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

Results

Respondent Characteristics and Study Population Validation

Five hundred participants provided complete responses. Average survey duration was 7.2 ± 2.7 minutes. Participant demographics are summarized in Table 1. The majority (68.8 percent) of respondents were Caucasian, had at least a 2-year degree (68.2 percent), and had an annual household income of greater than $25,000 (76.8 percent). The mean age of participants was 37.6 ± 12.2 years. These statistics were in accordance with prior surveys of laywomen through Amazon Mechanical Turk.[16,17] Compared to national statistics of female Internet users published by the Pew Research Center, participants were similar in age/race but were more educated.[20]

Survey Reliability and Validity

Survey reliability was assessed using split-half testing of questions on baseline perceptions of breast implant safety (Pearson correlation coefficient, 0.81). Survey validity was assessed by determining concordance of participants' responses to convergent questions during pretesting: 92.5 percent of participants who answered that breast implants had low associated medical risk also answered that they considered breast implants to be safe/very safe.

Baseline Opinions/Knowledge

Fourteen percent of participants had a personal history of cosmetic breast implants, 3.4 percent had reconstructive implants, 76.8 percent knew of someone with breast implants, and 74.8 percent knew of a celebrity/influencer with implants. Although 95.3 percent of participants with breast implants knew what type of implants they received (silicone versus saline), only 44.7 percent were very confident in their ability to easily access information about their implant texture and style, and 40.0 percent were very confident about their ability to easily access their implant serial number.

Figure 1 summarizes participants' baseline willingness to receive breast implants—those with a history of implants were significantly more willing to receive future implants (p = 0.003). At baseline, of those willing to receive reconstructive implants, 81 (46.5 percent) were also willing to consider autologous breast reconstruction after viewing information on its benefits/risks. Of those willing to receive cosmetic implants, 57 (33.3 percent) were also willing to consider alternative augmentation methods (i.e., fat grafting) after viewing information on benefits/risks (Figure 2).

Figure 1.

Willingness to receive future breast implants for cosmetic or reconstructive purposes, stratified by participants' personal history of implants.

Figure 2.

Participants' willingness to consider alternative modalities for breast augmentation or reconstruction at baseline and after survey. Participants who responded that they would be willing to consider future cosmetic implants (green) were queried for willingness to also consider other options for breast augmentation (i.e., fat grafting) after being educated on risks/benefits. Similarly, participants who responded that they would be willing to consider future reconstructive implants (yellow) were queried for willingness to also consider other options for breast reconstruction (i.e. autologous reconstruction) after being educated on risks/benefits.

Baseline opinions/knowledge on breast implant safety, stratified by participants' personal history of implants, are summarized in Table 2 and Figures 3 and 4. At baseline, 353 participants (70.6 percent) considered breast implants to be at least somewhat safe (Figure 3, above). In addition, participants' perceptions of breast implants as medical devices varied significantly by their personal history of implants (p < 0.001) (Figure 3, below). Implant-associated safety issues that participants most commonly identified at baseline were infection (49.8 percent), implant rupture (49.0 percent), and autoimmune disease (36.8 percent). Also, although 266 participants (53.2 percent) knew of breast implant illness at baseline, only 114 (22.8 percent) knew of BIA-ALCL (p < 0.001). Participants' opinions on the utility of breast implants varied significantly by indication (reconstructive versus cosmetic) and by participants' baseline willingness to receive implants (Figure 4). Participants' baseline opinions/knowledge did not vary significantly by income or education level. Participants most frequently received information about breast implants from social media (22.6 percent) and media/news outlets (12.8 percent), whereas those with a personal history of implants also received information from health care professionals (77.6 percent).

Figure 3.

Participants' perceptions of breast implant safety at baseline and after survey. Responses are stratified by participants' personal history of implants. (Above) Participants' responses to the question, "How safe, from a medical standpoint, do you consider breast implants to be?" (Below) Participants' responses to the question, "Which of the following do you consider to be medical devices?"

Figure 4.

Participants' perceptions of breast implant utility at baseline and after survey, for reconstructive and cosmetic indications. Responses are stratified by participants' baseline willingness to receive future implants. Participants were asked the questions, "How do you think that breast implants, when used for cosmetic purposes, impact a woman's quality of life and self-esteem?" and "How do you think that breast implants, when used for reconstructive purposes, impact a woman's quality of life and self-esteem?"

Impact of Exposure to U.S. Food and Drug Administration Draft Recommendations and Utility Research

Overall, 252 participants (50.4 percent) responded that they would be less likely to receive implants after viewing the boxed warning, compared to 204 (40.8 percent) after viewing the chemical composition of implants, and 184 (36.8 percent) after viewing the patient decision checklist (p < 0.01). After learning about the utility of implant-based breast procedures, 75 participants (15.0 percent) responded that they would be more likely to receive implants. These percentages did not vary by income or education levels, but did vary significantly in subgroup analyses stratified by personal history of implants (p = 0.03) (Figure 5, above) and baseline willingness to receive implants (p = 0.006) (Figure 5, below).

Figure 5.

Impact of proposed breast implant labeling changes and breast implant utility research on participants' opinions regarding breast implants. For the boxed warnings "implant chemical composition" and "patient decision checklist," percentages represent the proportion of participants who responded that they would be "less likely" to receive breast implants after exposure to each item. For "implant utility research," the percentage represents the proportion of participants who responded that they would be "more likely" to receive breast implants after exposure. Participant responses are stratified by (above) personal history of implants and (below) baseline willingness to receive implants.

Postsurvey Opinions/Knowledge

Changes in participants' opinions on breast implants are summarized in Figures 3 and 4. A significantly greater proportion of participants considered breast implants to be unsafe/very unsafe by the end of the survey when compared to baseline (58.4 percent versus 28.8 percent; p = 0.001). By the end of the survey, willingness to consider other options for breast augmentation/reconstruction increased significantly from baseline (Figure 2). On multivariable logistic regression adjusting for demographics, income/education, and implant history, greater baseline perceptions of breast implant utility significantly increased odds of continuing to want implants after the survey (OR, 1.87; 95 percent CI, 1.45 to 2.23; p < 0.01). Furthermore, those who were unsure about breast implants at baseline had significantly greater odds of being less willing to receive implants after survey (OR, 1.50; 95 percent CI, 1.31 to 1.65; p < 0.01).

Among participants with breast implants, only 17 (20.0 percent) believed that they were comprehensively informed on implant benefits/risks after taking the survey. Furthermore, 53 (62.4 percent) responded that they were at least moderately worried about their implants. Although most [n = 69 (81.2 percent)] received an implant device card, only 22 (25.9 percent) felt that it was easy or very easy to understand the information on these cards.

Overall, participants were able to better discriminate evidence-based medical risks associated with breast implants after survey, especially those with higher education levels (Table 3 and Table 4). Furthermore, 365 participants (73.0 percent) considered a decision checklist to be helpful or very helpful to their understanding of breast implant safety, and 441 participants (88.2 percent) believed that knowing the chemical composition of implants was either important or very important when considering breast implants. Two hundred thirty-nine participants (47.8 percent) believed it was important or very important to know data from studies on breast implant utility. Finally, 375 women (75.0 percent) felt that a boxed warning was important or very important in appropriately informing women about breast implant safety. Postsurvey opinions did not vary significantly by education level or income.

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