scholarly journals A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea

Medicina ◽  
2021 ◽  
Vol 57 (12) ◽  
pp. 1370
Author(s):  
Sanghyuk Han ◽  
Robert Kim ◽  
Tae Seob Kim ◽  
Jung Heum Park ◽  
Seung Soo Kim ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Postoperative Complications ◽  
Subgroup Analysis ◽  
Safety Profile ◽  
Breast Implant ◽  
Breast Implants ◽  
Augmentation Mammaplasty ◽  
Korean Women ◽  
Short Term ◽  
Silicone Gel

Background and objectives We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods The current retrospective, observational study was conducted in a total of 2612 patients (n =2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January, 2017 and 31 August 2021. Results Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39–1712.32). Then, the Motiva Ergonomix™SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48–1837.56]), followed by the BellaGelÒSmoothFine (1458.4 ± 65.76 days [95% CI 1329.56–1587.28]), the SebbinÒ Sublimity (1322.00 ± 51.20 days [95% CI 1221.64–1422.32]), the BellaGelÒ Smooth (1138.72 ± 161.28 days [95% CI 822.6–1454.84), the MentorÒ MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28–801.52]) and the NatrelleÒ INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04–714.96]) in the decreasing order. On subgroup analysis, both the Motiva ErgonomixTM and MentorÒ MemoryGel™ Xtra showed no postoperative complications. However, the BellaGelÒSmoothFine, SebbinÒ Sublimity and BellaGelÒ Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center studywith long periods of follow-up.

scholarly journals 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

2021 ◽  
Author(s):  
Sangdal Lee ◽  
Jeong Pil Jeong ◽  
Jung Youp Sung ◽  
Woo Sik Choi ◽  
Dong Seung Moon ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Large Scale ◽  
Breast Implant ◽  
Capsular Contracture ◽  
Augmentation Mammaplasty ◽  
Korean Women ◽  
Short Term ◽  
Fifth Generation ◽  
Body Sensation ◽  
Safety Outcomes

Abstract 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.

scholarly journals An Ultrasound-Assisted Approach to an Early Detection of Complications of an Implant-Based Augmentation Mammaplasty using the BellaGel® SmoothFine: Preliminary 3-year Clinical Experience

2021 ◽  
Vol 7 (2) ◽  
Author(s):  
Song KY ◽  
Sung JY ◽  
Choi WS ◽  
Lim HG ◽  
Kim JH
Keyword(s):  
Breast Implant ◽  
Breast Implants ◽  
Augmentation Mammaplasty ◽  
Evidence Based ◽  
Korean Women ◽  
Background Selection ◽  
Essential Factor ◽  
Patients Satisfaction ◽  
Ultrasound Assisted ◽  
Selection Of

Background: Selection of optimal types of breast implants is an essential factor that determines the degree of patients’ satisfaction with outcomes of augmentation mammaplasty, for which an evidence-based approach to it is mandatory. Several studies have supported the safety of the BellaGel® SmoothFine (HansBiomed Co. Ltd., Seoul, Korea), a silicone gel-filled breast implant from a Korean manufacturer. But such studies have been conducted in a manufacturer-sponsored setting. We therefore conducted this non-manufacturer-sponsored, retrospective study to assess its 3-year safety outcomes in Korean women.

scholarly journals A Rare Case of a Woman Presenting with Axillary Silicone Lymphadenopathy Accompanied by Extracapsular Siliconoma and Thickened Capsule after an Implant-based Augmentation Mammaplasty

2021 ◽  
Vol 7 (2) ◽  
Author(s):  
Kim JH
Keyword(s):  
Rare Case ◽  
Breast Implant ◽  
Augmentation Mammaplasty ◽  
Current Case ◽  
Silicone Gel ◽  
Systemic Disorder

According to a review of literatures, silicone-induced lymphadenopathy occurs in association with rupture or silicone leakage. It has been reported to cause inflammation, neuropathy or systemic disorder. It should therefore be detected both correctly and promptly. The author experienced a rare case of a 38-year-old woman presenting with axillary silicone lymphadenopathy due to rupture of a silicone gel-filled breast implant. The patient received primary augmentation mammaplasty using a breast implant at other hospital; the current case highlights the importance of an ultrasoundassisted diagnosis of silicone lymphadenopathy before reoperation in a patient with rupture.

The Silicone Gel Breast Implant Controversy—A Chronology of Recent Regulations and Decisions

1993 ◽  
Vol 10 (2) ◽  
pp. 89-93
Author(s):  
Howard A. Tobin
Keyword(s):  
Drug Administration ◽  
Breast Implant ◽  
Breast Implants ◽  
Press Coverage ◽  
Silicone Breast Implants ◽  
Consumer Activism ◽  
Silicone Gel ◽  
Congressional Investigations ◽  
Regulatory Actions

This article summarizes the regulatory actions of the Food & Drug Administration as related to gel-filled silicone breast implants. It also relates the actions to the influences of outside forces such as press coverage, congressional investigations, and consumer activism.

Breastfeeding After Breast Implant Surgery

2020 ◽  
Vol 11 (4) ◽  
pp. 202-206
Author(s):  
Catherine Watson Genna
Keyword(s):  
Milk Production ◽  
Breast Augmentation ◽  
Breast Surgery ◽  
Breast Implant ◽  
Significant Risk ◽  
Breast Implants ◽  
Augmentation Mammaplasty ◽  
Implant Surgery ◽  
History Of ◽  
Type Of Surgery

Breast surgery increases the risk for difficulties with milk production and breastfeeding. Research on lactation outcomes of breast augmentation with implants is reassuring, but reveals a significant risk of low milk production that varies with the type of surgery and position of the implants. Understanding the potential effects of breast implants on breastfeeding can help lactation professionals optimize outcomes for families with a history of augmentation mammaplasty.

The Breast Implant and Disease: An Observed Association or a Verdict of Causation? Part I

1996 ◽  
Vol 13 (3) ◽  
pp. 267-273
Author(s):  
Tony A. Discoe
Keyword(s):  
Causal Relationship ◽  
Breast Implant ◽  
Breast Implants ◽  
Complex Method ◽  
Legal Environment ◽  
Causal Relationships ◽  
Potential Harm ◽  
Silicone Gel ◽  
Determining Factor ◽  
Careful Thought

The issue presented in breast implant litigation, whether breast implants cause harm, graphically displays the frontiers of the interface of law and medicine, and the complex method of evaluating causal relationships in medicine. Should the law wait for an answer? This paper provides a system for evaluating the results of studies in the area of breast implant litigation, in terms of the extent to which those results support or refute a causal relationship. The concept and characteristics of causation and the reliability of cases, reports, descriptive studies, and anecdotal cases as evidence of causation are discussed. Because of the current media and medical legal environment, recommendations for the care and treatment of patients with breast implants are being made without careful thought. The consequences of widespread litigation may be the determining factor in attempting to resolve the question of the potential harm of the silicone-gel breast implant.

The Breast Implant and Disease: An Observed Association or a Verdict of Causation? Part II

1996 ◽  
Vol 13 (4) ◽  
pp. 381-387
Author(s):  
Tony A. Discoe
Keyword(s):  
Causal Relationship ◽  
Breast Implant ◽  
Breast Implants ◽  
Complex Method ◽  
Legal Environment ◽  
Causal Relationships ◽  
Potential Harm ◽  
Silicone Gel ◽  
Determining Factor ◽  
Careful Thought

The issue presented in breast implant litigation, whether breast implants cause harm, graphically displays the fron-tiers of the interface of law and medicine, and the complex method of evaluating causal relationships in medicine. Should the law wait for an answer? This paper provides a system for evaluating the results of studies in the area of breast implant litigation, in terms of the extent to which those results support or refute a causal relationship. The concept and characteristics of causation and the re-liability of cases, reports, descriptive studies, and anecdotal cases as evidence of causation are discussed. Because of the current media and medical legal environment, recommen-dations for the care and treatment of patients with breast implants are being made without careful thought. The con-sequences of widespread litigation may be the determining factor in attempting to resolve the question of the potential harm of the silicone-gel breast implant.

scholarly journals Thoracic migration of silicone gel after breast implant rupture: a case report and literature review

2021 ◽  
Author(s):  
Benedetta Fanelli ◽  
Marco Marcasciano ◽  
Stefano Lovero ◽  
Luca Codolini ◽  
Donato Casella ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Biological Membrane ◽  
Breast Implant ◽  
Granulomatous Inflammation ◽  
Breast Implants ◽  
Silicone Implants ◽  
Axillary Lymph ◽  
Implant Rupture ◽  
Silicone Gel ◽  
Breast Implant Rupture

AbstractNowadays silicone is a widespread material for medical devices. In particular, it is commonly used for implants manufacturing, for that patients undergoing breast augmentation or breast reconstruction after mastectomy. However, the use of silicone implants is not free from risks. Ruptures of silicone breast implants are uncommon, in general post-traumatic or iatrogenic, and usually related to implant’s wall weakness of unknown origin but probably due to biochemical reactions that cause wall rupture. As a consequence of a rupture, silicone gel from damaged implants may have a continuity migration to the chest wall, axillae, and upper extremities, resulting in granulomatous inflammation or siliconoma, or a lymphatic migration to axillary lymph nodes. In this regard, silicone thoracic migration is extremely rare, and nowadays a leakage is unlikely to happen with more modern cohesive silicone gel implants. Nevertheless, procedures such as thoracic surgery and thoracotomies may be responsible for accidental breast implant rupture, capsular discontinuity, and eventually intrathoracic silicone migration, especially when dealing with older generations of breast implants. We report a rare case of a 75-year-old woman presenting with pleural silicone effusion, 18 years after a right breast reconstruction for breast cancer, followed by right upper lobe resection for a lung carcinoma. A combination of muscular flap and DTI pre-pectoral breast reconstruction with biological membrane (ADM) has been used for treatment. Literature was reviewed for cases of breast implants free silicone localization in the chest cavity, focusing on previous surgeries, anamnestic relevances, and surgical management.Level of Evidence: Level V, risk/prognostic study.

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