Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants
Background:. 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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer
2022-11-01
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| Series: | Plastic and Reconstructive Surgery, Global Open |
| Online Access: | http://journals.lww.com/prsgo/fulltext/10.1097/GOX.0000000000004439 |
| _version_ | 1811216718270300160 |
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| author | Colby J. Hyland, AB Goutam Gadiraju, BS Neil Parikh, BS Tanujit Dey, PhD Justin M. Broyles, MD |
| author_facet | Colby J. Hyland, AB Goutam Gadiraju, BS Neil Parikh, BS Tanujit Dey, PhD Justin M. Broyles, MD |
| author_sort | Colby J. Hyland, AB |
| collection | DOAJ |
| description | Background:. 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; P < 0.01) and lower odds among higher-income respondents (OR, 0.64; P = 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. |
| first_indexed | 2024-04-12T06:43:24Z |
| format | Article |
| id | doaj.art-19b62150a67348eab1ee85f2af26bcb4 |
| institution | Directory Open Access Journal |
| issn | 2169-7574 |
| language | English |
| last_indexed | 2024-04-12T06:43:24Z |
| publishDate | 2022-11-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Plastic and Reconstructive Surgery, Global Open |
| spelling | doaj.art-19b62150a67348eab1ee85f2af26bcb42022-12-22T03:43:39ZengWolters KluwerPlastic and Reconstructive Surgery, Global Open2169-75742022-11-011011e443910.1097/GOX.0000000000004439202211000-00017Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on ImplantsColby J. Hyland, AB0Goutam Gadiraju, BS1Neil Parikh, BS2Tanujit Dey, PhD3Justin M. Broyles, MD4From the * Department of Plastic and Reconstructive Surgery, Harvard Medical School, Brigham and Women’s Hospital, Boston, Mass.From the * Department of Plastic and Reconstructive Surgery, Harvard Medical School, Brigham and Women’s Hospital, Boston, Mass.† Department of Surgery, Boston University School of Medicine, Boston, Mass.‡ Department of General Surgery, Harvard Medical School, Brigham and Women’s Hospital, Boston, Mass.From the * Department of Plastic and Reconstructive Surgery, Harvard Medical School, Brigham and Women’s Hospital, Boston, Mass.Background:. 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; P < 0.01) and lower odds among higher-income respondents (OR, 0.64; P = 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.http://journals.lww.com/prsgo/fulltext/10.1097/GOX.0000000000004439 |
| spellingShingle | Colby J. Hyland, AB Goutam Gadiraju, BS Neil Parikh, BS Tanujit Dey, PhD Justin M. Broyles, MD Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants Plastic and Reconstructive Surgery, Global Open |
| title | Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants |
| title_full | Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants |
| title_fullStr | Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants |
| title_full_unstemmed | Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants |
| title_short | Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants |
| title_sort | public perceptions of breast implant complications and the fda boxed warning on implants |
| url | http://journals.lww.com/prsgo/fulltext/10.1097/GOX.0000000000004439 |
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