Abstract
Background:
Textured implants have been linked to breast implant-associated anaplastic large-cell lymphoma. Patients who undergo explantation have options for reconstruction, but data on safety and patient-reported outcomes (PROs) is limited. The purpose of this study was to classify complications and PROs in patients opting for surgical management of textured implants.
Methods:
Complication rates and BREAST-Q scores were compared between (i) asymptomatic patients who underwent conversion from textured to smooth implants (n=224), (ii) symptomatic patients who underwent conversion from textured to smooth implants (n=83), (iii) patients who underwent explantation without replacement (n=44), and (iv) patients who underwent replacement with autologous reconstruction (n=33). Linear regression examined PROs controlling for clinical and surgical variables.
Results:
Overall complication rates in 384 patients (637 implants) differed across groups (p=0.034) with the highest rate (25%) in patients who underwent explantation without replacement. These patients were specifically more impacted by minor complications, notably seroma. Capsulectomy extent did not significantly impact complications. Asymptomatic and symptomatic smooth implant patients had improvements in satisfaction with breasts (<0.05). Autologous reconstruction patients had significant improvements in satisfaction with breasts sustained after 3 months postoperative (p<0.01) and sexual well-being sustained after 6-months postoperative (p<0.05). Patients who underwent removal without replacement had lower physical well-being of the chest scores at ≥1 year than the other groups.
Conclusions:
Replacement of textured implants with smooth implants or flaps is safe and is associated with improved satisfaction with breasts and quality of life. The degree of capsulectomy does not appear to impact the incidence of perioperative complications.
INTRODUCTION
Textured breast implants were first used in the 1970s to mitigate the incidence of capsular contracture, prevent implant malposition, and enhance the breast’s natural appearance.1–5 Despite their purported benefits, textured implants became controversial after studies linked them to breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).6–11 The discourse surrounding their usage culminated in July 2019, when the U.S. Food and Drug Administration (FDA) recalled Allergan Biocell textured implants,12 raising questions for the millions of patients with such implants in place. Currently, the FDA does not recommend removal of textured implants in patients without symptoms.12,13
Despite the relatively rare incidence of BIA-ALCL8,14,15 many patients with textured implants remain concerned about their chances of malignancy and inquire about implant replacement. The lack of data guiding the management of textured breast implants often results in anxiety as patients seek information from unverified sources.16 A 2019 study assessing the effects of informing patients with textured implants about their risk for BIA-ALCL reported that of 16 patients with textured implants, 9 requested surgical intervention.17 Recently described algorithms for the management of textured implants are based largely on best-practice judgment rather than evidence-based data,13,18,19 and they focus mostly on patients experiencing symptoms such as new-onset rash or seroma rather than asymptomatic patients.20 One recent study outlined a preliminary treatment algorithm for asymptomatic patients, however this study focuses on aesthetic rather than reconstructive patients.19 Furthermore, all of these studies reference the scarcity of outcomes-related data, and frequently call for further evidence-based research on how to best address the management of patients with textured implants.
Our group previously identified three types of surgical management for patients with textured implants: conversion from textured to smooth implants, removal of textured implants without further reconstruction, and conversion from textured implants to autologous reconstruction.21 There is a gap in knowledge regarding the relative safety of each surgical pathway, as well as how outcomes compare. One of the most critical aspects of a postoperative assessment are patient-reported outcomes (PROs). PROs have the potential to disclose aspects of the patient experience that strongly influence quality of life (QOL) and provide knowledge that contributes to patient-centered care.22–25 For reconstructive and aesthetic breast surgery, PROs are commonly measured with the BREAST-Q, a validated survey that has been in use since 2009.26–30 Its repeated validation in the field of reconstructive breast surgery makes it an especially useful tool for assessing postoperative outcomes from the patient’s perspective.31 BREAST-Q provides both a quantitative and qualitative assessment of PROs, capturing quality of life and satisfaction. The aim of this study was to compare surgical options for managing textured implants in terms of complication profiles and PROs and to evaluate the effect of capsulectomy extent on rates of complications. The study tested the hypotheses that all three surgical options can be performed safely, that PROs do not differ meaningfully between them, and that QOL increases following surgical intervention for textured implants.
METHODS
Patients
This study was approved by the Institutional Review Board of Memorial Sloan Kettering Cancer Center with a waiver of informed consent as it was a retrospective analysis of previously collected data with no more than minimal risk to participants. We searched the institutional database to identify female patients ≥18 years of age who underwent surgical management for textured implants at Memorial Sloan Kettering between January 2018 and June 2021. Patients were excluded if they had tissue expanders placed between the removal of textured implants and further reconstruction. Patients who did not complete at least one BREAST-Q survey were excluded from the analysis of PROs. All patients had a history of breast reconstruction rather than augmentation.
We identified three surgical interventions for the management of textured implants: 1) removal of the textured implant and conversion to smooth implants; 2) removal of the textured implant and conversion to autologous reconstruction; 3) and removal of the textured implant with no replacement.21 After using CPT codes 11970 and 19342 to identify patients who underwent implant placement, we reviewed the medical records to identify patients with textured implants. We then used CPT codes 19340 and 19342 to identify patients who underwent replacement of textured implants with smooth implants, CPT code 19328 to identify patients who underwent implant removal without further reconstruction, and CPT code 19364 to identify patients who underwent autologous reconstruction. For patients who underwent replacement with smooth implants, complication and PRO profiles were analyzed separately for symptomatic and asymptomatic patients. Inclusion criteria for symptoms in patients undergoing implant exchange included capsular contracture (Baker grade III/IV), chronic infection/seroma, rupture, and pain, with 59% of patients presenting with capsular contracture. Asymptomatic patients sought surgical management because of their concern for BIA-ALCL.
Outcomes
For analysis of complication rates, data were collected for the following complications: hematoma, cellulitis or other infection, capsular contracture (Baker grade III or IV), seroma, wound dehiscence, and reconstructive failure (smooth implant removal or flap failure). We included complications that occurred both within and beyond 90 days of surgery. We examined the association between cohort and complications at both the patient and implant level. Major complications were defined as any of the above complications requiring a return to the OR. Minor complications were defined as any of the above complications that were managed without operative intervention.
For analysis of PROs, responses on the following BREAST-Q subscales were analyzed: Satisfaction with Breasts, Physical Well-Being of the Chest, Psychosocial Well-Being, and Sexual Well-Being. Patients were asked to complete the survey before the surgical intervention and at the following time points after the intervention: 2 and 6 weeks; 3 and 6 months; and 1, 2, 3, and 4 years. Average scores were calculated for surveys completed at 1 year and later. For patients who underwent removal of textured implants without replacement, Satisfaction with Breasts was not analyzed, as these patients removed their reconstructions.
Statistical Analysis
We compared the baseline demographic characteristics of patients using Fisher’s exact test for categorical variables and the Kruskal-Wallis test for continuous variables. Fisher’s exact test was used to compare complication rates between cohorts, and the Kruskal-Wallis test was used to evaluate associations between BREAST-Q scores and surgical management strategies. Preoperative and postoperative BREAST-Q scores were compared using the Mann-Whitney U test. We also used linear regressions to identify explanatory variables for BREAST-Q scores and adjust for cofounding variables. A p-value of <0.05 was considered significant. All statistical analyses were conducted with R software version 4.0.3.
RESULTS
Patient Groups
Of 384 patients (637 textured implants) included in the analysis of surgical complications, 224 asymptomatic patients (58%) and 83 symptomatic patients (22%) underwent replacement of their textured implants with smooth implants, 44 patients (12%) underwent removal of their textured implants without replacement, and 33 patients (9%) underwent removal of their textured implants with conversion to autologous reconstruction (Fig. 1). BREAST-Q data were available for 239 of the 384 patients. The distribution of the 239 patients among the surgical intervention groups was similar to the distribution of the 384 patients included in the analysis of complications (Fig. 1).
Fig. 1.
Patient groups.
The groups of patients differed significantly in age, race, some comorbidities (diabetes, congestive heart failure, hypertension, and immune disease), cancer treatments (neoadjuvant chemotherapy and postoperative radiotherapy), and medical insurance (Table 1). Patients who underwent conversion to smooth implants were more likely to undergo bilateral replacement (73% and 64% for asymptomatic and symptomatic patients, respectively), whereas in patients who underwent removal without replacement or autologous reconstruction, the procedure was more likely unilateral (52% for both respective groups). The rates of subpectoral implants, textured silicone implants, and complete capsulectomies differed significantly between groups. Mean time between placement of textured implants and surgical intervention and the distributions of implant manufacturers and smooth implant fill materials did not differ significantly (Table 1). ADM was not typically utilized in the exchange procedure. All removed capsules were sent for pathologic examination; none were noted to have BIA-ALCL. For the 239 patients with PRO data available, group characteristics are listed in Table, Supplemental Digital Content 1.
Table 1.
Patient and Treatment Characteristics
| Characteristic | No. of Patients (%) |
p | ||||
|---|---|---|---|---|---|---|
| Full Cohort (n = 384) |
Replacement with Smooth Implants |
Removal without Replacement (n = 44) |
Replacement with Autologous Reconstruction (n = 33) | |||
| Asymptomatic (n = 224) |
Symptomatic (n = 83) |
|||||
|
| ||||||
| Age (yrs) | <0.001 | |||||
| Mean ± SD Median (1st, 3rd quartiles) |
57.4 ± 9.7 57 (51, 64) |
56.7 ± 9.8 56 (32, 80) |
58.5 ± 9.6 58 (40, 82) |
62.7 ± 9.0 62 (40, 80) |
52.8 ± 6.7 53 (37, 64) |
|
| Race | 0.001 | |||||
| White Black Asian Other |
345 (89.8) 20 (5.2) 13 (3.4) 6 (1.6) |
209 (93.3) 4 (1.8) 6 (2.7) 5 (2.1) |
75 (90.4) 4 (4.8) 3 (3.6) 1 (1.2) |
36 (81.8) 7 (15.9) 1 (2.3) 0 |
25 (75.8) 5 (15.2) 3 (9.1) 0 |
|
| Ethnicity | 0.630 | |||||
| Not Hispanic Hispanic Unknown |
344 (89.6) 21 (5.5) 19 (4.9) |
201 (89.7) 12 (5.4) 11 (4.9) |
73 (88.0) 6 (7.2) 4 (4.8) |
39 (88.6) 1 (2.3) 4 (9.1) |
31 (93.9) 2 (6.1) 0 |
|
| BMI | 0.086 | |||||
| Mean ± SD Median (1st, 3rd quartiles) |
25.3 ± 6.5 24.8 (22, 27.9) |
24.8 ± 6.7 24.3 (0, 56.4) |
26.3 ± 5.1 25.1 (17.2, 40) |
26.3 ± 6.5 25.8 (0, 40.2) |
25.1 ± 8.0 25.5 (0, 43.9) |
|
| Marital status | 0.392 | |||||
| Married Single Divorced/widowed/separated |
291 (75.8) 48 (12.5) 45 (11.7) |
177 (79.0) 23 (10.3) 24 (10.7) |
57 (68.7) 15 (18.1) 11 (13.3) |
30 (68.2) 7 (15.9) 7 (15.9) |
27 (81.8) 3 (9.1) 3 (9.1) |
|
| Insurance | 0.006 | |||||
| Commercial Medicare Medicaid Self-pay |
279 (72.7) 97 (25.3) 7 (1.8) 1 (0.3) |
165 (73.7) 56 (25.0) 3 (1.3) 0 |
60 (72.3) 21 (25.3) 1 (1.2) 1 (1.2) |
25 (56.8) 18 (40.9) 1 (2.3) 0 |
29 (87.9) 2 (6.1) 2 (6.1) 0 |
|
| Smoking history | 0.316 | |||||
| None Current Previous |
256 (66.7) 27 (7.0) 101 (26.3) |
157 (70.1) 14 (6.3) 53 (23.7) |
53 (63.9) 8 (9.6) 22 (26.5) |
23 (52.3) 3 (6.8) 18 (40.9) |
23 (69.7) 2 (6.1) 8 (24.2) |
|
| Diabetes | 26 (6.8) | 11 (4.9) | 5 (6.0) | 9 (20.5) | 1 (3.0) | 0.007 |
| Cardiovascular disease | 117 (30.5) | 61 (27.2) | 24 (28.9) | 16 (36.4) | 16 (48.5) | 0.078 |
| CHF | 3 (0.8) | 0 | 2 (2.4) | 0 | 1 (3.0) | 0.042 |
| COPD | 57 (14.8) | 30 (13.4) | 13 (15.7) | 9 (20.5) | 5 (15.2) | 0.628 |
| CKD | 2 (0.5) | 1 (0.4) | 0 | 1 (2.3) | 0 | 0.408 |
| Hypertension | 101 (26.3) | 48 (21.4) | 26 (31.3) | 18 (40.9) | 9 (27.3) | 0.035 |
| Immune disease | 64 (16.7) | 28 (12.5) | 15 (18.1) | 11 (25.0) | 10 (30.3) | 0.023 |
| Liver disease | 21 (5.5) | 10 (4.5) | 6 (7.2) | 5 (11.4) | 0 | 0.118 |
| Neoadjuvant chemotherapy | 166 (43.2) | 90 (40.2) | 37 (44.6) | 17 (38.6) | 22 (66.7) | 0.035 |
| Adjuvant chemotherapy | 18 (4.7) | 9 (4.0) | 7 (8.4) | 1 (2.3) | 1 (3.0) | 0.372 |
| Neoadjuvant radiotherapy | 13 (3.4) | 5 (2.2) | 4 (4.8) | 3 (6.8) | 1 (3.0) | 0.243 |
| Adjuvant radiotherapy | 44 (11.5) | 15 (6.7) | 8 (9.6) | 10 (22.7) | 11 (33.3) | <0.001 |
| Laterality | 0.001 | |||||
| Unilateral Bilateral |
131 (34.1) 253 (65.9) |
61 (27.2) 163 (72.8) |
30 (36.1) 53 (63.9) |
23 (52.3) 21 (47.7) |
17 (51.5) 16 (48.5) |
|
| 0.002 | ||||||
| Subpectoral Other* |
360 (93.8) 24 (6.3) |
218 (97.3) 6 (2.7) |
73 (88.0) 10 (12.0) |
38 (86.4) 6 (13.6) |
31 (93.9) 2 (6.1) |
|
| Capsulectomy | 0.031 | |||||
| None Partial Complete |
39 (10.2) 115 (29.9) 230 (59.9) |
25 (11.2) 70 (31.3) 129 (57.6) |
9 (10.8) 30 (36.1) 44 (53.0) |
4 (9.1) 12 (27.3) 28 (63.6) |
1 (3.0) 3 (9.1) 29 (87.9) |
|
| Textured implant lifespan (yrs) | 0.522 | |||||
| Mean ± SD Median (1st, 3rd quartiles) |
9.7 ± 4.8 9.8 (5.4, 12.2) |
9.7 ± 4.4 9.6 (0.5, 26.2) |
9.7 ± 56.0 9.9 (0.3, 25.7) |
9.8 ± 4.7 9.9 (1.5, 19.6) |
9.5 ± 4.1 10.5 (1.4, 17.0) |
|
| Textured implant fill | 0.005 | |||||
| Saline Silicone Other |
86 (22.4) 297 (77.3) 1 (0.3) |
43 (19.2) 180 (80.4) 1 (0.4) |
15 (18.1) 68 (81.9) 0 |
20 (45.4) 24 (54.5) 0 |
8 (24.2) 25 (75.8) 0 |
|
| Smooth implant fill† | 0.820 | |||||
| Saline Silicone Other |
64 (20.8) 242 (78.8) 1 (0.3) |
48 (21.4) 175 (78.1) 1 (0.4) |
16 (19.3) 67 (80.7) 0 |
|||
| Textured implant manufacturer | 0.236 | |||||
| Allergan Inamed McGhan Mentor Natrelle Sientra |
205 (53.4) 64 (16.7) 56 (14.6) 29 (7.6) 1 (0.3) 29 (7.6) |
127 (56.7) 34 (15.2) 25 (11.2) 17 (7.6) 1 (0.4) 20 (8.9) |
38 (45.8) 16 (19.3) 16 (19.3) 10 (12.0) 0 (0) 3 (3.6) |
24 (54.5) 6 (13.6) 9 (0.5) 2 (4.5) 0 (0) 3 (6.8) |
16 (48.5) 8 (24.2) 6 (18.2) 0 (0) 0 (0) 3 (9.1) |
|
| Smooth implant manufacturer† | 0.121 | |||||
| Allergan Inamed Mentor Sientra |
285 (92.8) 1 (0.3) 1 (0.3) 20 (6.5) |
210 (93.8) 0 (0) 0 (0) 14 (6.3) |
75 (90.4) 1 (1.2) 1 (1.2) 6 (7.2) |
|||
SD, standard deviation; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CKD, chronic kidney disease; HTN, hypertension; XRT, radiation therapy.
Prepectoral, latissimus, subpectoral to prepectoral conversion, or unknown.
n = 307.
Complications
For the 384 patients in the full cohort, the rate of complications was 10.9%, with mean follow-up of 19.6 ± 11.3 months. Patients who underwent removal without replacement had a significantly higher overall rate of complications (25%) than both of the textured to smooth groups (9 %, p=0.007 and 9%, p=0.034 for the asymptomatic and symptomatic groups, respectively). There were no statistically significant differences observed among the four groups with regards to major complications. However, patients who had removal without replacement had significantly higher rates of minor complications (25%) than the other groups (4.5%, p<0.001, 7.2% p = 0.011 and 3%, p = 0.01 for the asymptomatic, symptomatic, and autologous groups, respectively). Seromas accounted for a large percentage of these minor complications, and rates of seroma differed significantly between groups (18% for removal without replacement vs. 0% for all other groups; p<0.01) (Table 2). Many complications occurred within 90 days of surgery, however, of the 11 cases of capsular contracture (more commonly a late complication) only 3 occurred within 90 days. The extent of capsulectomy was not associated with overall or specific complication rates (Table 3).
Table 2.
Complications
| Complication | No. of Patients (%) |
p | |||
|---|---|---|---|---|---|
| Replacement with Smooth Implants |
Removal without Replacement (n = 44) |
Replacement with Autologous Reconstruction (n = 33) | |||
| Asymptomatic (n = 224) |
Symptomatic (n = 83) |
||||
|
| |||||
| Any complication (n = 42; 10.9%) |
20 (8.9) | 8 (9.6) | 11 (25.0) | 3 (9.1) | 0.034 * |
|
| |||||
| Major Complications (n = 14; 3.6%) |
10 (4.5) | 2 (2.4) | 0 | 2 (6.1) | 0.391 |
| Minor Complications (n = 28; 7.3%) |
10 (4.5) | 6 (7.2) | 11 (25.0) | 1 (3.0) | <0.001 $ |
|
| |||||
| Cellulitis | 7 (3.1) | 5 (6.0) | 1 (2.3) | 1 (3.0) | 0.635 |
| Capsular contracture | 6 (2.7) | 3 (3.6) | 2 (4.5) | 0 | 0.707 |
| Hematoma | 7 (3.1) | 1 (1.2) | 1 (2.3) | 1 (3.0) | 0.871 |
| Reconstruction failure | 2 (0.9) | 1 (1.2) | 0 | 1 (3.0) | 0.425 |
| Seroma | 0 | 0 | 8 (18.2) | 0 | <0.001 † |
| Wound dehiscence | 2 (0.9) | 0 | 0 | 1 (3.0)^ | 0.464 |
A pairwise analysis found the difference in overall complication rates exists between patients converting from textured to smooth implants and patients removing their implants without replacement (Removal without Replacement vs Asymptomatic Textured to Smooth p=0.007, Removal without Replacement vs Symptomatic Textured to Smooth p=0.034).
A pairwise analysis found the difference in rates of minor complications exists between each cohort when compared to the patients removing their implants without replacement (Removal without Replacement vs Asymptomatic Textured to Smooth p<0.001, Removal without Replacement vs Symptomatic Textured to Smooth p = 0.011, Removal without Replacement vs Replacement with Autologous p=0.010).
A pairwise analysis found the difference in rates of seroma exists between each cohort when compared to the patients removing their implants without replacement (Removal without Replacement vs Asymptomatic Textured to Smooth p<0.001, Removal without Replacement vs Symptomatic Textured to Smooth p<0.001, Removal without Replacement vs Replacement with Autologous p=0.009).
The single case of wound dehiscence in the replacement with autologous reconstruction group was abdominal and was categorized as a unilateral complication.
Table 3.
Complication Rates in Relation to Capsulectomy Extent
| Complication | No. of Patients (%) |
p | ||
|---|---|---|---|---|
| No Capsulectomy (n = 39; 10.2%) |
Partial Capsulectomy* (n = 115; 29.9%) |
Complete Capsulectomy (n = 230; 59.9%) |
||
|
| ||||
| Any complication | 7 (23.3) | 8 (7.0) | 27 (11.7) | 0.119 |
| Major Complications | 1 (2.6) | 2 (1.7%) | 11 (4.8) | 0.424 |
| Minor Complications | 6 (15.4) | 6 (5.2%) | 16 (7.0) | 0.117 |
| Cellulitis | 3 (7.7) | 2 (1.7) | 9 (3.9) | 0.172 |
| Capsular contracture | 2 (5.1) | 2 (1.7) | 7 (3.0) | 0.473 |
| Hematoma | 1 (2.6) | 1 (0.9) | 8 (3.5) | 0.324 |
| Reconstruction failure | 0 | 1 (0.9) | 3 (1.3) | 1.000 |
| Seroma | 2 (5.1) | 2 (1.7) | 4 (1.7) | 0.331 |
| Wound dehiscence | 0 | 2 (1.7) | 1 (2.3) | 0.463 |
A capsulectomy was categorized as at least partial if a specimen was sent for pathology analysis.
The 384 patients in the full cohort had a total of 637 textured implants: 387 (61%) were exchanged for smooth implants in asymptomatic patients, 136 (21%) were exchanged for smooth implants in symptomatic patients, 65 (10%) were removed without replacement, and 49 (8%) were exchanged for autologous reconstruction. As with the patient level analysis, the association of removal without replacement with the overall rate of complications, the rate of minor complications, and with the rate of seroma was significant at the implant level (Table, Supplemental Digital Content 2). Additionally, no association was found between complication rates and the extent of capsulectomy (Table, Supplemental Digital Content 3).
PROs
Satisfaction with Breasts
Patients who underwent autologous reconstruction had significantly lower average preintervention scores on the BREAST-Q scale Satisfaction with Breasts (37 ± 15) than patients who underwent removal without replacement (49 ± 23, p=0.036), or replacement with smooth implants (asymptomatic: 56 ± 21; p<0.001); symptomatic: 51 ± 23, p=0.003; Table 4, Fig. 2). Compared to their mean preoperative scores, this group had significantly higher scores at 3 months (60 ± 16, p=0.003), 6 months (72 ± 18, p<0.001), and >1 year (63 ± 20, p<0.001). Asymptomatic patients who underwent replacement with smooth implants also had significantly higher scores at 3 months (64 ± 25, p=0.007), 6 months (63 ± 19, p=0.031), and ≥1 year (64 ± 22, p<0.001) compared to their baseline (56 ± 21). Symptomatic patients who underwent replacement with smooth implants had significantly higher scores at 3 months (67 ± 31, p=0.001) and ≥1 year (65 ± 20, p=0.004) after replacement compared to their baseline (51 ± 23). These values all met the minimal clinically important difference (MCID).32 In regression modeling, no significant association was found between postintervention scores and any patient or treatment variable examined (Table, Supplemental Digital Content 4).
Table 4.
BREAST-Q Scores for Satisfaction with Breasts
| Time of Survey | Score* |
p | |||
|---|---|---|---|---|---|
| Replacement with Smooth Implants |
Removal without Replacement | Replacement with Autologous Reconstruction | |||
| Asymptomatic | Symptomatic | ||||
|
| |||||
| Preoperative | n = 137 | n = 50 | n = 28 | n = 18 | 0.003 # |
| Median (1st, 3rd quartiles) | 53 (0, 100) | 53 (0, 100) | 50.5 (0, 100) | 39 (0, 58) | |
| 3 mo post-operative | n = 55 | n = 24 | n = 9 | 0.616 | |
| Median (1st, 3rd quartiles) | 62 (0, 100) | 67 (0, 100) | 59 (32, 86) | ||
| Change in mean score† (p) | +7.9 (0.007) | +15.4 (0.001) | +22.8 (0.003) | ||
| 6 mo post-operative | n = 55 | n = 21 | n = 14 | 0.155 | |
| Median (1st, 3rd quartiles) | 59 (23, 100) | 58 (0, 100) | 74 (39, 100) | ||
| Change in mean score† (p) | +6.9 (0.031) | +5.9 (0.184) | +34.9 (<0.001) | ||
| ≥1 yr post-operative‡ | n = 117 | n = 40 | n = 17 | 0.133 | |
| Median (1st, 3rd quartiles) | 64 (0, 100) | 60.75 (19.5, 100) | 61.5 (29, 88) | ||
| Change in mean score† (p) | +8.2 (<0.001) | +14.2 (0.004) | +25.8 (<0.001) | ||
The numbers of patients who completed the survey at the different time points are indicated.
Compared with the preoperative survey.
Averages of scores from surveys completed at 1, 2, 3, and 4 years after removal of textured implants.
A pairwise analysis found the difference in pre-operative Satisfaction with Breasts score exists between each cohort when compared to the Replacement with Autologous group (Replacement with Autologous vs Asymptomatic Textured to Smooth p<0.001, Replacement with Autologous vs Symptomatic Textured to Smooth p=0.003, Replacement with Autologous vs Removal without Replacement p=0.036).
Fig. 2.
BREAST-Q scores on the scale Satisfaction with Breasts. The boxes represent interquartile ranges, with the mean indicated by the horizontal line within the box.
Physical Well-Being of the Chest
Patients who underwent removal without replacement had significantly lower average preintervention scores on the BREAST-Q scale Physical Well-Being of the Chest (58 ± 30) than the patients who underwent replacement with smooth implants (asymptomatic: 75 ± 20, p=0.005; symptomatic: 75 ± 17, p=0.008; Table 5; Figure, Supplemental Digital Content 5).
Table 5.
BREAST-Q Scores for Physical Well-Being of the Chest
| Time of Survey | Score* |
p | |||
|---|---|---|---|---|---|
| Replacement with Smooth Implants |
Removal without Replacement | Replacement with Autologous Reconstruction | |||
| Asymptomatic | Symptomatic | ||||
|
| |||||
| Preoperative | n = 137 | n = 52 | n = 29 | n = 18 | 0.033 # |
| Median (1st, 3rd quartiles) | 76 (28, 100) | 76 (24, 100) | 64 (0, 100) | 74 (32, 100) | |
| 2 wk post-operative | n = 140 | n = 50 | n = 13 | n = 17 | 0.933 |
| Median (1st, 3rd quartiles) | 60 (0, 100) | 60 (14, 100) | 55 (0, 100) | 60 (8, 100) | |
| Change in mean score† (p) | −14.7 (<0.001) | −14.8 (<0.001) | −4.4 (0.774) | −10.7 (0.191) | |
| 6 wk post-operative | n = 55 | n = 18 | n = 2 | n = 8 | 0.340 |
| Median (1st, 3rd quartiles) | 72 (8, 100) | 78 (45, 100) | 56 (36, 76) | 62 (40, 100) | |
| Change in mean score† (p) | −3.1 (0.303) | +2.1 (0.700) | −2.2 (0.840) | −4.2 (0.596) | |
| 3 mo post-operative | n = 61 | n = 27 | n = 8 | n = 9 | 0.639 |
| Median (1st, 3rd quartiles) | 72 (14, 100) | 85 (20, 100) | 78.5 (14, 100) | 72 (45, 92) | |
| Change in mean score† (p) | −1.1 (0.717) | +2.3 (0.472) | +9.7 (0.374) | +2.0 (0.917) | |
| 6 mo post-operative | n = 56 | n = 22 | n = 8 | n = 14 | 0.333 |
| Median (1st, 3rd quartiles) | 76 (8, 100) | 78 (50, 100) | 76 (55, 100) | 85 (50, 100) | |
| Change in mean score† (p) | −1.1 (0.856) | +6.5 (0.188) | +18.2 (0.120) | +14.1 (0.112) | |
| ≥1 yr post-operative ‡ | n = 117 | n = 40 | n = 7 | n = 19 | 0.012 § |
| Median (1st, 3rd quartiles) | 80 (7, 100) | 85.5 (54.5, 100) | 60 (0, 80) | 87.3 (40, 100) | |
| Change in mean score† (p) | +4.3 (0.067) | +8.0 (0.050) | −10.2 (0.434) | +12.4 (0.082) | |
The numbers of patients who completed the survey at the different time points are indicated.
Compared with the preoperative survey.
Averages of scores from surveys completed at 1, 2, 3, and 4 years after removal of textured implants.
A pairwise analysis found the difference in pre-operative Physical Well-Being of the Chest score exists between patients converting from textured to smooth implants and patients removing their implants without replacement (Removal without Replacement vs Asymptomatic Textured to Smooth p=0.005, Removal without Replacement vs Symptomatic Textured to Smooth p=0.008).
A pairwise analysis found the difference in 1+ year post-operative Physical Well-Being of the Chest score exists between each cohort when compared to patients removing their implants without replacement (Removal without Replacement vs Asymptomatic Textured to Smooth p=0.002, Removal without Replacement vs Symptomatic Textured to Smooth p=0.001, Removal without Replacement vs Replacement with Autologous p=0.009).
Compared to their preoperative scores, patients who underwent exchange from textured to smooth implants had significantly lower scores 2 weeks postoperatively (asymptomatic: 60 ± 22, p<0.001; symptomatic: 61 ± 20, p<0.001). At ≥1 year postoperatively, patients who converted to smooth implants (asymptomatic: 79 ± 20; symptomatic: 83 ± 15) and patients who underwent autologous reconstruction (81 ± 20) had significantly higher scores than patients who underwent removal without replacement (48 ± 29, p<0.01 for each pairwise comparison against the removal without replacement cohort). In regression modeling, implant removal without replacement was an independent predictor of lower scores (p < 0.001; Table, Supplemental Digital Content 6).
Psychosocial Well-Being
Patients who underwent autologous reconstruction had significantly lower average preintervention scores on the BREAST-Q scale Psychosocial Well-Being (59 ± 15) than patients who underwent replacement with smooth implants (asymptomatic: 73 ± 18, p=0.002; symptomatic: 67 ± 22, p=0.047; Table 6; Fig. 3). Patients who underwent replacement with autologous reconstruction had significantly higher scores 6 months (73 ± 15, p=0.014) after reconstruction than before, but not at other postintervention time points. This value met the MCID.32 For the other groups, postintervention scores did not differ significantly from preintervention scores. In regression modeling, implant removal without replacement was an independent predictor of lower scores (p = 0.030; Table, Supplemental Digital Content 7).
Table 6.
BREAST-Q Scores for Psychosocial Well-Being
| Time of Survey | Score* |
p | |||
|---|---|---|---|---|---|
| Replacement with Smooth Implants |
Removal without Replacement | Replacement with Autologous Reconstruction | |||
| Asymptomatic | Symptomatic | ||||
|
| |||||
| Preoperative | n = 137 | n = 51 | n = 29 | n = 18 | 0.015 # |
| Median (1st, 3rd quartiles) | 71 (37, 100) | 64 (0, 100) | 71 (24, 100) | 56.5 (30, 93) | |
| 3 mo post-operative | n = 56 | n = 24 | n = 8 | n = 9 | 0.823 |
| Median (1st, 3rd quartiles) | 75.5 (0, 100) | 68.5 (0, 100) | 66.5 (45, 100) | 66 (35, 100) | |
| Change in mean score† (p) | −1.9 (0.904) | +3.3 (0.304) | −0.1 (0.839) | +9.4 (0.116) | |
| 6 mo post-operative | n = 57 | n = 22 | n = 8 | n = 14 | 0.954 |
| Median (1st, 3rd quartiles) | 69 (0, 100) | 70 (0, 100) | 64 (34, 100) | 69 (55, 100) | |
| Change in mean score† (p) | −3.5 (0.319) | +1.6 (0.630) | +1.7 (0.839) | +14 (0.014) | |
| ≥1 yr post-operative‡ | n = 117 | n = 40 | n = 6 | n = 17 | 0.161 |
| Median (1st, 3rd quartiles) | 74 (0, 100) | 72.5 (24, 100) | 54.8 (0, 93) | 65 (0, 93) | |
| Change in mean score† (p) | 0 (0.630) | +6.4 (0.209) | −2.4 (0.263) | +6.5 (0.080) | |
The numbers of patients who completed the survey at the different time points are indicated.
Compared with the preoperative survey.
Averages of scores from surveys completed at 1, 2, 3, and 4 years after removal of textured implants.
A pairwise analysis found the difference in pre-operative Psychosocial Well-Being score exists between patients converting from textured to smooth implants and patients converting to autologous reconstruction (Replacement with Autologous vs Asymptomatic Textured to Smooth p=0.002, Replacement with Autologous vs Symptomatic Textured to Smooth p=0.047).
Fig. 3.
BREAST-Q scores on the scale Psychosocial Well-Being. The boxes represent interquartile ranges, with the mean indicated by the horizontal line within the box.
Sexual Well-Being
Scores on the BREAST-Q scale Sexual Well-Being did not differ significantly between groups at any of the time points the survey was administered (Table 7; Figure, Supplemental Digital Content 8). Patients who underwent replacement of textured implants with autologous reconstruction had significantly higher scores at 6 months (59 ± 18; p=0.005) and ≥1 year after reconstruction (54 ± 26, p=0.043) than prior (39 ± 17). These values met the MCID.32 For the other groups, postintervention scores did not differ significantly from preintervention scores. In regression modeling, no significant association was found between postintervention scores and any patient or treatment variable examined (Table, Supplemental Digital Content 9).
Table 7.
BREAST-Q Scores for Sexual Well-Being
| Time of Survey | Score* |
p | |||
|---|---|---|---|---|---|
| Replacement with Smooth Implants |
Removal without Replacement | Replacement with Autologous Reconstruction | |||
| Asymptomatic | Symptomatic | ||||
|
| |||||
| Preoperative | n = 130 | n = 47 | n = 27 | n = 17 | 0.196 |
| Median (1st, 3rd quartiles) | 50 (0, 100) | 53 (0, 100) | 48 (0, 100) | 41 (0, 66) | |
| 3 mo post-operative | n = 54 | n = 21 | n = 8 | n = 8 | 0.214 |
| Median (1st, 3rd quartiles) | 50 (0, 100) | 66 (0, 100) | 52 (20, 62) | 45.5 (14, 66) | |
| Change in mean score† (p) | +0.3 (0.984) | +10.2 (0.089) | +2.2 (0.767) | +2.1 (0.725) | |
| 6 mo post-operative | n = 53 | n = 21 | n = 7 | n = 14 | 0.613 |
| Median (1st, 3rd quartiles) | 50 (0, 100) | 48 (0, 100) | 48 (0, 100) | 62 (24, 100) | |
| Change in mean score† (p) | 0 (0.939) | +4.2 (0.719) | −0.5 (0.864) | +19.4 (0.005) | |
| ≥1 yr post-operative‡ | n = 111 | n = 35 | n = 6 | n = 16 | 0.321 |
| Median (1st, 3rd quartiles) | 53 (0, 100) | 53 (0, 100) | 38.75 (0, 66) | 62.5 (0, 92) | |
| Change in mean score† (p) | +4.2 (0.151) | +0.9 (0.822) | −9.8 (0.387) | +14.7 (0.043) | |
The numbers of patients who completed the survey at the different time points are indicated.
Compared with the preoperative survey.
Averages of scores from surveys completed at 1, 2, 3, and 4 years after removal of textured implants.
DISCUSSION
Patients with textured implants are faced with challenging decisions regarding device management: active surveillance or surgical removal of the implants. The current study examined a cohort of nearly 400 women who have elected surgical removal of their textured devices and provides needed data to aid in the informed consent process by analyzing complications and PROs. The results suggest that removal of textured implants is safe and is associated with stable or improved PROs.
Our findings indicate that both replacement of textured implants with smooth implants or replacement of textured implants with autologous reconstruction is safe, with complication rates of <10%. For implant removal without replacement or reconstruction, the complication rate was 25%, which was significantly higher, largely due to the higher rate of seroma. The association with seroma is an important finding, as removal without replacement is generally considered the least invasive of the three procedures. Such seromas are likely related to the dead space created by implant removal; even with conservative drain management, rates were still significantly higher in the no reconstruction cohort. Our drain management protocol was consistent across patients, with drains remaining until output was less than 30cc for two consecutive days.
Both removal with replacement by smooth implants and removal with autologous reconstruction were associated with significant increases in satisfaction with breasts, which were sustained over the long term. For physical well-being of the chest at ≥1 year after surgical intervention, we found that patients who underwent implant removal without replacement or reconstruction had lower scores than the other groups. Our findings are consistent with a large body of evidence indicating that breast reconstruction after mastectomy is associated with improvements in well-being and satisfaction.33
For autologous reconstruction, the increase in satisfaction with breasts is consistent with using BREAST-Q,34–36 as is the sustained increase in sexual well-being.34 Additionally, our group has previously demonstrated improvement in PROs following conversion from implants to autologous reconstruction.37 Interestingly, many patients seeking conversion from textured implants to autologous reconstruction had significantly lower pre-operative BREAST-Q than other groups, across several domains. It is possible that these lower initial satisfaction rates were the principal drivers for autologous reconstruction conversion, as these patients may have been counseled on the known improved satisfaction following autologous reconstruction. While we did not control for the pre-operative scores due to low sample sizes, future work should be done to determine the impact of baseline patient perspectives on patient-reported outcomes.
The absence of a significant association between the extent of capsulectomy and the rate of complications contrasts with other reports38,39 but is consistent with data from a study of 248 patients with breast implant illness (BII) who underwent bilateral explantation and capsulectomy.40 While our study focused on capsulectomy in the management of textured implants (rather than BII) we similarly show that capsulectomy can be performed without conferring significant morbidity. The benefits of prophylactic capsulectomy have been debated, with some investigators recommending that all capsules be removed because they do not always undergo resorption and may necessitate revision surgery later on41 and others advocating individualized assessment.42 Our data suggest that with individualized assessment and careful intraoperative decision making, both partial and complete capsulectomy are safe procedures for patients who undergo removal of textured implants.
The proportion of reconstructive patients seeking implant removal has increased over the last decade,43,44 and will likely continue to increase as more BIA-ALCL cases are identified. 45 Thus, patients need evidence-guided surgical management. A 2021 study reported that many patients weigh their perceived risk of BIA-ALCL against their value of breast reconstruction when selecting management.46 The decision to pursue breast reconstruction is nuanced and synthesizes patient preferences, cultural norms, and additional psychosocial factors.47 Ultimately, patients wishing to undergo breast reconstruction after textured implant removal can use the data presented here when weighing their options. Recommendations are summarized in Table 8.
Table 8.
Evidence-based Recommendations for Surgical Intervention of Textured Implants.
| Textured to Smooth Replacement | Removal without Replacement | Textured to Autologous Replacement | |
|---|---|---|---|
| Recommendations for Choosing a Management Type |
|
|
|
| Recommendations for Capsulectomy |
|
||
The study’s strengths include long-term follow-up (>1.5 years for complications and up to 4 years for PROs), the large sample size for analysis of complications, and the use of a validated instrument for analysis of PROs. The limitations include the retrospective study design and the underpowered analysis of PROs. We were also unable to use propensity matching for controlling baseline factors because the study had four groups, and while we examined the relationship of certain variables on BREAST-Q scores with regression modeling, we may have omitted some potentially confounding variables. An additional limitation is that, given the small incidence rate of complications across the four groups, we were unable to reliably apply regression modeling techniques for these clinical outcomes, which would control for confounding. Lastly, the vast majority of patients were white, and had either commercial insurance or Medicare, limiting generalizability to other patient populations. Further research is needed to prospectively evaluate complication rates for the different surgical interventions and to characterize in detail factors associated with PROs. Additional work can be done in more diverse patient populations to comprehensively characterize outcomes.
CONCLUSIONS
Patients considering removal of textured implants should be counseled on the limited data available regarding the risks and benefits of the different surgical options in relation to the risk of BIA-ALCL. The findings of our study suggest that both textured implant removal with replacement by smooth implants or with replacement by autologous reconstruction result in significant and sustained increases in satisfaction with breasts in most patients and are associated with relatively low rates of complications. Compared with these two surgical interventions, removal without replacement or reconstruction is associated with a significantly higher risk of minor complications, namely seroma. Complete capsulectomy does not seem to be associated with a significant risk of complications. Patients and physicians should weigh all relevant factors in choosing a course of action that best addresses the patient’s needs, concerns, preferences, and values.
Supplementary Material
Figure. Supplemental Digital Content 5. BREAST-Q scores on the scale Physical Well-Being of the Chest. The boxes represent interquartile ranges, with the mean indicated by the horizontal line within the box.
Figure. Supplemental Digital Content 8. BREAST-Q scores on the scale Sexual Well-Being. The boxes represent interquartile ranges, with the mean indicated by the horizontal line within the box.
Table. Supplemental Digital Content 4. Regression analysis for association with BREAST-Q scores on Satisfaction with Breasts.
Table. Supplemental Digital Content 6. Regression analysis for association with BREAST-Q scores on Physical Well-Being of the Chest.
Table. Supplemental Digital Content 7. Regression analysis for association with BREAST-Q scores on Psychosocial Well-Being.
Table. Supplemental Digital Content 9. Regression analysis for association with BREAST-Q scores on Sexual Well-Being.
Table. Supplemental Digital Content 1. Characteristics of patients included in the analysis of PROs.
Table. Supplemental Digital Content 2. Complication rates at the implant level.
Table. Supplemental Digital Content 3. Complication rates at the implant level in relation to capsulectomy extent.
Financial Disclosures:
Dr. Mehrara is a consultant for PureTech Health and receives research funding from Regeneron. Dr. Dayan is a paid consultant for Stryker. Dr Stern is founder of MirrorMe3D with equity interest. This research was funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748, which supports Memorial Sloan Kettering Cancer Center’s research infrastructure.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Figure. Supplemental Digital Content 5. BREAST-Q scores on the scale Physical Well-Being of the Chest. The boxes represent interquartile ranges, with the mean indicated by the horizontal line within the box.
Figure. Supplemental Digital Content 8. BREAST-Q scores on the scale Sexual Well-Being. The boxes represent interquartile ranges, with the mean indicated by the horizontal line within the box.
Table. Supplemental Digital Content 4. Regression analysis for association with BREAST-Q scores on Satisfaction with Breasts.
Table. Supplemental Digital Content 6. Regression analysis for association with BREAST-Q scores on Physical Well-Being of the Chest.
Table. Supplemental Digital Content 7. Regression analysis for association with BREAST-Q scores on Psychosocial Well-Being.
Table. Supplemental Digital Content 9. Regression analysis for association with BREAST-Q scores on Sexual Well-Being.
Table. Supplemental Digital Content 1. Characteristics of patients included in the analysis of PROs.
Table. Supplemental Digital Content 2. Complication rates at the implant level.
Table. Supplemental Digital Content 3. Complication rates at the implant level in relation to capsulectomy extent.