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

Discussion

Breast implant safety is an increasingly salient topic in plastic and reconstructive surgery, as we continue to learn more about the long-term implications of these medical devices.[21–23] This study surveyed laywomen for perceptions of breast implant safety/utility and assessed the impact of new labeling recommendations on these perceptions. Understanding laywomen's perceptions was our foremost concern when creating this survey. By doing so, we hoped to inform surgeons and policymakers about the laywoman's perspective, to help guide the translation of new information on breast implant safety into clinical practice.[24]

Boxed Warnings can be Controversial

Proposed changes to breast implant labeling call for a boxed warning. Boxed warnings, or black box warnings, have a mixed history.[25,26] Although these warnings effectively reduce use of the drug/device to which they are applied, it is important to ensure that they do not discourage clinicians from offering treatment where appropriate.[27–29] Implant-based breast procedures result in sustained improvements in psychosocial well-being and satisfaction.[30–32] Even in the setting of a boxed warning, plastic surgeons should objectively discuss both risks and benefits of implants, in addition to appropriate autologous alternatives, to allow women to make an informed decision that best suits their lifestyle.[33]

In addition to the proposed U.S. Food and Drug Administration guidance (i.e., boxed warning), our survey also included information on the utility of implant-based breast procedures. In addition, we discussed alternatives (i.e., autologous reconstruction). In doing so, we assessed the impact of breast implant–related information within a realistic clinical context, and not simply in a vacuum. We found that women who perceived breast implants to have high baseline utility were more positively influenced by information on the benefits of breast implants and were more likely to continue wanting implants even after education on risks and alternatives (Figure 5, above). Thus, although some women may certainly be deterred by a boxed warning, this was not universal, particularly among those with a baseline predilection for implant-based procedures. These data may suggest that surgeons who are comfortable with performing implant-based procedures should continue to offer them, while ensuring that patients are appropriately informed on benefits/risks. This is especially important when patients are not candidates for alternative, autologous procedures.[34]

Breast Implants: Ubiquitous yet Unassuming Medical Devices

The number of prosthetic breast procedures has risen steadily over the past two decades in the United States.[6] Breast implants have also become prevalent in contemporary popular culture.[35,36] In fact, the majority of participants knew of a celebrity or influencer with breast implants (Table 1). Despite the relative ubiquity of breast implants, our survey demonstrated that most laywomen do not consider implants to be medical devices in the same way that they considered a prosthetic knee to be a medical device (Figure 3, below). Furthermore, at baseline, a significantly greater proportion of participants had heard of breast implant illness compared with BIA-ALCL (Table 2). Given that one of the participants' leading sources of information on breast implants was news/media outlets, it follows that laywomen's perceptions of breast implants may not reflect evidence-based medicine. Even among those with a personal history of implants, most of whom received an implant device card, many did not consider implants to be medical devices at baseline (Figure 3, below).

After survey, more respondents considered breast implants to be medical devices, and a significantly greater proportion of respondents were able to accurately discriminate medically substantiated risks (Figure 3, below). This highlights the importance of improved labeling and appropriate education on public perceptions of breast implant safety, in addition to the need for more accessible and widely disseminated information on breast implants. The fact that more-educated women were able to better distinguish medically substantiated risks is also important (Table 4). Providers must ensure that future application of proposed U.S. Food and Drug Administration changes to implant labeling accommodates patients of all education levels.

Boxed Warnings Significantly Influenced Laywomen's Opinions

Overall, the proposed boxed warning had the greatest impact on participants' perceptions (Figure 5, above). A significantly greater proportion of participants changed their preferences after exposure to the boxed warning compared to any of the other survey items. This is fitting given that boxed warnings are the U.S. Food and Drug Administration's strongest communication of risk and have received much media attention over the years.

Women with a personal history of implants were most impacted by the chemical composition of breast implants (Figure 5, above). Although these participants may have discussed implant risks with health care providers, they likely were not exposed to the composition of implants before this survey. Although is important for women to be fully informed about breast implants, our survey demonstrates that such information can impact perceptions. Many of the chemicals listed in the labeling are known to be safe in humans, but simply providing an implant composition list does not convey this safety information.[37] Thus, if proposed recommendations to breast implant labeling are implemented, providers should be aware of how these recommendations can impact patient perceptions, and ensure that patient-provider discussions continue to focus on the most pertinent implant-associated benefits and risks.

Although learning about the benefits of implant-based procedures engendered a positive response in some participants, it was not of equal magnitude to the negative responses to the boxed warning (Figure 5, above). However, as we mentioned earlier, those who perceived breast implants to have greater utility at baseline were more likely to have a positive response to learning about these benefits, suggesting differences in risk assessment among study subgroups. Five respondents (1 percent) marked that they would be more likely to receive breast implants after exposure to the boxed warning, chemical composition, and decision checklist. Three of these participants had seen implant utility information before the information on risks, because of survey randomization. Although order may have influenced responses, it is also possible that these responses may have been erroneous. It is a limitation of our anonymous study design that we could not investigate these individuals further.

Improved Labeling Enhanced Perceptions of Informed Decision-making

Informed decision-making, especially when facilitated by decision aids, is known to enhance decision quality and prevent decision regret in postmastectomy breast reconstruction.[38] Overall, most respondents agreed that having a decision checklist, transparent labeling, and a boxed warning would aid informed decision-making. This is critical to note, given that only a minority of participants with a personal history of breast implants felt completely informed during their initial consultation. Further study is required to determine whether improved labeling can influence such perceived deficiencies during the consultation and informed consent process for implant-based breast procedures.

Future Directions

It is important to characterize the impact of proposed implant labeling recommendations on public perceptions of breast implant safety on a global scale. Regulatory science is critical in promoting global public health, and though the U.S. Food and Drug Administration is a federal agency, its messaging has international implications that can influence global implant regulations.[39,40] Further work should also evaluate proposed breast implant labeling recommendations in clinical settings. In addition, information from such surveys should be used to develop and evaluate appropriate breast implant safety education materials using elements from U.S. Food and Drug Administration draft recommendations. Given that plastic surgeons and implant manufacturers are also important stakeholders in breast implant safety and utility, their perspectives on proposed changes to labeling should be investigated. Lastly, if labeling guidelines are implemented, breast implant use trends will be important to investigate.

Limitations

This study was not without limitations. First, this study was limited by the quality of the survey instrument and honesty of responses. However, we assessed survey validity and reliability through multiple rounds of pretesting to maximize the quality of information collected. We also improved response quality by excluding responses of inadequate duration. Second, because participants were asked to answer questions on a hypothetical basis, their answers may not reflect decisions made in a clinical setting. However, our study was aimed at gauging public perceptions rather than true decision-making behavior. Responses elicited in our survey may approximate the baseline knowledge of patients during initial consultations. Finally, the generalizability of our results from laywomen Amazon Mechanical Turk responders may be limited.[41] However, crowdsourcing still provides important information from a large, diverse population.[15,42]

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