The Objective Effect of Breast Implant Removal and Capsulectomy on Pulmonary Function : Plastic and Reconstructive Surgery – Global Open

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Breast: Original Article

The Objective Effect of Breast Implant Removal and Capsulectomy on Pulmonary Function

Wee, Corinne E. MD*; Younis, Joseph BS*; Boas, Samuel BS*; Isbester, Kelsey BS*; Smith, Arvin BS*; Harvey, Donald J. MD*; Patil, Nirav MBBS, MPH; Kumar, Anand R. MD*; Feng, Lu-Jean MD

Author Information
Plastic and Reconstructive Surgery - Global Open 9(6):p e3636, June 2021. | DOI: 10.1097/GOX.0000000000003636
  • Open
  • UNITED STATES

Abstract

INTRODUCTION

Breast augmentation is one of the most popular cosmetic procedures in the United States, based on an estimated market share of approximately 1.2 billion dollars in 2017.1 Although many patients with breast implants remain asymptomatic, a finite, yet demonstrable cohort of patients presents with symptoms which they attribute to their breast implants. Complications such as capsular contracture and implant rupture are well-described, but this constitutional collection of symptoms [known as breast implant illness (BII)] remain underdefined and understudied. Described in the early 1960s as human adjuvant disease and recently designated as BII, BII encompasses a constellation of symptoms, including fatigue, arthralgia, myalgia, cognitive impairment, dry eyes and mouth, alopecia, skin lesions, shortness of breath, and Raynaud’s syndrome, all of which begin after the placement of breast implants.2–6,7–15

Our group recently published a study that found a significant improvement in patient-reported symptoms following explantation in a cohort of women experiencing symptoms after breast augmentation.16 Symptoms included in our study were fatigue, memory loss, joint and muscle pain, numbness and tingling in extremities, dry eyes and blurry vision, hair loss, rashes and hives, food intolerances, flu-like symptoms, breast pain, and difficulty breathing. We sought to further characterize difficulty breathing as a symptom of BII using objective and validated measures. We hypothesized that patients presenting with constitutional symptoms attributed to their breast implants, specifically, “difficulty breathing,” would demonstrate significant objective improvement in pulmonary function after removal of the implants and total capsulectomy. The aim of this study was to measure objective functional parameters [pulmonary function tests (PFTs)] to study abnormal breathing in women undergoing removal of their implants/capsules due to symptomatic breast implants.

METHODS

A retrospective study was initiated after approval from the institutional review board (Case SPARTA IRB). All patients who had previously undergone breast augmentation and requested removal of their breast implants due to symptoms from 2017 to 2018 (24 months) were included in the initial screening. Data collected included patient demographics, comorbidities, implant size, fill, texture, and symptoms. Patient demographics were collected in a descriptive, de-identified manner to evaluate related characteristics of patients who underwent removal of breast implants. Regarding symptom reporting, patients were asked both preoperatively and postoperatively to rate their “difficulty breathing” on a scale from zero (absent) to five (very severe). Pulmonary function tests were obtained before and after surgery at various time points (postoperative day 20 to postoperative day 634) for all patients. Due to the effort-dependent quality of PFT testing, six trials were performed at each time period. The highest score with the best effort was recorded for data collection. After explantation, PFTs were obtained post procedure when patient reported pain was resolved. Patients with allergy or upper respiratory symptoms or other symptoms that may confound their PFT score were tested after resolution of nonsurgical symptoms. Total capsulectomies were performed for both subglandular and submuscular implants by the senior surgeon (LJF). Capsules and implants were resected in an en bloc fashion when possible, through prior existing incisions. Surgical drains were placed routinely and removed after the output was less than 30 ml per day.

Statistical analyses were performed using both SAS Enterprise Guide, version 7.1 (SAS Institute, Cary, N.C.) and R, version 4.0.2 (The R Foundation, Vienna, Austria). Paired T-test was used to compare pre and postoperative pulmonary function test scores. Univariate and multivariate association of various clinical, demographic, and implant-related factors were assessed using linear regression models for their impact on change in each of the PFT measures. Pearson’s correlations were used to determine if changes in PFT values were correlated with a change in clinical symptoms reported on pre and postoperative surveys. For these correlations, patients who reported no symptoms pre or postoperatively were eliminated from the analysis. A P value less than 0.05 was considered significant.

RESULTS

Patient Demographics and Clinical Characteristics

A total of 72 patients were identified who underwent explantation with total capsulectomy from 2017 to 2018 and had pre- and postoperative PFTs were included in this analysis. Of the 72 patients, three (4%) were excluded due to significant diagnosed preexisting airway or parenchymal disease. Of the remaining 69 included patients, 53 (77%) reported pulmonary symptoms and complaints on their preoperative surveys.

The average age of the removed implant was 12 years. The majority of implants were silicone (41 of 69; 59%), smooth (41 of 69; 59%), and subpectoral (57 of 69; 82%). Thirty-six percent of women who complained of respiratory difficulty reported their breasts felt firm or painful; these patients were graded to have capsular contracture (grade III or IV) based on symptomology and are reported in Table 1. An estimated 53 patients (77%) reported difficulty breathing preoperatively, compared with only 14 patients (20%) postoperatively. Mean preoperative breathing severity was two of five; mean postoperative breathing score was 0.3 of five. When the 16 patients who did not report difficulty breathing preoperatively were eliminated from the analysis, 100% of the 53 remaining subjects reported subjective improvement in breathing.

Table 1. - Patient Demographics and Clinical Characteristics
Total n = 69
Age at Surgery (Years), Mean ± SD 47.3 ± 9.3
BMI, Mean ± SD 23.5 ± 3.8
BMI class, n (%)
Normal 51 (73.9)
Overweight 12 (17.4)
Obese 6 (8.7)
Smoking status, n (%)
Never 55 (79.7)
Current 1 (1.4)
Former 13 (18.8)
Preexisting illness, n (%) 28 (40.6)
Asthma, n (%) 10 (14.5)
COPD, n (%) 2 (2.9)
Bronchitis, n (%) 0 (0)
Pneumonia, n (%) 0 (0)
Other lung disease, n (%) 9 (13.0)
No. previous implants, n (%)
0 50 (72.5)
1 15 (21.7)
2 1 (1.4)
3 2 (2.9)
4 1 (1.4)
Age of implant, mean ± SD 12.8 ± 87
Material, n (%)
Saline 28 (40.6)
Silicone 41 (59.4)
Surface, n (%)
Smooth 41 (59.4)
Textured 28 (40.6)
Location, n (%)
Subglandular 12 (17.4)
Subpectoral 57 (82.6)
Contracture, n (%) 36 (52.2)
Contracture on right, n (%) 35 (50.7)
Contracture on left, n (%) 36 (52.2)

Pulmonary Function Test Values before and after Breast Implant Removal Surgery

Pulmonary function tests were performed at a mean of 135 days postoperatively (range: 20–634 days). Comparisons of pulmonary function test values before and after explantation are described in Table 2. There was a significant change in FVC (or the total volume of air that a patient can exhale), forced expiratory volume in 1 second (FEV1, or the total volume of air a patient can exhale during the first second of maximal effort exhalation), and PEFR (or the maximum speed of expiration) values after surgery. There was no statistically significant difference in FEV1/FVC ratio (FEV1 expressed as percentage of FVC), or FEF 25%–75% (the forced expiratory flow over the middle half of the FVC).

Table 2. - Pulmonary Function Test Values before and after Breast Implant Removal Surgery
Parameters Before Removal (Mean ± SD) After Removal (Mean ± SD) Mean Difference (95% Confidence Interval) P
FVC 3.7 ± 0.6 3.8 ± 0.6 0.12 (0.03–0.21) 0.008
FEV1 2.8 ± 0.4 2.9 ± 0.4 0.096 (0.02–0.17) 0.009
FEV1% 75.4 ± 7.8 76 ± 6.7 0.59 (−1.24–2.43) 0.521
FEV1/FVC Ratio 0.75 ± 0.1 0.75 ± 0.1 0.001 (−0.02–0.02) 0.908
FEF25%–75% 2.4 ± 0.8 2.5 ± 0.9 0.17 (−0.04–0.37) 0.112
PEFR 5.9 ± 1.4 6.6 ± 1.1 0.54 (0.23–0.85) 0.001

Univariate and Multivariate Association with Change in Pulmonary Function Test Parameters and Symptoms after Surgery

Univariate and multivariate associations of patient- and implant-related factors are described in Table 3 which shows the impact of these factors on change in PFT values. There was a significant correlation of implant surface type and change in FEV1 values; removal of textured implants yielded a more significant improvement than removal of smooth implants. Capsular contracture, implant size, and implant size relative to body mass index were not found to correlate with symptom improvement. Any preexisting illness also significantly impacted changes in PFT values; those without a preexisting illness experienced a smaller average improvement (5.92–6.19, difference of 0.27) in Peak Expiratory Flow Rate (PEFR) compared with those with a preexisting illness (5.97–6.92, difference of 0.95, P = 0.026). When correlated with patient-reported symptoms, there were significant correlations between FEV1 and symptom improvement (R = 0.35, P < 0.01), and FEV1/FVC ratio and symptom improvement (R = 0.28, P = 0.04). Correlations between FVC and symptom improvement and PEFR and symptom improvement did not reach statistical significance.

Table 3. - Univariate and Multivariate Association with Change in Pulmonary Function Test Parameters and Symptoms after Surgery
FVC FEV1 PEFR
Univariate Multivariate Univariate Multivariate Univariate Multivariate
Postoperative day 0.189 0.289 0.688 0.674 0.566 0.502
Size R (ml) 0.552 0.684 0.687 0.714 0.358 0.349
Size L (ml) 0.557 0.988 0.594 0.703 0.388 0.226
Location (SG versus SP) 0.786 0.477 0.707 0.458 0.148 0.058
Age at surgery 0.092 0.13 0.402 0.479 0.63 0.286
Contracture (yes versus no) 0.312 0.599 0.607 0.305 0.718 0.274
BMI 0.749 0.394 0.63 0.955 0.955 0.263
BMI class (normal versus overweight versus obese) 0.906 0.955 0.728
Asthma (yes versus no) 0.235 0.198 0.396 0.555 0.692 0.558
Smoker (current or former versus never) 0.237 0.205 0.983 0.894 0.62 0.868
Presence of any preexisting illness 0.666 0.605 0.187 0.252 0.107 0.026
Material (saline versus silicone) 0.822 0.603 0.878 0.991 0.477 0.586
Surface (smooth versus textured) 0.238 0.234 0.009 0.018 0.767 0.945
Average implant size to patient weight ratio 0.95 0.607 0.569 0.489 0.569 0.226

DISCUSSION

Our study evaluating the objective changes in PFTs after removal of symptomatic breast implant and capsules demonstrated a significant improvement in respiratory capacity following removal of breast implants and total capsulectomy in FVC, FEV1, and PEFR. The improvement in FVC in our study was a measure of an increase in the total amount of air that can be exhaled. The improvement in FEV1 and PEFR additionally highlighted an improved chest wall mechanical motion as demonstrated by the greater velocity and volume of air flow during exhalation.

Pulmonary function tests are typically interpreted by examining FVC, FEV1, the FEV1/FVC ratio, mid expiratory flow rate FEF25-75, and PEFR, which can help differentiate between obstructive (eg, asthma) and restrictive (eg, interstitial lung disease) processes. An FEV1/FVC ratio less than 0.7 indicates an obstructive process, while an FVC lower than the fifth percentile based on NHANESIII data indicates a restrictive process.17 Certain pulmonary pathologies such as chronic obstructive pulmonary disease represent mixed processes and may fit both criteria. Our patient study demonstrated a FEV1/FVC ratio of 0.75 both before and after explantation, consistent with a restrictive and nonobstructive process. Based on the NHANESIII data, however, the mean FVC for our cohort was still greater than that associated with a strictly defined restrictive process (3.42–3.51)18 in age and height-matched patients. Thus, while neither the pre- nor post- explantation group demonstrated pathologic PFT results that meet the strict definition of a restrictive process, there was statistically significant improvement after implant removal and capsulectomy. Furthermore, an analysis of the relationship between PFT values and symptoms demonstrates that even modest improvements in PFT values correspond with clinical improvement of symptoms.

Although the pre and postexplantation PFT measurements in our cohort do not qualify as abnormal, the burden of subclinical restrictive lung disease without obvious distress has been shown to be associated with morbidity in other patient populations. Similar subclinical disease processes have been reported in patients with obstructive sleep apnea, obesity-hypoventilation syndrome, and restrictive lung pathologies with notable long-term cardiovascular and pulmonary consequences.19,20 A confounding factor, the size of the implant and its associated weight, may also play a role in symptomatology. Weight of the breast as a confounding factor has been studied, which demonstrated improvements in PFTs in women following breast reduction.21–25 Furthermore, the positive correlation between the amount of breast tissue removed and improvement in FVC has been reported.23 In our study, neither implant size nor implant size-to-body mass index ratio correlated with change in pulmonary function. This negative finding, along with a greater improvement of PFTs in women with textured implants, highlights the yet-to-be determined mechanism of pulmonary restriction in this cohort. Our study findings demonstrated that a simple mass problem such as weight or breast size or capsular contracture alone is not sufficient to explain symptom improvement.

Capsular contracture is one of the most commonly identified complications of breast augmentation, with some studies publishing rates of approximately 20%,26 and may mimic a restrictive lung process due to scarring and fibrosis of tissues of the chest wall. In our study, we noted that 52% of patients (Table 1) had some degree of contracture. Yet, there was no statistically significant difference in pulmonary function or symptom improvement (Table 3) when compared with patients without contracture. Rates of capsular contracture are known to increase with the age of implant27 and occur at a higher rate with smooth implants.28 Interestingly, this cohort did not demonstrate greater improvement in PFTs with older implants or with smooth implants. In contrast, women with textured implants showed statistically significantly greater improvement with explantation than those with smooth implants (0.33 versus 0.06, P = 0.018). These findings suggest that symptoms of respiratory difficulty in patients with breast implants may not be purely a mechanical problem associated with thick capsules on the intercostal muscles.

The results of this study are subject to several limitations, including its retrospective design and inherent selection bias and exclusion criteria. The findings of this study are limited by a small and biased sample of patients, who seek removal of their implants due to their perceived symptoms and thus may not be representative of the overall aesthetic implant breast enhanced or implant-based breast reconstruction patient populations. Despite these limitations, our study well documents and reproducibly measures symptoms both pre- and postexplantation in women presenting with symptomatic shortness of breath and chest tightness related to their breast implants. PFTs are an effort-dependent measure of pulmonary function and therefore not completely consistent and may depend on other patient factors such as pulmonary disease. Efforts to mitigate these confounders were made by performing six trials at each pulmonary function testing and taking the result with the highest numbers for each patient. Postoperatively, PFTs were taken once postoperative pain or discomfort had resolved to eliminate surgical factors that may affect PFT testing. Those with significant diagnosed pulmonary disease (eg, COPD or uncontrolled asthma) were also excluded from this study but this was dependent on accurate patient reporting. Despite these limitations, objectivity of PFT measurements utilized in this study provide increased validity compared with studies using only subjective patient reported determinants such as symptom scales.

CONCLUSIONS

Patients in our cohort presenting with symptomatic breast implants, specifically shortness of breath and chest tightness, had demonstrable and significant improvement in pulmonary function based on standard PFT evaluation after removal of the implant and capsule. Patient symptom relief was also highly correlated with objective improvements in pulmonary function testing. This study represents a necessary step toward greater understanding of symptomatic breast implants and patients seeking improvement in symptoms after removal. Future studies involving measurement of lung volumes using helium dilution or lung plethysmography may also shed light on the specific nature of the pulmonary dysfunction associated with symptomatic breast implant patients.

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