Impact of breast implants on surgical and oncologic outcomes in breast cancer patients

Introduction

Background

Breast augmentation is one of the most common cosmetic procedures in the U.S., with over 300,000 operations performed annually (1). Approximately four million women in the U.S. have breast implants, and one in eight of these women will develop breast cancer (BC) (2-5). While the majority of breast augmentation is for cosmetic indications, 25% are for reconstruction (6). As breast augmentation becomes more popular, the number of women with implants who will be diagnosed with BC is also likely to rise. This growing demographic underscores the need to understand how implants may influence BC treatment and long-term outcomes.

For women with prior breast augmentation, the diagnosis of BC can present unique challenges. The presence of implants can complicate mammography by potentially obscuring tumors or distorting breast tissue, which can decrease detection sensitivity. The Eklund technique, a modified positioning technique for women with implants, was developed in 1988 to improve image quality (7). However, magnetic resonance imaging (MRI) is now the recommended modality, particularly for detecting ruptures (8). Surgical options may also be influenced by implants, requiring patients and providers to carefully balance oncologic safety with cosmetic outcome.

Rationale and knowledge gap

Despite the increasing rates of breast augmentation and reconstruction, there is limited research on the outcomes in patients with preexisting implants who are diagnosed with BC. Most studies examining the impact of breast augmentation on BC management have focused on post-mastectomy reconstruction outcomes and their effect on cancer detection. Although these topics are essential, no large-scale studies, to our knowledge, have compared the risk of mastectomy in patients with and without prior breast implants, nor have they examined the risk of recurrence or mortality in these patients should they undergo breast-conserving surgery (BCS).

Objective

Our objective was to evaluate whether breast implants influence the likelihood of mastectomy and to compare oncologic outcomes following BCS between patients with and without prior implants. We hypothesize that BC patients with prior implants are more likely to receive a mastectomy due to smaller breast size, proximity of a lesion to the implant capsule, or fear of capsular contraction after radiation. We also hypothesize that overall survival (OS) and risk of local recurrence (LR) with BCS is no different with or without implants. We present this article in accordance with the STROBE reporting checklist (available at https://abs.amegroups.com/article/view/10.21037/abs-25-20/rc).

Methods

Data source

The data used in this study were collected on November 1, 2024, from the TriNetX Research Network’s U.S. Collaborative Network, a global federated health research database. The TriNetX platform provides access to electronic medical records from over 115 million patients in 66 Health Care Organizations (HCOs). Information available covers demographics, diagnoses (based on ICD-10-CM codes for the International Classification of Diseases, Tenth Revision, Clinical Modification), procedures (coded using ICD-10-PCS or CPT), medications [coded using RxNorm naming system, the Veterans Affairs National Formulary, or the Anatomical Therapeutic Chemical (ATC) classification system], and laboratory tests (coded using Logical Observation Identifiers Names and Numbers, or LOINC). The HCOs included patients with or without insurance from hospitals, primary care clinics, and specialists.

Design of cohort

We used the TriNetX database to create a retrospective cohort study for women 18 years or older with a diagnosis of BC (ICD-10-CM C50). Stage 4 and T4 cancers were excluded. Cohort one included women who had nonautologous breast implants at least one year before BC diagnosis. Cohort two included women who never had implants at any point before BC diagnosis. The following codes were used to identify patients with nonautologous implants:

• CPT 19325, 19340, 19342;
• ICD-10-CM Z98.82.

We then conducted another retrospective study using the same cohorts. In this study, however, all patients underwent BCS.

Outcomes

Outcomes for our cohorts were assessed during the follow-up period, one day after the index event, which was a BC diagnosis, to 5 years. The outcome of our first study was mastectomy, and the outcomes of our second study were LR and OS. The codes used were the following:

• Mastectomy: CPT 19303-19307, ICD-9-CM 85.4, ICD-10-PCS 0HTT, 0HTU, 0HTV, 0HTT0ZZ, 0HTU0ZZ, 0HTV0ZZ;
• LR: ICD-10-CM C77.3, C79.81;
• OS: coded as “Deceased” under Demographics.

Statistical analysis

All statistical analyses were performed using the TriNetX platform. To reduce the effect of confounding factors, we used propensity score matching to generate groups with matched baseline characteristics. We adopted the TriNetX built-in platform for covariate adjustment, which uses multiple software components to ensure accuracy. We matched the two cohorts for both studies at a 1:1 ratio through the greedy nearest-neighbor algorithm. The covariates used to balance our cohorts were age at index event, body mass index (BMI), cancer stage (0–3), tumor size (T1–T3), genetic carrier status (ICD-10-CM Z14-Z15), pregnancy status (Z33), history of irradiation (Z92.3) and comorbidities such as diabetes mellitus (E08–E13), chronic obstructive pulmonary disease (COPD; J44), and tobacco use (Z72.0).

The standardized difference was used to evaluate the balance of baseline characteristics in the propensity score-matched populations. A value less than 0.1 was considered an acceptable balanced match (9).

The Kaplan-Meier (KM) curve was used to analyze 5-year OS. All reported P values are based on two-sided tests, with a P value <0.05 with the log-rank test considered statistically significant. We evaluated the odds ratio (OR) and P value for mastectomy risk and LR using a 95% confidence interval (CI). This was considered statistically significant if the CI did not include 1.

Ethical consideration

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The ethical approval and informed consent were waived by the institutional review board (IRB) under the de-identification standard defined in Section §164.514(a) of the Health Insurance Portability and Accountability Act Privacy Rule, as data were directly retrieved from electronic health record systems of participating organizations in a systematic and standardized format.

Results

There were 31,794 women from 59 HCOs in the TriNetX U.S. Collaborative Network who had implants at least one year before BC diagnosis and 880,575 women from 68 HCOs who did not have implants at any point before BC diagnosis. After propensity matching, there were 28,414 patients in each cohort (Figure 1).

Figure 1 Flow diagram of cohort construction for female breast cancer patients who did or did not have implants. Female patients aged 18 years or older with stage I–III, T1–T3 breast cancer were identified, separated by either a history of prior implants or no implants, then propensity-matched. BMI, body mass index; HCO, Health Care Organization; T, tumor.

The covariate characteristics of the two cohorts before and after propensity score matching are presented in Tables 1,2, respectively. Before matching, patients in the implant group had more comorbidities, such as diabetes, COPD, and tobacco use. After propensity score matching (mean, standard difference <0.1), all covariates used for matching were similar in the two cohorts and are illustrated in Table 2.

For our first study comparing women with implants to those without implants, mastectomy risk after BC diagnosis was 11% in the cohort without implants and 2% in the cohort with implants (OR 5.645, 95% CI: 5.17–6.16, P<0.001) (Table 3).

For our BCS study, cohort one contained 10,792 women from 55 HCOs who had implants at least one year before BC diagnosis and underwent BCS. Cohort two contained 168,684 women from 59 HCOs who did not have implants at any point before BC diagnosis and underwent BCS. After propensity matching, there were 10,043 patients in each cohort (Figure 2).

Figure 2 Flow diagram of cohort construction for female breast cancer patients who did or did not have implants and underwent BCS. Female patients aged 18 years or older with stage I–III, T1–T3 breast cancer were identified, separated by either a history of prior implants or no implants, and underwent BCS, then propensity-matched. BCS, breast-conserving surgery; BMI, body mass index; HCO, Health Care Organization.

Patients with implants had a LR rate of 1.2% compared to 1.4% in the no implants group (OR 0.82, 95% CI: 0.64–1.05, P=0.12) (Table 4).

For 5-year OS, 484 deaths were reported among the implant cohort and 462 among the no-implants cohort (Table 4). KM analysis demonstrated a 5-year survival probability of 93.7% in the implant cohort compared to 93.5% in the no-implant cohort (Figure 3). This was statistically insignificant with the log-rank test (P=0.50).

Figure 3 Kaplan-Meier survival curve of cohort 1 (implants + BCS) and cohort 2 (no implants + BCS) after propensity score matching. BCS, breast-conserving surgery; df, degrees of freedom; χ², Chi-squared test.

Discussion

The number of women undergoing breast augmentation is increasing as literature continues to support the safety of breast implants. Multiple meta-analyses have now demonstrated that breast implants do not increase BC risk, although it is important to acknowledge that breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), though rare, remains a recognized risk in patients with preexisting textured implants (10-12). Consequently, as the population of women with augmented breasts ages, an increase in BC incidence among this group is expected.

BC patients with preexisting implants face unique challenges during treatment, with the two primary options being mastectomy and breast conservation therapy (BCT). Compared to patients without prior augmentation, these patients have altered breast anatomy due to the presence of an implant. They may have a smaller amount of autologous breast tissue, and tumors may be near the implant capsule. This could interfere with the surgical approach, particularly with multifocal disease or when obtaining margins, and patients may need to consider implant removal or additional reconstructive options. Patients with existing implants who wish to preserve them after surgery are also at risk of capsular contracture after radiation therapy, which could impact their choice between BCS and mastectomy (13,14). A 1996 study by Handel et al. questioned the appropriateness of BCT after augmentation. Of the 26 patients who underwent BCT in this study, 17 had radiation-induced contracture and were unsatisfied with their cosmetic results (15). Another retrospective study in 2003 by Karanas et al. found that 20 of 28 previously augmented women who underwent BCT experienced implant complications, including contracture, LRs, and inability to obtain negative margins. They, therefore, concluded that mastectomy with immediate reconstruction was a more suitable option (16). However, a randomized controlled trial in 2019 found that patients without implants who underwent BCS still had a 50% likelihood of having moderate to high shrinkage of the breast (17).

Despite these challenges, our retrospective cohort study found that BC patients with prior implants are not more likely to receive a mastectomy. This is in contrast to a small 2018 single-institution case-control study by Sosin et al., who found that BC patients with prior augmentation were more likely to receive a mastectomy than a lumpectomy (18). Perhaps when compared to nonaugmented patients, the majority of previously augmented patients have greater expectations about aesthetic results and, therefore, choose to pursue BCT. Our review of the literature found that not only are previously augmented patients more likely to undergo breast reconstruction (19), they are also more likely to undergo implant removal (20) or implant-based reconstruction (21).

It is important to note that the cosmetic outcome of BCT in patients with prior implants depends on several factors, including the operative technique, radiation dose to the whole breast, radiation boost to the tumor site, and location of the implant (22). Unnecessarily wide margins may lead to poor cosmesis. Lower total radiation doses may be associated with better cosmetic results, and boosts should be limited to a precisely defined area. In fact, an implant-sparing approach, the HALFMOON (helical altered fractionation for implant partial omission) technique, was developed in 2020 to reduce radiation dose and optimize coverage in patients with implants (13). However, the preliminary results in 2023 still reported nearly 88% of patients with Baker grade II capsular contracture after 1.2 years of follow-up (23). Studies have also shown that capsular contracture is more frequent in women with sub-glandular breast implants compared to retro-muscular implants (24). Of note, emerging techniques such as fat grafting have been utilized to mitigate some of the adverse cosmetic effects of radiation therapy, particularly in patients with smaller breast volumes (25). These factors should be considered when pursuing radiation therapy in the presence of preexisting implants.

Our study also found that women with implants who undergo BCS had no difference in 5-year OS and LR rate compared to propensity-matched women without implants. Several studies have demonstrated that implant-based reconstruction after BC surgery does not increase the recurrence risk or affect survival (26-31). Additionally, no differences were observed in tumor size, nodal positivity, stage, or survival (12,31-33) when comparing augmented to nonaugmented patients. While our study evaluated patients with implants prior to BC surgery, it is well known that postmastectomy radiation therapy reduces the risk of LR (34,35), so we suspect that augmented patients who undergo BCS are likely pursuing adjuvant radiation. Thus, there should be no significant difference in OS or LR risk.

In general, it is recommended that patients have preexisting implants removed before BC surgery if they have sub-glandular implants, ruptures or leaks, implant exposure or infection, capsular contractures, pain, indolent seromas, aged silicone implants, plans for radiation therapy, or if the tumor is in close proximity to the implant (20). Most plastic surgeons advise waiting six months after radiation before undergoing definitive breast reconstruction surgery to allow the inflammatory process to subside (36). Regardless of whether reconstruction is performed, surgical planning should consider the patient’s breast size, shape, and symmetry goals to help optimize cosmetic outcomes (37).

Patients who elect to keep their implants and pursue BCT should be counseled about the risk of capsular contracture, poor cosmesis, wound complications, higher rate of reoperation, and potential limitations of future BC screening (38). Although augmented breasts can obscure cancer detection on mammography due to tissue distortion (33), implants may actually facilitate physical examination. Patients with previous augmentation are more likely to present with a palpable mass due to breast tissue compression, thinning, and atrophy from the implant (31,32,39). The limited reliability of mammography and the high proportion of patients with palpable lesions highlight the importance of thorough breast examinations in patients with prior augmentation. MRI is now the recommended imaging modality for those with implants (8).

We acknowledge several limitations due to the study’s retrospective nature and reliance on electronic records from multiple institutions, which could lead to potential misdiagnosis, selection bias, inaccurate coding, and documentation errors. Additionally, we were unable to determine the time from implant placement to BC diagnosis. We were also unable to determine the type of implant (textured versus smooth), the location of the implant, and the starting breast size and ptosis. We also did not have information on surgical margins, degree of nodal involvement, duration or dose of radiation therapy, cosmetic outcomes, re-operation rates, and patient satisfaction. Furthermore, while propensity score matching was utilized to minimize baseline differences and create balanced cohorts, it is possible that residual imbalance may persist despite matching. Future studies could consider employing regression-based analyses to refine effect size estimation. Despite these limitations, the strength of our study stems from the analysis of a large and diverse multicenter database with a nationally validated set of outcome data and a rigorous audit process. We obtained a large sample size, collected long-term clinical outcomes data, and matched patients on characteristics including tumor size and stage, exposure to prior radiation, and genetic carrier status, thus accounting for multiple potential confounders.

Conclusions

Stage I–III, T1–T3 BC patients with prior breast augmentation are not more likely to receive a mastectomy compared to nonaugmented patients. Those receiving BCS have no difference in 5-year OS or LR risk. Thus, the presence of implants should not influence the decision between BCS and mastectomy. We recommend considering removal of preexisting implants in patients who plan to receive radiation therapy given the higher risk of capsular contracture (~10%) and cosmetic dissatisfaction (13,15,22). Furthermore, the extensive literature demonstrating the adverse effect of implants on cancer detection underscores the importance of research evaluating BC detection and treatment in patients with prior augmentation.

Acknowledgments

We would like to thank the University of Texas Medical Branch at Galveston for providing access to the TriNetX Research Network, which enabled the collection of data for this study. We also extend our gratitude to our colleagues in the Department of Surgery for their valuable insights and support throughout the research process. Finally, we acknowledge the patients whose data contributed to this study. Our abstract has been accepted for presentation at the 2025 Annual Meeting of the American Society of Breast Surgeons and published in the Annals of Surgical Oncology (Volume 32, Supplement 2, pages 311-952, 2025). DOI: https://doi.org/10.1245/s10434-025-17646-6.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://abs.amegroups.com/article/view/10.21037/abs-25-20/rc

Data Sharing Statement: Available at https://abs.amegroups.com/article/view/10.21037/abs-25-20/dss

Peer Review File: Available at https://abs.amegroups.com/article/view/10.21037/abs-25-20/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://abs.amegroups.com/article/view/10.21037/abs-25-20/coif). V.S.K. serves as an unpaid editorial board member of Annals of Breast Surgery from March 2025 to December 2026. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments.The ethical approval and informed consent were waived by the institutional review board (IRB) under the de-identification standard defined in Section §164.514(a) of the Health Insurance Portability and Accountability Act Privacy Rule, as data were directly retrieved from electronic health record systems of participating organizations in a systematic and standardized format.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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