Breast implants with a textured surface used for reconstruction following a total mastectomy were associated with inferior disease-free survival (DFS) and a higher risk of breast cancer recurrence compared with reconstruction using a smooth surface implant, the first retrospective cohort study of its kind suggested.
At 5 years, DFS was over 3 times lower among women who had received a textured breast implant than for those who received a smooth breast implant (Hazard Ratio [HR] of 3.05 [95% CI, 1.15-8.05; P=0.02]), even after adjusting for estrogen receptor (ER) status and tumor stage, senior author Sa Ik Bang, MD, PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and colleagues reported in JAMA Surgery.
On multivariable analysis, local and regional recurrence-free survival (LRRFS) rates were 70% lower among women who received a textured breast implant (HR of 1.70 [95% CI, 0.60-4.80]) compared with women who received a smooth breast implant, investigators added.
The association between the use of a textured implant with lower DFS rates was even more pronounced among women with later-stage II or III tumors (HR of 8.87 [95% CI, 1.14-68.7; P=0.04]), they noted.
“We initiated this study for the purpose of obtaining evidence that implant surface type is not significantly associated with breast cancer prognosis in an effort to relieve the vague anxiety of patients with breast cancer,” Bang and colleagues observed. “Contrary to expectations, we found that the textured implant group had a significantly worse DFS than the smooth group, and this difference remained significant after adjusting for tumor stage and ER status [although f]urther investigation is required to verify these results,” they emphasized.
A total of 650 patients who had undergone total mastectomy and an immediate, 2-stage tissue expander/implant reconstruction were identified from the Samsung Medical Center database. All patients were female and had a mean age of 43.5 years.
Of the 687 cases of breast cancer included in the analysis, approximately 40% received a smooth-surface implant while approximately 60% received a textured-surface implant. Baseline age, body mass index, lymph node operation, tumor stage and use of both adjuvant radiotherapy and chemotherapy were very similar between the 2 groups, as the authors pointed out.
Overall, 4.1% of women were diagnosed with any type of breast cancer recurrence during the study interval, and the researchers noted that the LRRFS rate at 5 years overall was 96.7% while the overall 5-year, DFS rate was 95.2%. However, at the same follow-up point, the textured group had lower rates of LRRFS at 95.9% compared with 97.8% for the smooth group while the DFS rates were also lower at 93.3% in the textured group compared with 97.8% in the smooth group, they added. The textured group also had a higher number of all types of recurrence at 23 events compared with only 5 events for the smooth group.
DFS rates remained significantly different between the 2 groups at 3, 4 and 5 years of follow-up with a P=0.01 at all time points:
- DFS at 3 years: 96.1% in the textured group versus 98.9% for the smooth group.
- DFS at 4 years: 94.7% in the textured group versus 98.5% in the smooth group.
- DFS at 5 years: 93.3% in the textured group versus 97.8% for the smooth group.
In both univariable and multivariable analysis, women with ER-positive tumors who received a textured implant also had a significantly worse DFS than those who had received a smooth implant at 94.3% at 5 years for the textured group compared with 98% for the smooth group (P=0.04).
Similar trends were also seen in women with ER-negative tumors but the difference between the 2 groups did not reach statistical significance, as the authors observed.
As the authors explained, breast implant safety again become a topic of concern with the emergence of reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a severe and unexpected complication of reconstructive surgery and possibly associated with implant surface texture.
Whether or not textured implants could be associated with breast cancer recurrence was a question that patients themselves raised during clinic visits but there had been little evidence to support this association until now.
Indeed, historically, surgeons would explain that the implant is inserted into the subpectoral space created for breast reconstruction which, because it is isolated from the region where breast cancer normally occurs, should not alter the behavior of a tumor regardless of its surface texture.
“With this plausible presumption, many surgeons have relieved the anxiety of their patients by explaining that the inserted implants were probably not associated with the outcomes of breast cancer,” Balk and colleagues pointed out.
Now, however, “[these] results may amplify survivors’ concern regarding the potentially detrimental implications of a textured implant for oncologic outcomes,” they suggested.
The authors also suggested that chronic inflammation is likely a major contributor to the association between the use of textured breast implants and an elevated risk for breast cancer recurrence.
It has been established that textured implants are more likely to lead to the formation of a biofilm than smooth implants, thereby promoting chronic inflammation in the periprosthetic space.
Commenting on the findings, Michael Cassidy, MD, Boston University School of Medicine, Boston, Massachusetts, and colleagues pointed out a number of limitations in the study, including the fact that no data were presented on the use of adjuvant endocrine therapy despite the fact that 85% of the cohort had ER-positive breast cancer. Furthermore, no information was given on the treatment of ERBB2 (formerly HER2)-positive cancer despite the fact that 21% of patients had ERBB2-positive tumors.
“Therefore, whether the recurrences were associated with inadequate systemic therapy remains unclear,” the editorialists wrote.
They pointed to another issue with the study — while most recurrences were confirmed pathologically, “those with clear evidence of recurrence by imaging were not confirmed by biopsy,” Cassidy and colleagues pointed out. Nor was it evident how many of the recurrences in the study were unconfirmed or in which group they occurred, thus limiting interpretation of the data.
They also noted that textured implants were originally designed to reduce capsular contraction and implants that are shaped to provide a more cosmetically pleasing contour have textured surfaces that decrease the risk of implant malrotation, however, they asked: “Given the association of textured implants with [BIA-ALCL], and now the suggestion that they are associated with increased risk for breast cancer recurrence… will the advantages of textured implants remain compelling enough to justify their continued use in breast reconstruction?”
At the very least, surgeons who continue to use textured implants must warn patients about any possible consequences, they advised, although that said, many reconstructive surgeons across the world have already abandoned the use of textured implants altogether, the editorialists noted.
Disease-free survival rates were lower among women who received a breast implant with a textured surface following total mastectomy compared with women who received a smooth surface implant after the same procedure.
The association between textured-surfaced breast implants and poorer patient outcomes, together with a possible risk of anaplastic large cell lymphoma, is calling into question whether these implants should be used at all by reconstructive surgeons.
Pam Harrison, Contributing Writer, BreakingMED™
Neither the authors nor the editorialists had any conflicts of interest to declare.
Cat ID: 22
Topic ID: 78,22,22,691,192,925,159,162