What is the Process for Breast Implant Manufacturing? Inside Eight Breast Implant Factories.

BACKGROUND 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. METHODS 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. RESULTS 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). CONCLUSION 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. LEVEL OF EVIDENCE V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .