Thinking Outside the Black Box

Current Perceptions on Breast Implant Safety and Utility

Pooja S. Yesantharao, M.S.; Erica Lee, M.S.; Nima Khavanin, M.D.; Sarah Persing, M.D., M.P.H.; Hillary Jenny, M.D., M.P.H.; Mya Abousy, B.S.; Kristen P. Broderick, M.D.; Justin M. Sacks, M.D., M.B.A.

Disclosures

Plast Reconstr Surg. 2021;147(3):593-603. 

In This Article

Patients and Methods

Study Design

This was a Johns Hopkins Institutional Review Board–exempt cross-sectional investigation. Inclusion criteria included the following: (1) woman in the United States, (2) older than 18 years, (3) native English speaker, and (4) Internet access.

Survey Design and Development

The survey instrument was iteratively developed for laywomen using published guidelines.[11–13] Initially, an open-ended assessment on implant safety/utility was administered to 40 laywomen. (See Appendix, Supplemental Digital Content 1, which shows an open-ended assessment on breast implant safety/utility. Responses were used to formulate the final study survey, http://links.lww.com/PRS/E334.) Common themes were aggregated to inform the final survey. Compensation for the open-ended assessment was $1.50. After development of the final survey, two rounds of pretesting with 20 respondents each were completed. Answer choices were randomized to distribute bias from order effects.

In the final survey, participants were first queried regarding their personal breast implant history. (See Appendix, Supplemental Digital Content 2, which shows a final study survey, http://links.lww.com/PRS/E335.) Respondents were also surveyed for baseline willingness to receive cosmetic/reconstructive implants and for willingness to consider alternative options (autologous reconstruction). Next, participants' baseline opinions/knowledge about breast implants were assessed.

Participants then viewed the U.S. Food and Drug Administration's proposed changes to breast implant labeling (patient decision checklist, boxed warning, and description of the chemical composition of implants) (see Appendix, Supplemental Digital Content 2, http://links.lww.com/PRS/E335). Participants also viewed information on the benefits of implants.[14] The order of this information was randomized between participants. Participants' opinions were queried after exposure to each component.

The penultimate section was a postsurvey assessment of participants' opinions on implants and proposed labeling changes. The final section surveyed participant demographics.

Data Collection

Study procedures/analyses were conducted using Strengthening the Reporting of Observational Studies in Epidemiology guidelines. Amazon Mechanical Turk and Qualtrics (Qualtrics, Provo, Utah) were used to anonymously survey eligible participants between November 1, 2019, and December 28, 2019. Amazon Mechanical Turk is a widely used, online crowdsourcing platform composed of a population of Internet users who participate in tasks (i.e., survey-based research) in exchange for monetary compensation. Amazon Mechanical Turk has been demonstrated to be a source of reliable data, and has been successfully used for prior breast reconstruction/implant-focused investigations.[15–17] Respondents could take the survey only once and were compensated $0.85 on completion. The final survey was completed by 500 respondents, based on power analyses and prior Amazon Mechanical Turk literature using crowdsourcing techniques.[16,18,19]

Statistical Analysis

Statistical analyses were performed using Stata MP version 15 (StataCorp, College Station, Texas). Responses with a duration greater than 2 SD below the mean were rejected before payment under the assumption that they did not accurately reflect respondents' opinions. Chi-square and analysis of variance were used as appropriate for subgroup analyses. McNemar analyses were used to analyze changes in participants' responses. Multivariable logistic regression identified characteristics of women who changed their opinions on breast implants. The two-tailed threshold for statistical significance was 0.05.

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