Breast Implant Selection Following The “ALCL-pandemic”.  A Two-Stage Survey.

Breast Implant Selection Following The “ALCL-pandemic”. 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A Two-Stage Survey. Roman Rysin, Leonid Kogan, Tomer Tzur, Yair Shachar This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6074241/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 26 Apr, 2025 Read the published version in European Journal of Plastic Surgery → Version 1 posted 7 You are reading this latest preprint version Abstract Introduction: Almost 20,000 breast implants are being used annually in Israel. The majority of which (approximately 80%) are used for aesthetic breast augmentation and the reminder for reconstructive surgery. The vast majority are silicon-filled implants. Data regarding BIA-ALCL and the possible link to implant texture induced a shift towards different implant selection over the last 5–10 years. As in every change we make in our surgical technique, we should diligently examine the impact on our results over time. Materials and Methods We used an anonymous internet-based survey that was sent to active members of the Israeli society of plastic and aesthetic surgery. Questions regarding practice volume, type (aesthetic vs. reconstructive) and surgeon's experience were asked. Surgeons were asked to specify the brand and type of breast implants they are currently using, did they change their implant selection process and if so, how. The primary survey was done on 2019, right after the withdrawal of Allergan implants. A follow-up survey was done on 2023, aiming to examine the effect of implant change on surgical outcomes. Results In the primary survey done and presented in 2019, a significant shift towards less-textured implants was demonstrated, as an expectable reaction to BIA-ALCL concerns. The recent survey demonstrates the effects of these changes on surgical outcomes, as well as complications, seen after 4 years. Conclusion The first part of this Israel survey showed how new evidence influences the evolution of our breast implant selection practice. The second part now shows the impact this change had on our results. Introduction In 1997, John Keech, and Brevator Creech [1], wrote a letter to the Journal of Plastic and Reconstructive Surgery, reporting an unusual finding in one of their patients with breast implants. The description of a new entity of breast malignancy was made,Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Over the next decade, sporadic case reports and small case series were published regarding breast implants and ALCL [2–6]. The U.S. medical community became aware of breast implant associated ALCL in January 2011 following a U.S. Food and Drug Administration (FDA) safety communication warning of the “possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL) [6]. In 2012, Brody [7] concluded that the appearance of BIA-ALCL coincided with texturing of the implant surface [7]. Since then, a rapidly accumulating body of evidence has highlighted the association of both micro-and macro-textured implants with the development of device-associated lymphoma. The FDA's statement concerning Allergan ( Allergan ; AbbVie Inc, North Chicago, IL, USA) Biocell textured implants and their global market recall [8], has led many surgeons to shift toward smooth implants to avoid any risk of BIA-ALCL [9]. Although ALCL is a rare entity of malignancy, representing only 0.75% of all lymphomas and less than 0.7% of all breast malignancies [10], hundreds of scientific papers have been written on this subject, which became one of the most renowned entities of malignancy in the field of plastic and reconstructive surgery worldwide. While numerous papers describe ALCL illness in terms of screening, diagnosis and treatment. However, there is only sparse information regarding ALCL influence on surgical decision-making among plastic surgeons, and even less information on surgical outcomes and satisfaction profile. In order to fully understand and evaluate the entire spectrum of impact of this new arising entity of malignancy on the decision making process of plastic surgeons, time perspective is mandatory. In this manuscript we would like to delineate the plastic surgery society paradigm shift and compare it to recent literature. We would like to provide a surgeon’s view on decision making and surgical results due to this paradigm shift and to describe the surgeon’s viewpoint immediately after FDA recall in 2019 and over the course of 4 years. Methods The senior author has published an electronic questionnaire among the members of the Israeli society of plastic and aesthetic surgery (ISPAS). The participation was anonymous, no financial or other promotion due to participation was entitled. The primary questionnaire was in January 2019, included 10 questions. The second point in time, in order to evaluate the wind of change, was in January 2023, the secondary questionnaire included 15 questions. This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Hadassah Medical Center (HMO). Descriptive statistics analysis was computed for each sample size, using IBM SPSS Version 22.0 (IBM Corp., Armonk, NY). Continuous variables were expressed as mean ± SD, and categorical variables were expressed as frequencies and percentages. Results Primary questionnaire was filled by 75 senior plastic surgeons, 40% of Israeli ISAPS members, majority of which had at least 15 years of experience. Most breast procedures took place in a private setting. Majority of surgeons had more than 100 breast operations per year. The indication for alloplastic breast surgery was aesthetic in most of the cases. During those aesthetic breast surgeries, the most common implant that was used is round textured implant. When reconstructive breast procedures were being conducted, the primary implant used was an anatomical implant. Prior to the BIA-ALCL era, the most popular implants in Israel were Mentor and Allergan implants. After the publication of scientific papers elucidating ALCL and its association to textured prosthetic devices, in 2019, approximately half of the surgeons started to use smooth implants, the other half continued to use the same implant, and a small portion of surgeons continued to use textured devices of other manufacturers. By January 2019, the vast majority of surgeons that took this questionnaire had never witnessed BIA-ALCL patients in their clinical practice. A minority of surgeons witnessed one BIA-ALCL patient. The second part of this questionnaire took place in January 2023. The questioner was published in a similar matter. 105 members, which are 55% of the Israeli society of plastic and aesthetic surgery (ISPAS) participated. Approximately half of the participants had at least 15 years of seniority. Still, the majority of operations took place in a private setting. Majority of surgeons had between 10–50 annual breast procedures. The primary indication for alloplastic breast procedures was aesthetic. Primary breast implant for aesthetic purposes was a round textured implant. For reconstructive surgeries the primary implant used was a round smooth implant (full distribution can be seen in table 1). Before the ALCL entity of malignancy and its association to breast implant texturization was known, the majority of surgeons used mentor implants. After FDA notification and papers describing ALCL phenomenon, the majority of surgeons continued to use the same manufacturer. Yet, a considerate part of surgeons (38%) switched to smooth implants instead of textured. The change that was made in implant selection led to no change in aesthetic outcome, as was noticed by half of the surgeons that took this survey. The vast majority (85%) of surgeons that changed implants witnessed no change in the total complication rate. More specifically, no change in capsular contracture rate was witnessed after implant exchange to smooth implants. The same is true for the rates of implant malposition, implant rotation and rippling, (See Table. 1. Questioner results comparison). Discussion The field of breast surgery is characterized by continuous evolution and can be described as an ever-changing horizon. All efforts are directed towards achieving optimal surgical outcomes, reducing postoperative complication rates, and ensuring the highest level of patient satisfaction. Most importantly, these efforts are aimed at ensuring maximum patient safety. Over the years, this industry knew significant developments and constantly reacted to new implant models arriving as well as to changes in scientific data. These trends normally take the course of several years and often act as a pendulum swing with a natural back and forth motion. Since the early moratorium on silicon implant back in 1992, there was no other event that changed this industry so dramatically. Following the FDA announcement in 2019, an earthquake in the breast surgery world has occurred. Such a rapid shift in breast implant selection, prompted by the recall of textured breast implants and their association with the BIA-ALCL malignancy, has never been documented before. This manuscript highlights the shift among plastic surgeons in response to these significant changes, examining their implication on surgical techniques, aesthetic outcomes, complication rates, and the effects on both patients and physicians. After conducting a comprehensive literature review using widely used search engines such as PubMed and Google Scholar, and to the best of our knowledge, this is the first comparison made at two distinct points in time. First, in 2019, immediately following the identification of BIA-ALCL entity of malignancy. This marked the initial impact on physicians due to the recognition of this unique pathology. The second point in time was 2023, which examined the significant paradigm shift as physicians gained better understanding, and became better acclimated to this new entity of malignancy. In this manuscript, we aim to assess the impact of BIA-ALCL on physicians and how it has influenced their decision-making process in selecting implants for alloplastic breast surgeries at two key points in time. Majority of Israeli plastic surgeons, with a seniority of at least 15 years, and an equal rate of time division between private clinics and an academic hospital participated in this survey. Surgical indication, divided almost equally between aesthetic and reconstructive indication among the plastic surgeons. In aesthetic surgery in both questionnaires, round textured implants were primarily chosen. Nevertheless, in 2023, Motiva Ergonomix implant ( Motiva Establishment Laboratories, Costa Rica) gained increased popularity. In reconstructive breast surgery, in 2019 the majority of implants selected were anatomical implants, followed by round textured implants. In 2023, anatomical implants are still the first choice among plastic surgeons, although to a lesser degree, followed by ergonomic and round textured implants. Hence we can deduce Motiva Ergonomix implants have gained an increasing interest among plastic surgeons since FDA announcement. Prior to the association between implant shell texturization and its association to BIA-ALCL entity of malignancy, the majority of Israeli surgeons used Mentor implants ( Mentor Worldwide LLC, Irvine, CA), followed by Allergan’s. In 2019, following the publication of literature introducing BIA-ALCL, a paradigm shift occurred among plastic surgeons, leading to a preference for smooth implants (43.5% of physicians). The paradigm shift persisted in 2023, as the growing body of evidence in the literature further reinforced the ongoing preference for smooth implants ( 38%). This was followed by surgeons who continued using the same implants as before the introduction of BIA-ALCL (43%), as well as those who switched to smooth implants from different manufacturers( 11.3%). The majority of plastic surgeons (83.3%) report that implant exchange did not affect the quality of the final aesthetic results, the complication profile, or patient satisfaction. Additionally, a group of physicians (8.3%) noted a decrease in complication rates. An important observation is the decrease in the rate of capsular contracture among plastic surgeons following the change in implant selection (10%). Implant malposition was found to be comparable after implant exchange (72% of physicians), with only a slight increase in malposition as indicated by 19.7% of physicians. Implant rotation and rippling, was reported to have a slightly better complication profile, with usage of smooth implants, 15.5% and 22.1% of decrease, respectively. This article does not pretend to be a prospective study that correlates the type of implant envelope to results or complications. This was done many times in the past and will probably happen again with each of the new implant generations that will be developed. We aim only to shed some light on how such a significant and dramatic event might change our surgical choices and, on-turn, our outcomes. The survey was done on a rather small number of surgeons, and this is an obvious drawback. However, it does seem to give a good sense of direction as to where the wind blows. In addition, comparison of this sample in two different time frames after the change gives valuable information regarding physicians decision making and post-operative impact on aesthetic result and complication profile. Hence, we believe further research is mandatory in order to understand the full magnitude and implication of implant exchange among plastic surgeons on a national scale, integrally with the test of time. Conclusion This manuscript delineates the paradigm shift, that has occurred following the FDA safety communication warning and recall of textured breast implants and it׳s association to BIA-ALCL arising entity of malignancy, on a national scale. As can be seen ALCL phenomenon has led a considerate part of surgeons to switched to smooth implants instead of textured, and thus an increasing interest in Motiva Ergonomix implants was noted. The change that was made in implant selection led to no change in aesthetic outcome or in total complication rate. Declarations Human Ethics and Consent to Participate declarations Human Ethics and Consent to Participate declarations: not applicable. Informed consent: Informed consent was obtained from all individual participants included in the study. Funding: No funding was received for this study. Competing Interests: The authors have no relevant financial or non-financial interests to disclose Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Hadassah Medical Center (HMO). Clinical trial number: not applicable. Author Contribution Roman Rysin M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work Leonid Kogan M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work.Tomer Tzur M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work.Yair Shachar M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work.All authors reviewed the manuscript. References Keech JA Jr, Creech BJ (1997) Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg 100(2):554–555. 10.1097/00006534-199708000-00065 Sahoo S, Rosen PP, Feddersen RM, Viswanatha DS, Clark DA, Chadburn A (2003) Anaplastic large cell lymphoma arising in a silicone breast implant capsule: a case report and review of the literature. Arch Pathol Lab Med 127(3):e115–e118. 10.5858/2003-127-e115-ALCLAI Gaudet G, Friedberg JW, Weng A, Pinkus GS, Freedman AS (2002) Breast lymphoma associated with breast implants: two case-reports and a review of the literature. Leuk Lymphoma 43(1):115–119. 10.1080/10428190210189 Olack B, Gupta R, Brooks GS (2007) Anaplastic large cell lymphoma arising in a saline breast implant capsule after tissue expander breast reconstruction. Ann Plast Surg 59(1):56–57. 10.1097/SAP.0b013e31804d442e Newman MK, Zemmel NJ, Bandak AZ, Kaplan BJ (2008) Primary breast lymphoma in a patient with silicone breast implants: a case report and review of the literature. J Plast Reconstr Aesthet Surg 61(7):822–825. 10.1016/j.bjps.2007.03.027 Miranda RN, Medeiros LJ, Ferrufino-Schmidt MC et al (2019) Pioneers of Breast Implant-Associated Anaplastic Large Cell Lymphoma: History from Case Report to Global Recognition. Plast Reconstr Surg . ;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):7S-14S. 10.1097/PRS.0000000000005564 Brody GS (2012) Brief recommendations for dealing with a new case of anaplastic large T-cell lymphoma. Plast Reconstr Surg 129(5):871e–872e. 10.1097/PRS.0b013e31824a9e6d The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. U.S. Food & Drug Administration. July 2019. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan Danilla SV, Jara RP, Miranda F et al (2020) Is Banning Texturized Implants to Prevent Breast Implant-Associated Anaplastic Large Cell Lymphoma a Rational Decision? A Meta-Analysis and Cost-Effectiveness Study. Aesthet Surg J 40(7):721–731. 10.1093/asj/sjz343 Mankowski P, Carr M, Cherukupalli A et al (2022) The Macrotextured Implant Recall: Breast Implant-Associated-Anaplastic Large Cell Lymphoma Risk Aversion in Cosmetic and Reconstructive Plastic Surgery Practices. Aesthet Surg J 42(12):1408–1413. 10.1093/asj/sjac158 Tables Table 1 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.Questionerresultscomparison..docx Cite Share Download PDF Status: Published Journal Publication published 26 Apr, 2025 Read the published version in European Journal of Plastic Surgery → Version 1 posted Editorial decision: Revision requested 21 Mar, 2025 Reviews received at journal 21 Mar, 2025 Reviewers agreed at journal 21 Mar, 2025 Reviewers invited by journal 08 Mar, 2025 Editor assigned by journal 07 Mar, 2025 Submission checks completed at journal 07 Mar, 2025 First submitted to journal 20 Feb, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6074241","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":426011576,"identity":"5445118b-0a93-438d-a988-f9f835039727","order_by":0,"name":"Roman Rysin","email":"","orcid":"","institution":"GALILEE MEDICAL CENTER","correspondingAuthor":false,"prefix":"","firstName":"Roman","middleName":"","lastName":"Rysin","suffix":""},{"id":426011577,"identity":"e3d4871f-3fbe-4928-a6b2-14bf97ddd156","order_by":1,"name":"Leonid Kogan","email":"","orcid":"","institution":"GALILEE MEDICAL CENTER","correspondingAuthor":false,"prefix":"","firstName":"Leonid","middleName":"","lastName":"Kogan","suffix":""},{"id":426011578,"identity":"a9c4a42c-ea3e-4774-a2a4-66343f23f640","order_by":2,"name":"Tomer Tzur","email":"","orcid":"","institution":"Hadassah Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Tomer","middleName":"","lastName":"Tzur","suffix":""},{"id":426011579,"identity":"a229bc5f-c1a0-4992-857f-68017f72523c","order_by":3,"name":"Yair Shachar","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAklEQVRIiWNgGAWjYFACxgYgcYCBQQJIJVQACWbmBhK0PDgD0sJISAsYQLQwPmyDG4IbGBw/3PaB4c8def7Zzc8+JM6rjeZvB2r5UbENt5Yzic0zGNueGc64c8x4RuK247kzDjM2MPacuY1by4HEZqBLDjNukEgwZkjcdiwXyG5gZmzDo+X8w2YGhj+H7TdIpH9mSJxzLHc+QS03gLYwsB1O3CCRA7SloSZ3AyEtkjeAtiS2HU6ecSOnmCHh2IHcjUAtB/H5he98+mOGD38O2/bPSN/M+KOmLnfe+cMHH/yowK1F4QCQSEDwD4PJAzjVA4F8Ayq/Dp/iUTAKRsEoGKEAABPWZNX8LygQAAAAAElFTkSuQmCC","orcid":"","institution":"Hadassah Medical Center","correspondingAuthor":true,"prefix":"","firstName":"Yair","middleName":"","lastName":"Shachar","suffix":""}],"badges":[],"createdAt":"2025-02-20 18:53:17","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6074241/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6074241/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00238-025-02297-3","type":"published","date":"2025-04-26T15:57:10+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":81570594,"identity":"e46e4a74-bcf8-493d-8e5e-1e6dfcecb52e","added_by":"auto","created_at":"2025-04-28 16:13:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":347914,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6074241/v1/0cf45897-c1f8-4bf8-83f6-0fdf615db821.pdf"},{"id":78221817,"identity":"5b40638c-0bfa-4022-8a93-449b3bf24c70","added_by":"auto","created_at":"2025-03-11 06:12:52","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":175685,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.Questionerresultscomparison..docx","url":"https://assets-eu.researchsquare.com/files/rs-6074241/v1/ae2b2a8c934c6d49c65606a8.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Breast Implant Selection Following The “ALCL-pandemic”. A Two-Stage Survey.","fulltext":[{"header":"Introduction","content":"\u003cp\u003eIn 1997, John Keech, and Brevator Creech [1], wrote a letter to the Journal of Plastic and Reconstructive Surgery, reporting an unusual finding in one of their patients with breast implants. The description of a new entity of breast malignancy was made,Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Over the next decade, sporadic case reports and small case series were published regarding breast implants and ALCL [2\u0026ndash;6].\u003c/p\u003e \u003cp\u003eThe U.S. medical community became aware of breast implant associated ALCL in January 2011 following a U.S. Food and Drug Administration (FDA) safety communication warning of the \u0026ldquo;possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL) [6]. In 2012, Brody [7] concluded that the appearance of BIA-ALCL coincided with texturing of the implant surface [7].\u003c/p\u003e \u003cp\u003eSince then, a rapidly accumulating body of evidence has highlighted the association of both micro-and macro-textured implants with the development of device-associated lymphoma. The FDA's statement concerning Allergan (\u003cb\u003eAllergan\u003c/b\u003e; AbbVie Inc, North Chicago, IL, USA) Biocell textured implants and their global market recall [8], has led many surgeons to shift toward smooth implants to avoid any risk of BIA-ALCL [9].\u003c/p\u003e \u003cp\u003eAlthough ALCL is a rare entity of malignancy, representing only 0.75% of all lymphomas and less than 0.7% of all breast malignancies [10], hundreds of scientific papers have been written on this subject, which became one of the most renowned entities of malignancy in the field of plastic and reconstructive surgery worldwide.\u003c/p\u003e \u003cp\u003eWhile numerous papers describe ALCL illness in terms of screening, diagnosis and treatment. However, there is only sparse information regarding ALCL influence on surgical decision-making among plastic surgeons, and even less information on surgical outcomes and satisfaction profile.\u003c/p\u003e \u003cp\u003eIn order to fully understand and evaluate the entire spectrum of impact of this new arising entity of malignancy on the decision making process of plastic surgeons, time perspective is mandatory.\u003c/p\u003e \u003cp\u003eIn this manuscript we would like to delineate the plastic surgery society paradigm shift and compare it to recent literature. We would like to provide a surgeon\u0026rsquo;s view on decision making and surgical results due to this paradigm shift and to describe the surgeon\u0026rsquo;s viewpoint immediately after FDA recall in 2019 and over the course of 4 years.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe senior author has published an electronic questionnaire among the members of the Israeli society of plastic and aesthetic surgery (ISPAS). The participation was anonymous, no financial or other promotion due to participation was entitled.\u003c/p\u003e \u003cp\u003eThe primary questionnaire was in January 2019, included 10 questions. The second point in time, in order to evaluate the wind of change, was in January 2023, the secondary questionnaire included 15 questions.\u003c/p\u003e \u003cp\u003e This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Hadassah Medical Center (HMO). Descriptive statistics analysis was computed for each sample size, using IBM SPSS Version 22.0 (IBM Corp., Armonk, NY). Continuous variables were expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD, and categorical variables were expressed as frequencies and percentages.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003ePrimary questionnaire was filled by 75 senior plastic surgeons, 40% of Israeli ISAPS members, majority of which had at least 15 years of experience. Most breast procedures took place in a private setting. Majority of surgeons had more than 100 breast operations per year. The indication for alloplastic breast surgery was aesthetic in most of the cases. During those aesthetic breast surgeries, the most common implant that was used is round textured implant. When reconstructive breast procedures were being conducted, the primary implant used was an anatomical implant. Prior to the BIA-ALCL era, the most popular implants in Israel were Mentor and Allergan implants. After the publication of scientific papers elucidating ALCL and its association to textured prosthetic devices, in 2019, approximately half of the surgeons started to use smooth implants, the other half continued to use the same implant, and a small portion of surgeons continued to use textured devices of other manufacturers. By January 2019, the vast majority of surgeons that took this questionnaire had never witnessed BIA-ALCL patients in their clinical practice. A minority of surgeons witnessed one BIA-ALCL patient.\u003c/p\u003e \u003cp\u003eThe second part of this questionnaire took place in January 2023. The questioner was published in a similar matter. 105 members, which are 55% of the Israeli society of plastic and aesthetic surgery (ISPAS) participated. Approximately half of the participants had at least 15 years of seniority. Still, the majority of operations took place in a private setting. Majority of surgeons had between 10\u0026ndash;50 annual breast procedures. The primary indication for alloplastic breast procedures was aesthetic. Primary breast implant for aesthetic purposes was a round textured implant. For reconstructive surgeries the primary implant used was a round smooth implant (full distribution can be seen in table 1). Before the ALCL entity of malignancy and its association to breast implant texturization was known, the majority of surgeons used mentor implants. After FDA notification and papers describing ALCL phenomenon, the majority of surgeons continued to use the same manufacturer. Yet, a considerate part of surgeons (38%) switched to smooth implants instead of textured. The change that was made in implant selection led to no change in aesthetic outcome, as was noticed by half of the surgeons that took this survey. The vast majority (85%) of surgeons that changed implants witnessed no change in the total complication rate. More specifically, no change in capsular contracture rate was witnessed after implant exchange to smooth implants. The same is true for the rates of implant malposition, implant rotation and rippling, (See Table. 1. Questioner results comparison).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe field of breast surgery is characterized by continuous evolution and can be described as an ever-changing horizon. All efforts are directed towards achieving optimal surgical outcomes, reducing postoperative complication rates, and ensuring the highest level of patient satisfaction. Most importantly, these efforts are aimed at ensuring maximum patient safety.\u003c/p\u003e \u003cp\u003eOver the years, this industry knew significant developments and constantly reacted to new implant models arriving as well as to changes in scientific data. These trends normally take the course of several years and often act as a pendulum swing with a natural back and forth motion. Since the early moratorium on silicon implant back in 1992, there was no other event that changed this industry so dramatically. Following the FDA announcement in 2019, an earthquake in the breast surgery world has occurred. Such a rapid shift in breast implant selection, prompted by the recall of textured breast implants and their association with the BIA-ALCL malignancy, has never been documented before.\u003c/p\u003e \u003cp\u003eThis manuscript highlights the shift among plastic surgeons in response to these significant changes, examining their implication on surgical techniques, aesthetic outcomes, complication rates, and the effects on both patients and physicians.\u003c/p\u003e \u003cp\u003eAfter conducting a comprehensive literature review using widely used search engines such as PubMed and Google Scholar, and to the best of our knowledge, this is the first comparison made at two distinct points in time. First, in 2019, immediately following the identification of BIA-ALCL entity of malignancy. This marked the initial impact on physicians due to the recognition of this unique pathology. The second point in time was 2023, which examined the significant paradigm shift as physicians gained better understanding, and became better acclimated to this new entity of malignancy.\u003c/p\u003e \u003cp\u003eIn this manuscript, we aim to assess the impact of BIA-ALCL on physicians and how it has influenced their decision-making process in selecting implants for alloplastic breast surgeries at two key points in time.\u003c/p\u003e \u003cp\u003e Majority of Israeli plastic surgeons, with a seniority of at least 15 years, and an equal rate of time division between private clinics and an academic hospital participated in this survey.\u003c/p\u003e \u003cp\u003eSurgical indication, divided almost equally between aesthetic and reconstructive indication among the plastic surgeons.\u003c/p\u003e \u003cp\u003eIn aesthetic surgery in both questionnaires, round textured implants were primarily chosen. Nevertheless, in 2023, Motiva Ergonomix implant (\u003cb\u003eMotiva\u003c/b\u003e Establishment Laboratories, Costa Rica) gained increased popularity.\u003c/p\u003e \u003cp\u003eIn reconstructive breast surgery, in 2019 the majority of implants selected were anatomical implants, followed by round textured implants. In 2023, anatomical implants are still the first choice among plastic surgeons, although to a lesser degree, followed by ergonomic and round textured implants. Hence we can deduce Motiva Ergonomix implants have gained an increasing interest among plastic surgeons since FDA announcement.\u003c/p\u003e \u003cp\u003ePrior to the association between implant shell texturization and its association to BIA-ALCL entity of malignancy, the majority of Israeli surgeons used Mentor implants (\u003cb\u003eMentor\u003c/b\u003e Worldwide LLC, Irvine, CA), followed by Allergan\u0026rsquo;s.\u003c/p\u003e \u003cp\u003eIn 2019, following the publication of literature introducing BIA-ALCL, a paradigm shift occurred among plastic surgeons, leading to a preference for smooth implants (43.5% of physicians). The paradigm shift persisted in 2023, as the growing body of evidence in the literature further reinforced the ongoing preference for smooth implants ( 38%). This was followed by surgeons who continued using the same implants as before the introduction of BIA-ALCL (43%), as well as those who switched to smooth implants from different manufacturers( 11.3%). The majority of plastic surgeons (83.3%) report that implant exchange did not affect the quality of the final aesthetic results, the complication profile, or patient satisfaction. Additionally, a group of physicians (8.3%) noted a decrease in complication rates. An important observation is the decrease in the rate of capsular contracture among plastic surgeons following the change in implant selection (10%). Implant malposition was found to be comparable after implant exchange (72% of physicians), with only a slight increase in malposition as indicated by 19.7% of physicians. Implant rotation and rippling, was reported to have a slightly better complication profile, with usage of smooth implants, 15.5% and 22.1% of decrease, respectively.\u003c/p\u003e \u003cp\u003eThis article does not pretend to be a prospective study that correlates the type of implant envelope to results or complications. This was done many times in the past and will probably happen again with each of the new implant generations that will be developed. We aim only to shed some light on how such a significant and dramatic event might change our surgical choices and, on-turn, our outcomes. The survey was done on a rather small number of surgeons, and this is an obvious drawback. However, it does seem to give a good sense of direction as to where the wind blows. In addition, comparison of this sample in two different time frames after the change gives valuable information regarding physicians decision making and post-operative impact on aesthetic result and complication profile. Hence, we believe further research is mandatory in order to understand the full magnitude and implication of implant exchange among plastic surgeons on a national scale, integrally with the test of time.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis manuscript delineates the paradigm shift, that has occurred following the FDA safety communication warning and recall of textured breast implants and it׳s association to BIA-ALCL arising entity of malignancy, on a national scale. As can be seen ALCL phenomenon has led a considerate part of surgeons to switched to smooth implants instead of textured, and thus an increasing interest in Motiva Ergonomix implants was noted. The change that was made in implant selection led to no change in aesthetic outcome or in total complication rate.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eHuman Ethics and Consent to Participate declarations\u0026nbsp;\u003c/strong\u003eHuman Ethics and Consent to Participate declarations: not applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed consent:\u003c/strong\u003e Informed consent was obtained from all individual participants included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eNo funding was received for this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests:\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eThe authors have no relevant financial or non-financial interests to disclose\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval:\u0026nbsp;\u003c/strong\u003eThis study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Hadassah Medical Center (HMO). Clinical trial number: not applicable.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eRoman Rysin M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work Leonid Kogan M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work.Tomer Tzur M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work.Yair Shachar M.D: 1) substantial contributions to conception and design, acquisition of data, analysis, and interpretation of data; 2) drafting the article; 3) final approval of the version to be published; 4) Agreement to be accountable for all aspects of the work.All authors reviewed the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eKeech JA Jr, Creech BJ (1997) Anaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg 100(2):554\u0026ndash;555. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/00006534-199708000-00065\u003c/span\u003e\u003cspan address=\"10.1097/00006534-199708000-00065\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSahoo S, Rosen PP, Feddersen RM, Viswanatha DS, Clark DA, Chadburn A (2003) Anaplastic large cell lymphoma arising in a silicone breast implant capsule: a case report and review of the literature. Arch Pathol Lab Med 127(3):e115\u0026ndash;e118. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.5858/2003-127-e115-ALCLAI\u003c/span\u003e\u003cspan address=\"10.5858/2003-127-e115-ALCLAI\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGaudet G, Friedberg JW, Weng A, Pinkus GS, Freedman AS (2002) Breast lymphoma associated with breast implants: two case-reports and a review of the literature. Leuk Lymphoma 43(1):115\u0026ndash;119. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1080/10428190210189\u003c/span\u003e\u003cspan address=\"10.1080/10428190210189\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOlack B, Gupta R, Brooks GS (2007) Anaplastic large cell lymphoma arising in a saline breast implant capsule after tissue expander breast reconstruction. Ann Plast Surg 59(1):56\u0026ndash;57. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/SAP.0b013e31804d442e\u003c/span\u003e\u003cspan address=\"10.1097/SAP.0b013e31804d442e\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNewman MK, Zemmel NJ, Bandak AZ, Kaplan BJ (2008) Primary breast lymphoma in a patient with silicone breast implants: a case report and review of the literature. J Plast Reconstr Aesthet Surg 61(7):822\u0026ndash;825. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.bjps.2007.03.027\u003c/span\u003e\u003cspan address=\"10.1016/j.bjps.2007.03.027\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMiranda RN, Medeiros LJ, Ferrufino-Schmidt MC et al (2019) Pioneers of Breast Implant-Associated Anaplastic Large Cell Lymphoma: History from Case Report to Global Recognition. \u003cem\u003ePlast Reconstr Surg\u003c/em\u003e. ;143(3S A Review of Breast Implant-Associated Anaplastic Large Cell Lymphoma):7S-14S. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/PRS.0000000000005564\u003c/span\u003e\u003cspan address=\"10.1097/PRS.0000000000005564\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBrody GS (2012) Brief recommendations for dealing with a new case of anaplastic large T-cell lymphoma. Plast Reconstr Surg 129(5):871e\u0026ndash;872e. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/PRS.0b013e31824a9e6d\u003c/span\u003e\u003cspan address=\"10.1097/PRS.0b013e31824a9e6d\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eThe FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication. U.S. Food \u0026amp; Drug Administration. July 2019. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan\u003c/span\u003e\u003cspan address=\"https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDanilla SV, Jara RP, Miranda F et al (2020) Is Banning Texturized Implants to Prevent Breast Implant-Associated Anaplastic Large Cell Lymphoma a Rational Decision? A Meta-Analysis and Cost-Effectiveness Study. Aesthet Surg J 40(7):721\u0026ndash;731. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1093/asj/sjz343\u003c/span\u003e\u003cspan address=\"10.1093/asj/sjz343\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMankowski P, Carr M, Cherukupalli A et al (2022) The Macrotextured Implant Recall: Breast Implant-Associated-Anaplastic Large Cell Lymphoma Risk Aversion in Cosmetic and Reconstructive Plastic Surgery Practices. Aesthet Surg J 42(12):1408\u0026ndash;1413. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1093/asj/sjac158\u003c/span\u003e\u003cspan address=\"10.1093/asj/sjac158\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"european-journal-of-plastic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejps","sideBox":"Learn more about [European Journal of Plastic Surgery](https://link.springer.com/journal/238)","snPcode":"238","submissionUrl":"https://submission.nature.com/new-submission/238/3","title":"European Journal of Plastic Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-6074241/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6074241/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eIntroduction:\u003c/h2\u003e \u003cp\u003eAlmost 20,000 breast implants are being used annually in Israel. The majority of which (approximately 80%) are used for aesthetic breast augmentation and the reminder for reconstructive surgery. The vast majority are silicon-filled implants. Data regarding BIA-ALCL and the possible link to implant texture induced a shift towards different implant selection over the last 5\u0026ndash;10 years. As in every change we make in our surgical technique, we should diligently examine the impact on our results over time.\u003c/p\u003e\u003ch2\u003eMaterials and Methods\u003c/h2\u003e \u003cp\u003eWe used an anonymous internet-based survey that was sent to active members of the Israeli society of plastic and aesthetic surgery. Questions regarding practice volume, type (aesthetic vs. reconstructive) and surgeon's experience were asked. Surgeons were asked to specify the brand and type of breast implants they are currently using, did they change their implant selection process and if so, how. The primary survey was done on 2019, right after the withdrawal of Allergan implants. A follow-up survey was done on 2023, aiming to examine the effect of implant change on surgical outcomes.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eIn the primary survey done and presented in 2019, a significant shift towards less-textured implants was demonstrated, as an expectable reaction to BIA-ALCL concerns. The recent survey demonstrates the effects of these changes on surgical outcomes, as well as complications, seen after 4 years.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe first part of this Israel survey showed how new evidence influences the evolution of our breast implant selection practice. The second part now shows the impact this change had on our results.\u003c/p\u003e","manuscriptTitle":"Breast Implant Selection Following The “ALCL-pandemic”. A Two-Stage Survey.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-11 06:12:48","doi":"10.21203/rs.3.rs-6074241/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-03-21T12:34:17+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-03-21T12:24:43+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"169017074429273786991852274180720980521","date":"2025-03-21T12:14:01+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-03-08T15:41:51+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-07T11:01:54+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-03-07T10:58:29+00:00","index":"","fulltext":""},{"type":"submitted","content":"European Journal of Plastic Surgery","date":"2025-02-20T18:49:07+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"european-journal-of-plastic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ejps","sideBox":"Learn more about [European Journal of Plastic Surgery](https://link.springer.com/journal/238)","snPcode":"238","submissionUrl":"https://submission.nature.com/new-submission/238/3","title":"European Journal of Plastic Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"242b4208-ebf4-43be-ad38-7542c29adcc8","owner":[],"postedDate":"March 11th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-04-28T16:12:26+00:00","versionOfRecord":{"articleIdentity":"rs-6074241","link":"https://doi.org/10.1007/s00238-025-02297-3","journal":{"identity":"european-journal-of-plastic-surgery","isVorOnly":false,"title":"European Journal of Plastic Surgery"},"publishedOn":"2025-04-26 15:57:10","publishedOnDateReadable":"April 26th, 2025"},"versionCreatedAt":"2025-03-11 06:12:48","video":"","vorDoi":"10.1007/s00238-025-02297-3","vorDoiUrl":"https://doi.org/10.1007/s00238-025-02297-3","workflowStages":[]},"version":"v1","identity":"rs-6074241","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6074241","identity":"rs-6074241","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}