Devil's Advocate: Evidence-Based Recommendation for "One Breast-One Insertion Funnel" Policy.

BACKGROUND: Rates of capsular contracture have reduced significantly since the use of insertion funnels to place breast implants became routine. However, due to financial constraints, the same funnel is usually used for implantation of both sides. OBJECTIVES: The aim of this study was to determine whether the risk of capsular contracture is higher for the second breast when the same insertion funnel is used for both breasts. METHODS: The authors collected a sample of the insertion funnel tip immediately after removing the funnel from its sterile packaging and another tip sample after the funnel had been used to insert the first implant. These samples were sent for microbiological culture evaluations. Capsular contracture rates in the first implanted breast vs the second implanted breast were then retrospectively analyzed. RESULTS: All samples taken from the funnel before the first implantation showed no bacterial growth. All 10 samples taken from the funnel after the first implantation showed organism growth (8 were positive for Staphylococcus epidermidis and 2 for Cutibacterium acnes). Retrospective analysis of the results revealed that the overall capsular contracture rate had reduced after the authors began to use insertion funnels. However, this complication was still more common on the second implanted breast. CONCLUSIONS: Surgeons should consider the use of separate insertion funnels for each breast. This might help to slightly reduce the incidence of capsular contracture.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, and Chinese (Simplified and Traditional) online here: https://doi.org/10.1093/asj/sjad288.

Outcomes in Subfascial Versus Subglandular Planes in Breast Augmentation: A Systematic Review and Meta-analysis.

Breast augmentation is the most commonly performed aesthetic surgery procedure in women worldwide. The use of the subfascial plane has been suggested to decrease the incidence of capsular contracture compared with the subglandular plane, while simultaneously avoiding the complication of animation deformity in the subpectoral plane. The aim of this systematic review and meta-analysis was to compare the adverse outcomes of subfascial vs subglandular planes in breast augmentation. This review was registered a priori on OSF (https://osf.io/pm92e/). A search from inception to June 2023 was performed on MEDLINE, Embase, and CENTRAL. A hand search was also performed. All randomized and comparative cohort studies that assessed the use of the subfascial plane for breast augmentation were included. Outcomes evaluated included the incidences of seroma, hematoma, infection, rippling, capsular contracture, and revision surgery. Ten studies were included in this systematic review. Three randomized controlled trials and 7 comparative cohort studies were used for quantitative synthesis. There was a significant difference favoring subfascial compared with subglandular planes in the incidence of hematoma, rippling, and capsular contracture. All included studies had a high risk of bias. The current evidence suggests that the subfascial plane for breast augmentation decreases the risk of capsular contracture, hematoma, and rippling compared with the subglandular plane. Further randomized evidence with high methodological rigor is still required to validate these findings.

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.

Reducing Peri-implant Capsule Thickness in Submuscular Rodent Model of Breast Reconstruction With Delayed Radiotherapy.

INTRODUCTION: Capsular contracture remains the most common complication following device-based breast reconstruction, occurring in up to 50% of women who also undergo adjuvant radiotherapy either before or after device-based reconstruction. While certain risk factors for capsular contracture have been identified, there remains no clinically effective method of prevention. The purpose of the present study is to determine the effect of coating the implant with the novel small molecule Met-Z2-Y12, with and without delayed, targeted radiotherapy, on capsule thickness and morphologic change around smooth silicone implants placed under the latissimus dorsi in a rodent model. METHODS: Twenty-four female Sprague Dawley rats each had 2 mL smooth round silicone breast implants implanted bilaterally under the latissimus dorsi muscle. Twelve received uncoated implants and twelve received implants coated with Met-Z2-Y12. Half of the animals from each group received targeted radiotherapy (20 Gray) on postoperative day ten. At three and 6 months after implantation, the tissue surrounding the implants was harvested for analysis of capsular histology including capsule thickness. Additionally, microCT scans were qualitatively analyzed for morphologic change. RESULTS: Capsules surrounding Met-Z2-Y12-coated implants were significantly thinner (P = 0.006). The greatest difference in capsule thickness was seen in the irradiated 6-month groups, where mean capsule thickness was 79.1 ± 27.3 µm for uncoated versus 50.9 ± 9.6 µm for Met-Z2-Y12-coated implants (P = 0.038). At the time of explant, there were no capsular morphologic differences between the groups either grossly or per microCT. CONCLUSIONS: Met-Z2-Y12 coating of smooth silicone breast implants significantly reduces capsule thickness in a rodent model of submuscular breast reconstruction with delayed radiotherapy.

Use of Antimicrobial Irrigation and Incidence of Capsular Contracture in Breast Augmentation and Immediate Implant-Based Breast Reconstruction.

Capsular contracture (CC) is one of the most common complications of implant-based breast reconstruction or augmentation surgery. Common risk factors of CC include biofilm, surgical site infections, history of prior CC or fibrosis, history of radiation therapy, and implant characteristics. Though bacterial contamination of breast protheses is associated with adverse sequelae, there are not universally accepted guidelines and limited best practice recommendations for antimicrobial breast pocket irrigation. Despite advanced molecular biology, the exact mechanism of this complication is not fully understood. Interventions that decrease the rate of CC include antibiotic prophylaxis or irrigation, acellular dermal matrix, leukotriene inhibitors, surgical techniques, and others. However, there is inconsistent evidence supporting these risk factors, and the current data was based on broad heterogeneous studies. The objective of this review was to provide a summary of the current data of contributing risk factors as well as preventative and treatment measures for CC.Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these evidence-based medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266.

Enhancing Patient Outcomes in Aesthetic Breast Implant Procedures Using Proven Antimicrobial Breast Pocket Irrigations: A 20-Year Follow-up.

BACKGROUND: Capsular contracture (CC) remains the most common complication of implant-based aesthetic and reconstructive breast surgery. With subclinical infection proven to be the primary etiology, antimicrobial breast pocket irrigation has been recommended as the key step to reduce CC but has not been universally adopted. OBJECTIVES: The purpose of this study was to review the rates of CC observed when applying proven antimicrobial breast pocket irrigations. METHODS: Data from patients undergoing cosmetic breast augmentation were recorded prospectively from 1997 to 2017. The irrigation was performed with either a Betadine-containing (50% Betadine or "Betadine triple") or a non-Betadine triple antibiotic regimen. The database was assessed to determine the type of implant used, the incidence of CC, and possible contributing factors. The degree of CC was recorded according to the Baker classification. RESULTS: A 20-year prospective data collection yielded 2088 patients with 4176 implants; of these patients, 826 had textured implants and 1262 had smooth implants. The incidence of Grade III/IV CC was found to be 0.57% in all patients undergoing primary breast augmentation (1.21% in textured implants and 0.16% in smooth implants). CONCLUSIONS: This study constitutes the largest and longest review of CC in a controlled, single-surgeon setting. The incidence of CC is low and reinforces the efficacy/utility of antimicrobial breast pocket irrigation. Both the Betadine and non-Betadine antibiotic regimens were found to be effective, with the Betadine regimen being preferred. Universal adoption of Betadine-containing antimicrobial breast pocket irrigation is recommended to reduce CC and other device-associated infections.

Pharmacological Approaches for the Prevention of Breast Implant Capsular Contracture.

Capsular contracture is a common complication associated with breast implants following reconstructive or aesthetic surgery in which a tight or constricting scar tissue capsule forms around the implant, often distorting the breast shape and resulting in chronic pain. Capsulectomy (involving full removal of the capsule surrounding the implant) and capsulotomy (where the capsule is released and/or partly removed to create more space for the implant) are the most common surgical procedures used to treat capsular contracture. Various structural modifications of the implant device (including use of textured implants, submuscular placement of the implant, and the use of polyurethane-coated implants) and surgical strategies (including pre-operative skin washing and irrigation of the implant pocket with antibiotics) have been and/or are currently used to help reduce the incidence of capsular contracture. In this article, we review the pharmacological approaches-both commonly practiced in the clinic and experimental-reported in the scientific and clinical literature aimed at either preventing or treating capsular contracture, including (i) pre- and post-operative intravenous administration of drug substances, (ii) systemic (usually oral) administration of drugs before and after surgery, (iii) modification of the implant surface with grafted drug substances, (iv) irrigation of the implant or peri-implant tissue with drugs prior to implantation, and (v) incorporation of drugs into the implant shell or filler prior to surgery followed by drug release in situ after implantation.

In Vivo and In Vitro Fibroblasts' Behavior and Capsular Formation in Correlation with Smooth and Textured Silicone Surfaces.

BACKGROUND: As the most principal complication following breast augmentation with silicone breast implants, capsular contracture is greatly influenced by surface texture. However, there have long been widespread debates on the function of smooth or textured surface implants in reducing capsular contracture. MATERIALS AND METHODS: Three commercially available silicone breast implants with smooth and textured surfaces were subjected to surface characterization, and in vitro and in vivo assessments were then implemented to investigate the effect of these different surfaces on the biological behaviors of fibroblasts and capsular formation in rat models. RESULTS: Surface characterization demonstrated that all three samples were hydrophobic with distinct roughness values. Comparing the interactions of fibroblasts or tissues with different surfaces, we observed that as surface roughness increased, the adhesion and cell spreading of fibroblasts, the level of echogenicity, the density of collagen and α-SMA-positive immunoreactivity decreased, while the proliferation of fibroblasts and capsule thickness increased. CONCLUSIONS: Our findings elucidated that the effect of silicone implant surface texture on fibroblasts' behaviors and capsular formation was associated with variations in surface roughness, and the number of myofibroblasts may have a more significant influence on the process of contracture than capsule thickness in the early stage of capsular formation. These results highlight that targeting myofibroblasts may be wielded in the prevention and treatment strategies of capsular contracture clinically. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Influence of Irradiation on Capsules of Silicone Implants Covered with Acellular Dermal Matrix in Mice.

BACKGROUND: In advanced breast cancer, radiotherapy is recommended as adjuvant therapy following breast reconstructive surgery. This inevitably led to growing concerns over possible complications of radiotherapy on implants. In this experimental animal study, we investigated the utility of acellular dermal matrix (ADM) wraps around implants as preventive management for radiotherapy complications. METHODS: Black mice (C57NL6; n = 32) were assigned to groups that either received radiation or did not: groups A and B underwent surgery using implants without radiotherapy; while groups C and D underwent surgery using implants with radiotherapy for one and three months, respectively. The hemispheric silicone implants with an 0.8-cm-diameter were inserted on the left back of each mouse, and implants wrapped by ADM were inserted on the right back. The Clinic 23EX LINAC model was used for irradiation at 10 Gy. The samples were evaluated by gross assessment, histological analysis, immunohistochemical analysis, and the Western blotting test. RESULTS: The H&E staining analysis showed that membrane thickness is smallest in group A, followed by groups C, D, and B. In a Masson trichrome histological analysis, collagen fibers became less dense and more widespread over time in the groups that received an ADM. Immunohistochemistry findings were similarly constant. However, the expression of TGF-ß1 was increased in the irradiated groups, whereas it was decreased in the non-irradiated groups as observed over time. CONCLUSIONS: Radiotherapy was shown to increase risk factors for capsular contracture, including inflammatory response, pseudoepithelium, thinning of membrane, and TGF-ß1 expression over time; however, the accompanying framework using an ADM as a barrier between implant and tissue was shown to be effective in alleviating these risks. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Complete Implant Wrapping with Porcine-Derived Acellular Dermal Matrix for the Treatment of Capsular Contracture in Breast Reconstruction: A Case-Control Study.

BACKGROUND: Capsular contracture (CC) represents one of the most common complications in breast reconstruction surgery, impairing final result and patients' well-being. The role of acellular dermal matrixes (ADM) has been widely described for the treatment and prevention of contracture. The aim of the study was to evaluate the efficacy and safety of complete implant coverage with porcine-derived ADM in preventing CC limiting complications. In addition, patients' reported outcomes were evaluated in order to define the role of ADM in improving sexual, physical and psychosocial well-being and satisfaction. METHODS: 42 patients who underwent surgical treatment of 46 contracted reconstructed breasts from May 2018th to May 2019th were collected in the two groups (ADM group vs. Control group). RESULTS: The ADM group showed lower rate of CC recurrence and a higher rate of implant losses and minor complications. A significant difference was observed in red breast syndrome (27.3% in the ADM group vs. absent in control the group) and skin ulceration rates (18.2% in the ADM group vs. 4.18% in the control group). As for patients' perceived outcomes, the ADM group showed a statistically significant higher postoperative Satisfaction of Breast Scale score compared to the control group. In addition, a significant difference was observed in the improvement of Physical Well-Being of the Chest Scale and the Satisfaction of Breast Scale after surgery, in favor to the ADM group. CONCLUSION: Complete implant coverage with ADM may reduce the risk of CC recurrence in breast reconstruction. An accurate patient selection allows minimizing complications improving patient well-being and satisfaction. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

The Role of Verteporfin in Prevention of Periprosthetic Capsular Fibrosis: An Experimental Study.

BACKGROUND: Capsular contracture (CC) characterized by excessive fibrosis is one of the most common complications after silicone implant surgery. Verteporfin (VP), an inhibitor of Yes-associated protein 1 (YAP1), has recently been found to reduce the fibrotic process. OBJECTIVES: The aim of this study was to use an in vivo rabbit model to evaluate the efficacy of VP for the prevention of CC. METHODS: Twenty-four New Zealand rabbits received 10-cc smooth saline silicone implants inserted in the dorsal skin and were randomly divided into 2 groups to receive 2 mL VP (1.5 mg/mL) or 2 mL phosphate-buffered saline solution instillation in the implant pocket. When the animals were killed on Day 60, capsule formation was observed both macroscopically and microscopically. Histologic evaluation included capsule thickness, fibrosis degree, and myofibroblast (α smooth muscle actin positive) content. In addition, the YAP1 expression level was examined by immunofluorescence staining. Transforming growth factor ß1, collagen I, and connective tissue growth factor expression were measured by real-time quantitative polymerase chain reaction. RESULTS: The VP-treated group exhibited thinner, more transparent capsules and less fibrosis than the control group at 60 days postsurgery (P < 0.05). Moreover, the VP treatment significantly reduced α smooth muscle actin, YAP1, transforming growth factor ß1, collagen I, and connective tissue growth factor expression levels in the capsular tissues (P < 0.05). CONCLUSIONS: VP reduced capsule formation after silicone implantation by inhibiting YAP1-mediated mechanical signaling, thereby attenuating excessive collagen deposition in the rabbit model. This preclinical study may provide a feasible strategy to prevent periprosthetic capsular fibrosis in clinical application.

Implants and Breast Pocket Irrigation: Outcomes of Antibiotic, Antiseptic, and Saline Irrigation.

BACKGROUND: Breast implant-associated infection and capsular contracture are challenging complications that can result in poor outcomes following implant-based breast surgery. Antimicrobial irrigation of the breast pocket or implant is a widely accepted strategy to prevent these complications, but the literature lacks an evidence-based consensus on the optimal irrigation solution. OBJECTIVES: The objective of this systematic review was to compare clinical outcomes, specifically capsular contracture, infection, and reoperation rates, associated with the use of antibiotic, antiseptic, and saline irrigation. METHODS: A systematic review was performed in March 2020 based on the following search terms: "breast implant," "irrigation," "antibiotic," "bacitracin," "antiseptic," "povidone iodine," "betadine," "low concentration chlorhexidine," and "hypochlorous acid." Capsular contracture, infection, and reoperation rates were compared by analysis of forest plots. RESULTS: Out of the 104 articles screened, 14 met the inclusion criteria. There was no significant difference in capsular contracture rates between antibiotic and povidone-iodine irrigation, although the data comparing these 2 groups were limited and confounded by the concurrent use of steroids. Antibiotic irrigation showed a significantly lower rate of capsular contracture compared with saline irrigation and a lower rate of capsular contracture and reoperation compared with no irrigation at all. Povidone-iodine was associated with lower rates of capsular contracture and reoperation compared with saline irrigation but there were no data on infection rates specific to povidone-iodine irrigation. CONCLUSIONS: Our study supports the use of antibiotics or povidone-iodine for breast implant irrigation. Further research is required to better determine which of these 2 irrigation types is superior.

Treatment and Prevention of Periprosthetic Capsular Contracture in Breast Surgery With Prosthesis Using Leukotriene Receptor Antagonists: A Meta-Analysis.

BACKGROUND: Capsular contracture (CC) is the most common long-term complication of breast surgery with prosthesis. Leukotriene receptor antagonists (LRAs) have been tested as a potential treatment; however, mixed results have been observed. OBJECTIVES: The aim of this study was to undertake a meta-analysis to clarify the treatment and prophylactic capabilities of LRAs in the management of CC. METHODS: A systematic literature search of the most popular English-language databases was performed to identify relevant primary publications. We included all studies that used the Baker scale to evaluate the treatment and preventive capabilities of LRAs. RESULTS: Six eligible studies were included based on predefined inclusion and exclusion criteria, totalling 2276 breasts, of which 775 did not receive LRAs and 1501 did. Final pooled results showed that LRAs could help manage CC with a risk difference (RD) of -0.38 with a corresponding 95% CI of -0.69 to -0.08, showing statistical significance at a Z value of 2.48, P = 0.01. Subgroup analysis based on the type of drug showed that only montelukast yielded statistical significance (RD = -0.27, 95% CI = -0.51 to -0.03, Z = 2.20, P = 0.03). Zafirlukast did not seem to influence CC. Further subgroup analysis based on treatment timing showed that prophylaxis was ineffective and only treatment for ongoing CC yielded statistically significant improvements. CONCLUSIONS: The current meta-analysis proved that LRAs could be used in the management of CC. Only treatment for ongoing CC showed statistically significant improvements. Montelukast seemed to be more efficient with a safer profile for adverse effects, whereas zafirlukast yielded no statistically significant results.

Angiotensin-Converting Enzyme Inhibitor Reduces Radiation-Induced Periprosthetic Capsular Fibrosis.

BACKGROUND: The capsular contracture is one of the main complications after radiotherapy in patients with implant-based reconstruction. The aim of this study is to evaluate the efficacy of ramipril for the prevention of radiation-induced fibrosis around the silicone implant. MATERIALS AND METHODS: Thirty Wistar rats in 5 groups were used. Group 1: implant; group 2: implant + radiation; group 3: ramipril + implant; group 4: ramipril + implant + radiation; group 5: sham. Ramipril treatment was started 5 d before surgery and continued for 12 wk after surgery. A mini silicone implant was placed in the back of the rats. A single fraction of 21.5 Gy radiation was applied. Tissues were examined histologically and immunohistochemically (TGF-ß1, MMP-2, and TIMP-2 expression). The alteration of plasma TGF-ß1 levels was examined before and after the experiment. RESULTS: After applying implant or implant + radiation, capsular thickness, percentage of fibrotic area, tissue and plasma TGF-ß1 levels significantly increased, and MMP-2/TIMP-2 ratio significantly decreased compared with the sham group. In ramipril-treated groups, the decrease in capsular thickness, fibrosis, TGF-ß1 positivity, and an increase in MMP-2/TIMP-2 ratio were found significant. In the ramipril + implant + radiation group, the alteration values of TGF-ß1 dramatically decreased. CONCLUSIONS: Our results show that ramipril reduces radiation-induced fibrosis and contracture. The results of our study may be important for the design of the clinical trials required to investigate the effective and safe doses of ramipril, which is an inexpensive and easily tolerated drug, on humans.

Reduced capsular contracture with smooth and textured breast implants following submuscular mammoplasty: systematic literature review.

Background: Capsular contracture is common in breast augmentation and reconstruction surgery. The present systematic review discusses the safety of textured and smooth implants in the submuscular position. Methods: A literature search was conducted on PubMed and EMBASE from inception until June 2020. The primary outcome was reduction of capsular contracture (Baker grade); others included time of capsular contracture onset, implant position/rupture rate/surface, hematoma/seroma risk, surgeon assessment and patient satisfaction. A total of 7731 patients were included from six publications. Results: The overall risk rate for capsular contracture increased from 7.6 to 25% in 10 years. The capsular contracture rates in textured and smooth implants were 3-14% and 6-20%, respectively, and no significant difference between implants was observed when the implants were placed submuscularly. Submuscular placement and textured implants also reduced the incidence of other complications. Conclusion: This systematic review suggests that appropriate placement reduces capsular contracture rate, irrespective of implant surface.

Lay abstract Breast reconstruction using breast implants is accompanied by complications that occur following surgery and which can lead to repeated surgeries and, ultimately, patient dissatisfaction. A search of published research was conducted on two major databases, and research published before June 2020 was included in our analysis. The primary outcome was the reduction of capsular contracture, a particular postoperative complication. Six articles (including one randomized controlled trial) were identified, with a total of 7731 patients. The overall risk for developing capsular contracture in breast reconstruction and augmentation patients increased from 7.6 to 25% over a period of 10 years. This systematic review suggests that with appropriate placement of the implant, the rate of capsular contracture and other complications can be reduced in women undergoing surgery, irrespective of implant surface type.

Autologous Fat Grafting and the Occurrence of Radiation-Induced Capsular Contracture.

INTRODUCTION: Radiation therapy is a known risk factor for capsular contracture formation after implant-based breast reconstruction. Although autologous fat grafting (AFG) has been shown to reverse radiation-induced tissue fibrosis, its use as a prophylactic agent against capsular contraction has not been assessed in the clinical setting. In the setting of 2-stage implant-based reconstruction and postmastectomy radiation therapy, we explored the effect AFG has on the prevalence of capsular contracture. MATERIALS AND METHODS: A retrospective chart review of patients who underwent immediate tissue expander (TE) placement followed by postmastectomy radiation therapy and secondary implant-based reconstruction at our institution between January 2012 and December 2019 was performed. Patients were divided into 2 cohorts based on whether or not AFG was performed at the time of secondary reconstruction. The primary outcome of interest was the occurrence of capsular contracture after TE exchange. RESULTS: Overall 57 patients (57 breasts) were included, 33 of whom received AFG at the time of TE exchange. All but 1 patient underwent submuscular implant placement, and the mean follow-up was 1.96 years. There was no significant difference in the prevalence of medical comorbidities between the study groups.Capsular contracture occurred in 24 patients (42.1%). Seventeen of these patients had undergone AFG at the time of TE exchange (17/33 patients, 51.5%), and 7 of these patients had not (7/24 patients, 29.2%). Most of the capsular contracture cases were Baker grades III or IV (14 patients, 58.3%), and 50% of patients with capsular contracture of any grade ultimately required operative intervention. Multivariate logistic regression analysis demonstrated that AFG did not significantly influence the occurrence or severity of capsular contracture, or did not impact the need for operative intervention in this patient population. CONCLUSIONS: Implant-based reconstruction of the irradiated breast is associated with high postoperative capsular contracture rates. Although AFG has shown promise in reversing radiation-induced dermal fibrosis, no protective effect on the development of capsular contracture after stage 2 reconstruction was observed in this study population. Further investigation in the form of randomized, prospective studies is needed to better assess the utility of AFG in preventing capsular contracture in irradiated patients.

Plane Change Vs Capsulotomy: A Comparison of Treatments for Capsular Contraction in Breast Augmentation Using the Subfascial Plane.

BACKGROUND: The management of capsular contraction following breast augmentation has numerous, often conflicting potential treatment protocols, each designed to reduce the incidence of further recurrence. The use of the subfascial plane has not been investigated as an alternative to other treatment options. OBJECTIVES: To examine the outcomes from patients presenting with recurrent capsular contraction after being treated for the first capsule by placement of an implant into the subfascial (SF) plane. METHODS: Retrospective analysis of 111 case notes of patients who presented with capsular contraction. 65 had undergone SF augmentation, 17 submuscular (SM) and 29 subglandular (SG) placement of implant at the primary procedure. At a secondary procedure, those with SF implants underwent open capsulotomy and those with SM and SG implants underwent a change in plane to SF. RESULTS: There is a significant difference in the proportion of patients that developed a capsule following the second surgery between the groups that had undergone capsulotomy (SF = 16.9%) or plane change (SM = 47% and SG = 37.9%, X2 (2,111) = 8.6, P = 0.02). When recurrence at the same site was examined, there was also a significant difference between the groups (X2 (2111) = 10.7, P < 0.01). A ruptured implant significantly increased the incidence of further capsular contraction when in the SG plane (X2 (2,29) = 12.1, P < 0.01). CONCLUSIONS: In the absence of implant rupture, changing the plane of an implant to a SF position at revision surgery does not reduce the incidence of subsequent capsular contracture compared with open capsulotomy. Open capsulotomy is a reasonable choice following recurrence of capsular contraction following initial SF placement. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Proper Skin Management in Breast Augmentation with a Periareolar Incision Prevents Implant Contamination and Biofilm-Related Capsular Contracture.

BACKGROUND: Capsular contracture (CC) is a significant complication and major reason for revision in breast augmentation. Many studies indicate that most bacteria found in contracted capsules originate from the skin, especially that of the nipple-areolar complex (NAC). To prevent implant contamination, protocols without a periareolar incision have been proposed and have become a limitation for breast augmentation. We sought to propose a strategy of proper skin management for periareolar incisions to prevent implant contamination and biofilm-related CC. METHODS: The analyses in this study are based on data collected from February 2017 to July 2020. A total of 129 patients were included, and they were randomized into two groups. The control group was subjected to no skin treatment before the surgery, and the treatment group underwent preoperative cleaning and disinfection of the NAC. We collected bacteriologic swabs used to rub the skin of the NAC and chest after draping and suturing from the control and treatment groups. We assessed the potential risk of detecting bacteria or fungi in the swabs, and we analyzed the data. The relationship between the positive culture rate and complication rate indicated the effectiveness of our strategy. RESULTS: Initially, 774 swabs were obtained. In the control group, 6 swabs tested positive for pathogens, including 2 NAC swabs positive for Staphylococcus epidermidis (S. epidermidis) after draping and 3 and 1 NAC swabs positive for S. epidermidis and Staphylococcus aureus (S. aureus) after suturing, respectively. All the other samples in the control and treatment groups were negative for bacteria or fungi. All patients had at least 16 months of follow-up. No CC (Baker grades II-IV) was recorded during the follow-up, and the treatment group experienced a better outcome associated with a lower rate of minor complications. CONCLUSIONS: Proper preoperative skin management helps keep the field pristine and potentially prevents implant contamination and even biofilm-related CC. With this strategy, breast augmentation using a periareolar incision or any other approach, even other surgery, could be a safe procedure. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Epidemiology and Prevention of Breast Prosthesis Capsular Contracture Recurrence.

INTRODUCTION: Baker grade III and IV breast prosthesis capsular contractures represent a major problem for patients undergoing mammoplasties. The risk factors involved in recurrence are debated, and the best surgical approach for their prevention is not established. The objective was to identify these. MATERIALS AND METHODS: We carried out a retrospective study of patients operated on for capsular contracture at the Saint-Louis Hospital in Paris from 2012 to 2014. The characteristics at inclusion were compared so as to determine the risk factors of recurrence. The surgical approaches were compared between the patients with recurrence and those without at 5 years. RESULTS: Of the 100 patients included, 24 had a recurrence. The minimal follow-up was 5 years. No risk factors of recurrence of capsular contracture were identified. The surgical approach associated with the lowest rate of recurrence was anterior capsulectomy [OR total capsulectomy = 2.36 (0.73; 8.037) OR capsulotomy = 4.33 (1.37; 14.81)] (p < 0.040) with alteration of the volume of the implant, whether greater or less than initially [OR greater volume = 0.30 (0.096; 0.83); OR smaller volume = 0.14 (0.008; 0.85)] (p < 0.018). CONCLUSION: The occurrence of capsular contracture is a major problem with prosthetic breast surgery. The main risk factors identified to date are essentially in regard to the occurrence of a first episode. No significant risk factors for recurrence were identified. The best prevention appears to be an anterior capsulectomy with reducing the volume of the implant. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . IV.

Comparison of the Effects of Acellular Dermal Matrix and Montelukast on Radiation-Induced Peri-implant Capsular Formation in Rabbits.

PURPOSE: Capsular contracture (CC) is a troublesome complication after breast surgery with breast implants, and the risk increases in breast cancer patients after radiotherapy. Studies investigating leukotriene antagonists (eg, montelukast, zafirlukast) found that the acellular dermal matrix (ADM) can help prevent CC. We aimed to compare the effects of ADM and montelukast on CC after irradiation. METHODS: Eighteen New Zealand white rabbits were randomly divided into 3 groups of 6 each. Miniature cohesive gel implants were inserted into the pocket under the latissimus dorsi muscle. The lateral part was uncovered by the latissimus dorsi muscle. Six animals were included in the control group. In experimental group A (EG-A) (n = 6), the site was partially wrapped with ADM but not covered with muscle. Montelukast (Singulair, 0.2 mg/kg) was administered in experimental group B (EG-B) (n = 6) daily. Groups were irradiated at postoperative day 21 with Co-60 γ rays (25 Gy, single fraction) at the peri-implant area. Rabbits were sacrificed 12 weeks after surgery; implants with peri-implant capsule were harvested. Capsule thickness, collagen pattern, myofibroblast, and transforming growth factor (TGF) ß1/2 levels in the peri-implant capsule were evaluated. RESULTS: On histological evaluation, the capsule was thinner on the lateral aspect (covered with ADM) in EG-A (P = 0.004) and the entire capsule in EG-B (P = 0.004) than in the control group. However, there was no significant difference between EG-A and EG-B (P = 0.073). The collagen distribution pattern was more parallel with low density in the lateral capsular aspect in EG-A, but in the entire capsule in EG-B. The myofibroblast amount (EG-A, P = 0.031; EG-B, P = 0.016) and levels of TGF-ß1 and TGF-ß2 were reduced in the experimental groups (TGF-ß1, EG-A, P = 0.019; TGF-ß1, EG-B, P = 0.045; TGF-ß2, EG-A, P = 0.018; TGF-ß2, EG-B, P = 0.022). There was no significant difference between EG-A and EG-B (myofibroblast, P = 0.201; TGF-ß1, P = 0.665; TGF-ß2, P = 0.665). CONCLUSIONS: Acellular dermal matrix and montelukast have a prophylactic effect for CC even when the breast is irradiated. There was no significant difference between ADM and montelukast in preventing capsular formation. The difference is that ADM will only have the effect of covering the capsular formation with ADM and montelukast can cause systemic effects or complications.