Thinking Outside the Black Box: Current Perceptions on Breast Implant Safety and Utility.
Adult
Breast Implants
/ adverse effects
Cross-Sectional Studies
Decision Making
Female
Health Care Surveys
Health Knowledge, Attitudes, Practice
Humans
Logistic Models
Middle Aged
Patient Acceptance of Health Care
/ psychology
Patient Safety
/ standards
Product Labeling
United States
United States Food and Drug Administration
Journal
Plastic and reconstructive surgery
ISSN: 1529-4242
Titre abrégé: Plast Reconstr Surg
Pays: United States
ID NLM: 1306050
Informations de publication
Date de publication:
01 03 2021
01 03 2021
Historique:
entrez:
23
2
2021
pubmed:
24
2
2021
medline:
3
8
2021
Statut:
ppublish
Résumé
There is growing public concern surrounding breast implant safety. In fact, the U.S. Food and Drug Administration recently proposed changes to breast implant labeling, which include a boxed warning. Given such efforts to increase transparency on breast implant safety, this study assessed laywomen's perceptions of breast implant safety, and the impact of proposed changes to breast implant labeling on laywomen's decision-making regarding breast implants. This was a cross-sectional investigation of women recruited through Amazon Mechanical Turk. Discrete choice modeling was used to query opinions on breast implants after viewing proposed labeling changes. Chi-square and analysis of variance were used for subgroup analyses, and McNemar analyses were used to assess changes in participants' responses. The authors received 500 survey responses. At baseline, 353 participants (70.6 percent) considered breast implants to be at least somewhat safe. After viewing the proposed boxed warning, 252 participants (50.4 percent) responded that they would be less likely to receive implants. In fact, a significantly greater proportion of participants considered breast implants to be either unsafe or very unsafe after viewing suggested changes to implant labeling than at baseline (58.4 percent versus 28.8 percent; p = 0.001). By the end of the survey, willingness to consider alternative options for breast augmentation/reconstruction increased significantly from baseline. Improved labeling can enhance laywomen's understanding of breast implant safety and can impact decision-making. However, greater scrutiny of breast implants should not prevent women who need implants from receiving them. Transparency and objectivity in the surgeon-patient dialogue can ensure the appropriate use of medical devices such as breast implants.
Sections du résumé
BACKGROUND
There is growing public concern surrounding breast implant safety. In fact, the U.S. Food and Drug Administration recently proposed changes to breast implant labeling, which include a boxed warning. Given such efforts to increase transparency on breast implant safety, this study assessed laywomen's perceptions of breast implant safety, and the impact of proposed changes to breast implant labeling on laywomen's decision-making regarding breast implants.
METHODS
This was a cross-sectional investigation of women recruited through Amazon Mechanical Turk. Discrete choice modeling was used to query opinions on breast implants after viewing proposed labeling changes. Chi-square and analysis of variance were used for subgroup analyses, and McNemar analyses were used to assess changes in participants' responses.
RESULTS
The authors received 500 survey responses. At baseline, 353 participants (70.6 percent) considered breast implants to be at least somewhat safe. After viewing the proposed boxed warning, 252 participants (50.4 percent) responded that they would be less likely to receive implants. In fact, a significantly greater proportion of participants considered breast implants to be either unsafe or very unsafe after viewing suggested changes to implant labeling than at baseline (58.4 percent versus 28.8 percent; p = 0.001). By the end of the survey, willingness to consider alternative options for breast augmentation/reconstruction increased significantly from baseline.
CONCLUSIONS
Improved labeling can enhance laywomen's understanding of breast implant safety and can impact decision-making. However, greater scrutiny of breast implants should not prevent women who need implants from receiving them. Transparency and objectivity in the surgeon-patient dialogue can ensure the appropriate use of medical devices such as breast implants.
Identifiants
pubmed: 33620927
doi: 10.1097/PRS.0000000000007626
pii: 00006534-202103000-00011
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
593-603Informations de copyright
Copyright © 2021 by the American Society of Plastic Surgeons.
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