Redefining the Axillary Aesthetic: Surgical Management of Axillary Tissue Hypertrophy.

Background and Objectives: Axillary tissue hypertrophy consists of ectopic breast tissue and occurs in up to six percent of women. Women complain of pain, interference with activity, and dissatisfaction with appearance. While it is recommended that accessory breast tissue be removed via surgical excision, there is lack of consensus on the best technique for the surgical management of axillary tissue hypertrophy. In this study, the senior authors (BC and NT) review outcomes and complications as they pertain to the surgical treatment of axillary tissue hypertrophy and axillary contouring. Materials and Methods: A retrospective review of all patients (n = 35), from two separate institutions, who presented with axillary tissue hypertrophy between December 2019 and August 2021 was conducted. All patients underwent a technique that included direct crescentic dermato-lipectomy and glandular excision with axillary crease obliteration. Tissue was sent for histological analysis after removal. During a six-month follow-up period, all patient outcomes were recorded. Results: The authors treated 35 women with axillary tissue hypertrophy. All patients complained of aesthetic deformity with significant discomfort leading to the desire for surgery. Histologically, all specimens contained benign breast and adipose tissue. Hypertrophic scarring, seroma, and axillary cording were noted complications. Conclusions: Detailed is the surgical management and optimal technique that can be used to treat both adipose and fibroglandular axillary tissue hypertrophy while simultaneously providing a favorable axillary aesthetic.

Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the US Post-Approval Study.

BACKGROUND: After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. post-approval study. We present results from the first 6 years of this study. METHODS: An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients receiving breast augmentation, reconstruction, and revision in the post-market environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015, (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022). RESULTS: Across all cohorts who received an implant, the Kaplan-Meier risk of investigator-reported Baker grade III/IV capsular contracture was 4.1 percent (3.9 percent with submuscular placement and 6.7 percent with subglandular placement), the risk of reoperation was 11.6 percent, and the risk of implant removal was 7.8 percent (5.9 percent with implant replacement and 2.0 percent without replacement). The primary reason (over 50 percent) for reoperation was aesthetic (e.g., style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8 percent. Overall, 82.6 percent of patients were highly satisfied/happy with their implant. No cases of breast implant-associated anaplastic large cell lymphoma were reported. CONCLUSIONS: Six-year results of the post-approval study were consistent with the 10-year core study and provide additional evidence in a large dataset supporting the comprehensive safety and effectiveness profile of the Sientra implants.

Trends in Aesthetic Surgery Fellowship Training: An Analysis of Supply and Demand.

BACKGROUND: Aesthetic surgery fellowship applications were consolidated under the San Francisco Match in 2018. The impact of these changes on aesthetic program and applicant numbers had not yet been investigated. OBJECTIVES: In this study we sought to evaluate changes in programs, positions, applications, match rates, and fill rates since aesthetic surgery joined the San Francisco Match. We also aimed to compare these trends to craniofacial surgery, microsurgery, and hand surgery fellowships over this same time period. METHODS: San Francisco and National Resident Matching Program (NRMP) match data for aesthetic, craniofacial, microsurgery, and hand fellowships were obtained from 2018 to 2022, and the number of applications, positions, programs, and successful matches were evaluated. RESULTS: The number of aesthetic fellowship positions increased from 17 to 41 (141%) over the period studied. This resulted in increased match rates and more unfilled positions. Over the same period, fellowship positions for craniofacial, hand, and microsurgery increased by 3.4%, 6%, and 2.5% respectively. There was no increase in applications to any postgraduate subspecialty, nor was there any change in the number of residents pursuing fellowship. Similarly, there was no change in the percentage of fellowship-bound residents applying to any given discipline. CONCLUSIONS: The increase in aesthetic fellowship programs and positions did not generate an increase in applications. Applications to other plastic surgery subspecialties also failed to increase. Unlike aesthetic fellowships, their program numbers have remained stable. Given the limited fellowship applicant pool, our focus should be on enhancing the quality of existing aesthetic programs rather than continuing to increase the number of aesthetic positions.

Elective Implant Removal and Replacement in Asymptomatic Aesthetic Patients with Textured Devices.

SUMMARY: The management of patients with breast implants requires secondary procedures through the life of the implant, sometimes in the early postoperative period and more commonly many years after the initial surgery. In performing revisional procedures, removal and replacement of the implants is often required for a variety of reasons. With growing concerns of implant safety, implant exchange or removal with or without a capsulectomy has been increasingly requested by patients. In particular, textured breast implants have been under increased scrutiny secondary to their association with breast implant-associated anaplastic large cell lymphoma. Unfortunately, to date, there are no data and very little guidance as to the appropriate management of patients currently with textured implants as well as patients with a history of having had textured implants placed in the past. The surgeon must not only consider the appropriate management of patients with uncomplicated, asymptomatic textured devices but also consider the appropriate management when faced with another indication for revisional surgery and the need determine the appropriate course of action. An algorithm for the management of the explantation patient in general will be introduced in this review with a focus on the rationale, planning, and management of patients with an uncomplicated, asymptomatic textured implants.

Not All Breast Explants Are Equal: Contemporary Strategies in Breast Explantation Surgery.

SUMMARY: Breast implant removal and replacement has been a common secondary breast procedure in the long-term maintenance of breast augmentation, but more recently growing concerns about silicone-related systemic illness, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and changing perceptions of aesthetic beauty have seen breast implant removal without replacement become increasingly requested by patients. Explantation can be challenging, especially when performed with a total capsulectomy. Currently, there is no evidence regarding whether a partial or total capsulectomy has any effect on BIA-ALCL risk mitigation in patients that have textured implants without disease. Total capsulectomy with incomplete resection of a mass can contribute to hyperprogression of BIA-ALCL and death. There have also been cases of BIA-ALCL diagnosed years after removal of the textured device and "total capsulectomy." Therefore, the common practice of simple prophylactic capsulectomy in a textured implant to mitigate future disease has not been established and at the current time should be discouraged. In addition, aesthetic outcomes can be quite variable, and patients should have appropriate preoperative counseling regarding the indications and contraindications for explantation, associated risks, financial implications, and postoperative appearance. The authors review salient aspects related to the planning and management of breast implant removal.

MemoryGel Breast Implants: Final Safety and Efficacy Results after 10 Years of Follow-Up.

BACKGROUND: Mentor MemoryGel Breast Implants were approved by the U.S. Food and Drug Administration in November of 2006. Patients in the Core clinical study supporting this approval were followed for 10 years. METHODS: This prospective, multicenter, clinical study included primary augmentation, revision augmentation, primary reconstruction, and revision reconstruction patients implanted with smooth or Siltex Texture MemoryGel Implants. Incidence, severity, and method of resolution for all postoperative complications were assessed on per-patient and per-implant bases. The primary effectiveness endpoints were overall mean change in chest circumference and bra cup size following the implantation procedure. RESULTS: Primary augmentation (n = 552), revision augmentation (n = 145), primary reconstruction (n = 251), and revision reconstruction (n = 60) patients were enrolled in the study. Kaplan-Meier estimated 10-year cumulative incidence rates for key complications at the subject level for Baker grade III/IV capsular contracture were as follows: primary augmentation, 12.1 percent; revision augmentation, 24.4 percent; primary reconstruction, 20.5 percent; and revision reconstruction, 36.9 percent. For infection, rates were as follows: primary augmentation, 1.6 percent; revision augmentation, 1.4 percent; primary reconstruction, 6.2 percent; and revision reconstruction, 0 percent. For explantation with or without replacement, rates were as follows: primary augmentation, 11.6 percent; revision augmentation, 24.1 percent; primary reconstruction, 33.4 percent; and revision reconstruction; 37.8 percent. For rupture, rates were as follows: primary augmentation, 24.2 percent; revision augmentation, 23.7 percent; primary reconstruction, 32.7 percent; and revision reconstruction, 38.7 percent. For any reoperation, rates were as follows: primary augmentation, 25.5 percent; revision augmentation, 43.6 percent; primary reconstruction, 49.0 percent; and revision reconstruction, 50.7 percent. CONCLUSION: The results of this study demonstrate that MemoryGel Implants are safe and effective for use in women undergoing breast augmentation or reconstruction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Advising patients about breast implant associated anaplastic large cell lymphoma.

The United States Food and Drug Administration (FDA) recently recognized the necessity for improved patient education and public awareness of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is an uncommon T-cell lymphoma that can arise years after placement of a textured breast implant or tissue expander. Patients and providers would greatly benefit from a broader awareness of BIA-ALCL and how it presents with both common and rare symptoms. Disease awareness can be improved with specific steps moving forward. This includes improved counseling about annual recommendations from the FDA, standard of care guidelines, current estimates of disease prevalence, and manufacturer-specific risk for developing the malignancy. Informed consent for implant-based breast surgery should include a discussion of BIA-ALCL, symptoms, inherent risks and alternatives. Consideration should be given for reasonable efforts to retroactively contact patients with textured implants to inform them of recent regulatory actions as well as the risk of developing the disease and the signs and symptoms to watch for. Where risk can be reduced, all steps should be taken to ensure patient safety. In keeping with our commitment to patient safety, the strategies moving forward for implant-based breast surgery should be marked by patient awareness, physician vigilance, and defined by evidence-based diagnosis and treatment.

An Algorithm for the Management of Explantation Surgery.

Creating pleasing breast aesthetics after an explantation can be challenging, especially when performed with a total capsulectomy. The necessity of a capsulectomy for a variety of breast issues is not completely agreed on and can increase adverse events, patient morbidity, and cost of the operation and often impairs the final aesthetic result. In this article, an algorithm for the management of explantation patients provides a framework for treatment of the capsule and the breast to optimize outcomes.

Mastopexy with Autoaugmentation and Fat Transfer.

Patients have been requesting implant removal in revisional breast surgery and options for breast improvement without the use of breast implants in primary breast surgery. This article focuses on perioperative decision making and surgical technique in performing a mastopexy with autoaugmentation and fat grafting. The use of a lower island of breast parenchyma relocated to the upper pole through a central pedicle in primary surgery and a superior pedicle in postexplantation cases, along with fat grafting can provide improvement in global volume or simply additional volume in areas of deficiency, such as the upper poles and medial cleavage region.

Why Do We Need Anatomical Implants? the Science and Rationale for Maintaining Their Availability and Use in Breast Surgery.

The choice between anatomical and round implants is an important decision in breast augmentation surgery; however, both have their place and the decision between them that should be made on a patient-by-patient basis, taking into account the patient's desires, anatomy, and surgical history. In some individuals, there are clear indications for using either anatomical or round devices, and there is good evidence that aesthetic outcomes are better with anatomical implants in some instances. When both types are an option, anatomical devices may offer increased flexibility and, despite a longer learning curve needed to properly manage them, they are associated with positive long-term outcomes and high levels of patient satisfaction. Concerns about implant rotation can be minimized with proper patient selection and surgical technique, and the overall complication rate may favor anatomical over round devices in appropriate patients. Breast implant-associated anaplastic large-cell lymphoma is an important issue, and while rare, it must be considered in the context of the entire patient risk profile. Both anatomical and round implants remain key elements of a complete surgical toolbox in breast augmentation. 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.

Popcorn Capsulorrhaphy in Revision Aesthetic Breast Surgery.

BACKGROUND: Control of the pocket in revisional breast surgery can be technically challenging and unpredictable. A capsulorrhaphy technique has been utilized in altering capsules in secondary aesthetic breast surgery. OBJECTIVES: The authors sought to determine the effectiveness of popcorn capsulorrhaphy in revisional breast surgery. METHODS: A retrospective chart review of revisional breast cases utilizing popcorn capsulorrhaphy was conducted between September 2015 and August 2017. Only aesthetic breast cases were included. Data were collected for 149 patients. RESULTS: One hundred forty-nine patients representing 266 breasts were operated on. The average patient age was 42 years and the mean body mass index was 24.2 kg/m2. The average time from their original surgery to the popcorn capsulorrhaphy secondary procedure was 9.3 years. Indications for capsulorrhaphy included malposition in 163 breasts (61.3%), implant positioning for breast ptosis in 34 breasts (12.8%), pocket adjustment for implant size change in 49 breasts (18.4%), and postexplantation pocket reduction in 20 breasts (7.5%). Of the 266 implants, 145 (54.5%) were smooth, 101 (38%) textured, and 20 (7.5%) were explanted. The average original implant size was 405 cc and the average size placed at the time of capsulorrhaphy was 422 cc. Two hundred thirty-six (88.7%) were in a submuscular pocket and 30 (11.3%) were subglandular. The total number of complications was 39 (14.7%), and 16 (6%) required some type of operative revision. CONCLUSIONS: Popcorn capsulorrhaphy can provide pocket control and stability with low complication and revision rates. The addition of a mesh or biologic at the time of popcorn capsulorrhaphy can further lower the complication and revision rates.

Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

BACKGROUND: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years. METHODS: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction. RESULTS: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons. CONCLUSION: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.