Use of textured breast implants for postmastectomy reconstruction led to a small but significant increase in breast cancer recurrence as compared with smooth-surface implants, a retrospective study from South Korea showed.
Overall, 4% of 650 women had some form of disease recurrence during a median follow-up of 52 months after receiving breast implants. The 5-year locoregional recurrence-free survival (LRRFS) rate was 95.9% among women who received textured implants and 97.8% in those who had smooth implants, a nonsignificant difference, reported Sa Ik Bang, MD, PhD, of Sungkyunkwan University and Samsung Medical Center in Seoul, and colleagues.
As shown in their study online in JAMA Surgery, the 5-year disease-free survival (DFS) rate was significantly lower with textured implants: 93.3% vs 97.8%.
In a Kaplan-Meier survival analysis, LRRFS did not differ by implant surface type, but DFS remained significantly lower in the textured-implant group at 3, 4, and 5 years.
“Textured implant use could be associated with a lower DFS and high risk for recurrence than use of a smooth implant,” the researchers concluded. “This association may be valid regardless of other factors, including tumor stage and ER [estrogen receptor] status. Further investigation is required to verify these results.”
The results added to the well-documented risk of anaplastic large-cell lymphoma (ALCL) associated with breast implants, which have been blamed for 733 cases of ALCL and 36 deaths worldwide as of early 2020. The accumulation of adverse data makes a case for discontinuing use of textured implants, according to the authors of a commentary that accompanied the article by Bang and colleagues.
“Given the association of textured implants with ALCL, 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,” wrote Michael R. Cassidy, MD, and Daniel S. Roh, MD, PhD, both of Boston University School of Medicine. “Many reconstructive surgeons across the world have already abandoned the use of textured implants altogether.”
The sudden emergence of the breast implant-associated (BIA) ALCL, and its possible relationship with implant-surface texture, focused more emphasis on implant safety, Bang and co-authors noted. Patients have raised concern about whether the implants might also be associated with breast cancer recurrence when used in reconstruction procedures after mastectomy, the team added.
No clinical studies had examined the association between breast implants and breast cancer recurrence. Chronic inflammation associated with an implant or the surgical procedure has been hypothesized as a potential trigger for BIA-ALCL.
Clinical and preclinical studies showed that surgery-induced inflammation could have implications for local residual or dormant tumor cells, including the potential to trigger tumor regrowth and metastasis, the authors continued.
To examine the issue, Bang and colleagues retrospectively analyzed data for patients whose breast cancer treatment included use of an implant during reconstruction procedures performed at Samsung Medical Center in Seoul from 2011 through 2016.
The researchers identified 650 patients who received a total of 687 implants, which had textured surfaces in 413 cases and smooth surfaces in 274 cases. The primary outcomes were LRRFS and DFS.
The study population had a mean age of 43.5. Stage I and stage II disease accounted for 70-80% of cases and did not differ substantively between women who received textured or smooth implants. About 15% of patients received adjuvant radiotherapy, and 44% received adjuvant chemotherapy.
Overall, the 5-year LRRFS rate was 97.7% in all patients, and the 5-year DFS rate was 95.2%. A total of 28 breast cancer recurrences occurred during the study period. After adjustment for ER status and tumor stage, DFS remained significantly lower in the patients who received textured implants (HR 3.054, 95% CI 1.158-8.051, P=0.02).
A multivariate analysis showed lower DFS among patients with ER-positive breast cancer (HR 3.130, 95% CI 1.053-9.307, P=0.04) and among patients with invasive cancer (HR 3.044, 95% CI 1.152-8.039, P=0.03). The association between textured implants and lower DFS was more prominent in patients with stage II-III tumors (HR 8.874, 95% CI 1.146-68.748, P=0.04).
LRRFS did not differ statistically by implant surface texture in any of the analyses, the researchers reported.
Last Updated October 07, 2020
Bang and co-authors reported no conflicts of interest.
Cassidy and Roh reported no conflicts of interest.