Anatomical Breast Implant Assessment Using Ultrasound: A Case Series from the International Breast Implant Check Clinic.

Background: Breast augmentation with anatomic implants can achieve a natural look, but over time, implant-related complications can occur. This includes a risk of potential rotation, which can cause a change in breast shape. Reported rates of rotation vary widely (0%-42%). Implant rotation is often detected by physical examination only or as a perioperative finding. Change in breast shape after augmentation requires clinical evaluation. In-office ultrasound allows for detailed assessment of implants for rotation and other complications. Methods: Women with anatomical breast implants seeking follow-up at the International Breast Implant Check Clinic in Stockholm, Sweden, from April 2020 to July 2022 were included in the study. Using a standardized protocol, subjective symptoms were recorded, and a physical examination followed by an ultrasound assessment was performed by a single board-certified plastic surgeon (M.J.) trained in implant assessment via ultrasound. Rotation was defined as an implant rotated past 30 degrees off the breast midline at 6 o'clock. Results: The study included 308 women (mean age 40.1, range 20-78) with bilateral anatomical implants. Overall, 40 women (13.0%) reported a change in breast shape; 35 had one or more implant-related complications, including five with rotation on ultrasound. Of the 308 women, 11 (3.6%) had rotations upon physical examination, and an additional 10 cases were identified using ultrasound. Conclusions: Rotation is a potential complication of anatomical breast implants. However, in this study, change in breast shape was more commonly caused by other implant-related complications. Ultrasound is a valuable tool in evaluating causes of change in breast shape.

Six-Year Evaluation of Motiva Round and Ergonomix SmoothSilk Surface Silicone Breast Implants: A Two-Center, Two-Surgeon Outcome Analysis of 1053 Primary and Secondary Breast Augmentations and Augmentation Mastopexy.

BACKGROUND: The emerging concerns around breast implant-associated anaplastic large cell lymphoma and other chronic inflammatory-related conditions have instigated a wider use of smooth devices. OBJECTIVES: The authors aimed to present 6-year data following the introduction of Motiva implants (Establishment Labs Holdings Inc.; Alajuela, Costa Rica) into their previously texture-dominated practice. Additionally, the authors aimed to provide technical recommendations on how to efficiently incorporate these devices into surgical practice and minimize the learning curve. METHODS: Data of 1053 primary and secondary breast augmentations conducted between April 2015 and December 2020 in 2 centers (Victoriakliniken in Sweden and the European Institute of Plastic Surgery in Cyprus) were retrospectively evaluated to obtain data on chosen implant characteristics and complications that led to reoperation, prior to and following modifications to surgical practice in 2018. RESULTS: The data from 6 consecutive years demonstrate a low device-related complication rate with Motiva implants. In 2018, following adaptions in surgical practice, the complication rate significantly declined. CONCLUSIONS: Motiva implants demonstrate a low complication rate and safety profile for women undergoing primary and secondary breast augmentation procedures. However, to reap the benefits of the antifibrotic profile, technical adaptions and optimal patient planning based on the patient and device characteristics are instrumental. Employing the key principles laid out in this study provides a means for delivering both clinically safe options to patients with aesthetically pleasing long-term results.

Breast augmentation surgery using an inframammary fold incision in Southeast Asian women: Patient-reported outcomes.

BACKGROUND: This analysis presents patient-reported outcomes of breast augmentation procedures performed in Singapore using an inframammary fold incision and the "5 Ps" best practice principles for breast augmentation. These data are the first of their kind in Southeast Asian patients. METHODS: Through a retrospective chart review, patients who underwent primary breast augmentation with anatomical form-stable silicone gel breast implants using an inframammary fold incision were followed for ≥6 months postoperatively. The BREAST-Q Augmentation Module (scores standardized to 0 [worst] - 100 [best]) and Patient and Observer Scar Assessment Scale (POSAS; 1 [normal skin] to 10 [worst scar imaginable]) were administered. Responses were summarized using descriptive statistics. Patient-reported events were collected. RESULTS: Twenty-two Southeast Asian patients (mean age, 35.1 years) completed ≥1 postoperative BREAST-Q and POSAS assessment and were assessed 11 months to 5.5 years postoperatively. The mean postoperative BREAST-Q satisfaction with breasts and psychosocial well-being scores were 69.2 and 84.0, respectively. The mean POSAS score for their overall opinion of the scar was 4.2; the mean scores for all scar characteristics ranged from 1.2 to 4.2. Over 90% of patients (20/22) said that they would recommend the procedure. Patient complaints following surgery included anisomastia (possibly pre-existing; n=2), sensory loss at the nipple (n=2) or around the nipple (n=3), scarring (n=4), and slight capsular contracture (n=1). No patients required reoperation. CONCLUSIONS: Southeast Asian patients reported high long-term satisfaction scores on the BREAST-Q scale and with their scar characteristics following breast augmentation using an inframammary fold incision, and nearly all said they would recommend this procedure. No reoperations were necessary in patients assessed for up to 5.5 years postoperatively.

MBN 2016 Aesthetic Breast Meeting BIA-ALCL Consensus Conference Report.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon neoplasia occurring in women with either cosmetic or reconstructive breast implants. The actual knowledge about BIA-ALCL deriving from the literature presents several limits, and it remains difficult to make inferences about BIA-ALCL epidemiology, cause, and pathogenesis. This is the reason why the authors decided to organize an evidence-based consensus conference during the Maurizio Bruno Nava (MBN 2016) Aesthetic Breast Meeting held in Milan in December of 2016. Twenty key opinion leaders in the field of plastic surgery from all over the world have been invited to express and discuss their opinion about some key questions on BIA-ALCL, trying to reach a consensus about BIA-ALCL cause, pathogenesis, diagnosis, and treatment in light of the actual best evidence.

International importance of robust breast device registries.

BACKGROUND: Breast implants are high-risk devices that have been at the epicenter of much debate and controversy. In light of the Poly Implant Prothèse crisis, data registries among 11 national societies around the world are cooperatively calling for the urgent need to establish robust national clinical quality registries based on international best practice within a framework of international collaboration. METHODS: A survey was conducted on the historic and current status of national breast device registries. Eleven countries participated in the study, illustrating different data collection systems and registries around the world. Data collection was designed to illustrate the capabilities of current national registries, with particular focus on capture rate and outcome reporting mechanisms. RESULTS: A study of national breast implant registries revealed that less than half of the participating countries had operational registries and that none of these had adequately high data capture to enable reliable outcome analysis. The study revealed that the two most common problems that discouraged participation are the complexity of data sets and the opt-in consent model. CONCLUSIONS: Recent implant crises have highlighted the need for robust registries. This article argues the importance of securing at least 90 percent data capture, which is achievable through the opt-out consent model. Since adopting this model, the Australian Breast Device Registry has increased data capture from 4 percent to over 97 percent. Simultaneously, it is important to foster international collaboration from the outset to avoid duplication of efforts and enable the development of effective international early warning systems.