The Emerging Crisis of Stakeholders in Implant-based Augmentation Mammaplasty in Korea

Abstract

Background: Korea is no longer safe from the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL); the first reported case was a Korean woman in her 40s who had a 7-year-history of receiving an implant-based augmentation mammaplasty using a textured implant. We conducted this study to discuss the emerging crisis of stakeholders in implant-based augmentation mammaplasty and to propose a multidisciplinary approach to early detection of its complications. Methods: We analyzed medical examination data that was collected from patients who visited us between August 12 and September 27, 2019. We evaluated a total of 114 women (n = 114) in the current study. They were evaluated for whether they were in healthy condition. Moreover, their baseline characteristics were also examined; these included age, gender, height (cm), weight (kg), duration since surgery (years), possession of a breast implant card, the site of surgical incision, side of symptoms and reasons for outpatient visit. Furthermore, the patients were also evaluated for their subjective awareness of the manufacturer, surface and shape of the breast implant. Potential complications include malrotation, folding, seroma, capsule thickening, upside-down rotation, rupture, capsule mass and breast mass. Results: A majority of the patients had a past history of receiving textured implants. The corresponding percentage was 78.95% (90/114) and 85.09% (97/114) based on their subjective awareness of a breast implant and sonographic findings, respectively. That is, it was slightly increased with the use of a breast ultrasound. Conclusion: Here, we propose the following approaches. First, patient data should be prospectively collected. By tracking outcomes and complications of an implant-based augmentation mammaplasty, both high-quality care and patient safety can be ensured. Second, stakeholders in implant-based augmentation mammaplasty should collaborate with customers and regulatory authorities. Third, surgeons should consider applying imaging modalities for early detection of postoperative complications.

Association of the BellaGel® Breast Implant Scandal with the Poly Implant Prothèse Fraud: A Review of Literatures

“…After the onset of the first Korean case of BIA-ALCL, reported in August 16, 2019, the clinical use of textured breast implants was prohibited by the KMFDS [120]. Therefore, there has been an interest in whether there is a possible causal relationship between a microtextured surface of the device and a risk of complications of an implant-based augmentation mammaplasty in Korea, as well illustrated in studies comparing between the BellaGel ® SmoothFine and the Motiva Ergonomix™ [27,29,85].…”

“…A patient registry should be considered as an infrastructure for the standardized recording of data from patients receiving the BellaGel ® implants. In 2019, when we noticed the first report of the Korean case of BIA-ALCL, we proposed that possible impacts of BIA-ALCL be rigorously analyzed and appropriate measures be taken as promptly as possible [120]. From similar contexts, we'll prospectively collect from patients receiving the BellaGel ® implants and then track their outcomes and complications, thus endeavoring to ensure both high-quality care and patient safety.…”

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

“…We, at the Korean Society of Breast Implant Research, propose the following recommendations: First, a patient registry should be considered as an infrastructure for the standardized recording of data from patients receiving the BellaGel® implants. In 2019, when we noticed the first report of the Korean case of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), we proposed that possible impacts of BIA-ALCL be rigorously analyzed and appropriate measures be taken as promptly as possible [60]. From similar contexts, we'll prospectively collect from patients receiving the BellaGel® implants and then track their outcomes and complications, thus endeavoring to ensure both high-quality care and patient safety.…”

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

“…Of these, the Establishment Labs Holdings Inc. triggered the popularity of a microtextured breast implant when it released the Motiva Ergonomix™ Round SilkSurface in 17 June 2016 [12,13]. Use of a microtextured device has become predominant since that of a macrotextured device was banned by the Korean Ministry of Food and Drug Safety (KMFDS) in 29 August 2019 when it announced the first Korean case of BIA-ALCL to the public [14].…”

“…Likewise, stakeholders in the Korean industry of an SGBI have recently experienced breast implant crises from BIA-ALCL and the first Korean case of a medical device fraud. This led to a ban of textured breast implants and devices from a Korean manufacturer, the HansBiomed Co. Ltd., as mandated by the KMFDS in 29 August 2019 and 13 November 2020, respectively [11][12][13][14]. Therefore, it is allegedly known that only traditional smooth or microtextured breast implants from foreign manufacturers are commercially available currently in Korea; these include the Motiva Ergonomix™ SilkSurface (Establishment Labs Holdings Inc.), the Sebbin ® Integrity™, Sublimity™ and Purity™ (Groupe Sebbin SAS), the Eurosilicone Round Collection™ (GC Aesthetics PLC), the Mentor ® MemoryGel TM Xtra (Mentor Worldwide LLC.)…”