Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants.

Plastic and reconstructive surgery. Global open 2022 Vol.10(11) p. e4439

Hyland CJ, Gadiraju G, Parikh N, Dey T, Broyles JM

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Abstract

[UNLABELLED] The US Food and Drug Administration (FDA) issued a boxed warning on breast implants in October 2021, requiring communication of certain risks to patients. This study assessed how this boxed warning may impact public perceptions of breast implants.

[METHODS] A cross-sectional survey was administered to adult women in the United States in December 2021 using Amazon Mechanical Turk to assess perceptions of breast implant risks communicated in the FDA-issued guidance. Sociodemographic predictors of responses were identified using multivariable models.

[RESULTS] There were 494 complete responses. Respondents had a mean age of 36.9 years, and 80% had an associate's degree or higher. At baseline, most would consider receiving implants for reconstructive or cosmetic purposes (65%). Some were unsure or indicated that it is not possible to undergo mammograms after receiving implants (42%). After provided information in the FDA guidance, the majority strongly agreed or agreed that they were less likely to receive implants knowing the risk of anaplastic large cell lymphoma (75%), because implants contain chemicals/heavy metals (74%), and because implants are not lifetime devices (68%), with greater odds among Hispanic respondents (OR, 2.35; < 0.01) and lower odds among higher-income respondents (OR, 0.64; = 0.03).

[CONCLUSIONS] There are misconceptions with regard to breast implant-associated risks. Despite most laywomen indicating that they would consider receiving implants at baseline, the risks communicated in the 2021 FDA boxed warning may make patients less likely to receive implants, with variability among different sociodemographic populations.

추출된 의학 개체 (NER)

유형영어 표현한국어 / 풀이UMLS CUI출처등장
해부 breast 유방 dict 5
합병증 anaplastic large cell lymphoma 보형물연관 역형성대세포림프종 dict 1
합병증 breast implant scispacy 1
약물 FDA → Food and Drug Administration scispacy 1
약물 [CONCLUSIONS] scispacy 1
질환 breast implant C0178391
breast implant procedure
scispacy 1
질환 breast implant-associated scispacy 1
질환 Breast Implant Complications scispacy 1
기타 patients scispacy 1
기타 women scispacy 1
기타 FDA-issued scispacy 1

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