Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Risk and Associated Product Recall Approach: Description of a Patient-Centered Multidisciplinary Information, Decision Aid and Support Structure

Introduction: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare form of cancer mainly associated with textured breast implants and tissue expanders recalled in early 2019 in Canada. Currently, there are no consensus and no shared best practices to approach the BIA-ALCL associated social and psychological implications. This article aims to share the CHU de Québec-Université Laval’s practice in taking its social responsibility and approaching the BIA-ALCL associated recall as well as its psychological implications.

Materials and methods: The patient-centered multidisciplinary information, decision aid, and support structure that was put in place is described and comprises: a dedicated support phone line with staff members answering on business hours; an information and psycho-education group intervention specifically developed to inform, reassure and guide patients at risk of BIA-ALCL; a consultation with a member of the psycho-oncology team for decision aid and emotional support if desired; and a consultation with a plastic surgeon if desired.

Results: Women at risk of BIA-ALCL’s needs were met by the support phone line, group interventions, and consultations with plastic surgeons. Patient experience questionnaire analysis related to the group intervention shows that it is judged worth it, acceptable and relevant in the BIA-ALCL context and shows lower levels of distress, anxiety, depression, and information needs after the intervention.

Discussion: Women at risk of developing BIA-ALCL have important information and emotional needs that need to be addressed with a patient-centered multidisciplinary tailored approach to help them cope and support them in making informed decisions.

Conclusion: The shared model of practice, a support structure enabling access to individual and group interventions, allows to meet the needs of women at risk of BIA-ALCL, by providing relevant information, helping them cope with associated negative emotions and support them through their decision-making process.

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is an emerging disease entity, a rare form of cancer, uniquely iatrogenic in nature, mainly associated with textured breast implants and tissue expanders with a certain textured surface. First described by Keech and Creech [1], the possible association between ALCL and breast implants was later examined by the U.S. Food and Drug Administration (FDA) in 2011 and confirmed in the following years [2,3]. In 2016, while the BIA-ALCL was recognized and classified as a novel lymphoma by the World Health Organization (WHO), the National Comprehensive Cancer Network (NCCN) established consensus guidelines for the diagnosis and treatment of the disease, which were revised and updated in 2019 [4]. In 2017, Health Canada published a first safety review concerning breast implants which described low incidence BIA-ALCL [5,6]. Health Canada's safety review was updated in February, 2019, concluding an increased risk of BIA-ALCL for textured breast implants and tissue expanders [7,8]. This led to the recall and suspension of Allergan's licenses for its Biocell textured breast implants and its Natrelle textured tissue expanders [9,10]. Currently, there is no consensus and no shared best practices to approach the BIA-ALCL associated social and psychological implications [11].

In early 2019, Quebec's Ministry of Health and Social Services (MSSS) asked all its establishments to review their records of patients who have had breast implant surgery since 1995 in order to identify those who have textured breast implants or textured tissue expanders. The MSSS requested to contact identified patients and provide information about the potential risk of BIA-ALCL and the symptoms or signs to monitor.

The purpose of this article is to share the CHU de Québec-Université Laval's practice in promptly taking its social responsibility, responding to the MSSS' request, and approaching the BIA-ALCL associated recall, as well as its psychological implications. More specifically, this article will describe the patient-centered multidisciplinary information, decision aid, and support structure that was put in place to help women who are at risk of developing BIA-ALCL, and present exploratory results about the structure's use and related to the achievement of the group intervention's objectives (inform, reassure and guide patients at risk of BIA-ALCL).

The CHU de Québec-Université Laval: The CHU de Québec-Université Laval is the largest University Hospital in the Canadian Quebec province and comprises five hospital centers, all situated in Quebec City. Recognized by Quebec's MSSS as a specialized and sub-specialized center, it provides health care, teaching, research, and evaluation. It also comprises the Deschênes-Fabia Breast Disease Center, which is dedicated to patients with breast problems and comprises a multidisciplinary and integrated oncology center where all aspects of breast cancer are treated, from prevention, genetics, and screening, to palliative care, through diagnosis, treatment, surgery, and breast reconstruction [12].

Design and implementation of a support structure: The CHU de Québec-Université Laval had to react in a timely manner to the MSSS' request, to Health Canada's recall, as well as to the media crisis that was going on in parallel. Indeed, a quantity of information from an array of sources that were not always reliable circulated in all forms of media, leading women to look for information, answers and support because some of them were experiencing high levels of insecurity and negative emotions such as anxiety and emotional distress [13]. The first actions that the organization took in early 2019 were to name a responsibility to coordinate the efforts to approach the BIA-ALCL issue. Moreover, mobilize its archives service staff to identify patients through official records and operating room binders in which stickers with the serial number of the products used were kept, who have had textured breast implants or tissue expanders surgically implanted in a CHU de Québec-Université Laval were operating room since 1995. In order to do that in a timely manner, the organization had to hire additional staff. Then, a tailored information letter (tailored by being personalized, and information given according to the type of implant and nature of the surgery undergone, namely cosmetic or breast reconstruction) was sent to each patient identified, giving them basic information on BIA-ALCL. Its potential risk and incidence, the symptoms or signs to monitor (breast swelling, pain, or a palpable mass), the procedure to follow in case of symptoms or signs (please consult your doctor), and giving them a phone line number to call if they had further questions, needed support concerning this issue or were considering having their implants removed even the slightest.

Additionally, the BIA-ALCL issue was established as a priority for the CHU de Québec-Université Laval directors' board management committee, which held 21 meetings concerning the BIA-ALCL issue and participated in seven meetings with Quebec's MSSS in 2019. Six of its 19 directors were closely involved in designing and implementing the patient-centered support structure that would not only answer the MSSS' base request. However, that would go further by helping involved patients cope with associated negative emotions (anxiety, emotional distress, worry, and fear) and support them through their decision-making process of keeping their textured breast implants or removing them [13].

Indeed, women at risk of developing BIA-ALCL who only have access to scarce, unreliable information from an array of sources may face dramatically increased negative emotions producing suboptimal decisions [11]. In order to help women cope with these emotions and to support them in making informed decisions, Marra and colleagues [11] recommend not only clearly providing relevant and reliable information and tailored to patient characteristics but also implementing decision aids or health communication systems. This is what the support structure, which will be described in more detail in the next section, was aiming for.

Description of the information, decision aid, and support structure: The structure implemented comprises four elements that complement each other, the two first elements being the core of the structure: 

1. A dedicated support phone line; 
2. An information and psycho-education group intervention specifically developed to inform, reassure and guide patients at risk of BIA-ALCL; 
3. A consultation with a member of the psycho-oncology team if desired; and 
4. A consultation with a plastic surgeon if desired.

It is a multidisciplinary structure involving doctors, surgeons, nurses, psychologists, social workers, and the administrative staff who manage the dedicated support phone line. Note that any of the four elements of the structure can be accessed as needed, not in any particular order.

Descriptive data: use of every element of the structure: Since the implementation of the information, decision aid, and support structure, data was compiled in order to monitor the use of every element (Figure 1).

Note that at the time of the data collection, no woman treated at the CHU de Québec-Université Laval had been diagnosed with BIA-ALCL. 

Quantitative results: information and psycho-education group: There were respectively 18, 14, 26, 14 and 3 participants in each live group, for a total of 75 participants, with a mean age of 56.8 years. Levels of distress, anxiety, depression and information needs were all lower after the group intervention, and all in a statistically significant way (distress (t(27) = 4.3, p < 0.001); anxiety (t(57) = 7.0, p < 0.001); depression (t(57) = 2.1, p = 0 .04); and information need (t(56) = 12.1, p < .001) (Figure 2)).

Appreciation of the group intervention was high for the group format (mean of 8.4 out of 10), for the relevance of the content (mean of 8.3 out of 10), and was very high for the feeling of participating in the group intervention being worth it (mean of 9.1 out of 10).

Women at risk of developing BIA-ALCL have important information and emotional needs that need to be addressed with a patient-centered multidisciplinary tailored approach in order to help them cope and support them in making informed decisions by clearly providing relevant and reliable information and tailored to patient characteristics, emotional support and decision aids [11]. The support structure that was put in place does that, and results show that women at risk of BIA-ALCL’s needs were met by the support phone line, group interventions, and consultations with plastic surgeons. In the CHU de Québec-Université Laval’s experience, no individual consultation with a psycho-oncology staff member was requested, highlighting that the emotional needs were met by the support phone line and the group intervention.

The group intervention’s objectives were to inform, reassure and guide patients at risk of BIA-ALCL. Data suggests that the group intervention was not only judged worth it, acceptable and relevant but that its objectives were met: it contributed to lower levels of distress, anxiety, depression, and information needs while guiding participants.

Concerning information, information need levels were the highest before the group and the one which diminished the most post-intervention. However, all information needs were not completely covered, which was also noted in the comments. These unmet information needs only seemed to be able to be met by a plastic surgeon, which is reflected by the 27 consultation requests with a plastic surgeon (14.8% of the 183 women in the care of the support structure). It can be noted that women did not need to participate in the group intervention or view it online to have access to a consultation with a plastic surgeon, but that the vast majority of the 27 requests involved women who had participated in live or viewed online group interventions. It is also important to note that most of the 27 women asked for a consultation with a plastic surgeon to decide to have their implants removed or not, rather than just having remaining informational needs.

Study limitations: The main limitations of this study are linked with a limited sample size and voluntary response bias. However, the study did not aim at producing findings that can be extrapolated but aimed at improving the support structure put in place and its group intervention through a continuous quality improvement in the health care process.

BIA-ALCL is an emerging disease entity, mainly associated with textured breast implants, for which the medical, social, and psychological implications must be taken very seriously. However, the authors noted no shared best practices to approach the BIA-ALCL associated social and psychological implications [11]. Therefore, this article shared a model of practice, a patient-centered multidisciplinary support structure that enables to meet the needs of women at risk of developing BIA-ALCL by providing accessible, clear, tailored, relevant, and reliable information, as well as by helping women at risk of BIA-ALCL cope with associated negative emotions and support them through their decision-making process of keeping their textured breast implants or having them removed.

It described a support structure, and an approach that can serve as a model used by quality risk management teams in case of other product recalls, putting people at risk of major health issues and implying a decision-making process. Because the structure and approach are patient-centered and have demonstrated a positive change while being efficient, notably because of its group intervention, our organization aims to submit it to Accreditation Canada as a Leading Practice to be exported to other health organizations. 

Finally, the support structure and approach taken by the CHU de Québec-Université Laval were not only patient-centered and multidisciplinary–but they were also coherent with the CHU de Québec-Université Laval’s strategic directions, values, and priorities concerning patient experience: to provide our patients, partners in their care and services, and their loved ones, and experience marked with humanism, centered on their specific needs and respectful of their expectations [18].

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Cancer; Breast implants; Patient-centered care; Product recalls; Psycho-education group intervention; Breast implant-associated anaplastic large cell lymphoma

Rainville F, Casault L, Bergeron S, Martel L, Tremblay S, Laferrière MC, et al. Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) risk and associated product recall approach: description of a patient-centered multidisciplinary information, decision aid and support structure. Clin Oncol J. 2021;2(1):1–7.

© 2021 Rainville F. This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY-4.0).