J Korean Med Sci.  2020 Apr;35(15):e103. 10.3346/jkms.2020.35.e103.

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

• Kim JH
• Paik NS
• Nam SY
• Cho Y
• Park HK

• KMID: 2500190
• DOI: http://doi.org/10.3346/jkms.2020.35.e103

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 multi-disciplinary 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.

Keyword

Breast; Breast Implants; Breast Implantation; Mammaplasty; Safety

Figure

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  Fig. 1 Years since surgery. Of the total patients, 38.60% (44/114) had a duration since surgery of 6-15 years during which breast implant-associated anaplastic large cell lymphoma may occur.

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  Fig. 2 Distribution of the patients' subjective awareness of the surface of a breast implant.

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  Fig. 3 Distribution of sonographic findings of the surface of a breast implant.

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  Fig. 4 Sonographic findings of a textured implant. Textured implants are visualized as hypoechoic images on breast ultrasound.

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