A Single Center's Clinical Experience With Ergonomix Breast Implants

Background This retrospective study reports on the early experience of a private surgical center with Motiva Ergonomix SilkSurface SikSurface breast implants. Objectives to examine the incidence of complications and satisfaction levels in women who received primary and revision breast augmentation or augmentation-mastopexy with this device. Methods 356 consecutive patients received Motiva Ergonomix breast implants from April 2014 to October 2018 by 3 different surgeons and were followed-up for a minimum of 12 months. Complications were assessed by measuring the rate of rupture, capsular contracture, malposition, late seroma, double capsule, reoperation, symmastia, ptosis, extrusion, and infection. Satisfaction with aesthetic results was assessed by both surgeon and patient, using the Likert scale. Results Only six major complications were observed in these 356 patients (712 implants). One unilateral implant ptosis (“bottoming out”) at 12 months (0.14 %) and 2 capsular contractures (0.28 %), one at 14 months and the other at 2 years. At all time-points, 98% of the patients were “extremely satisfied or very satisfied” with the aesthetic results and surgeons categorized the outcomes as “very important or important improvement” in 96% of the cases. Conclusions Motiva Ergonomix SilkSurface devices provided high patient satisfaction up to more than 5 years postoperatively with very few complications. These data are consistent with other reports in the literature. The observed favorable outcomes might be attributed, at least in part, to Motiva Ergonomix’s bio-engineered “cell-friendly” surface.

High-resolution Ultrasound-assisted Assessment of Preliminary Short-term Safety Outcomes of an Implant-based Augmentation Mammaplasty using a Bioengineered, Cell-friendly, Smooth-surface Device in Korean Women

Background The Motiva Ergonomix™ Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is one the representative brands of the fifth-generation of a silicone gel-filled breast implant with a microtextured surface. Objectives In this study, we describe preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women. Methods We performed a retrospective analysis of medical records in a total of 69 women (n=69) receiving an implant-based augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface between September 26, 2017 and December 31, 2020. We analyzed incidences of postoperative complications. Results A total of 6 cases (8.7%) of postoperative complications occurred; these include 2 cases (2.9%) of early seroma, 1 case (1.4%) of capsular contracture, 2 cases (2.9%) of alterations in the shape and 1 case (1.4%) of foreign body sensation. Time-to-events were estimated at 266.81±273.17 days. Conclusions We describe our preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix TM Round SilkSurface in Korean women. But this deserves further large-scale studies with long periods of follow-up.

Activin A and Follistatin Serum Concentrations in Breast Augmentation Patients

Background: Capsular contracture is caused by an excessive fibrotic reaction similar as observed in other progressive fibrotic disorders. For their pathogenesis, several studies confirmed the importance of activins and follistatin. The aim of this study was to determine and analyze serum levels of Activin A and follistatin in patients with capsular contracture after aesthetic breast augmentation. Methods: The study included 361 female patients who underwent primary aesthetic breast augmentation, came for control examination after breast augmentation or for revision operation because of capsular contracture. Blood samples were taken and using a specific ELISA to determine the serum concentration levels of Activin A and Follistatin. Results: Ninety-six patients (n = 96), who developed a capsular contracture Baker ≥°III and underwent revision surgery were collected (capsular fibrosis group). One-hundred and fourteen patients (n = 114) were asymptomatic for capsular fibrosis Baker ≥°III after primary breast augmentation and 33 (n = 33) of them had developed no capsular fibrosis after more than 10 years (long-term group). For control group, blood samples were taken from 167 patients (n = 167) before primary aesthetic breast augmentation. Serum Activin A levels were significantly higher in the long-term Group compared with those in the capsular fibrosis- and the control groups. Follistatin levels were significantly lower in the capsular fibrosis group compared to the control- and the long-term groups. A small amount of control group patients (n = 16) developed a capsular fibrosis within 2 years after primary breast augmentation with significant lower follistatin levels. Retrospectively, they showed significantly lower serum follistatin levels than the control group even before the onset of capsular contracture. Conclusions: Capsular fibrosis has no effect on Activin A serum levels. In contrast, follistatin serum levels are lower in patients with capsular fibrosis. These results show that besides many other factors, a dysregulation of the Activin–follistatin axis may have importance on the pathogenesis of capsular contracture.

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.

Use of PEAK PlasmaBlade in implant-based breast reconstruction and radiotherapy: new strategy to reduce complications

Background: Implant-based breast reconstruction in the setting of radiotherapy often leads to higher complications rates (mainly capsular contracture and wound dehiscence) and poor cosmetic outcomes. We hypothesized that the combination of pulsed-electron avalanche knife (PEAK) PlasmaBlade (a pulsed radiofrequency electrosurgery) and acellular dermal matrix Veritas® in postmastectomy radiotherapy implant-based breast reconstruction could result in lower complications rate, better reconstructive results, and patient satisfaction. Methods: A prospective observational study focused on the use of PEAK PlasmaBlade in implant-based breast reconstruction and radiotherapy was carried out in the Plastic Reconstructive Surgery Unit at Fondazione IRCCS Istituto Nazionale Tumori Milano between December 2017 and 2019 (2017–2018: enrollment; 2018–2019: follow-up). Patient demographics were queried and complication rates and patient and surgeon satisfaction were assessed. Results: A total of 88 patients were enrolled; 2 patients received bilateral reconstruction, leading to a total of 90 procedures. Sixty-two women received contralateral symmetrization. Seroma was the most frequent minor complication (8.8%); implant exposure was the most recorded among major complications (5.5%). Preoperative lipofilling was the most substantial protective factor for preventing complications ( p < 0.001). A significant association between capsular thermal damage thickness and the type of electrosurgery used (traditional electrosurgery vs PEAK PlasmaBlade) was observed, with lower values with PEAK PlasmaBlade ( p < 0.0001). Conclusions: Our protocol results in low rates of surgical complications and a high level of patient and surgeon satisfaction although longer follow-up is needed.

A comparative discussion of incisional methods in total capsulectomy of the breast

Background Capsular contracture is a frequent complication of breast augmentation that constitutes one of the most common reasons for secondary operations. Capsular contracture is treated surgically, often with total capsulectomy. Therefore, in this study, we aimed to study correlations among intraoperative observations, physical examination findings, and characteristics of the previous operation in patients with capsular contracture who underwent total capsulectomy.Methods A retrospective chart review was conducted for patients treated from May 2017 to April 2019, analyzing 24 breasts in 12 female patients. The patients were classified in terms of the Baker grade, incision type, implant type, and implant plane. During the operation, we evaluated the ease of dissection based on intraoperative features such as anterior and posterior wall dissection, bleeding tendency, and scar length. Statistical analysis was performed to identify association between variablesResults The implant was changed in eight patients, while only explantation was performed in the remaining four patients. The ease of capsule dissection had a proportional correlation with the Baker grade (P=0.005). Intraoperative dissection was significantly easier in the inframammary fold (IMF) group than in the periareolar group (P=0.035).Conclusions An IMF incision is preferable for planning en bloc capsulectomy. However, for aesthetic concerns, a periareolar incision would be preferable. In addition, a lower Baker grade (grade I or II) was associated with easier dissection. Therefore, surgeons should choose the incision type depending on the necessity of performing en bloc capsulectomy, Baker grade, and scar length.