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 .

What is the Evidence of Lymphoma in Patients with Prostheses Other Than Breast Implants?

INTRODUCTION: Medical devices such as hip, knee, breast, vascular prostheses, among others, are very useful in different pathologies. We cannot doubt that their use is a great tool, besides being an advance in medicine; they provide a change in the quality of life of many patients; however, they are not exempt from adverse reactions and events. METHODS: We conduct a systematic review about lymphoma in the presences of prostheses other than breast implants. RESULTS: We selected 21 publications with a total of 24 patients. The largest number of prostheses was related to long bones in a total of 13 prostheses. The most frequent symptoms were: pain (52%), inflammation (24%), visible or palpable mass 20%. The most frequent type of lymphoma was non-Hodgkin B cell lymphoma in 14 cases. DISCUSSION: The presence of microparticles make biological degradation and wear of the implants, with macrophage and lymphocyte activation and the consequent production of proinflammatory cytokines such as tumor necrosis factor α, interleukin-1ß, interleukin-6, and prostaglandin 2 (PGE2). CONCLUSION: Lymphoma is not a common disease in patients with prostheses, and more data are needed to identify risk factors and make proper diagnoses. LEVEL OF EVIDENCE III: 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.

How to stratify the risk of thrombosis for esthetic plastic surgery? The proposal of a new scale.

Scales to qualify the risk of thrombosis do not include all thrombogenic factors that are generated in esthetic plastic surgery. Methods: We performed a systematic review to assess the risk of thrombosis in plastic surgery. Thrombogenic factors in esthetic surgery were analyzed by a panel of experts. We proposed a scale with 2 versions. In the first version, factors were stratified according to their impact on the possible risk of thrombosis. The second version includes the same factors but in a simplified form. We evaluated the efficacy of the proposed scale by comparing it with the Caprini score; we scored the risk in 124 cases and controls. Results: Using the Caprini score, we found that 81.45% of the patients studied and 62.5% of the cases of thrombosis were observed in the low-risk group. Only 1 case of thrombosis was reported in the high-risk group. Using the stratified version of the scale, we found that the low-risk group comprised 25% of the patients, and there were no cases of thrombosis. The high-risk group included 14.51% of patients; 10 presented thrombosis (62.5%). The proposed scale was very effective in detecting both low-risk and high-risk patients undergoing esthetic surgery procedures.