matrix and type of procedure (one or two stages) are necessary.

Breast-conserving surgery using an inframammary fold incision technique for breast cancer.

BACKGROUND: Breast-conserving surgery is an established alternative for the majority of women with early stage breast cancer. Consensus on negative margins (no ink on tumour) for invasive cancer makes mutilating extensive lumpectomies unnecessary. Several breast-conserving surgical methods are described in the literature. The aim of this study was to describe and evaluate a technique using the inframammary fold incision. METHODS: Twenty-seven patients with suspected breast cancer (stage I-II) underwent breast-conserving surgery using the inframammary fold incision. Data regarding tumour characteristics, margin status, complications, oncologic and aesthetic outcome was analysed retrospectively. RESULTS: After a median follow-up of 35 months, 23 of the 24 patients with breast cancer (95.8%) had no evidence of disease. Post-operative complications (as defined by infection requiring antibiotic treatment and/or seroma requiring drainage) were seen in three of the 27 patients (11.1%). The final pathological examination revealed a positive excision margin in four patients (16.7%). Post-operative evaluation with the BREAST-Q™ BCT module showed a mean RASCH score of 72.5 regarding 'Satisfaction with breast'. The aesthetic result with a hidden scar is exemplified. CONCLUSION: Breast-conserving surgery using the inframammary fold incision seems to be a safe method with better cosmesis; however, further research is needed.

Poor correlation between spectrophotometric intracutaneous analysis and histopathology in melanoma and nonmelanoma lesions.

Spectrophotometric intracutaneous analysis (SIAscopy) is an imaging technique developed for diagnostics of pigmented skin lesions. By image analysis, the displayed images indicate the potential distribution and position of melanin, blood, and collagen within the lesion. A topographic comparison was performed between SIAscopic findings and histopathology. In total, 60 patients with suspicious pigmented skin lesions were included. The lesions were SIAscopically imaged and documented before excision and histopathological preparation. Topographical comparisons between SIAscopy findings and histopathology were made. A sensitivity and specificity of 24% and 84%, respectively, were obtained for invasive melanomas. The positive and negative predicted values were 58% and 54%, respectively. The features indicating dermal melanin, blood displacement and collagen holes did only show "no" to "slight" agreement with histopathology, i.e., κ ≤ 0.21. It was concluded that (i) SIAscopy-based diagnosis has low diagnostic accuracy for melanoma, (ii) single SIAscopic features do not provide reliable diagnostic information relating to the lesions internal structure on histopathology examination and (iii) SIAscopy cannot be used as a guide for localizing the maximum tumor thickness when performing the histopathological examination. The importance of validating new optical tools for tumor diagnostics with histopathological findings was demonstrated.

Vaginal construction with skin grafts and vacuum-assisted closure.

Probably the most common method of constructing a vagina in patients with the Mayer-Rokitansky-Küster syndrome is the technique popularised by McIndoe and Banister in 1938. A cavity is created between the rectum and urethra-bladder complex and is lined with split-thickness skin grafts. One of the disadvantages of using split-thickness skin grafts is the incidence of late contraction of the neovagina. To avoid this problem full-thickness skin grafts have been used, but their take is less reliable. A new technique to improve the take of skin grafts is the VAC-system (vacuum assisted closure, KCI) which has proved to be particularly valuable in grafting difficult anatomical sites. We have used the VAC-system in the construction of a vagina in one case with split-thickness skin grafts and in two cases with full-thickness skin grafts. In all three cases the take was excellent with little discomfort for the patients. It was not necessary to stent the neovagina in the postoperative period and coitus was possible within a month of operation.