Recall of Specific Types of Breast Implants and Tissue Expanders Has Far-Reaching Impact on Patients With Breast Cancer

The following article features coverage from the European Society for Medical Oncology 2020 virtual meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

High levels of anxiety were reported by approximately one-third of survey participants who had a history of breast cancer and were made aware of the voluntary recall in July 2019 of BIOCELL textured breast implants and tissue expanders manufactured by Allergan,¹ according to a study conducted in Japan that was reported at the European Society of Medical Oncology (ESMO) Virtual Congress 2020.²

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma that occurs in the fluid or scar tissue around a breast implant. Although early diagnosis and treatment of BIA-ALCL is often curative, there have been reports of BIA-ALCL–related deaths.

For example, in July 2019, the US Food and Drug Administration (FDA) reported 573 cases of BIA-ALCL in women who had undergone breast implantation, with 33 associated deaths. Of those cases of BIA-ALCL, 481 occurred in women with textured breast implants manufactured by Allergan. Furthermore, of the 13 deaths for which the manufacturer of the breast implant was identified, 12 occurred in women with an Allergan breast implant.³

Based on the evidence linking certain types of textured breast implants with a risk of BIA-ALCL, the FDA issued a request in July 2019 that Allergen recall specific models of textured breast implants, as well as certain types of tissue expanders used prior to breast reconstruction procedures.³

In this study, 958 Japanese women (median patient age was 48 years) with a history of breast cancer who were members of a cancer support group completed a web-based survey questionnaire during December 2019 regarding their awareness and attitudes related to the recent recall of these products.

Although this survey study was conducted in Japan, insurance coverage for breast implantation is limited to procedures using Allergen-manufactured products in that country.

Approximately 86% of survey participants reported having undergone mastectomy, with 40% of the 912 patients treated surgically during 2019.

Of the 821 patients for whom data were available regarding the status of the breast reconstruction process, 41.4%, 20.1%, 6.6%, and 16.3% were classified as having completed breast construction, being at the tissue expander phase, having future plans for breast reconstruction, and having not undergone breast reconstruction, respectively.

Forty-nine percent of those surveyed reported being affected by the recall of these products. Specifically, discontinuation of the reconstruction process, removal of silicone or tissue expander, and switching from silicone implants to autologous tissue in those scheduled for secondary reconstruction were reported by 4.5%, 2.2%, 3.7% of patients, respectively.

Furthermore, 13.3% and 27.8% of patients classified as “expander patients” and “secondary reconstruction patients,” respectively, reported that they were uncertain how to proceed with the reconstruction process.

Of note, 30.5% of survey participants also reported experiencing high levels of anxiety related to their increased awareness of the risk of BIA-ALCL associated with particular types of breast implants and tissue expanders.

In summarizing the results of this study, the authors noted the importance of providing “psychological care for these patients and provide accurate and prompt medical information.”

Disclosures: All authors reported no conflicts of interest.

Read more of Cancer Therapy Advisor‘s coverage of the ESMO Virtual Congress 2020 by visiting the conference page.

References

1. US Food and Drug Administration (FDA). Allergan voluntarily recalls BIOCELL^® textured breast implants and tissue expanders. Published July 25, 2019. Accessed September 18, 2020.
2. Suzuki H, Ueda N, Matsumura S, et al. A survey of breast cancer patients’ attitudes toward the breast reconstruction based on breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). Presented at: European Society of Medical Oncology (ESMO) Virtual Congress 2020; September 19-21, 2020. Abstract 246P.
3. US Food and Drug Administration (FDA). FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. Published July 24, 2019. Accessed September 18, 2020.