Sex: F
Vaccine: COVID19
Symptoms: Capsular contracture associated with breast implant
Clinical narrative: Capsular contracture following prosthetic breast Reconstruction; This literature-non-study case was reported in a literature article and describes the occurrence of CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT (Capsular contracture following prosthetic breast Reconstruction) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Breast reconstruction. Concurrent medical conditions included Breast cancer.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT (Capsular contracture following prosthetic breast Reconstruction) (seriousness criterion medically significant). At the time of the report, CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT (Capsular contracture following prosthetic breast Reconstruction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT (Capsular contracture following prosthetic breast Reconstruction) to be related.    Concomitant and treatment medications were not reported.  The source population was a defined registry of all breasts receiving implant or tissue expander (TE) based breast reconstruction with acellular dermal matrix (ADM) placement at four institutions between 2014 and 2022. The cases and controls were selected from patients with follow-up between December of 2020 and July 2022, to reflect when exposure to COVID-19 vaccination. The exclusion criteria included breasts that underwent prior revisional surgeries without implant exchange or delayed implant-based breast reconstruction as well as patients who had received adjuvant radiation following reconstruction.  All 85 included patients were female. Patient 1 age ranged from 24-78 years, with the average age being 50.0±10.6 years. Physician exams were significant for firmness/stiffness of breasts, rippling and mild hyperpigmentation. In total 3 of Moderna vaccine were involved, but only one showed Capsular contracture.   No patients in our study population developed BIA-ALCL (breast implant-associated anaplastic large cell carcinoma). Only one patient in the control group died from IDC during the study period.  COVID-19 vaccination was not a significant predictor of capsular contracture development informed its continued to use among this particularly vulnerable patient population. The case control study had several limitations, including its retrospective nature, which relies on the quality of the study.  Author concluded that direct association between CC (Capsular contracture) and COVID-19 vaccination was difficult to prove. Given the known risk of severe COVID-19 infection among immunocompromised patients, those with breast cancer who undergo PBBR should be properly counseled on the benefits and risks of vaccination. At the surface, these cases imply a possible 22 correlation between vaccination and CC that was both biologically and temporally plausible.  Company comment: This literature non-study case concerns an adult female patient with relevant medical history of breast cancer followed by Prosthetic Breast Reconstruction with acellular dermal matrix (ADM) placement and negative for revisional surgery and adjuvant radiation therapy following breast reconstruction, who experienced the unexpected serious (medically significant) event of Capsular contracture associated with breast implant (CC), with an unknown time to onset after receiving an unspecified dose of mRNA-1273 vaccine. Measures of clinical evaluation included associated symptoms, leukocyte count, and Baker scale of CC (I-IV). However, no patient specific information on type of breast cancer, co morbidities, concomitant therapy, risk factors such as smoking and obesity, investigations, treatment details and outcome was provided. Authors stated that given the relative infrequency of such reaction, compounded with a multitude of confounding factors, it remains difficult to prove a direct relationship between vaccination and cutaneous reactions as opposed to coincidence without causality. They also implied a possible correlation between vaccination and CC that is both biologically and temporally plausible. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2022: Follow up received by safety on 24-NOV-2022 has email with full text article received and contains reporter literature information, update suspect product and an updated narrative.; Sender's Comments: This literature non-study case concerns an adult female patient with relevant medical history of breast cancer followed by Prosthetic Breast Reconstruction with acellular dermal matrix (ADM) placement and negative for revisional surgery and adjuvant radiation therapy following breast reconstruction, who experienced the unexpected serious (medically significant) event of Capsular contracture associated with breast implant (CC), with an unknown time to onset after receiving an unspecified dose of mRNA-1273 vaccine. Measures of clinical evaluation included associated symptoms, leukocyte count, and Baker scale of CC (I-IV). However, no patient specific information on type of breast cancer, co morbidities, concomitant therapy, risk factors such as smoking and obesity, investigations, treatment details and outcome was provided. Authors stated that given the relative infrequency of such reaction, compounded with a multitude of confounding factors, it remains difficult to prove a direct relationship between vaccination and cutaneous reactions as opposed to coincidence without causality. They also implied a possible correlation between vaccination and CC that is both biologically and temporally plausible. The benefit-risk relationship of mRNA-1273 is not affected by this report.