Since 2018, monitoring for BIA-ALCL and mitigating the risks of developing this malignancy has taken on greater urgency. Although the Food and Drug Administration previously stated that 1 in 30,000 to 1 in 3,817 women with textured implants (3.3 – 26.2 in 100,000) could develop BIA-ALCL, a study following up on 3,546 women who received textured breast implants at one center between 1992 and 2017 found that a much higher rate, 1 in 355 (281.7 in 100,000), were later diagnosed with BIA-ALCL (Cordeiro et al., 2020). Dr. Mark Clemens at the University of Texas MD Anderson Cancer Center has said that BIA-ALCL should no longer be referred to as “rare”, but instead as “uncommon and emerging”. As of July 2019, the FDA requested that Allergan initiate a recall of its BIOCELL-brand textured breast implants and tissue expanders due to the risk of BIA-ALCL; this brand of implants was reported to be present in 481 of 573 BIA-ALCL cases known to the FDA, as well as 12 of 13 deaths where the manufacturer of the textured implants was known. Allergan is now attempting to notify all recipients of these implants about its recall.
A substantial proportion of transgender women and transfeminine people seek or receive breast augmentation surgery: 8% of assigned-male respondents to the 2015 US Trans Survey reported having received breast augmentation, while an additional 36% wanted this procedure; in comparison, an estimated 1% of all women in the United States have received breast implants (Maher et al., 2020). Plastic surgeon Dr. Rachel Bluebond-Langner of NYU Langone Health has stated that a trans woman with textured implants could be assumed to be at the same risk as a cis woman with these implants, and a more recent review examines a series of four cases of trans women with BIA-ALCL reported in the literature.
Zaveri, Yao, & Schmidt (2020) found that these women received textured implants at a mean age of 37 years, and while they began experiencing symptoms of BIA-ALCL at an average of 5 years after getting these implants, they did not present for treatment until an average of 12.75 years after their augmentation surgery. Their initial symptoms were noted to be “vague”, including breast pain, discomfort, and itching, but all had palpable breast masses by the time they sought treatment. All four underwent removal of the implant, scar tissue capsule, and cancerous mass; two had a portion of their pectoral muscle removed; and one was found to have experienced spread of disease to one nearby lymph node, which was removed. Three of the four women had chemotherapy following surgery, and the woman whose disease had spread to a lymph node also underwent numerous cycles of radiation therapy to the affected breast and underarm area. At six months following surgery, all of the women were tumor-free, although the longest reported followup time was only two years.
Notably, the authors found that all four trans women were diagnosed with BIA-ALCL at a later stage than cis women are usually diagnosed:
There are significant differences in the stage at diagnosis of BIA-ALCL in most patients compared to the reported transgender patients. 35- 70% of typical BIA-ALCL cases are diagnosed at stage IA with tumor confined to the effusion or the luminal aspect of the capsule and no lymph node involvement. As seen in Table 3, all the transgender patients were diagnosed at a late stage, IIA and higher, with tumor infiltrates already spread beyond the capsule.
When BIA-ALCL is detected at an earlier stage limited to the area of the implant capsule without further spread, surgery alone can often be curative, but the “rate of disease events and recurrence is 2.6-fold higher for stage II disease and 2.7-fold higher for stage III disease compared with stage I disease” (Clemens, Jacobsen, & Horwitz, 2019). For this reason, monitoring and early detection of BIA-ALCL are essential.
The FDA has recommended that recipients of textured breast implants be aware of BIA-ALCL symptoms, including “persistent swelling, presence of a mass or pain in the vicinity of the breast implant”. Although Allergan BIOCELL implants have been recalled and should not be used in new procedures, the FDA has not recommended the removal of these or other textured breast implants in those without any symptoms of disease. Similarly, the Australian Department of Health’s Therapeutic Goods Administration recommends against routine removal of textured implants in the absence of disease symptoms, stating that the “risk of developing BIA ALCL is lower than the risks associated with an anaesthetic and surgery”, and the “complication rate of revision surgery involving implant removal or replacement is also higher with each revision procedure.”
The bottom line is that textured breast implants are associated with a risk of developing a serious and potentially fatal cancer, and that risk appears to be greater than previously believed. Trans women seeking breast augmentation should take these risks into account when considering which type of implant to use, and trans women who have received textured breast implants should monitor themselves for any symptoms associated with BIA-ALCL. ■