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Breast: Original Articles

“You Helped Create This, Help Me Now”: A Qualitative Analysis of Patients’ Concerns about Breast Implants and a Proposed Strategy for Moving Forward

Steve, Anna K. M.D.; Temple-Oberle, Claire M.D.; Yeung, Justin K. M.D.; Lafreniere, Ann-Sophie M.D.; Harrop, A. Robertson M.D.

Author Information
Plastic and Reconstructive Surgery: January 2021 - Volume 147 - Issue 1 - p 16e-24e
doi: 10.1097/PRS.0000000000007422
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Abstract

The recent public spotlight on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has resulted in growing patient concern about risks related to breast implants. BIA-ALCL is a T-cell–mediated, non-Hodgkin lymphoma associated with textured breast implants, now formally recognized by the World Health Organization as a lymphoid neoplasm.1,2 In concert with this very real concern, many women with breast implants of all types have become concerned that their breast implants may be causing them to experience a variety of systemic symptoms and medical conditions.3 This in turn has led to further concern among patients with breast implants about their safety. In what has become an emotionally charged discussion, it is important that the medical community better understand the perspective of patients concerned about the possible impact of breast implants on their health.

Although less common in the surgical literature and therefore less familiar to surgeons than quantitative research, qualitative research lends itself to understanding the patient perspective and the context in which their perspectives and experiences are situated.4 There is growing recognition that qualitative research methods may be valuable to surgeons to better understand the perspectives of individuals in a specific but relevant situation.5,6 Sir William Osler said, “The good physician treats the disease; the great physician treats the patient who has the disease.”7 Qualitative research offers the opportunity to enhance plastic surgeons’ understanding of patients’ perspectives, not possible with conventional quantitative study designs.

Although most patients with breast implants and their surgeons are believed to be satisfied with their situation, there are a subset of patients who express significant dissatisfaction. The purpose of this study was to understand the perspective of these dissatisfied patients and in particular to evaluate their perceptions of the challenges, barriers, and worries that they are experiencing that plastic surgeons may not understand. A grounded theory approach was used to extract and identify common themes from patients’ responses.

PATIENTS AND METHODS

Previously described standards for conducting and reporting qualitative research were followed to maintain rigor during the qualitative data analysis.4 A Project Ethics Community Consensus Initiative screening tool identified this study as low risk, therefore deeming formal research ethics board review unnecessary. Appropriate standards for conducting ethical online research were followed, adhering to the following principles: formal identification of investigators to the study group, asking permission from the online group, protecting the anonymity of individuals posting comments, and ensuring review and feedback incorporated from the online community, including honoring the request for redaction of any participant comments.

Convenience sampling was used to elicit responses from members of a closed Canadian BIA-ALCL Facebook advocacy group (with English and French subgroups). Designated leaders of these groups had been in regular communication with one author (A.R.H.) related to his role as president of the Canadian Society of Plastic Surgeons. The emphasis of their communications was that the Canadian plastic surgery community was unaware of or not listening to concerns of patients with problems perceived to be related to their breast implants. Members of this advocacy group were formally asked to open-endedly “elaborate on the three most important issues (challenges, barriers, or worries) that women with breast implants experience but feel plastic surgeons do not understand.” A second request for responses was posted by the advocacy group leaders after 4 weeks.

Qualitative data were collected by means of these Facebook groups between January 20, 2019, and February 15, 2019. Responses were anonymized by the advocacy group administrator before analysis by the research team. Responses were received in English and French. French responses were translated using the Facebook translation feature. All Facebook translations were reviewed for errors in content or context by a bilingual member of the research team, a plastic surgery resident who understands the nature of both BIA-ALCL and breast implant-related illnesses and speaks French as her first language.

Three authors (A.R.H., C.T.O., and A.K.S.) reviewed and analyzed the data corpus in English or French translated to English. Each reviewer read and reread the data, independently performing preliminary and secondary coding cycles. Thematic analysis was used to identify emergent themes. All three reviewers then collaboratively reflected on any biases and developed a consensus on common themes, using a grounded theory approach. A grounded theory approach begins with a question and collection of qualitative data and, after multiple coding cycles, allows for emerging themes to become the basis for a new theory, as described here.

To ensure maximal qualitative methodologic rigor, previously described standards for promoting qualitative research were followed, including description of researchers’ and participants’ contextual characteristics and potential biases.4 Confidentiality and deidentification of data were maintained. Data processing and analysis were performed by multiple researchers using the grounded theory approach. Member checking was used to enhance trustworthiness of data collected and included in the final article. Supportive quotes and analytic memos are included to substantiate qualitative findings.

RESULTS

Description of Participants

Sixty-four women responded (28 in English and 36 in French) to questions posed regarding patient perceptions of barriers, concerns, and worries. All participants were members of the closed Canadian BIA-ALCL Facebook advocacy group. The group, founded by a patient treated for BIA-ALCL, was initiated as a support group for women with breast implants who had BIA-ALCL or concerns that they might be at risk for BIA-ALCL. Over time, it has grown to include more than 1900 members, and now includes women with concerns about their breast implants that are unrelated to BIA-ALCL.

Description of Investigators

Qualitative data analysis was performed by three investigators: two staff plastic surgeons (A.R.H. and C.T.O.) and one fourth-year plastic surgery resident (A.K.S.). One of the plastic surgeons (C.T.O.) has a large breast reconstruction–based practice, whereas the other is a pediatric plastic surgeon with no focus in breast reconstruction or cosmetic augmentation. The plastic surgery resident is involved in breast reconstruction and augmentation using implants during training. A bilingual (French-English) plastic surgery resident (A.S.L.) verified the fidelity of French-to-English translations. There were no major changes in content between Facebook-generated and human-generated translations. The most common contextual error was the automatic Facebook translation tool translating “BII” to “breast implant” rather than “breast implant illness.”

Thematic Analysis

Four main themes were initially agreed on by the reviewers. These were in turn shared with the Facebook group leaders, whose feedback identified an additional fifth theme. These five final consensus themes were informing, listening, acknowledging, clarifying, and moving forward. Themes and representative quotes are listed in Table 1 and described below.

Table 1. - Main Themes Extracted and Representative Quotes
Theme Representative Quote
Informing “It bothers me that plastic surgeons are not informing patients of the true risks of getting implants. I know I was lied to and not properly informed.”
“Since the first report of BIA-ALCL in 2011, why haven’t plastic surgeons informed their patients prior to implanting textured implants? Why are they not required to discuss this?”
“I only heard about the issues [of BIA-ALCL] because of CBC doing a series on the radio. Doctors should be informing us not ignoring us once they have completed [placement of breast implants].”
“[At-risk women] need to be sought out and have information sent directly to them.”
Listening “Doctors have one job—to listen to their patient and help them with their well-being. No one has seemingly listened to any concerns raised or helped any of us with our well-being.”
“[I had to] start with a whole new referral and wait for a year just for a consult [which] is ridiculous; you helped create this, help me now when I need help.”
“Please stop telling me that ‘breast implants are the most studied medical device.’”
Acknowledging “To recognize the high risk of illness associated with all types of breast implants, and to not minimize the symptoms of these illnesses when women come to them asking for help.”
“[Few surgeons] believe that their patients’ symptoms are real.”
“It’s pretty nervy to implant women with high-risk medical devices with known risks, many serious and irreversible, and then tell us we’re nuts when we experience complications or get sick. Even a basic understanding of biofilms should be reason enough to understand implants can make women sick, never mind the other ways they impact our health. If they don’t know what’s in [and around] breast implants they have zero evidence to back up their claim that they’re safe.”
“Understand that my illnesses are related to my implants and that I am worried I have the cancer associated with implants.”
Clarifying “They must absolutely and without exception do en bloc resection of the implant and capsule.”
“Few are trained to perform [proper] technique of explantation with en bloc capsulectomy, and muscle reconstruction.”
“[There is difficulty in gaining] access to a [plastic surgeon] who can perform the en bloc, total capsulectomy and who will also do cytology on periprosthetic fluids…[for] patients with textured breast implants from all manufacturers.”
Moving forward “[It is concerning that] the patient has to become an expert herself [in BIA-ALCL] to ensure the path forward is optimal. [We find ourselves] battling, fighting, reasoning, negotiating with doctors to widen their knowledge.”
“[Plastic surgeons need to] work with Health Canada to set up rigid monitoring and testing standards and timeframes that all provinces must adhere to for all woman with implants.”
“These procedures should be covered financially when causing illness and harm.”

Informing

“Informing” refers to failure in the information-sharing process. Two relative time points were emphasized: the initial consultation to discuss and consider breast implants, and later when plastic surgeons became aware of the potential risk of BIA-ALCL among patients with textured breast implants after implantation.

Regarding the initial consultation, respondents indicated they did not feel fully informed about the health risks they were accepting by having implants placed. Participants recognized that although they asked for and agreed to proceed with breast implantation, they felt that a complete list of potential risks and complications was not provided. Therefore, they felt that the process of informed consent was inadequate. Some participants described understanding that their implants would last the entirety of their lifetime. Many wished they had heard about biofilms, autoimmune diseases, silicone bleed, BIA-ALCL, and breast implant–related illness.

Second, there was disappointment about the lack of communication from plastic surgeons, hospitals, and manufacturers about the growing awareness of the risk of BIA-ALCL in women with textured implants. Learning of these risks from the media rather than from their plastic surgeon or other medical professional was upsetting and frightening for participants. Some respondents felt that plastic surgeons were colluding with manufacturers, minimizing risks and thus continuing to profit from placement of implants. Many expressed that once plastic surgeons became aware of the potential risk of BIA-ALCL in women with textured implants, they had an obligation to communicate this information to their patients at risk.

Listening

Many women indicated it was very important to have access to a knowledgeable plastic surgeon who would listen earnestly to concerns about their breast implants. Some experienced difficulty in getting to see their plastic surgeon in a timely fashion. Others, who had moved or whose original plastic surgeon had retired, expressed difficulty being seen by a different plastic surgeon. Some stated that their concerns were met with condescension or dismissiveness. They felt that listening was a critical first step in helping them with their concerns.

Acknowledging

Respondents wanted surgeons and other health care providers to acknowledge the possibility that symptoms or signs they are experiencing may be related to their breast implants. For many with textured implants, the fear of developing BIA-ALCL had caused significant “emotional turmoil.” Others expressed that they want health care providers to simply acknowledge the possibility that their breast implants may be contributing to systemic problems they are experiencing. Several respondents related that the commonly heard generic safety statement that breast implants are the most studied implanted medical device contributed to a sense of dismissiveness of the risk of disease associated with implants.

Clarifying

Many informants perceive breast implant concerns as one entity with a single surgical solution: removal of the implant and the surrounding capsule. Surgeons, on the other hand, see a more nuanced variety of concerns and a corresponding variety of treatment options. This would suggest that there can exist a significant gap between surgeons and patients in the understanding of implant-related problems and their appropriate treatment.

Moving Forward

Respondents wanted to feel their surgeon was confident and knowledgeable in following and monitoring them, and in developing and implementing a suitable treatment plan when problems arise. Some participants expressed feeling that their surgeon was unsure about or unfamiliar with managing the problems they were having. Others found that during discussions with their surgeon, the question about who would or should pay for any proposed surgery became contentious and in turn became a potential barrier to care.

Finally, from a population perspective, respondents expressed that there should be a formal registry for all breast implants and associated adverse events, not only to better study problems related to implants but also to facilitate contacting patients in the event that new risks are identified.

Examination of Extracted Themes in the Context of Trust Theory

Trust is a basic foundation in the patient-physician relationship and has been described in five domains by trust theorists: fidelity, competence, honesty, confidentiality, and global trust.8 It is helpful to examine the respondents’ five themes in the context of these five domains. Representative quotes relating to these domains are listed in Table 2.

Table 2. - Dimensions of Trust and Representative Quotes
Dimension of Trust Representative Quote
Fidelity “[Plastic surgeons are] not advocating for their patients, [and are] letting them fall through the system.”
“The sound of silence can be really loud when you are sick.”
Competence “Surgeons lack the skills and knowledge to [perform] adequate explantation (en bloc with total capsulectomy). In my opinion, all surgeons should be trained to do this type of surgery! They are able to dissect the pectoral muscle off the [rib] cage to [put in] an implant, they should have the knowledge and skills to remove them properly without causing damage!”
“[There is a] lack of knowledge and awareness amongst medical professionals involved, from surgeons to lymphoma specialists to general practitioners in both identifying and treating BIA-ALCL.”
“Very few surgeons Canada-wide are aware of, or competent in, proper peer-reviewed follow-up care for breast implant recipients.”
Honesty “Shouldn’t the companies who make these implants and the plastic surgeons who have used these be held accountable for their lack of honesty?”
“We cannot assume that all [patients] will see the rare news reports. These people need to be sought out and sent information directly to them.”
“[Women are] not being fully and comprehensively informed of the risks; including downplaying the risks.”
Confidentiality “[There should be] a systematic effort to identify all women with implants (especially textured ones) so that they can all be told that BIA-ALCL exists and what they can do about it.”
“Women with implants and doctors were [previously] actively told that symptoms that are now known to be symptoms of BIA-ALCL are common benign complications. So unless some effort is made to reeducate all at-risk women and doctors, we are not doing enough to prevent harm from BIA-ALCL.”
Global trust “Do they (doctors) even have a clue about the number of adverse events there are for breast implants? Are they aware of the hidden data?”
“Plastic surgeons are falling short of their responsibility to reeducate all at-risk women, and until such an effort is made we are not doing enough to prevent harm from BIA-ALCL.”

Fidelity refers to prioritizing a patient’s best interests and avoiding exploitation of her vulnerabilities.8 Within this dimension, trust can be established through respect, advocacy, and avoiding conflicts of interest.8 Several respondents felt that plastic surgeons could provide better acknowledgement of their specific concerns, advocate for standards of care, and help navigate access and financial barriers.

Competence refers to avoiding mistakes, achieving the best possible results, and being aware of accepted standards of care.8 Patients lose trust when they perceive physicians have made errors in judgment or technical execution. Several respondents in this study felt their plastic surgeons could be better educated in the diagnosis and management of BIA-ALCL and breast implant–related illness and could improve their monitoring of patients with breast implants.

Honesty refers to telling the truth and avoiding intentional falsehoods.8 Lack of honesty may involve lies, half-truths, or deception by silence.9 Several informants felt that they were not fully aware of all known risks associated—or possibly associated—with breast implants.

Confidentiality refers to the proper use and protection of sensitive and private patient information. Although no patients reported that their own confidentiality had been violated, some indicated that the premise of patient confidentiality should not be used to withhold information from groups of patients potentially at risk for certain adverse outcomes. On the contrary, they feel that once doctors or manufacturers become aware of the possibility of certain adverse events, they should proactively reach out to inform any known to be at risk.

Finally, global trust refers to holistic or collective trust in a group of similar individuals, in this case trust in plastic surgery as a profession.8 Several informants with breast implant–related problems expressed high praise for their own plastic surgeon, and expressed a discordant sentiment that plastic surgeons, manufacturers, and regulatory bodies could have done more to monitor outcomes in existing patients or to educate patients and health care professionals about potential adverse events related to breast implants. On the whole, it would this seem that with respect to breast implants, plastic surgeons as a group were considered by informants to need improvement across the five domains of trust.

DISCUSSION

Breast implants have been in use around the world for more than 50 years,10 and women with breast implants are generally satisfied with their current status and the care provided by their plastic surgeon. Recently, there has been concern among some women with breast implants and members of the media about the safety of breast implants. Much of this relates to the now-established risk of BIA-ALCL in women with textured implants. As the global plastic surgery community has been grappling with this complex issue, there has also been a resurgence in public concern regarding the separate issue of the condition referred to as breast implant illness, in which a wide variety of systemic symptoms are suggested to be related to the presence of breast implants. This qualitative study sought to understand the perceptions among a group of Canadian women sharing a Facebook group for women with a variety of breast implant issues who are concerned about the safety of their implants and the response to their concerns from the Canadian plastic surgery community.

A subset of women subscribing to the Canadian BIA-ALCL Facebook groups responded to a request from the president of the Canadian Society of Plastic Surgeons to describe the challenges, barriers, and worries they are experiencing but feel plastic surgeons may not realize. Five common themes where plastic surgeons could improve were extracted from their responses, including the informing process, listening to patients with concerns, acknowledging patients’ concerns, understanding the difference between the informant and surgeon management plan, and preparing a path for moving forward. When these themes are further examined within the context of trust theory, informants felt that the plastic surgery community should aim to restore the five key domains of trust in the context of patients’ concerns about breast implants. Breast surgery is an integral part of the practice and identity of plastic surgery. Loss of trust by patients could be considered an existential crisis for our specialty. On the surface, these common patient themes appear highly critical; alternatively, they could be reframed as a recipe for moving forward to regain trust.

Trust is well established as an integral part of the patient-physician relationship.7,11–13 Most medical literature divides trust into the broad categories of trust of individual physicians and trust of the profession.11,12 The most basic definition of trust in the context of the doctor-patient relationship is the belief that physicians are working in their patient’s best interests.11 Trust theorists have further suggested that trust in physicians and in medical institutions can be examined along five different dimensions: fidelity, competence, honesty, confidentiality, and global trust.8 These domains represent necessary components of trust in a patient-physician relationship and highlight targets for regaining trust. Examples of possible strategies to regain trust are listed in Table 3.

Table 3. - Matrix for Plastic Surgeons to Address Patient Concerns and Regain Trust
Patient Concerns Domains of Trust
Fidelity Competence Honesty Confidentiality Global Trust
Informing To present all treatment options To improve the informed consent process (written and verbal)
To reach out to existing breast illness patients with new information and advice
To intensify efforts to increase access to manufacturers’ data regarding registered patients
To further study existing registry data and disseminate new findings
To increase efforts by national societies to collaborate with regulatory bodies to establish national registries
To include patient representatives in the development of national registries
Listening To make efforts to understand patients’ concerns; to be available to see all patients (including other surgeons’ patients) To educate plastic surgeons about information that patients want to know about To continue dialogue between national societies and patient groups
Acknowledging To be open-minded about the possibility that patients’ symptoms may be related to breast implants To continue to educate plastic surgeons about adverse outcomes related to breast implants, appropriate monitoring, and treatment To participate in ongoing studies relating to the possibility of BII
Clarification To make better efforts to educate individual patients regarding their particular adverse outcome and appropriate treatment recommendations To make better efforts to explain the difference between BIA-ALCL and BII and the resulting different treatment implications To make better efforts to explain the rationale for proposed treatments To be leaders in interpreting available evidence regarding adverse outcomes related to breast implants and to work with investigators from other specialty areas
Moving forward To take a proactive role in educating other medical professionals about BIA-ALCL To develop evidence-based guidelines for monitoring patients and treatment of various types of adverse events
To consider establishing regional centers of expertise for BIA-ALCL and BII
To continue encouraging national societies to serve as leaders in knowledge translation and dissemination To advocate for mandatory breast implant registries and adverse outcomes documentation To work with patient advocacy groups to develop practical strategies for communicating with and guiding this population of patients; to collaborate with other medical specialists to provide high-level evidence-based care
To advocate for funding assistance for costs related to explantation and capsulectomy
BII, breast implant–related illness.

This qualitative study used open-ended questioning posed to members of a Canadian Facebook BIA-ALCL advocacy group to solicit information about patient concerns related to breast implants. This group was initially established to facilitate communication and knowledge dissemination among a small group of women with the (at the time of inception) new entity of BIA-ALCL. It has subsequently grown into a much larger, blended group of not only women with BIA-ALCL but also women who self-identify as having breast implant–related illness. Patients with concerns about BIA-ALCL and breast implant–related illness were treated as a heterogeneous group for the purpose of this study. On the one hand, this blending represents a limitation in describing the pure experience of women with BIA-ALCL; it also represents the clinical reality in many plastic surgeons’ practices who are seeing a diverse group of breast implant patients with a wide variety of symptoms, concerns, and fears. Themes extracted from this collective patient experience may prove informative to plastic surgeons whose practices include breast implantation for aesthetic and/or reconstructive purposes.

The convenience sampling used here to understand patients’ concerns represents a group of women highly motivated to respond to articulate their concerns. The purpose of this study was not to understand or generalize to all women or all women with implants. Rather, qualitative methods were used to try to understand the perceptions of this distinct, expressive subset of Canadian women with concerns about the safety of their breast implants. Similarly, the aim here was not statistical significance, but rather social significance in an attempt to clarify these concerns for the benefit of the plastic surgeons who may be caring for similar women in their offices. In contrast to quantitative research methods, qualitative research does not presuppose homogeneity. Quantitative research is underpinned by the philosophic standpoint of positivism in which there is one reality that can be measured to determine truth in an unbiased manner. Qualitative research, on the other hand, seeks to provide an understanding of social phenomena that have previously not been recognized to provide insight into an area of social interaction—in this case, the interaction between surgeon and patient5,14—which is why qualitative research methodology was used for this exploration. Based on the themes identified, we offer that one path to reestablishing trust would include the following:

  1. An improved informed consent process for those considering breast implants, with emphasis on disclosure of real and possible risks and explicit acknowledgement from the patient that these risks were understood.
  2. A process for informing patients about existing and evolving risks related to breast implants. This should include informing known patients about risks specific to their situation, and clarifying for the general public the different types of concerns related to breast implants.
  3. Reflecting that, as plastic surgeons, our obligation as physicians is to do our best to listen to, understand, acknowledge, clarify, and advise on the needs of our patients with, or wanting, breast implants.
  4. Advocating for mandatory registration of all breast implants and associated adverse outcomes, to study the short- and long-term safety of breast implants and enable notification of patients as risk for specific problems.
  5. Establishing guidelines for monitoring patients with breast implants over time.
  6. Continuing efforts to establish evidence-based guidelines for the treatment of women with various problems related to their implants.
  7. Addressing the gaps in financial coverage for the treatment of various breast implant–related problems.
  8. Advocating for expansion of existing breast health centers to accommodate women with a variety of concerns related to breast implants.

CONCLUSIONS

There is a subgroup of women with breast implants who present to plastic surgeons with concerns related to their breast implants, including worries about BIA-ALCL and, more recently, the less well-defined collection of symptoms referred to as breast implant–related illness. The respondents in this study have expressed that plastic surgeons could improve in information provision regarding adverse outcomes, should listen to their concerns without dismissing conditions the respondents feel may be related to their implants, and need to have a clear plan for the path forward for each individual situation. Finally, there is an apparent gap between surgeons’ and patients’ understanding of the problems related to breast implants and the optimal management of each. These concerns and gaps have eroded trust in the specialty of plastic surgery. Addressing the themes of patient concern could help to improve deficiencies in the five domains of trust and restore a healthy physician-patient relationship.

PSYCHOSOCIAL INSIGHTS

Dr. David B. Sarwer, associate dean for research, professor of social and behavioral sciences, director of the Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pa.

Concerns about the safety of breast implants have followed their usage for decades. When the U.S. Food and Drug Administration reapproved the widespread use of silicone gel–filled implants in the mid-2000s, there was some degree of optimism that issues of safety would be left behind. Unfortunately, the past decade has witnessed the development of breast implant illness—a broad and not-yet-well-defined constellation of symptoms that women attribute to their breast implants. Similarly, there has been the identification of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL), seen with the use of textured breast implants. Both issues have garnered the attention of patients and providers alike.

The plastic surgery literature now has a growing number of case reports and small case series about both breast implant illness and BIA-ALCL. Much of this work has focused on diagnosis and treatment, while understanding of patients’ concerns about these issues has lagged. The qualitative study by Steve and colleagues provides important information about the concerns women have about both conditions. In interviewing 64 women from the Canadian BIA-ALCL Advocacy Facebook Group, the authors identified five main themes. Three themes—“informing,” “listening,” and “acknowledging”—spoke to the desire of women to have more clear and supportive communication with their treating surgeon. Themes of “clarifying” and “moving forward” highlighted the desire of these women to have a well-articulated plan to monitor their implants and address symptoms if and when they arise.

Qualitative research methods are often at their strongest when applied to new or rare conditions and when the research participants’ experiences may be so unique that widely used, psychometrically sound measures do not exist. Thus, their use here is well justified. Recruiting women from a BIA-ALCL Advocacy Facebook Group allows for an understanding of the women most likely concerned with or affected by breast implant illness or BIA-ALCL. It also, however, results in a biased sample. Replication of the study with a more representative group of women with implants, including both those with and those without self-reported symptoms of breast implant illness, would provide a more complete picture of these concerns and themes.

Steve and colleagues frame their observations in terms of reestablishing trust between patients and providers. Trust is a foundational tenant of the health professions. While the authors argue that the BIA-ALCL issue has compromised that trust, other elements of contemporary health have eroded trust as well. Patient visits are often too brief to result in a detailed conversation of concerns and symptoms that promotes trust. Reliance on the electronic medical record has providers looking at computer screens and not at the eyes of their patients. The commercialization of plastic surgery, coupled with the often-unrealistic portrayal of the specialty in the mass media, further threatens the development of trust between patient and provider.

Rebuilding trust will need more than just the safest possible products. The authors propose a reconsideration of the informed consent process. Medical ethicists have been advocating for a more active informed consent process for years—that true informed consent is a conversation between patient and provider and not just the signing of a form. Such conversations also allow for shared decision making between patients and providers. Shared decision making is considered the “gold standard” of interpersonal health communication. In shared decision making, patient and provider share information and work together to come to a treatment decision. Patients must understand the risks and benefits of the range of treatment options in order to make a “good” decision. Commonly used by organ transplantation teams, as well as professionals who provide end-of-life care, shared decision making has not been widely used in plastic surgery. Given the issues around breast implant illness and BIA-ALCL, as well as the more general psychosocial considerations in plastic surgery, perhaps it is time for the field to reexamine patient-provider communication and begin to include shared decision making in order to instill greater trust from current as well as future patients.

Disclosure: Dr. Sarwer currently has grant funding from the National Institute of Diabetes, Digestive, and Kidney Disease (R01-DK-108628-01), the National Institute of Dental and Craniofacial Research (R01 DE026603), the Department of Defense, and the Commonwealth of Pennsylvania (PA CURE). He has consulting relationships with Ethicon, Merz, and Novo Nordisk.

ACKNOWLEDGMENTS

The authors would most gratefully like to acknowledge Terri McGregor, Dawn Criss, Julie Elliott, and all of the members of the Canadian BIA-ALCL Facebook group who facilitated the collection of the data used in this study.

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