One-third of women with a history of breast cancer surveyed who were made aware of the July 2019 recall of Allergan BIOCELL textured breast implants and tissue expanders due to health risks reported feeling high levels of anxiety about the news, according to a study reported at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. Many breast cancer patients choose to undergo breast reconstruction with breast implants following their treatment, after losing their own breasts.
The U.S. Food and Drug Administration (FDA) pulled Allergan’s BIOCELL implants last year due to the risk of breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The FDA said it had identified 573 cases of cancer worldwide in women who had received implants in general, including 33 deaths. Among the cases, 481 were Allergan implants and, among the 33 deaths, only 13 had reported the type of implant used and all but one involved Allergan implants.
BIA-ALCL is not a form of breast cancer but a rare type of T-cell lymphoma that develops in the fluid or scar tissue around a breast implant. Early diagnosis and treatment of the disease is generally successful but in some cases, the cancer has spread and patients have died.
The study reported at the ESMO conference involved 958 Japanese women with a history of breast cancer who agreed to complete a questionnaire six months after the Allergan recall. The goal of the survey was to gauge their awareness and attitudes related to the safety issues with the recalled implant. About 86% (912) of the study participants said they underwent a mastectomy and of those who did, 40% said they were treated surgically during 2019. Of the 821 for whom information was available regarding their breast reconstruction, 41.4% had completed breast reconstruction, 20.1% were at the tissue expander phase, 6.6% had future plans for reconstruction, and 16.3% have not had breast reconstruction.
About half (49%) said they were affected in some way by the recall, such as had their reconstruction process discontinued, had their silicone or tissue expander removed, or switched from silicone implants. More than 30% of respondents said they were experiencing high levels of anxiety about their risk for BIA-ALCL.
Researchers said these findings indicate the need for “psychological care for these patients and [the need to] provide accurate and prompt medical information.”