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.

Silicone Leakage from Breast Implants Is Determined by Silicone Cohesiveness: A Histological Study of 493 Patients.

BACKGROUND: Silicone leakage from breast implants is a concern with potential implications for patient health. This study aimed to quantify and model silicone leakage from implants to the breast implant capsule and to investigate whether silicone cohesiveness affected the silicone leakage rate. METHODS: Silicone content in the breast implant capsule was quantified histologically by measuring the area of silicone deposits. This was used to model silicone leakage over time based on the time of implantation. The effect of cohesiveness on silicone leakage was investigated across all implant brands with declared cohesiveness and in a subanalysis comparing only Mentor cohesive I implants with cohesive II and III implants. RESULTS: The study included 493 patients with 872 breasts and a median time of implantation of 13.0 years (range 0.4 to 51 years). The modeling of silicone leakage from intact implants showed that leakage and the acceleration of the leakage rate were significantly higher in low-cohesive implants than in highly cohesive implants (p<0.05). This was confirmed when analyzing only Mentor implants (p<0.05) and in the case of implant rupture (p<0.01) where low-cohesive implants also leaked significantly more than highly cohesive implants. CONCLUSIONS: Our results suggest that highly cohesive implants are superior to low-cohesive implants in preventing silicone leakage. Due to the accelerating rate of silicone leakage especially found in low-cohesive implants, we propose that exchange of low-cohesive implants could be discussed with patients 10 to 15 years after implantation to minimize silicone leakage even in the absence of implant rupture.

Factors Influencing Patient Satisfaction With Breast Augmentation: A BREAST-Q Effect of Magnitude Analysis.

BACKGROUND: Breast augmentation is one of the most performed cosmetic surgeries. Despite this, patient satisfaction following breast augmentation is poorly understood. OBJECTIVES: The aim of this study was to investigate what patient and surgical factors influence patient satisfaction following primary breast augmentation. METHODS: The BREAST-Q Augmentation module was sent to all females undergoing primary breast augmentation at a single private clinic (Amalieklinikken, Copenhagen, Denmark) between 2012 and 2019. Patient and surgical characteristics at the time of surgery were obtained from the patients' medical records, and data on factors that occurred after the surgery (eg, breastfeeding) were obtained by patient contact. Multivariate linear regression modeled the impact of these factors on BREAST-Q outcomes. RESULTS: A total of 554 females with a mean follow-up time of 5 years after primary breast augmentation were included in this study. Implant type and volume did not affect patient satisfaction. However, higher patient age was associated with significantly higher postoperative patient satisfaction, psychosocial well-being, and sexual well-being (P < .05). Conversely, higher patient BMI, postoperative weight gain, and breastfeeding were associated with significantly lower satisfaction (P < .05). Additionally, subglandular implant placement was associated with significantly lower satisfaction than submuscular implant placement (P < .05). CONCLUSIONS: Implant type and volume did not affect patient satisfaction with breast augmentation. However, young age, higher BMI, subglandular implant placement, and postoperative weight gain were associated with lower patient satisfaction. These factors should be considered when aligning outcome expectations with breast augmentation.

Antibiotic implant irrigation and deep infection: A retrospective study of 1508 patients undergoing breast reconstruction with implants.

BACKGROUND: Antibiotic implant irrigation is increasingly used to prevent deep infection after implant-based breast reconstruction. However, there is limited evidence of the clinical effect. In this study, we compare the risk of a deep infection in a Danish population of women who either received antibiotic implant irrigation with gentamycin or vancomycin, or no irrigation. METHODS: We retrospectively reviewed consecutive patients undergoing all types of breast reconstruction with implants at Rigshospitalet and Herlev Hospital, Denmark, in 2010-2019. Logistic regression was used to compare the risk of deep infection between no irrigation and irrigation with gentamicin or vancomycin, and to account for the difference in risk between patient subgroups and risk factors. RESULTS: We included 1508 patients who received antibiotic irrigation with gentamicin (500 patients), vancomycin (304 patients) or no irrigation (704 patients). The univariable risk analysis showed a significant decreased risk of deep infection using gentamicin irrigation compared with no irrigation (OR 0.58, p<0.05). However, when adjusting for risk factors for infection, there was no significant decrease in the risk of infection when using gentamicin (OR 0.90, p=0.71) or vancomycin (OR 1.0, p=0.99) compared with the control group. CONCLUSIONS: We found no significant effect of using antibiotic implant irrigation after isolating it from risk factors for deep infection. However, due to the limitations of the study, we cannot conclude that there is no effect of antibiotic implant irrigation. There is a need for a randomized, placebo-controlled trial to investigate the effect, and potential side-effects, of antibiotic implant irrigation.

Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: protocol for a randomised, double-blind, placebo-controlled trial (The BREAST-AB trial).

INTRODUCTION: Periprosthetic infection is one of the most severe complications following implant-based breast reconstruction affecting 5%-10% of the women. Currently, many surgeons apply antibiotics locally on the breast implant to reduce the risk of postoperative infection, but no randomised, placebo-controlled trials have tested the treatment's efficacy. METHODS AND ANALYSIS: The BREAST-AB trial (BREAST-AntiBiotics) is an investigator-initiated, multicentre, randomised, placebo-controlled, double-blind trial of local treatment with gentamicin, vancomycin and cefazolin on breast implants in women undergoing implant-based breast reconstruction. The trial drug consists of 80 mg gentamicin, 1 g vancomycin and 1 g cefazolin dissolved in 500 mL of isotonic saline. The placebo solution consists of 500 mL isotonic saline. The trial drug is used to wash the dissected tissue pocket and the breast implant prior to insertion. The primary outcome is all-cause explantation of the breast implant within 180 days after the breast reconstruction surgery. This excludes cases where the implant is replaced with a new permanent implant, for example, for cosmetic reasons. Key long-term outcomes include capsular contracture and quality of life. The trial started on 26 January 2021 and is currently recruiting. ETHICS AND DISSEMINATION: The trial was approved by the Regional Ethics Committee of the Capital Region (H-20056592) on 1 January 2021 and the Danish Medicines Agency (2020070016) on 2 August 2020. The main paper will include the primary and secondary outcomes and will be submitted to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04731025.

How to Report Data on Bilateral Procedures and Other Issues with Clustered Data: The CLUDA Reporting Guidelines.

BACKGROUND: Research in plastic surgery often includes bilateral procedures. This gives rise to issues with clustered data. Clustering is when individual data points within a data set are internally related. However, many authors do not account for clustering within their data, which can lead to incorrect statistical conclusions. METHODS: In February of 2020, the authors searched PubMed to investigate the prevalence of reporting issues with bilateral breast procedures in plastic surgery literature. The review focused on breast surgery, as it often involves bilateral procedures and, therefore, clustering. Based on the review, the authors developed guidelines for how to identify and address clustered data. The guidelines were modified by a multidisciplinary group consisting of a biostatistician with expertise in clustered data at the Section of Biostatistics, University of Copenhagen, and three doctors (M.D.s and Ph.D.s) with expertise in statistical analysis and scientific methodology from the Copenhagen University Hospital, Rigshospitalet. RESULTS: A total of 113 studies were included in the review. Seventy-five studies (66 percent) contained clustered data, but only eight studies (11 percent) took clustering into account in the statistical analysis. These results were used to develop the Clustered Data, or CLUDA, reporting guidelines which consist of two sections: one to identify clustering and one for reporting and analyzing clustered data. CONCLUSIONS: Clustered data are abundant in plastic surgery literature. The authors propose using the Clustered Data reporting guidelines to identify and report clustered data and consulting with a biostatistician when designing a study.

Hematoma and deep surgical site infection following primary breast augmentation: A retrospective review of 1128 patients.

BACKGROUND: Breast augmentation is one of the most frequently performed cosmetic surgery worldwide. Some of the most severe short-term complications after breast augmentation are hematoma and deep surgical site infection. However, these complications are relatively rare; therefore, large patient populations are required to perform statistical analyses. In this study, we provide a detailed analysis of the complications after primary breast augmentation with an emphasis on deep surgical site infection and hematoma. METHOD: We retrospectively reviewed the medical records of women who underwent primary breast augmentation without the use of pocket irrigation between 2012 and 2019 in a single private clinic. A cumulative hazard function and a multivariate analysis on the risk of hematoma were performed. RESULTS: We included 1128 patients in the study. Thirty patients (2.7%) developed postoperative hematoma after a median time of 14 h (IQR 5 h-9 days). Six patients (0.5%) contracted a deep surgical site infection after a median time of 14 days (range 4-41 days). Age, BMI, implant volume, or implant placement was not significantly associated with hematoma. CONCLUSION: Our findings support that the risk of hematoma after primary breast augmentation is highest within the first 24 h after the surgery. This time period should be considered when planning postoperative care for these patients. We did not find an increased rate of deep surgical site infection compared with studies of breast augmentations with pocket irrigation. Further studies and meta-analyses are needed to explore the effect of pocket irrigation and other risk factors.

Histological Analyses of Capsular Contracture and Associated Risk Factors: A Systematic Review.

BACKGROUND: Capsular contracture is a severe complication to breast surgery with implants. Previous studies suggest multiple risk factors are associated with capsular contracture, but the etiology is still unknown. We performed a literature review to investigate existing studies on histological analyses of breast implant capsules and how clinical risk factors impact the capsule morphology. METHODS: The literature search was conducted in PubMed. Studies that performed histological analyses of breast implant capsules were included. Animal studies or studies with a study population of less than five patients were excluded. RESULTS: Fifty-two studies were included. The histological analyses showed that the breast implant capsules were organized in multiple layers with an inner layer of synovial-like metaplasia which was reported to diminish in capsules with capsular contracture. The remaining layers of the capsule mostly consisted of collagen. The alignment of the collagen fibers differed between contracted and non-contracted capsules, and capsules with higher Baker grade were generally thickest and contained more tissue inflammation. Studies investigating capsules affected by radiotherapy found a more pronounced inflammatory response and the capsules were generally thicker and fibrotic compared with nonirradiated capsules. CONCLUSIONS: The included studies offer valuable insights into the histological changes caused by capsular contracture and their relation to clinical risk factors. Further studies with larger sample sizes and more strict inclusion criteria are needed to further investigate implant capsules and the role of the synovial-like metaplasia for the development of capsular contracture. 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 https://www.springer.com/00266 .

Breast Augmentation with Microtextured Anatomical Implants in 653 Women: Indications and Risk of Rotation.

BACKGROUND: Anatomical implants provide a wide range of options in terms of implant dimensions for breast augmentation. Nevertheless, many surgeons choose not to use anatomical implants due to the risk of rotation malposition and because their advantages over round implants are not clearly defined. METHODS: A retrospective review of medical records was performed on all women who underwent breast augmentation or implant exchange with microtextured anatomical implants from 2012 to 2019 in a single private clinic. The authors focused on the outcomes of a subgroup of women with glandular ptosis and nipple placement below the inframammary fold who underwent breast augmentation with anatomical implants. Furthermore, the incidence and risk factors for implant rotation were analyzed. RESULTS: In total, 653 women underwent primary breast augmentation (n = 529) or implant exchange (n = 124) with anatomical implants. The median follow-up period was 2.7 years (interquartile range, 1.6 to 3.9 years). The incidence of implant rotation was 14 (2.6 percent) in the primary augmentation group and four (3.2 percent) in the implant exchange group. Implant rotation was not associated with type of surgery (p = 0.76), implant projection (p = 0.23), or implant height (p = 0.48). The authors successfully used anatomical implants to elevate the nipple in 92.9 percent of the women with glandular ptosis without using a mastopexy. CONCLUSIONS: The study results indicate that the rotation risk with microtextured implants is similar to that with macrotextured implants. Furthermore, the authors found that high-projection anatomical implants can be used as an alternative to augmentation-mastopexy in women with glandular ptosis. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Deskinning in Inverted-T Mastopexy and Augmentation Mastopexy: A Retrospective Cohort Study.

BACKGROUND: Most surgeons choose to de-epithelialize when performing a mastopexy to minimize the risk of nipple-areola-complex (NAC) necrosis. Preservation of the dermis and thus the subdermal plexus is thought to be crucial for the survival of the NAC. However, this has never been scientifically proven. Deskinning involves resection of the epidermis and the dermis and is a timesaving alternative to de-epithelialization. In this study, we present data from mastopexy patients with or without implant surgery with total deskinning of the Wise pattern. METHODS: From September 2012 to March 2020, a single surgeon performed all inverted-T mastopexies using the deskinning technique. The patients were included retrospectively, and data were collected by reviewing the patients' medical records with emphasis on NAC necrosis. RESULTS: The cohort consisted of 274 consecutive patients who underwent bilateral mastopexy. Of these, 134 patients underwent mastopexy as the only procedure and 140 patients underwent mastopexy in combination with implant surgery. The median follow-up was 29 months (IQR 13-40 months). No complete NAC-necrosis occurred. Unilateral, partial NAC necrosis occurred in three patients who underwent mastopexy in combination with implant surgery. CONCLUSION: The NAC necrosis rate following inverted-T mastopexy using the deskinning technique is comparable to the rate of NAC-necrosis reported in the literature following mastopexy using the de-epithelialization technique. Our findings support that the use of deskinning is a safe and time-efficient method for patients undergoing inverted-T mastopexy. 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.