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整形外科医生在2019年美国食品药品监督管理局听证会上为有纹理的乳房植入物辩护:为何是时候重新考虑了。

Plastic Surgeons Defend Textured Breast Implants at 2019 U.S. Food and Drug Administration Hearing: Why It Is Time to Reconsider.

作者信息

Swanson Eric

机构信息

Swanson Center, Leawood, Kans.

出版信息

Plast Reconstr Surg Glob Open. 2019 Aug 30;7(8):e2410. doi: 10.1097/GOX.0000000000002410. eCollection 2019 Aug.


DOI:10.1097/GOX.0000000000002410
PMID:31592028
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6756678/
Abstract

Textured breast implants were the subject of a U.S. Food and Drug Administration (FDA) hearing on March 25 and 26, 2019. Regulating agencies in other countries, including all of Europe and Canada, have already banned macrotextured implants. Patients affected by Breast Implant-Associated Anaplastic Large-Cell Lymphoma (BIA-ALCL) recounted their life-changing experiences, and requested a ban on textured devices. Plastic surgeons, many with industry ties, spoke in favor of keeping the devices available. The historical advantages of textured implants were presented, including a reduced capsular contracture rate. A 14-point plan to improve sterility at the time of implantation was promoted as an effective alternative to reduce both capsular contractures and BIA-ALCL risk. However, recent studies show that textured implants have not delivered on their early promise. Biocell implants perform worse, not better, than other implant types, and capsular contracture rates are not significantly reduced according to recent core studies. The only known risk factor for BIA-ALCL is textured implants. The lifetime risk for Biocell implants is at least 1:2, 200. There is no reliable evidence that surgical technique makes a difference in risk. This serious issue represents a case study of conflict of interest. In light of recent information, a re-analysis of the true risks and benefits of textured implants is justified. It is time for our professional societies to recognize that the device is the problem rather than surgical technique. On May 2, 2019, the FDA decided against a ban on textured breast implants.

摘要

2019年3月25日和26日,美国食品药品监督管理局(FDA)就表面有纹理的乳房植入物举行了听证会。包括整个欧洲和加拿大在内的其他国家的监管机构已经禁止使用大纹理植入物。受乳房植入物相关间变性大细胞淋巴瘤(BIA-ALCL)影响的患者讲述了他们改变人生的经历,并要求禁止使用有纹理的器械。许多与行业有联系的整形外科医生表示支持继续使用这些器械。会上介绍了有纹理植入物的历史优势,包括降低包膜挛缩率。一项在植入时提高无菌性的14点计划被推广为降低包膜挛缩和BIA-ALCL风险的有效替代方案。然而,最近的研究表明,有纹理的植入物并未兑现其早期承诺。Biocell植入物的表现比其他类型的植入物更差,而不是更好,并且根据最近的核心研究,包膜挛缩率并未显著降低。BIA-ALCL唯一已知的风险因素是有纹理的植入物。Biocell植入物的终身风险至少为1:2200。没有可靠的证据表明手术技术会影响风险。这个严重问题是一个利益冲突的案例研究。鉴于最近的信息,对有纹理植入物的真正风险和益处进行重新分析是合理的。现在是我们的专业协会认识到问题在于器械而非手术技术的时候了。2019年5月2日,FDA决定不禁止有纹理的乳房植入物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/552b/6756678/cb4845e89a71/gox-7-e2410-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/552b/6756678/e1206e885faf/gox-7-e2410-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/552b/6756678/ab08063671dd/gox-7-e2410-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/552b/6756678/cb4845e89a71/gox-7-e2410-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/552b/6756678/e1206e885faf/gox-7-e2410-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/552b/6756678/ab08063671dd/gox-7-e2410-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/552b/6756678/cb4845e89a71/gox-7-e2410-g003.jpg

相似文献

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引用本文的文献

[1]
Implant surface selection in primary cosmetic breast augmentation: A national cross-sectional study of UK plastic surgeons.

JPRAS Open. 2025-6-17

[2]
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Plast Reconstr Surg Glob Open. 2025-4-14

[3]
Perception of Risk and the Choice Between Smooth and Textured Breast Implants.

Ann Plast Surg. 2025-8-1

[4]
Conflict of Interest and Recommendations for Explantation in Asymptomatic Patients Concerned About BIA-ALCL Risk.

Ann Plast Surg. 2025-5-1

[5]
Have We Really Shifted to an Evidence-Based Practice? A Qualitative Analysis of Primary Breast Augmentation.

Eplasty. 2024-9-18

[6]
Breast implant iatrogenics: challenging the safety narrative.

Front Glob Womens Health. 2024-5-17

[7]
Smooth versus Textured Tissue Expanders: Comparison of Outcomes and Complications in 536 Implants.

Arch Plast Surg. 2024-2-7

[8]
models of soft tissue damage by implant-associated frictional shear stresses.

Pro Inst Mech Eng Part J J Eng Tribol. 2023-5

[9]
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[10]
Silicone Implant Surface Roughness, Friction, and Wear.

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本文引用的文献

[1]
The Textured Breast Implant Crisis: A Call for Action.

Ann Plast Surg. 2019-6

[2]
Breast Implant Illness: A Way Forward.

Plast Reconstr Surg. 2019-3

[3]
Breast Reconstruction Following Breast Implant-Associated Anaplastic Large Cell Lymphoma.

Plast Reconstr Surg. 2019-3

[4]
A Discussion of Conflicts of Interest in Plastic Surgery and Possible Remedies.

Plast Reconstr Surg Glob Open. 2018-12-12

[5]
Not All Breast Implants Are Equal: A 13-Year Review of Implant Longevity and Reasons for Explantation.

Plast Reconstr Surg. 2018-9

[6]
Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation.

Plast Reconstr Surg. 2018-4

[7]
Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

Plast Reconstr Surg. 2018-4

[8]
A 1-Point Plan to Eliminate Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

Ann Plast Surg. 2018-5

[9]
IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years.

Plast Reconstr Surg. 2018-7

[10]
Mentor Contour Profile Gel Implants: Clinical Outcomes at 10 Years.

Plast Reconstr Surg. 2017-12

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