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美学与重建乳房手术中微聚氨酯泡沫涂层Diagon/Gel(®)4Two植入物——一项正在进行的研究的3年结果

The micropolyurethane foam-coated Diagon/Gel(®)4Two implant in aesthetic and reconstructive breast surgery - 3-year results of an ongoing study.

作者信息

Brunnert Klaus E

机构信息

Klinik für Senologie, Osnabrück, Germany.

出版信息

GMS Interdiscip Plast Reconstr Surg DGPW. 2015 Dec 21;4:Doc20. doi: 10.3205/iprs000079. eCollection 2015.

DOI:10.3205/iprs000079
PMID:26713264
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4686800/
Abstract

BACKGROUND

Breast implants are worldwide in use since 1962. Initially there were some problems with capsular contracture and the palpability of the rim of the implant. In 1968 this led to the introduction of the micropolyurethane foam-coating and then in 1970 to the first micropolyurethane foam-coated implant by F.A. Ashley. As a result of additional technical refinements in manufacturing this new implant design significantly reduced complications i.e. capsular contracture and implant rotation.

METHODS

This study reports a single surgeon's experience with aesthetic and reconstructive breast surgery, in primary and secondary cases with the sole use of micropolyurethane foam-coated Diagon/gel(®)4Two implants, partly in combination with the additional use of synthetic meshes, acellular dermal matrices and lipofilling. The trial is a prospective, single center cohort study designed to demonstrate the safety and effectiveness of the new implant design in primary and secondary aesthetic and reconstructive breast surgery. The reported data provide an interim report of the implantations performed from November 2010 to December 2013.

RESULTS

90 patients were admitted to the study with 152 implants. The majority of the implants (n=95, 62.5%) were used in reoperative cases for either oncological (n=52, 34.2%) or aesthetic reasons (n=43, 28.3%). The median age of the study cohort was 45 years; the median body mass index was 21; the median observation time is 41 months. There was a very low complication rate, both short term within 6 weeks after the implantation of the silicone gel implant and in the follow up in November 2015. There were no serious complications needing explantation, no capsular fibrosis or implant rotation or rupture so far. There were only 4 minor complications (1.97%). There was 1 local recurrence 4 years after skin and nipple sparing mastectomy.

CONCLUSION

The micropolyurethane foam-coated Diagon/gel(®)4Two implant is a very reliable silicone gel implant filled with two high cross-linked, cohesive and form stable gels. The study demonstrated a very high safety profile of the 4Two implant and its effectiveness in both primary and secondary reoperative aesthetic, oncological and reconstructive breast surgery. The study is ongoing, a longer follow-up will be needed to consolidate the data.

摘要

背景

自1962年以来，乳房植入物在全球范围内得到使用。最初，包膜挛缩和植入物边缘的可触知性存在一些问题。1968年，这导致了微聚氨酯泡沫涂层的引入，然后在1970年，F.A. Ashley推出了首个微聚氨酯泡沫涂层植入物。由于制造过程中的进一步技术改进，这种新的植入物设计显著减少了并发症，即包膜挛缩和植入物旋转。

方法

本研究报告了一位外科医生在单纯使用微聚氨酯泡沫涂层的Diagon/gel(®)4Two植入物进行一期和二期美容及重建乳房手术中的经验，部分病例还额外使用了合成网片、脱细胞真皮基质和脂肪填充。该试验是一项前瞻性、单中心队列研究，旨在证明这种新的植入物设计在一期和二期美容及重建乳房手术中的安全性和有效性。报告的数据提供了2010年11月至2013年12月期间进行植入手术的中期报告。

结果

90名患者纳入研究，共植入152枚植入物。大多数植入物（n = 95，62.5%）用于再次手术病例，原因包括肿瘤学（n = 52，34.2%）或美容（n = 43，28.3%）。研究队列的中位年龄为45岁；中位体重指数为21；中位观察时间为41个月。无论是在硅胶凝胶植入物植入后6周内的短期还是在2015年11月的随访中，并发症发生率都非常低。目前没有需要取出植入物的严重并发症，没有包膜纤维化、植入物旋转或破裂。仅有4例轻微并发症（1.97%）。在保乳皮肤和乳头切除术后4年出现1例局部复发。

结论

微聚氨酯泡沫涂层的Diagon/gel(®)4Two植入物是一种非常可靠的硅胶凝胶植入物，填充有两种高度交联、粘性和形状稳定的凝胶。该研究证明了4Two植入物具有非常高的安全性，以及在一期和二期再次手术的美容、肿瘤学和重建乳房手术中的有效性。研究正在进行中，需要更长时间的随访来巩固数据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/7914cbaf04fb/IPRS-04-20-g-007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/119ec251b234/IPRS-04-20-t-001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/3e039f408172/IPRS-04-20-g-002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/723f45135eff/IPRS-04-20-g-003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/5c28fe60ce91/IPRS-04-20-g-004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/22fcab106f35/IPRS-04-20-g-005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/a41d315382d7/IPRS-04-20-g-006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/7914cbaf04fb/IPRS-04-20-g-007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/119ec251b234/IPRS-04-20-t-001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/ad82b811be57/IPRS-04-20-t-002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/f2bfa6e5e67d/IPRS-04-20-g-001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/3e039f408172/IPRS-04-20-g-002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/723f45135eff/IPRS-04-20-g-003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/5c28fe60ce91/IPRS-04-20-g-004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/22fcab106f35/IPRS-04-20-g-005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/a41d315382d7/IPRS-04-20-g-006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8414/4686800/7914cbaf04fb/IPRS-04-20-g-007.jpg

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本文引用的文献

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Plast Reconstr Surg. 1972 Apr;49(4):414-9. doi: 10.1097/00006534-197204000-00009.
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