Unnecessary Explantation of IDEAL IMPLANT Structured Saline Breast Implants Prompted byRadiologic Misdiagnosis of Rupture.

ABSTRACT: The unique dual-lumen and baffle design of the IDEAL IMPLANT Structured Saline breast implant gives it specific advantages over both silicone gel-filled and the original saline-filled implants. This internal baffle structure also gives it an appearance on various radiologic imaging studies that may be misinterpreted as a rupture because of similarities to the well-known radiologic appearance of a ruptured silicone gel implant. Patients may present with various misinterpreted imaging studies, highlighting the need for plastic surgeons and radiologists to be familiar with the normal appearance of the intact IDEAL IMPLANT and be able to distinguish it from a ruptured IDEAL IMPLANT. The radiology findings must be correlated with the clinical findings, or an intact IDEAL IMPLANT misdiagnosed as ruptured, may cause unnecessary patient worry, and may prompt unnecessary surgery for removal or replacement.

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.

Flow Cytometry Analysis in Breast Implant-Associated Anaplastic Large Cell Lymphoma: Three Case Reports.

Breast Implant-Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare T-cell non-Hodgkin lymphoma associated with breast prosthetic implants and represents a diagnostic challenge. The National Comprehensive Cancer Network (NCCN) guidelines, updated in 2024, recommend for diagnosis an integrated work-up that should include cell morphology, CD30 immunohistochemistry (IHC), and flow cytometry (FCM). CD30 IHC, although the test of choice for BIA-ALCL diagnosis, is not pathognomonic, and this supports the recommendation to apply a multidisciplinary approach. A close collaboration between pathologists and laboratory professionals allowed the diagnosis of three BIA-ALCLs, presented as case reports, within a series of 35 patients subjected to periprosthetic effusions aspiration from 2018 to 2023. In one case, rare neoplastic cells were identified by FCM, and this result was essential in leading the anatomopathological picture as indicative of this neoplasm. In fact, the distinction between a lymphomatous infiltrate from reactive cells may be very complex in the cytopathology and IHC setting when neoplastic cells are rare. On the other hand, one limitation of FCM analysis is the need for fresh samples. In this study, we provide evidence that a dedicated fixative allows the maintenance of an unaltered CD30 expression on the cell surface for up to 72 h.

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.

In hospital outcomes of autologous and implant-based breast reconstruction in patients with chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common comorbid condition that can be associated with postoperative mortality and morbidity. However, the outcome profile of patients with COPD after breast reconstruction has yet to be established. Therefore, this study aimed to assess the postoperative outcomes in patients with COPD who underwent autologous (ABR) and implant-based breast reconstruction (IBR). METHODS: National Inpatient Sample was used to identify patients who underwent ABR or IBR from Q4 2015 to 2020. Multivariable logistic regressions were used to compare inhospital outcomes between COPD and non-COPD patients while adjusting for demographics, primary payer status, hospital characteristics, and comorbidities. RESULTS: There were 1288 (9.92%) COPD and 11,696 non-COPD patients who underwent ABR. Meanwhile, 1742 (9.70%) COPD and 16,221 non-COPD patients underwent IBR. In both ABR and IBR, patients with COPD had higher rates of seroma (ABR, aOR = 1.863, 95% CI = 1.022-3.397, and p = 0.04; IBR, aOR = 1.524, 95% CI = 1.014-2.291, and p = 0.04), infection (ABR, aOR = 1.863, 95% CI = 1.022-3.397, and p = 0.04; IBR, aOR = 1.956, 95% CI = 1.205-3.176, and p = 0.01), and prolonged LOS (p < 0.01). Specifically, patients with COPD in ABR had higher risks of respiratory complications (aOR = 1.991, 95% CI = 1.291-3.071, and p < 0.01) and incurred higher total hospital charges (p < 0.01). Meanwhile, patients with COPD undergoing IBR had elevated risks of renal complications (aOR = 3.421, 95% CI = 2.108-5.55, and p < 0.01), deep wound complications (aOR = 3.191, 95% CI = 1.423-7.153, and p < 0.01), and a higher rate of transfers out (aOR = 1.815, 95% CI = 1.081-3.05, and p = 0.02). CONCLUSION: COPD is an independent risk factor associated with distinct adverse outcomes in ABR and IBR. These findings can be valuable for preoperative risk stratification, determining surgical candidacy, and planning postoperative management in patients with COPD.

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 case for a national breast implant registry in Canada.

SummaryThe House of Commons Standing Committee on Health proposed in 2022 to start a national registry for breast implants. Why, and what requirements are needed, will be outlined. Breast implant products are not always in compliance with international norms and standards, and several scandals have occurred because of industry fraud. To trace which patients have defective breast implants, a good registry is an absolute must. Furthermore, some diseases, such as lymphomas, autoimmune diseases, and so-called breast implant illness, are believed to be associated with breast implants. An accurate estimation of how often these diseases occur in patients with breast implants is lacking. A registry in which not only surgical data but also patient-reported outcome measurements are recorded will result in a better understanding of patient outcomes and device performance. The registry should not be a voluntary ("opt-in") registry but a mandatory ("opt-out") registry, in which only the patient (and not the surgeon) has the choice whether to participate.

From Case Reports to Molecular Insight: Examining the Outcomes and Underlying Mechanisms of Squamous Cell Carcinoma in Breast Implant Patients-A Systematic Review.

There is extensive coverage in the existing literature on implant-associated lymphomas like anaplastic large-cell lymphoma, but breast implant-associated squamous cell carcinoma (BIA-SCC) has received limited scholarly attention since its first case in 1992. Thus, this study aims to conduct a qualitative synthesis focused on the underexplored association between breast implants and BIA-SCC. A systematic review was conducted utilizing the PubMed, Web of Science, and Cochrane databases to identify all currently reported cases of BIA-SCC. Additionally, a literature review was performed to identify potential biochemical mechanisms that could lead to BIA-SCC. Studies were vetted for quality using the NIH quality assessment tool. From an initial pool of 246 papers, 11 met the quality criteria for inclusion, examining a total of 14 patients aged between 40 and 81 years. BIA-SCC was found in a diverse range of implants, including those with smooth and textured surfaces, as well as those filled with saline and silicone. The condition notably manifested a proclivity for aggressive clinical progression, as evidenced by a mortality rate approximating 21.4% within a post-diagnostic interval of six months. Our literature review reveals that chronic inflammation, driven by various external factors such as pathogens and implants, can initiate carcinogenesis through epigenetic modifications and immune system alterations. This includes effects from exosomes and macrophage polarization, showcasing potential pathways for the pathogenesis of BIA-SCC. The study highlights the pressing need for further investigation into BIA-SCC, a subject hitherto inadequately addressed in the academic sphere. This necessitates the urgency for early screening and intervention to improve postoperative outcomes. While the review is confined by its reliance on case reports and series, it serves as a valuable reference for future research endeavors.

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.

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.

Impact of polyurethane versus acellular dermal matrix coating on prepectoral reconstruction outcomes: Interface does matter.

BACKGROUND: Interfaces continue to be used in prepectoral breast reconstruction to refine breast appearance, but more clinical data are required to assess their effectiveness. This study compares the rates of capsular contracture, breast esthetics, and patient satisfaction between two commonly used interface materials, acellular dermal matrix (ADM) and polyurethane (PU) foam. METHODS: A cross-sectional assessment was conducted on all patients who underwent prepectoral direct-to-implant reconstruction with an interface material between June 2018 and June 2022. We compared capsular contracture rates (assessed in-person), esthetic outcomes (evaluated by a three-member panel using a specially designed scale), and patient satisfaction (measured using the Breast-Q questionnaire) among the members of the interface groups. RESULTS: Among the 79 reconstructed breasts (20 bilateral cases), 35 were reconstructed using ADM and 44 using PU implants. The ADM group had a significantly higher frequency of Baker III/IV capsular contracture compared with the PU group (14.3% vs. 0%, p = 0.014) and lower ratings from the panel in terms of capsular contracture (median 3.7 vs. 4.0, p < 0.001). PU reconstructions scored worse in implant visibility (median 2.3 vs. 3.3, p < 0.001) and rippling (median 3.0 vs. 3.7, p < 0.001). However, after appropriate adjustment for confounders, no significant differences in overall appearance and patient satisfaction were found. CONCLUSIONS: ADM reconstructions are prone to capsular contracture with all their related esthetic issues, but PU implants have certain cosmetic flaws, such as implant visibility and malposition. Since each technique has its own limitations, neither the experienced surgeons nor patients exhibited a clear preference for either approach.

Impact of mastectomy flap necrosis on prepectoral reconstructive outcomes.

INTRODUCTION: As reconstructive surgeons have increasingly transitioned to the prepectoral plane for prosthetic breast reconstruction, the implications of mastectomy skin flap necrosis have become more concerning. Our goal was to evaluate the effect of skin flap necrosis on reconstructive outcomes in patients undergoing immediate prepectoral breast reconstruction. METHODS: A retrospective review was conducted of patients undergoing immediate two-stage prepectoral reconstruction at a single center with at least 3 months follow-up. Postoperative complications, reconstructive outcome, and time to final implant were compared between patients with and without mastectomy skin necrosis. RESULTS: A total of 301 patients underwent 509 prepectoral breast reconstructions. Forty-four patients (14.6%) experienced postoperative mastectomy skin flap necrosis. Demographic and reconstructive characteristics were similar between the necrosis and no necrosis cohorts. Patients with skin necrosis were more likely to undergo reoperation after tissue expander (64% vs 19%, p < 0.01) and undergo expander replacement (13.6% vs 3.5%, p = 0.02). However, rates of reconstructive failure (6.8% vs 6.2%), major infection (9.1% vs 9.0%), and minor infection (13.6% vs 17.5%) after expander placement were statistically similar. Patients with skin necrosis trended toward longer time before final implant placement, although the difference was not statistically significant (6.5 vs 5.0 months, p = 0.08). There was no difference in complication rates between the necrosis and no necrosis cohort after final implant placement. There was a higher rate of revision surgery after implant placement in the necrosis cohort (12.5% vs 4.1%, p = 0.047). CONCLUSIONS: Mastectomy skin flap necrosis is a concerning postoperative event, particularly in patients with prepectoral prostheses. We observed that patients with skin necrosis experience higher reoperation rates in the expander period, yet have similar infection rates and achieve similar final reconstructive outcomes compared to patients without necrosis.

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.

Prevalence, clinical characteristics, and management of silicone lymphadenopathy: A systematic review of the literature.

INTRODUCTION: Implant-based breast augmentations and reconstructions are one of the most common surgical procedures performed by plastic surgeons in the United States, which has rapidly increased in popularity since the 2000s. Silicone lymphadenopathy (SL) is a complication of breast implants that involves migration of silicone to nearby soft tissue/lymph nodes. Data on its clinical features and management is scarce. METHODS: SL-related search terms were used to find articles in 3 databases. Of 598 articles, 101 studies met the inclusion criteria. Demographics, clinical presentation, workup, and management data were analyzed. RESULTS: Of 279 cases of SL and 107 with information on initial diagnosis, 35 (33%) were incidental. The most common symptom was painless lymphadenopathy, followed by painful lymphadenopathy. 251 (95%) and 13 (5%) patients had silicone and saline implants, respectively. 149 (68%) patients had implant rupture. Axillary lymphadenopathy was the most affected region (136 cases, 72%), followed by internal mammary (40 cases, 21%), cervical/supraclavicular (36 cases, 19%), and mediastinal (24 cases, 13%) regions. 25% of patients underwent fine-needle aspiration, 12% core needle biopsy, and 59% excisional biopsy. 32% of cases underwent explantation and/or implant exchange. The most common indication for surgery was implant rupture. Histology showed multinucleated giant cells, large histiocytes, and silicone accumulation. CONCLUSIONS: SL is a complication associated with breast implants. The majority of patients are asymptomatic, and most cases are managed conservatively. Minority need a biopsy and surgical interventions due to abnormal imaging, persistent symptoms, and/or implant rupture. Workup and management should be tailored to the patient.

Post-mastectomy Breast Reconstruction With Gas vs Saline Tissue Expanders: Does the Fill Type Matter?

The most common reconstruction technique following mastectomy is a 2-stage technique that involves tissue expansion followed by definitive implant-based reconstruction (IBR). Tissue expanders (TEs) have classically used saline for initial fill; however, TEs with an initial gas fill (GTE)-including the CO2-based AeroForm (AirXpanders, San Francisco, CA) TE and TEs initially filled with atmospheric air-have been increasingly used in the past decade. We aimed to compare the outcomes in breast reconstruction for tissue expanders initially filled with saline vs gas. PubMed was queried for studies comparing gas- and saline-filled tissue expanders (STEs) used in IBR. A meta-analysis was performed on major postoperative outcomes and the required expansion and definitive reconstruction time. Eleven studies were selected and included in the analysis. No significant differences existed between tissue expansion with GTEs vs STEs for 11 of the 13 postoperative outcomes investigated. Out of the complications investigated, only the risk of infection/cellulitis/abscess formation was significantly lower in the GTE cohort (odds ratio 0.62; 95% CI, 0.47 to 0.82; P = .0009). The time to definitive reconstruction was also significantly lower in the GTE cohort (mean difference [MD], 45.85 days; 95% CI, -57.80 to -33.90; P < .00001). The total time to full expansion approached significance in the GTE cohort (MD, -20.33 days; 95% CI, -41.71 to 1.04; P = .06). A cost analysis considering TE cost and infection risk determined that GTE use saved a predicted $2055.34 in overall healthcare costs. Surgical outcomes for both fill types were predominantly similar; however, GTEs were associated with a significantly decreased risk of postoperative infection compared to saline-filled TEs. GTEs could also reduce healthcare expenditures and require less time until definitive reconstruction after placement.

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.