Patient-Reported Outcomes and Complication Profiles of Implant-Based Breast Reconstruction in Patients With Postmastectomy Radiation Therapy.

OBJECTIVE: This study aims to investigate the patient-reported outcomes (PROs) and complications of distinct implant-based breast reconstruction modality for patients with postmastectomy radiation therapy (PMRT). METHODS: A retrospective review was conducted on breast cancer patients with stage II-III disease who performed implant-based breast reconstruction following with PMRT between September 2016 and April 2022. The patients were categorized into two matched groups: (1) patients receiving prepectoral breast reconstruction (PBR) or (2) subpectoral breast reconstruction (SBR) followed by PMRT. Following reconstruction, the patients were further compared for PMRT with the tissue expander (PMRT-TE) versus PMRT with permanent implant (PMRT-PI). PROs were measured with BREAST-Q questionnaire. Early and late complications were recorded and analyzed. RESULTS: A total of 55 eligible patients were recruited. Patients who underwent PBR reported significantly higher satisfaction with breasts scores (P = 0.003) compared with the SBR group. The PMRT-TE group had higher satisfaction with breasts (P = 0.001) but lower physical well-being (P = 0.029) scores compared with PMRT-PI group. Moreover, patients in SBR cohort had a higher risk of capsular contracture (Baker grade III or IV) (20.5% vs 6.3%) and implant dislocation (48.7% vs 12.5%) than patients in PBR cohort. Patients in PMRT-PI group had a slightly higher rate of capsular contracture (Baker grade III or IV) than PMRT-TE group (20.8% vs 12.9%). CONCLUSIONS: PBR was associated with lower rates of late complications, especially for implant dislocation, and higher satisfaction with breasts scores compared to SBR. In addition, compared to PMRT-TE with PMRT-PI, patients in PMRT-TE cohort reported superior PROs of satisfaction with breasts.

Breast reconstruction with mentor anatomical implants and the risk of implant rotation: A retrospective study of 1134 women.

BACKGROUND: Implant rotation is a known complication to breast reconstruction using anatomical implants. However, there is a lack of large studies investigating the risk of implant rotation and potential predisposing risk factors. METHOD: We reviewed the medical records of all patients who underwent breast reconstruction with Mentor anatomical implants from 2010 to 2021 at two Danish hospitals. We compared the risk of implant rotation between one- and two-stage breast reconstruction using univariate logistic regression. We analyzed the effect of biological mesh, immediate versus delayed reconstruction, and use of a higher final expander volume than the permanent implant volume on the risk of implant rotation. Finally, we analyzed the success rate of revision surgery for implant rotation. RESULTS: In total, 1134 patients were enrolled. Patients who underwent two-stage breast reconstruction (n = 720) had a significantly higher risk of implant rotation than those who underwent one-stage breast reconstruction (n = 426; 11% vs. 5%, p < 0.01). There was no significant association between implant rotation and the use of biological mesh, immediate breast reconstruction, or use of a higher final expander volume than the permanent implant volume. The success rate of revision surgery after implant rotation was 73% (62/85 rotations). CONCLUSIONS: Two-stage breast reconstruction significantly increased the risk of implant rotation compared to one-stage breast reconstruction. The overall risk of implant rotation was low and success rate of revision surgery was high. These findings suggest that anatomical implants are safe to use for breast reconstruction. However, surgeons and patients should be aware of the increased risk of implant rotation after two-stage reconstruction.

Breast Reduction with Implants or Augmentation Reduction: Patient-Reported Outcomes from a Single-Centre Retrospective Cohort Analysis.

Background and Objectives: The correction of breast hypertrophy and ptosis with implant placement has always posed a challenge for plastic surgeons. Various methods have been devised, yielding conflicting results. The purpose of this study is to describe our surgical technique of breast reduction with silicone implants, present the safety profile of the procedure, and report patient-reported outcomes. Materials and Methods: A retrospective review was performed on our case series of cosmetic breast surgery performed by the senior author between October 2020 and November 2023. Only patients who had over 300 g of breast tissue removed were included. The surgery and demographic characteristics were recorded. Patients were asked to complete a questionnaire about satisfaction with their breasts pre-operatively and after the surgery. Results: Over 745 cases were performed, and 25 were included in the analysis. In total, 78.3% of the patients presented with a Grade 3 ptosis. The mean implant size was 352.39 cc (range 300-455 cc). The breast tissue removed ranged from 312 to 657 g. The mean follow-up was 14.17 months. Only one case required revision surgery after developing capsular contracture and a waterfall deformity. Patients reported a statistically significant improvement across all domains of the questionnaire (p < 0.001). Conclusions: Breast reduction plus implants is a safe and effective alternative for patients with large ptotic breasts who wish to attain a full upper pole. It carries a similar risk profile to augmentation mastopexy and maintains its functional benefits in alleviating back, neck, and shoulder pain.

The influence of a previous implant-based breast reconstruction on postoperative sensation of the deep inferior epigastric artery perforator flap.

BACKGROUND: Implants and DIEP flaps have different outcomes regarding postoperative breast sensation. When compared to the preoperative healthy breast, implant-based breast reconstruction (IBBR) negatively influences postoperative breast sensation. However, it is currently unknown whether a prior IBBR also influences postoperative sensation of a replacing DIEP flap. The goal of this cohort study is to evaluate the influence of an IBBR on the postoperative sensation of a replacing DIEP flap. METHODS: Women were included if they received a DIEP flap reconstruction after mastectomy, with or without prior tissue expander (TE) and/or definitive breast implant. Sensation was measured at four intervals in 9 areas of the breast with Semmes-Weinstein monofilaments: T0 (preoperative, implant/no reconstruction), T1 (2-7 months postoperative, DIEP), T2 (± 12 months postoperative, DIEP), Tmax (maximum follow-up, DIEP). Linear mixed-effects models were used to investigate the relationship between an implant/TE prior to the DIEP flap and recovery of breast sensation. RESULTS: 142 women comprising 206 breasts were included. 48 (23.3%) breasts did, and 158 (76.7%) breasts did not have a TE/IBBR prior to their DIEP. No statistically significant or clinically relevant relationships were found between a prior implant/TE and recovery of DIEP flap breast sensation for the flap skin, native skin, or total breast skin at T1, T2, or Tmax. There were also no relationships found after adjustment for the confounders radiation therapy, BMI, diabetes, age, flap weight, follow-up, and nerve coaptation. CONCLUSIONS: An implant/TE prior to a DIEP flap does not influence the recovery of postoperative breast sensation of the DIEP flap.

Direct-to-Implant vs Tissue Expander Placement in Immediate Breast Reconstruction: A Prospective Cohort Study.

BACKGROUND: Direct-to-implant (DTI) breast reconstruction after mastectomy has gained increasing popularity. While concerns over ischemic complications related to tension on the mastectomy flap persist, newer techniques and technologies have enhanced safety of this technique. OBJECTIVES: To compare clinical and patient-reported outcomes of DTI and 2-stage tissue expander (TE) reconstruction. METHODS: A prospective cohort design was utilized to compare the incidence of reconstructive failure among patients undergoing DTI and TE reconstruction by unadjusted bivariate and adjusted multivariable logistic regression analyses. Secondary clinical outcomes of interest included specific complications requiring intervention (infection, seroma, hematoma, mastectomy flap necrosis, incisional dehiscence, device exposure) and time to final drain removal. Patient-reported outcomes on BREAST-Q were also compared. RESULTS: A total of 134 patients (257 breasts) underwent DTI reconstruction and 222 patients (405 breasts) received TEs. DTI patients were significantly younger with lower BMIs; less diabetes, hypertension, and smoking; and smaller breast sizes; they also underwent more nipple-sparing mastectomies with prepectoral reconstructions. Rates of any complication (18% DTI vs 24% TE, P = .047), reconstructive failure (5.1% vs 12%, P = .004), and seroma (3.9% vs 11%, P < .001) were significantly lower in the DTI cohort on unadjusted analyses; however, there were no significant differences on adjusted regressions. Patient-reported satisfaction with breasts, psychosocial well-being, and sexual well-being were more substantively improved with DTI reconstruction. CONCLUSIONS: Prepectoral DTI reconstruction is a viable option for postmastectomy reconstruction in carefully selected patients, with no significant increase in reconstructive failure or other complications.

Development and Validation of a Diagnostic Histopathological Scoring System for Capsular Contracture Based on 720 Breast Implant Capsules.

BACKGROUND: Capsular contracture is traditionally evaluated with the Baker classification, but this has notable limitations regarding reproducibility and objectivity. OBJECTIVES: The aim of this study was to develop and validate procedure-specific histopathological scoring systems to assess capsular contracture severity. METHODS: Biopsies of breast implant capsules were used to develop histopathological scoring systems for patients following breast augmentation and breast reconstruction. Ten histological parameters were evaluated by multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (P < .05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was assessed from the area under the curve (AUC) and the mean absolute error (MAE). RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system, namely, collagen layer thickness, fiber organization, inflammatory infiltration, and calcification, providing a combined maximum score of 26. The AUC and MAE for the augmentation scoring system were 81% and 0.8%, which is considered strong. Three parameters were selected for the reconstruction scoring system, namely, fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system were 72% and 7.1%, which is considered good. CONCLUSIONS: The new histopathological scoring systems provide an objective, reproducible, and accurate assessment of capsular contracture severity. We propose these novel scoring systems as a valuable tool for confirming capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.

The Spectrum of Non-neoplastic Changes Associated With Breast Implants: Histopathology, Imaging, and Clinical Significance.

Breast implant-associated anaplastic large cell lymphoma has been recognized as a distinct entity in the World Health Organization classification of hematolymphoid neoplasms. These neoplasms are causally related to textured implants that were used worldwide until recently. Consequently, there is an increased demand for processing periprosthetic capsules, adding new challenges for surgeons, clinicians, and pathologists. In the literature, the focus has been on breast implant-associated anaplastic large cell lymphoma; however, benign complications related to the placement of breast implants occur in up to 20% to 30% of patients. Imaging studies are helpful in assessing patients with breast implants for evidence of implant rupture, changes in tissues surrounding the implants, or regional lymphadenopathy related to breast implants, but pathologic examination is often required. In this review, we couple our experience with a review of the literature to describe a range of benign lesions associated with breast implants that can be associated with different clinical presentations or pathogenesis and that may require different diagnostic approaches. We illustrate the spectrum of the most common of these benign disorders, highlighting their clinical, imaging, gross, and microscopic features. Finally, we propose a systematic approach for the diagnosis and handling of breast implant specimens in general.

Breast Implants and the Risk of Squamous Cell Carcinoma of the Breast: A Systematic Literature Review and Epidemiologic Study.

Squamous cell carcinoma may arise primarily from the breast parenchyma (PSCCB) or from the periprosthetic capsule in patients with breast implants (breast implant-associated squamous cell carcinoma [BIA-SCC]). A systematic literature review was performed to identify all PSCCB and BIA-SCC cases, and to estimate prevalence, incidence rate (IR), and risk. Studies up to November 2023 were searched on PubMed, Web of Science, Google Scholar, and Cochrane Library for predefined keywords. The numerator for PSCCB and BIA-SCC was the number of cases obtained from the literature; the denominator for PSCCB was the female population aged from 18 to 99, and the denominator for BIA-SCC was the population with breast implants. Overall, 219 papers were included, featuring 2250 PSCCB and 30 BIA-SCC cases. PSCCB prevalence was 2.0 per 100,000 (95% CI, 0.2:100,000 to 7.2:100,000) individuals, with a lifetime risk of 1:49,509 (95% CI, 0.2:10,000 to 5.6:10,000); and BIA-SCC prevalence was 0.61 per 100,000 (95% CI, 0.2:100,000 to 1.3:100,000), with a lifetime risk of 1:164,884 (95% CI, 0.2:100,000 to 5.6:100,000). The prevalence of BIA-SCC is 3.33 times lower than that of PSCCB, while the prevalence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is 3.84 times higher than that of primary breast ALCL. When comparing the BIA-SCC prevalence of 1:164,910 individuals with breast implants regardless of texture to the BIA-ALCL prevalence of 1:914 patients with textured implants, the BIA-SCC risk is 180 times lower than the BIA-ALCL risk. BIA-SCC occurs less frequently than PSCCB and considerably less than BIA-ALCL. The association between textured implants and BIA-SCC cases is relevant for patient education regarding uncommon and rare risks associated with breast implants, and ongoing vigilance, research, and strengthened reporting systems remain imperative.

The Effect of 3-Dimensional-Printed Sequential Dual Drug-Releasing Patch on the Capsule Formation Around the Silicone Implant in a Rat Model.

BACKGROUND: Implant-based breast reconstruction is associated with increased risk of early infection and late-stage capsular contracture. OBJECTIVES: We evaluated the feasibility of a dual drug-releasing patch that enabled the controlled delivery of antibiotics and immunosuppressants in a temporally and spatially appropriate manner to the implant site. METHODS: The efficacy of a dual drug-releasing patch, which was 3-dimensional-printed (3D-printed) with tissue-derived biomaterial ink, was evaluated in rats with silicone implants. The groups included implant only (n = 10); implant plus bacterial inoculation (n = 14); implant, bacterial inoculation, and patch loaded with gentamycin placed on the ventral side of the implant (n = 10), and implant, bacterial inoculation, and patch loaded with gentamycin and triamcinolone acetonide (n = 9). Histologic and immunohistochemical analyses were performed 8 weeks after implantation. RESULTS: The 2 drugs were sequentially released from the dual drug-releasing patch and exhibited different release profiles. Compared to the animals with bacterial inoculation, those with the antibiotic-only and the dual drug-releasing patch exhibited thinner capsules and lower myofibroblast activity and inflammation, indicating better tissue integration and less foreign body response. These effects were more pronounced with the dual drug-releasing patch than with the antibiotic-only patch. CONCLUSIONS: The 3D-printed dual drug-releasing patch effectively reduced inflammation and capsule formation in a rat model of silicone breast reconstruction. The beneficial effect of the dual drug-releasing patch was better than that of the antibiotic-only patch, indicating its therapeutic potential as a novel approach to preventing capsular contracture while reducing concerns of systemic side effects.

Microbiologic Profile of Nipple Swab Culture and its Association With Postoperative Complications in Prosthetic Breast Reconstruction.

BACKGROUND: In breast surgeries, a lactiferous duct leading to lactic glands of breast parenchyma allows direct contamination by normal bacterial flora of the nipple-areola complex. Complete blockage of nipple flora from the intraoperative field is almost impossible. OBJECTIVES: We aimed to analyze the microbiological profile of nipple flora of breast cancer patients who underwent an implant-based immediate breast reconstruction after a total mastectomy, and to evaluate the association of nipple bacterial flora with postoperative complications. METHODS: A retrospective chart review was performed of patients who underwent an implant-based immediate breast reconstruction after a total mastectomy. A nipple swab culture was performed preoperatively. Patient demographics, surgical characteristics, and complications were compared between positive and negative nipple swab culture groups. Microbiological profile data including antibacterial resistance were collected. RESULTS: Among 128 breasts, 60 cases (46.9%) had positive preoperative nipple swab culture results. Staphylococcus epidermidis accounted for 41.4% of microorganisms isolated. A multivariate logistic regression analysis of postoperative complications revealed that the presence of nipple bacterial flora was a risk factor for capsular contracture. Seven cases of postoperative infection were analyzed. In 2 cases (40% of pathogen-proven infection), the causative pathogen matched the patient's nipple bacterial flora, which was methicillin-resistant S. epidermidis in both cases. CONCLUSIONS: Nipple bacterial flora was associated with an increased risk of capsular contracture. Preoperative analysis of nipple bacterial flora can be an informative source for treating clinically diagnosed postoperative infections. More studies are needed to determine the effectiveness of active antibiotic decolonization of the nipple.

Symptom Improvement After Explantation With No Capsulectomy for Systemic Symptoms Associated With Breast Implants.

BACKGROUND: Systemic symptoms associated with breast implants (SSBI) is a term used to describe a group of patients who attribute a variety of symptoms to their implants. Previous studies have shown symptom improvement after implant removal in these patients irrespective of whether part or all the implant capsule has been removed. OBJECTIVES: The aim of this study was to evaluate implant removal with no capsule removed in symptomatic and control subjects. METHODS: Eligible study subjects were sequentially enrolled at 5 investigator sites. The SSBI Cohort included patients with systemic symptoms they attributed to their implants who requested explantation. The Non-SSBI Cohort included subjects without systemic symptoms attributed to their implants who requested explantation with or without replacement. All subjects agreed to undergo explantation without removal of any capsule. RESULTS: Systemic symptom improvement was noted in SSBI subjects without removal of the implant capsule, comparable to the results of our previously published study. SSBI patients showed a 74% reduction in self-reported symptoms at 6 months with no capsulectomy which was not statistically different from partial or total capsulectomies (P = .23). CONCLUSIONS: Explantation with or without capsulectomy provides symptom improvement in patients with systemic symptoms they associate with their implants.

Comparison of Different Acellular Dermal Matrix in Breast Reconstruction: A Skin-to-Skin Study.

BACKGROUND: Since the early 2000s, acellular dermal matrix has been a popular adjunct to prepectoral breast reconstruction to enhance outcomes. OBJECTIVES: The aim of this study was to investigate the differences in the postoperative course of 2 standard acellular dermal matrix products, AlloDerm SELECT Ready To Use and DermACELL. METHODS: A prospective, patient-blind study of patients undergoing bilateral nipple and/or skin-sparing mastectomies with either tissue expander or silicone implant insertion between 2019 and 2022 were selected for this study. The study design used patients as their own controls between 2 products randomly assigned to the left or right breast. Outcomes between the products included average time for drain removal, infection rate, seroma rate, and incorporation rates. RESULTS: The prospective clinical data of 55 patients (110 breasts) were recorded for 90 days. There were no significant differences between drain removal time, average drain output, or seroma aspiration amount. A higher percentage of seromas was recorded in the breasts with AlloDerm (30.91%) compared with breasts containing DermACELL (14.55%, P < .05), and a statistically significant difference between the incorporation rates of AlloDerm (93.4%) and DermACELL (99.8%, P < .05) was observed. CONCLUSIONS: Irrespective of patient demographic disparities, both products had a 94.55% success rate for reconstruction outcomes. AlloDerm was determined to have a higher incidence of seromas as a postoperative complication and a trend to lower incorporation.

Technical Refinements and Outcomes Assessment in Prepectoral Pocket Conversion After Postmastectomy Radiotherapy.

BACKGROUND: Several studies show how submuscular breast reconstruction is linked to animation deformity, shoulder dysfunction, and increased postoperative chest pain, when compared to prepectoral breast reconstruction. In solving all these life-impairing side effects, prepectoral implant pocket conversion has shown encouraging results. OBJECTIVES: The aim of this study was to propose a refinement of the prepectoral implant pocket conversion applied to previously irradiated patients. METHODS: We conducted a retrospective study on 42 patients who underwent previous nipple- or skin-sparing mastectomy and immediate submuscular reconstruction, followed by radiotherapy. We performed fat grafting sessions as regenerative pretreatment. Six months after the last fat graft, we performed the conversion, with prepectoral placement of micropolyurethane foam-coated implants. We investigated the preconversion and postconversion differences in upper limb range of motion, Upper Extremity Functional Index, and patient satisfaction with the breast and physical well-being of the chest. RESULTS: We reported a resolution of animation deformity in 100% of cases. The range of motion and the Upper Extremity Functional Index scores were statistically improved after prepectoral implant pocket conversion. BREAST-Q scores for satisfaction with the breast and physical well-being of the chest were also improved. CONCLUSIONS: The refined prepectoral implant pocket conversion is a reliable technique for solving animation deformity and improving quality of life in patients previously treated with submuscular reconstruction and radiotherapy.

Polyurethane Implants in Revisional Breast Augmentation: A Prospective 5-Year Study.

BACKGROUND: Revisional surgery for aesthetic breast augmentation remains a challenging procedure. Polyurethane (PU) implants have been found to avoid capsular contracture recurrence as well as to prevent implant displacement by bio-integrating with the pocket. OBJECTIVES: Our study aimed to assess the use of PU implants in breast revisional surgery and to provide an algorithm. METHODS: Over a 5-year period, a prospective study was conducted involving consecutive patients undergoing implant revision. Patient demographics, previous breast procedures, and specific surgical details were documented. Postoperative outcomes were followed up. RESULTS: Out of 92 patients (184 breasts), 78 (156 breasts) were included in the analysis. The average age was 47.5, with a BMI of 22.3 and a mean follow-up of 5 years. A majority (63%) represented secondary revisional cases, while 37% were tertiary cases. Implant size averaged 296 cc, with 53% placed in retropectoral position and 47% prepectoral. Significantly more implants in secondary cases were changed from prepectoral to retropectoral (P = .005), and in tertiary changed from retropectoral to prepectoral (P = .002). Complete capsulectomy was performed in 61.5% and partial in 25.6%. Additional lipofilling was performed in 32%, and concurrent mastopexy in 40%. Revisional surgery in our series had a 1.9% acute complication rate, 4.5% longer-term reoperation rate for corrections, 0.6% implant exchange rate, and no recurrent capsular contracture. CONCLUSIONS: This is the first study to provide data on outcomes of revisional breast augmentation surgery with PU implants. It shows that polyurethane implants offer consistent stability and have low rates of recurrent capsular contracture in revisional surgery.

Preventing Bacterial Contamination of Breast Implants Using Infection Mitigation Techniques: An In Vitro Study.

BACKGROUND: Bacterial contamination of implants has been linked to biofilm formation and subsequent infection, capsular contracture, and breast implant-associated anaplastic large cell lymphoma. Reducing contamination during implant insertion should therefore reduce biofilm formation disease sequelae. OBJECTIVES: The aim of this study was to compare levels of contamination between preventative techniques. METHODS: A model to simulate the passage of implants through a skin incision was designed that utilized a sterile textured polyvinyl plastic sheet contaminated with Staphylococcus epidermidis. In the first stage of the polyvinyl contamination model, implants were subject to infection-mitigation techniques and passed through the incision, then placed onto horse blood agar plates and incubated for 24 hours. In the second stage of the study the same contamination was applied to human abdominal wall specimens. A 5 cm incision was made through skin and fat, then implants were passed through and levels of contamination were measured as described. RESULTS: Smooth implants grew a mean of 95 colony-forming units (CFUs; approximately 1 CFU/cm2) and textured implants grew 86 CFUs (also approximately 1 CFU/cm2). CFU counts were analyzed by the Mann-Whitney U-test which showed no significant difference between implant types (P < .05); independent-sample t-tests showed a significant difference. The dependent-variable techniques were then compared as groups by one-way analysis of variance, which also showed a significant reduction compared with the control group (P < .01). CONCLUSIONS: This in vitro study has shown the effectiveness of antiseptic rinse and skin/implant barrier techniques for reducing bacterial contamination of breast implants at the time of insertion.