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軟組織的隱憂
為何支撐如此重要
在 20 歲之後，我們的皮膚每年大約會流失 1% 的膠原蛋白——導致軟組織逐漸變薄並失去彈性。 而在手術後，軟組織的癒合僅能恢復至原本強度的 80%。
事實上，臨床研究顯示，在整形手術後 10 年內，有 32–48% 的患者會接受二次手術以改善初次手術的術後結果——最常見的原因即為軟組織薄弱或不足。
1,2,3
4
19-21
在 20 歲之後，我們的皮膚每年會流失 1% 的膠原蛋白。
1
原生組織在手術後僅能恢復至原本強度的 80%。
4
32–48% 的乳房手術患者會接受再次手術以修正其初始結果。
19-21
Our skin loses 1% of its collagen each year after age 20.
1
Native tissue only heals to 80% of its original strength after surgery.
4
32-48% of breast surgery patients undergo another breast surgery procedure to revise their initial results.
19-21
乳房下垂評估
Regnault 分級系統
22
22
IMF = 乳房下皺襞 (Inframammary fold)
IMF
正常
第一級
第二級
第三級
腺體下垂
乳頭位於乳房下皺襞 (IMF) 或低於 IMF 1 公分
輕度下垂（第一級）
Regnault 下垂分級²²
乳頭位於 IMF，且高於乳房下緣輪廓
中度下垂（第二級）
Regnault 下垂分級²²
乳頭位於 IMF，並與乳房下緣輪廓在同一水平
乳頭位於 IMF，乳腺組織低於乳房皺襞
重度下垂（第三級）
重度下垂（第三級）
乳頭位於 IMF，乳房發育不全且低於乳房皺襞
假性下垂
Regnault 下垂分級²²
腺體下垂
適當的組織支撐是實現持久且自然效果的重要因素。
接受美容乳房手術的患者理應獲得支撐。
GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation
Support and strength
for the long run -3
受支撐的組織更為強韌
透過 GalaFLEX™ Scaffold，讓組織修復更為強韌
7-11
以 GalaFLEX™ Scaffold 系列可預期的強度強化您的隆乳、重修、乳癌重建手術
GalaFLEX™ Scaffold 由生物來源的聚-4-羥基丁酸酯 (P4HB) 組成，能提供即時的軟組織補強，達到組織長期強度、穩定度與安全性。
7-11,13
1,2,11
原生組織在手術後僅能恢復至最初強度的 80%。
研究顯示，使用 GalaFLEX™ Scaffold 修復的組織在術後 12 個月時，其強度可達原生組織的 3–4 倍。
4,7-10
檔案中的臨床前數據。結果可能與實際臨床結果不一致。
術後原生組織僅能恢復至 80% 的強度⁴
使用 GalaFLEX™ Scaffold 修復的組織⁷⁻¹⁰
原生組織強度
GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation 1,2,11
長期支撐
留下比原生組織強度高出 3–4 倍的組織。⁷⁻¹⁰
Support and strength
for the long run -3
3–4 倍
研究已證實，GalaFLEX™ Scaffold 在植入後 12 個月時，能提供比原生組織高出 3–4 倍的強度⁷⁻¹⁰
更強韌
GalaFLEX Internal Bra™
提供持久的支撐
1,7-10
隆乳合併拉提手術 GalaFLEX Internal Bra™
手術前
2 年後
5 年後
10 年後
整形隆乳手術中，患者接受 GalaFLEX Scaffold Internal Bra™ 以支撐軟組織之手術前後對比照片，經由 Bruce Van Natta 醫師提供。
照片僅作為示例，並不構成對於使用 GalaFLEX Scaffold Internal Bra™ 的手術結果之任何明示或暗示的保證。所有手術結果均取決於患者的個別情況，以及臨床手術結果的正常差異性。
Before and after photos of patients who received GalaFLEX Scaffold Internal Bra™ for soft tissue support during an aesthetic breast procedure, courtesy of Bruce Van Natta, MD. Photographs serve as examples only, and do not constitute an implied or any other kind of certainty for the result of a surgical procedure where GalaFLEX Scaffold Internal Bra™ is used. All surgical results are subject to the individual results for the patient and the normal variability of clinical procedure results.
Breast lift with implant and GalaFLEX Internal Bra™
Before surgery
2 years later
10 years later
5 years later
Provides critical strength during the initial healing phase.⁷⁻¹¹,¹⁵
Promotes the maturation of stronger tissue.⁷⁻¹⁰
Leaves behind tissue 3-4x stronger than native tissue.⁷⁻¹⁰
在初期癒合階段提供關鍵支撐力。
7-11,15
促進更強韌組織的成熟。
7-10
7-10
留下比原生組織強度高出 3–4 倍的組織。
幫助軟組織癒合得更強韌
在初期癒合階段提供關鍵強度
GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation 1,2,11
14
Support and strength
for the long run -3
檔案中的臨床前數據。結果可能與臨床結果不一致。
手術日
1 個月
1 年
GalaFLEX™ Scaffold 為新修復的組織提供內部支撐，並作為新組織長入的網狀結構。
健康細胞進入支撐網中生長。⁷'¹⁸
健康的新生組織比原先強韌2-4倍
並在支撐網被吸收的同時保留下來。⁷⁻¹³
臨床前研究已證實，組織整合度可達 75% 以上。⁷⁻¹⁶
膠原蛋白已生成強化組織支撐力。⁷⁻¹⁶'²³
支撐網基本全數吸收完成。⁷⁻¹³
2 週
7 個月
7-11
1.5–2 年
Immediately
after surgery
GalaFLEX™ Scaffold provides internal support to newly repaired tissue, and a lattice for new tissue ingrowth.⁷⁻¹¹
2 Weeks
>75% tissue integration has been demonstrated in preclinical studies.⁷⁻¹⁶
1 month
Healthy cells grow into the scaffold, gradually transferring the load from the scaffold to the ingrown tissue.⁷'¹⁸
7 months
Mature collagen (i.e., Type I collagen) is prevalent.⁷⁻¹⁶'²³
1 year
Newly formed tissue (as a result of GalaFLEX™ Scaffold) provides support and stability to the tissue – and has been demonstrated to provide 3-4x greater strength then native tissue.⁷⁻¹³
1.5-2 years
The scaffold is essentially completely absorbed and eliminated from the body as water and carbon dioxide through natural physiologic pathways.⁷⁻¹³
準備好魅力提升您的整形隆乳、拉提、二修與乳房重建手術效果了嗎？
讓我們開始吧。
GalaFLEX™ Scaffold has been demonstrated to provide 2-4x greater strength than native tissue at 12-months following implantation 1,2,11
Support and strength
for the long run -3
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Obaji S. Why does skin wrinkle with age? What is the best way to slow or prevent this process? Scientific American. September 26, 2005. Accessed February 6, 2024. https://www.scientificamerican.com/article/why-does-skin-wrinkle-wit/
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Choi JW, Kwon SH, Huh CH, Park KC, Youn SW. The influences of skin visco-elasticity, hydration level and aging on the formation of wrinkles: a comprehensive and objective approach. Skin Res Technol. 2013;19(1):e349-e355. doi:10.1111/j.1600-0846.2012.00650.x
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Thornton MJ. Estrogens and aging skin. Dermatoendocrinol. 2013;5(2):264-270. doi:10.4161/derm.23872
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Xue M, Jackson CJ. Extracellular Matrix Reorganization During Wound Healing and Its Impact on Abnormal Scarring. Adv Wound Care (New Rochelle). 2015;4(3):119-136. doi:10.1089/wound.2013.0485.
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Mimi Y. Wu Young, Kathleen A. Holoyda, David W. Chang, Outcomes of progressive tension donor-site closure in abdominal-based autologous breast reconstruction, Journal of Plastic, Reconstructive & Aesthetic Surgery,Volume 75, Issue 9, 2022, Pages 2991-2995.
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Adetayo, OA MD; Salcedo, SE; Gupta, SC. 1: THE USE OF ACELLULAR DERMAL MATRIX IN BREAST AND ABDOMINAL WALL SURGERY: A META-ANALYSIS OF OUTCOMES AND RISK FACTORS PREDICTIVE OF COMPLICATIONS. Plastic and Reconstructive Surgery 127():p 9, May 2011.
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Preclinical data on file. Results may not correlate to clinical outcomes.
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Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-hydroxybutyrate-PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN Surg. 2013;2013:238067. Published 2013 May 28. doi:10.1155/2013/238067. Native abdominal wall tissue strength adapted from Deeken 2013 (69.7N +/- 13.6).
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Scott JR, Deeken CR, Martindale RG, Rosen MJ. Evaluation of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh in a porcine model of ventral hernia repair. Surg Endosc. 2016;30(9):3691-3701. doi:10.1007/s00464-016-5057-9.
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Martin DP, Williams SF. Medical applications of poly-4-hydroxybutyrate: a strong flexible absorbable biomaterial. Biochem Eng J 2003;16(2):97-105.
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Martin DP, Badhwar A, Shah DV, et al. Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. J Surg Res. 2013;184(2):766-773. doi:10.1016/j.jss.2013.03.044.
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GalaFLEX™ Scaffold Instructions for Use.
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Williams SF, Martin DP, Moses AC. The History of GalaFLEX P4HB Scaffold. Aesthet Surg J. 2016;36(suppl 2):S33-S42. doi:10.1093/asj/sjw141.
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Ireton, Jordan E. et al. “The Role of Wound Healing and Its Everyday Application in Plastic Surgery: A Practical Perspective and Systematic Review.” Plastic and reconstructive surgery. Global open (2013).
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Critical wound healing period adapted from Ireton 2013 (6 weeks to 3 months).
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Stoikes NFN, Scott JR, Badhwar A, Deeken CR, Voeller GR. Characterization of host response, resorption, and strength properties, and performance in the presence of bacteria for fully absorbable biomaterials for soft tissue repair. Hernia. (2017) 21 (5):771–82. doi: 10.1007/s10029-017-1638-3.
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Data on file. Results may not correlate to clinical outcomes.
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Healthy tissue is defined by tissue with abundant mature collagen (as indicated by positive type I collagen staining) and vascularization (as shown by positive CD31 and smooth muscle actin stains) has quickly integrated into the scaffold.
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G. Patrick Maxwell, MD et al. "Ten-Year Results From the Natrelle 410 Anatomical Form-Stable Silicone Breast Implant Core Study." Aesthetic Surgery Journal 2015, Vol 35(2) 145–155.
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W. Grant Stevens, MD, et al. "Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel." Plastic and Reconstructive Surgery. April Supplement 2018.
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Hammond DC, Canady JW, Love TR, Wixtrom RN, Caplin DA. Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years. Plast Reconstr Surg. 2017;140(6):1142-1150.
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Cuzalina, A., G. Tolomeo, P., & A. Mañón, V. (2023). Revisions for Complications of Aesthetic Breast Surgery. IntechOpen. doi: 10.5772/intechopen.112915.
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Data on file. Bruce Van Natta, MD Meridian Plastic Surgery pathology report of human GalaFLEX™ Scaffold tissue explant.