Asociación Mexicana de Cirugía Plástica, Estética Y Reconstructiva, Flamencos 74, San José Insurgentes, Benito Juárez, 03900, Mexico City, Mexico.
Centro Universitario de la Costa, Universidad de Guadalajara, Mexico City, Mexico.
Aesthetic Plast Surg. 2020 Dec;44(6):2063-2074. doi: 10.1007/s00266-020-01844-6. Epub 2020 Jul 8.
With the recent association between breast implants and anaplastic large cell lymphoma, breast implants have become the focus of many warnings. Surgeons and health professionals are not involved in all the processes of the manufacturing and distribution of this product. Not all countries have breast implant factories that are easy for surgeons to visit and better understand the manufacturing process.
A questionnaire about breast implant manufacturing and distribution was validated in consensus and form. Two plastic surgeons visited eight factories and administered the questionnaire in the presence of a photographer, who documented that the questionnaire was answered in the same way for all visits. Once the visitors finished obtaining the information (questionnaire responses and video recording), this information was validated by a different member of a safety committee in Mexico. For the observations to be considered valid, the information from the questionnaire and the video must be presented.
We visited eight factories: three in France (Sebbin, Arion and Eurosilicone), two in Costa Rica (Allergan and Motiva), one in Scotland (Nagor), one in Germany (Polytech) and one in Korea (Bellagel). In four factories (Eurosilicone, Motiva, Nagor and Sebbin), the information on the process for manufacturing an implant was observed and recorded (validated). The quality laboratory was visited, and video recording was performed in six factories (Bellagel, Eurosilicone, Motiva, Nagor, Polytech and Sebbin).
It was possible to observe and verify that most of the companies that distribute breast implants in Mexico perform their manufacturing processes according to ISO standards. A breast implant registry can help people further understand how BIA-ALCL will behave in the future and allow more tests to better understand this pathology.
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由于最近乳房植入物与间变性大细胞淋巴瘤之间的关联，乳房植入物已成为许多警告的焦点。外科医生和卫生专业人员并未参与该产品制造和分销的所有过程。并非所有国家都有乳房植入物工厂，这使得外科医生难以访问并更好地了解制造过程。
对乳房植入物制造和分销的问卷进行了共识和形式验证。两名整形外科医生访问了八家工厂，并在摄影师在场的情况下进行了问卷调查，摄影师记录了所有访问都以相同的方式回答了问卷。一旦访问者获得了信息（问卷回答和视频记录），墨西哥安全委员会的另一名成员就会验证该信息。为了使观察有效，必须提供问卷和视频的信息。
我们访问了八家工厂：法国的三家（Sebbin、Arion 和 Eurosilicone）、哥斯达黎加的两家（Allergan 和 Motiva）、苏格兰的一家（Nagor）、德国的一家（Polytech）和韩国的一家（Bellagel）。在四家工厂（Eurosilicone、Motiva、Nagor 和 Sebbin）中，观察并记录了制造植入物的过程信息（已验证）。参观了质量实验室，并在六家工厂（Bellagel、Eurosilicone、Motiva、Nagor、Polytech 和 Sebbin）进行了视频录制。
可以观察和验证分布在墨西哥的大多数乳房植入物公司都按照 ISO 标准执行其制造流程。乳房植入物登记册可以帮助人们进一步了解 BIA-ALCL 在未来的表现，并进行更多测试以更好地了解这种病理学。
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