The purpose of this Evidence Review column is to provide information about current literature of relevance to plastic and aesthetic nurses.
The potential for developing breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a concern that affects millions of women with textured breast implants. The number of women diagnosed with BIA-ALCL is increasing. In July 2019a, the U.S. Food and Drug Administration (FDA) requested the manufacturer recall specific models of textured breast implants. These implants are no longer used for reconstructive or elective breast augmentation; however, it is vitally important that plastic surgeons and nurses consulting with asymptomatic patients with textured breast implants develop a strategy for risk management.
Nelson et al. (2021) conducted a comprehensive literature search of multiple databases using multiple relevant key terms that yielded 276 publications, none of which met the researchers inclusion criteria of studies presenting "data examining the surgical risk reduction of BIA-ALCL among women with textured implants" (p. 8S). The researchers found no evidence that surgical removal of textured implants reduces the risk for developing BIA-ALCL.
The researchers found that the average time to diagnosis of BIA-ALCL is approximately 8-10 years following breast reconstruction or augmentation with textured breast implants. The researchers conducted a time-to-event analysis that showed the longer the exposure to the textured implant, the greater the risk for developing BIA-ALCL, with the risk at 10 years after implantation possibly being as high as one in 559 women. Developing BIA-ALCL can be especially devastating for women who have undergone breast reconstruction following mastectomy for cancer treatment and then learn that the reconstructive implant poses a cancer risk.
The pathology for BIA-ALCL and textured implants occurs as an inflammatory response to the implant surface that may result in malignant transformation of T lymphocytes characterized by the expression of CD30 antigen and the absence of anaplastic lymphoma kinase expression. The amount and style of texturing on the implant surface control the risk of malignancy, with the greatest risk associated with macrotextured implants, which have been recalled by the manufacturer (FDA, 2019b).
Currently, there is no screening test for BIA-ALCL; therefore, asymptomatic patients with textured implants have the following options for risk management:
1. Regular examinations by a plastic surgeon with magnetic resonance imaging scans to evaluate implant integrity. Notably, this method of risk management does not reduce the risk for BIA-ALCL. Plastic surgeons should explore any new breast swelling or palpable mass with imaging. If fluid is found during imaging, which is common,
a. Fluid aspiration and pathological examination should be performed (with the understanding that there is a risk for implant rupture or an inconclusive sample), or
b. Imaging should be repeated in 3-6 months to ensure the fluid volume is stable and not increasing.
2. Patients who wish to have their textured implants removed have three options, all of which begin with removal of the implant (with or without capsulectomy). Implant removal may be followed by
a. No implant replacement,
b. Replacement with smooth implants, or
c. Breast reconstruction with autologous tissue.
It is important that the patient understand the FDA does not recommend removing textured implants in asymptomatic patients. This decision may be due to the lack of data on the efficacy of implant removal or exchange for decreasing the risk of developing BIA-ALCL. Likewise, there are no data to support capsulectomy for reducing the risk of BIA-ALCL development. However, for many women, the perceived benefits of having the textured implants removed, with or without capsulectomy, outweigh the surgical risks.
If you have read or know about an important study relevant to plastic and aesthetic nurses and would like to write about it or see it presented in the Evidence Review column of PSN, please contact Sharon Ann Van Wicklin, Editor-in-Chief atmailto:[email protected].
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