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      Overview of Reported Breast Implant–Related Reactions After COVID-19 Infection or Vaccination

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      , MD , , MD, , MD
      Aesthetic Surgery Journal
      Oxford University Press

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          Abstract

          We have read with great interest the case report entitled “Development of Acute Seroma Around Breast Implants Following Administration of COVID-19 Vaccination” by Mak et al. 1 By sharing their case, the authors have added another important piece of data to an overlooked and underreported topic. Among the vast numbers of people vaccinated globally in the fight against SARS-CoV-2 (COVID-19), reports of adverse effects are plentiful. This also affects patients in the field of plastic surgery. Although reports of immune reactions to dermal fillers after COVID-19 vaccination were described in the early clinical trials of the vaccines, 2 the first cases of potential reactions to breast implants were published after they passed clinical trials. 3-5 Due to different clinical manifestations and lack of awareness by physicians, the total number can only be estimated. After reporting a series of cases with similar symptoms and medical histories as the current case report, we aimed to give an overview of the available cases found in the literature. 6 Since then, several new reports about similar cases after vaccination or COVID-19 infections have appeared. 1,7,8 Although these are rare occurrences considering the number of women with implants who received COVID-19 vaccines, the increasing number of case reports shows that despite the number of reported cases, it still is a novelty for the majority of physicians and surgeons. We agree with the authors that a direct causation of an inflammatory reaction to the virus or vaccine can be challenging to prove and some of the reported cases might simply be due to statistical chance as a consequence to the sheer number of administered vaccines. The temporal sequence and symptoms similar to other reports are nevertheless a strong indicator of an inflammation-triggered response. Due to the increasing number of cases, certain similarities can be seen regarding clinical presentations. To help other surgeons we have updated our overview of reported cases found in the literature (Table 1). The limited data available show that patients with breast implants presenting with sudden onset of unilateral or bilateral swelling and discomfort of the breast should be interviewed thoroughly regarding recent vaccinations or infections with COVID-19. If other symptoms are present, a test for an ongoing COVID-19 infection is advised. Seroma, swelling, and pain were the most common symptoms in the reported cases and ultrasound of the breast to confirm the diagnosis is recommended. The existing cases indicate that symptoms occur unrelated to the timing of the initial surgery. With respect to the collected cases shown in Table 1, it may be of interest that nearly all immunologic reactions occurred in patients older than 45 years of age and no cases for patients under the age of 30 have been reported to date. There is no indication so far of a correlation with the implant texture. Conservative treatment of the symptoms with anti-inflammatory drugs and drainage of the seroma, if present, has been shown to be effective in cases that involved undamaged implants. Collectively, these case reports show that these reactions occur to both the virus and the vaccine. Because symptoms can be similar to breast implant–associated anaplastic large cell lymphoma, immunohistochemistry and flow cytometry should be used to rule out malignant cause. Table 1. Reported Cases Found in the Literature Citation Age (years) Implant size/texture Time since implant surgery (years) Vaccine (dose) Infection Onset (days) Symptoms Treatment Weitgasser et al 5 55 620 cc/smooth 0.2 AstraZeneca, Cambridge, UK (1) – 2 Pain and seroma Surgery 76 360 cc/textured 5 Pfizer-BioNTech, New York, NY and Mainz, Germany (1) – 2 Pain and swelling Conservative 52 250 cc/smooth 1.5 Pfizer-BioNTech (1) – 2 Pain and redness Conservative 52 Unknown 0.7 J&J, New Brunswick, NJ – 3 Pain Conservative Restifo 4 34 440 cc/smooth 0.5 Pfizer-BioNTech (2) – 6 Pain and LAP Surgery Kayser et al 3 48 Textured 5 Pfizer-BioNTech (2) – 10 Pain and swelling Conservative Mak et al 1 49 350 cc/smooth 17 AstraZeneca (1) – 4-5 Pain and swelling Surgery Martínez Núñez et al 7 44 Microtextured 5 – Yes 4 Swelling and redness Seroma puncture 48 Unknown 8 – Yes – Pain and swelling Surgery Mahrhofer et al 6 48 Unknown 12 Pfizer-BioNTech (2) – 19 Pain and swelling Surgery Van Wert et al 8 50 Unknown 7 – Yes – Sterile abscess Surgery J&J, Johnson & Johnson; LAP, lymphadenopathy. More studies are needed to help us understand more precisely the biochemical mechanisms involved. Moreover, patients and surgeons should be made aware of possible inflammatory reactions and their treatment. We want to thank the authors for sharing their experience and shedding more light on this important topic and hope that others are encouraged to report their findings.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            Potential immune response to breast implants after immunization with COVID-19 vaccines

            Besides reports of alarming potential side effects after COVID-19 vaccinations there have been rare observations of rather benign reactions to foreign materials such as cosmetic hyaluronic acid filler injections after a COVID-19 immunization. Likewise to dermal fillers any foreign material may cause a reaction when the immune system is triggered. In the recent weeks we observed four noteworthy potential reactions in association with breast implants between one and three days after COVID-19 vaccinations. We release these information at the earliest to educate colleagues and draw attention to possible reactions between the COVID-19 vaccines and foreign bodies such as breast implants.
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              A Case Report of Capsular Contracture Immediately Following Covid-19 Vaccination

              Capsular contracture is fundamentally an immunological/inflammatory response to the implant, treating it as a foreign body in need of exclusion from the immune system. The capsule surrounding the implant is populated by a rich variety of immunologically active cells such as macrophages, T lymphocytes, and myofibroblasts. Vaccination in general and the Covid-19 vaccine in particular result in specific and nonspecific activation of the immune system, including those immune cells in proximity to the implant. This phenomenon has been previously demonstrated in delayed inflammatory reactions to previously implanted hyaluronic acid fillers following Covid 19 vaccination. This report is what is believed to be the first case of the rapid development of severe ipsilateral capsular contracture in the immediate aftermath of the second dose of the BNT162b2(Pfizer) vaccine.
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                Author and article information

                Contributors
                Journal
                Aesthet Surg J
                Aesthet Surg J
                asj
                Aesthetic Surgery Journal
                Oxford University Press (US )
                1090-820X
                1527-330X
                August 2022
                18 April 2022
                18 April 2022
                : 42
                : 8
                : NP569-NP570
                Affiliations
                Department of Plastic and Reconstructive Surgery, Marienhospital Stuttgart, Stuttgart , Germany
                Department of Plastic and Reconstructive Surgery, Marienhospital Stuttgart, Stuttgart , Germany
                Department of Plastic and Reconstructive Surgery, Marienhospital Stuttgart, Stuttgart , Germany
                Author notes
                Corresponding Author: Dr Maximilian Mahrhofer, Department of Plastic and Reconstructive Surgery, Marienhospital Stuttgart, Boeheimstrasse 37, 70199 Stuttgart, Germany. E-mail: maximilian.mahrhofer@ 123456vinzenz.de
                Author information
                https://orcid.org/0000-0003-1635-1502
                https://orcid.org/0000-0001-9629-2228
                Article
                sjac101
                10.1093/asj/sjac101
                9383747
                35435942
                d198f109-9e33-427c-a1e6-56e1c4f44616
                © The Author(s) 2022. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

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                This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

                History
                : 11 April 2022
                : 30 May 2022
                Page count
                Pages: 2
                Categories
                Letters to the Editor
                AcademicSubjects/MED00987

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