Numerous studies have demonstrated that textured breast implants predispose women who undergo breast reconstruction to breast implant-associated anaplastic large-cell lymphoma.
Now, an analysis of new data from a cohort study of 650 women who underwent total mastectomy and breast reconstruction demonstrates a significant association between textured implants, increased distant breast cancer recurrence, and decreased disease-free survival (DFS).
These associations were independent of tumor stage and estrogen receptor (ER) status, according to Sa Ik Bang, MD, PhD, of the Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and colleagues.
"We observed a statistically significant association between textured implant use and decreased DFS with an increased risk of recurrence," the investigators write in their article, which was published in JAMA Surgery in October.
"We believe that this study raises an urgent need for further well-designed investigations, which either may refute the findings of this study with more solid evidence and reassure patients or may produce similar results and lead to increased caution in breast cancer surveillance," they write.
The results were "unexpected," the researchers note. Instead of providing evidence that might relieve anxiety for patients with textured implants, "the results may amplify survivors' concern regarding the potentially detrimental implications of a textured implant for oncologic outcomes," they say.
In an accompanying commentary, Michael R. Cassidy, MD, and Daniel S. Roh, MD, PhD, Boston University School of Medicine, Boston, Massachusetts, called the study's preliminary data "both alarming and intriguing" and agreed that "larger, multi-institutional analysis is critical to confirming these findings."
Many reconstructive surgeons have abandoned the use of textured implants, the editorialists note. This study should convince those who haven't to make sure patients are aware of the risks, they emphasize.
"Given the association of textured implants with ALCL [anaplastic large-cell lymphoma], and now the suggestion that they are associated with increased risk for breast cancer recurrence, surgeons who choose textured implants should counsel their patients with breast cancer about their possible consequences," the pair write.
Editorialists Cassidy and Roh express concern that important details were missing from the analysis and presentation. Data on adjuvant endocrine therapy were not included, even though 85% of the cohort had ER-positive breast cancer, they point out.
Similarly, 21% of patients had ERBB2 (formerly, HER2-positive) disease, but no targeted ERBB2 agents were included in the list of adjuvant therapy regimens.
"Therefore, whether the recurrences were associated with inadequate systemic therapy remains unclear," Cassidy and Roh say. "A table that details the history and treatment of the 28 patients with breast cancer recurrence would be helpful in interpreting this study."
Including data from patients who underwent mastectomy for breast cancer recurrence rather than restricting the analysis to data from primary breast cancer cases alone had the effect of "further confounding matters," they add.
Study Details
For the study, Bang and colleagues identified patients with breast cancer who had undergone total mastectomy and immediate two-stage tissue expander/implant reconstruction from a single tertiary referral center database. Patients were categorized into two groups: those who received a smooth implant during reconstruction (39.9%), and those who were given a textured implant (60.1%).
Data analysis showed that 28 women (4.1%) were diagnosed with any type of breast cancer recurrence during the follow-up period. Of these, 23 received a textured implant, and five received a smooth implant.
The 5-year local and regional recurrence-free survival rate was 96.7; the rate did not differ significantly between the two implant groups.
The 5-year DFS was 95.2%, but there was a statistically significant association with lower DFS in the textured-implant group compared with the smooth-implant group after adjusting for ER status and tumor stage (hazard ratio [HR], 3.054; 95% CI; P = .02).
On multivariable analysis, there was a similar textured implant–specific association with worse DFS among patients with ER-positive cancer (HR, 3.130; 95% CI; P = .04) and invasive cancer (HR, 3.044; 95% CI; P = .03). The most pronounced association between textured-implant use and a lower rate of DFS was observed among patients with stage II or III cancer (HR, 8.874; 95% CI, P = .04).
Bang and colleagues note several study limitations. The sample size of the single-institution study was small, and the 4-year follow-up period after implant insertion was inadequate, they say, "especially for ER-positive breast cancer."
Bang and study coauthors as well as editorialists Cassidy and Roh have disclosed no relevant financial relationships.
JAMA Surg. Published online on October 7, 2020. Abstract, Commentary
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