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Plastic and Reconstructive Surgery Global Open logoLink to Plastic and Reconstructive Surgery Global Open
. 2023 Mar 8;11(3):e4843. doi: 10.1097/GOX.0000000000004843

How Big Is Too Big? Exploring the Relationship between Breast Implant Volume and Postoperative Complication Rates in Primary Breast Augmentations

Maria C Medor *, Gabriel Bouhadana *, Isabella F Churchill , Thomas Hemmerling , Michelle Bonapace-Potvin *, Constantine Papanastasiou §, Abiye Mussie , Daniel E Borsuk *,, Vasilios W Papanastasiou
PMCID: PMC9995107  PMID: 36910726

Background:

There is no consensus regarding implant size as an independent risk factor for complications in primary breast augmentation. Choosing appropriate implant volume is an integral part of the preoperative planning process. The current study aims to assess the relationship between implant size and the development of complications following augmentation mammaplasty.

Methods:

A retrospective chart review of patients undergoing primary breast augmentation at the Westmount Institute of Plastic Surgery between January 2000 and December 2021 was conducted. Demographics, implant characteristics, surgical technique, postoperative complications, and follow-up times were recorded. Univariate logistic regression was used to identify independent predictors, which were then included in multivariate logistic regressions of implant volume and implant volume/body mass index (BMI) ratio regarding complications.

Results:

A total of 1017 patients (2034 breasts) were included in this study. The average implant volume used was 321.4 ± 57.5 cm3 (range: 110–605). Increased volume and volume/BMI ratio were associated with a significant increase in risk of implant rupture (odds ratio = 1.012, P < 0.001 and 1.282, P < 0.001 respectively). Rates of asymmetry were significantly associated with increases in implant volume and volume/BMI ratio (odds ratio = 1.005, P = 0.004 and 1.151, P < 0.001, respectively). No single implant volume or volume/BMI ratio above which risks of complications significantly increase was identified.

Conclusions:

Implant rupture and postoperative asymmetries are positively correlated with bigger implant volumes. Implant size could likely be a useful independent predictor of certain complications, especially in patients with high implant to BMI ratios.


Takeaways

Question: Does a relationship exist between implant volume and the development of complications in the context of primary augmentation mammaplasty?

Findings: Increased volume and volume/BMI ratio were associated with a significant increase in risk of implant rupture. Rates of asymmetry were significantly associated with increases in implant volume and volume/BMI ratio.

Meaning: Implant size could likely be a useful independent predictor of certain complications, especially in patients with high implant to BMI ratios.

INTRODUCTION

Primary breast augmentation currently ranks among the most common cosmetic surgical procedures performed today. Accordingly in North America, the estimated proportion of adult women who have undergone primary breast augmentation approaches 1%.1 Further, the American Society of Plastic Surgeons National Databank Statistics found that primary breast augmentation is the second most commonly performed cosmetic procedure, with 364,753 procedures completed in North America in 2021, accounting for 41% of all breast procedures. The American Society of Plastic Surgeons also reports a comparative 35% increase in the annual incidence of primary breast augmentation between the years 2000 and 2019, further demonstrating a trend of increasing popularity of the procedure.2

With increasingly refined techniques in cosmetic surgery, most women undergoing primary breast augmentation do not experience significant postoperative complications. Prosthetic-based augmentation, however, carries additional morbidities specifically associated with implants, such as capsular contracture, breast implant-associated anaplastic large cell lymphoma, and mal-positioning, to name a few.2 Considering the elective nature of these procedures, plastic surgeons continue to strive toward minimizing the potential risks for their patients. To this end, several patient, surgical, and implant-specific risk factors have been identified in the development of adverse outcomes for implant-based primary breast augmentation. Patient factors include age, body mass index (BMI), and smoking status;3 surgical factors include incision type/size and antiseptic technique;46 implant-specific factors include texture, type, and plane of the implant.7,8 Although the literature is abundant in detailing contributing factors to prosthesis-associated complications, even the most recently published articles reveal a paucity of evidence specifically investigating implant volume as an independent risk-factor.9 This is especially of interest, considering that patients usually have a predetermined preference of their desired volume and that on average, US surgeons use larger implants than many of their international colleagues.10

The aim of this study was to assess the relationship between implant volume and the development of complications in the context of primary augmentation mammaplasty. Secondarily, as implant size is often evaluated in proportion to individual patients’ body morphology, implant size will also be assessed as a ratio to BMI in order to provide a more relative assessment. This is with the ultimate goal of improving informed consent, especially with patients who desire large volumes in the context of breast augmentation.

MATERIALS AND METHODS

Study Design and Patient Population

A retrospective review of the senior author’s (V.W.P.) medical records (Westmount Institute of Plastic Surgery, Montreal, Canada) for all patients who had a follow-up in the last 5 years was conducted. Patients were eligible for study inclusion if they had undergone a primary breast augmentation (including mastopexy-augmentation) and were over the age of 18. Patients were excluded if they underwent any other surgical procedure, were seen for a revision breast augmentation, or had incomplete medical records. All patient assessments were performed by the primary investigator both pre- and postoperatively, and were documented in their medical record.

Data Collection

Data regarding demographics (age, BMI, height, weight, bra size, smoking status, comorbidities, parity), implant characteristics (volume, manufacturer, type, texture, shape), surgical technique (incision/approach, plane, placement, operative time), postoperative complications [dehiscence/exposure, hematoma, infection, implant rotation, implant rupture, seroma (late), asymmetry, capsular contracture, hypertrophic/wide scarring, nipple areolar complex asymmetry, ptosis, and excess skin laxity], reoperation rate, and follow-up times were recorded. Patients unhappy with their result due to personal preference (fear of breast implant-associated anaplastic large cell lymphoma, hyperplasia, hypoplasia, and/or pain) were also recorded. Late seroma was defined as occurring more than 12 months postoperatively.1012 The complication category of “asymmetry” included implant displacement (bottoming out or laterally), double bubble, contour deformity, high riding implants, low inframmamary fold, and rippling. The frequency of complications was computed in regard to breasts affected.

Statistical Analysis

Overall demographic, surgical, and complications data were first summarized descriptively. Chi-square and Fisher exact test were used to compare demographics, implant characteristics, and surgical techniques between patients with and without complications (surgical/aesthetic). Comorbidities in general, as well as the most common/relevant ones (asthma, anxiety/depression, diabetes, hypertension, hypothyroidism) were compared. This was done to identify potential confounders. Followingly, a univariate logistic regression was carried out to identify independent predictors of complications. A multivariate regression model was then used to determine the impact of implant volume on the presence of (1) overall complications and (2) individual complications, omitting the confounders identified previously. Multivariate logistic regression analyses of implant volume/BMI ratio, implant volume/ height ratio, and height/BMI ratio were also conducted. Statistical significance was set a P value less than or equal to 0.05, and all statistical analyses were carried out using SPSS version 26 (IBM Corp., Armonk, N.Y.).

RESULTS

Overall Demographics, Implant Details, Surgical Techniques

A total of 1017 patients (2034 breasts) undergoing bilateral primary breast augmentation were eligible for study inclusion, all of whom were women. Included patients had a mean age of 35.1 ± 9.3 years (range: 18–70), mean BMI of 21.6 ± 3.0 (range: 15.4–38.4) with a mean height of 164.0 0 ± 6.2 cm (range: 125.2–185.4 cm), and mean weight of 58.2 ± 8.3 kg (range: 43.1–102.9 kg). Current smokers accounted for 17.0% (n = 173) of the included patients, and diabetic patients accounted for 0.7% (n = 7), while the most prevalent comorbidities were depression/anxiety (5.4%, n = 55) and hypothyroidism (5.1%, n = 52). In terms of parity, most women had given birth twice (35.5%, n = 361) or were nulliparous 31.9% (n = 324). The majority of patients’ self-reported preoperative bra band size was 34 (48.1%), and bra cup size was B (39.1%).

The average volume of implants used (n = 2034) was 321.4 ± 57.5 cm3 (range: 110–605 cm3). The majority of them were manufactured by Allergan (84.9%, n = 1726), with the remainder manufactured by Mentor (15.1%, n = 154). Most implants were made of gel (97.5%), while their shape (round versus anatomic) was almost equally split (50.7% versus 49.3%, respectively). A total of 65.6% of implants were textured (n = 1336), and 34.4% were smooth (n = 698).

A total of 722 patients (71.0%) underwent bilateral breast augmentations, 255 patients (25.1%) underwent a bilateral mastopexy-augmentation, and the remaining 40 patients (3.9%) underwent a unilateral breast augmentation with a contralateral mastopexy-augmentation. More specifically, 1489 breasts (73.2%) underwent a simple primary augmentation, and 545 breasts (26.8%) underwent augmentation-mastopexies. The majority of simple primary augmentations were approached via an inframammary incision (96.1%, n = 1431/1489), while augmentation mastopexies were most often carried out using a vertical technique (35.0%, n = 191/545). Most implants were placed in the subpectoral plane (86.0%, n = 1750/2034) and were inserted manually (93.5%, n = 1902/2034). On average, operative time was 54.0 ± 16.7 minutes (range: 30–115). These data are summarized in Tables 1 and 2.

Table 1.

Patient Demographics

Overall
(n = 1017)
No Complication
(n = 687)
Complication
(n = 330)
P
Age (y), mean ± SD 35.1 ± 9.3 35.0 ± 9.3 35.4 ± 9.2 0.582
Height (cm), mean ± SD 164.0 ± 6.2 163.9 ± 6.4 164.3 ± 5.8 0.088
Weight (kg), mean ± SD 58.2 ± 8.3 58.1 ± 8.4 58.4 ± 7.9 0.884
BMI (kg/m2), mean ± SD 21.6 ± 3.0 21.5 ± 2.9 21.9 ± 3.2 0.098
Bra size, n (%)
 A 370 (36.4) 274 (39.9) 96 (29.1) 0.01
 B 398 (39.1) 262 (38.1) 136 (41.2)
 C 167 (16.4) 102 (14.8) 65 (19.7)
 D 53 (5.2) 32 (4.7) 21 (6.4)
 32 274 (26.9) 204 (29.7) 70 (21.2) 0.003
 34 490 (48.2) 335 (48.8) 155 (47.0)
 36 194 (19.1) 116 (16.9) 78 (23.6)
Smoking status, n (%)
 Current smoker 173 (17.0) 101 (14.7) 72 (21.8) 0.016
 Current nonsmoker 844 (83.0) 586 (85.3) 258 (78.2)
Comorbidities, n (%)
 Asthma 27 (2.7) 16 (2.3) 11 (3.3) 0.438
 Anxiety/depression 51 (5.0) 33 (4.8) 18 (5.5)
 Diabetes 7 (0.7) 4 (0.6) 3 (0.9)
 Hypertension 9 (0.9) 4 (0.6) 5 (1.5)
 Hypothyroidism 46 (4.5) 33 (4.8) 13 (3.9)
 Other 62 (6.1) 47 (6.8) 15 (4.5)
 None 815 (80.1) 550 (80.1) 265 (80.3)
Parity, n (%)
 0 370 (36.4) 260 (37.8) 110 (33.3) 0.205
 1 139 (13.7) 96 (14.0) 43 (13.0)
 2 361 (35.5) 236 (34.4) 125 (37.9)
 3 121 (11.9) 81 (11.8) 40 (12.1)
 4 18 (1.8) 9 (1.3) 9 (2.7)
 5 2 (0.2) 0 (0) 2 (0.6)
 6 1 (0.1) 1 (0.1) 0 (0)

Table 2.

Implant Characteristics and Surgical Variables

Overall
(n = 1017)
No Complication
(n = 687)
Complication
(n = 330)
P
Implant volume (cm3), mean ± SD 321.4 ± 57.5 323.6 ± 56.0 317.1 ± 60.3 0.101
Manufacturer, n (%) Allergan 863 (84.9) 559 (81.4) 304 (92.1) <0.01
Mentor 154 (15.1) 128 (18.6) 26 (7.9)
Type, n (%) Gel 992 (97.5) 673 (98.0) 319 (96.7) 0.212
Saline 25 (2.5) 14 (2.0) 11 (3.3)
Texture, n (%) Smooth 349 (34.3) 253 (36.8) 96 (29.1) 0.015
Textured 668 (65.7) 434 (63.2) 234 (70.9)
Shape, n (%) Anatomic 501 (49.3) 348 (50.7) 153 (46.4) 0.200
Round 516 (50.7) 339 (49.3) 177 (53.6)
Surgery, n (%) Augmentation 722 (71.0) 535 (77.9) 187 (56.7) <0.01
Mastopexy-augmentation 255 (25.1) 133 (19.4) 122 (37.0)
Mixed 40 (3.9) 19 (2.8) 21 (6.4)
Plane, n (%) Dual 134 (13.2) 95 (13.8) 39 (11.8) 0.600
Prepectoral 8 (0.8) 6 (0.9) 2 (0.6)
Subpectoral 875 (86.0) 586 (85.3) 289 (87.6)
Placement, n (%) Funnel 64 (6.3) 61 (8.9) 3 (0.9) <0.01
Manual 953 (93.7) 626 (91.1) 327 (99.1)
Operative time (min), mean ± SD 54.0 ± 16.7 52.3 ± 16.2 58.0 ± 17.1 <0.01
Follow-up (mo), mean ± SD 40.1 ± 44.9 32.5 ± 40.0 55.7 ± 50.0 <0.01

Follow-up and Overall Complications

Patients were followed up for an average of 40.1 ± 44.9 months (range: 1–237). Overall, 32.5% (n = 330) of patients presented with postoperative complications, accounting for 443 breasts (21.7%) with complications. Of note, some patients presented with multiple concomitant initial complications, yielding a total of 460 individual complications. Among these complications, asymmetry (n = 141) and ptosis (n = 105) were the most common complications, followed by implant rupture (n = 33) and dehiscence/exposure (n = 18). A total of 492 breasts (24.2%) required revision surgery, some of which were due to patient preference (29.9%, n = 147/492) including fear of anaplastic large cell lymphoma (n = 62), hypoplasia (n = 59), hyperplasia (n = 21) and pain (n = 5). These results are summarized in Figures 1 and 2. Following re-operation or conservative treatment, 59 patients experienced additional complications.

Fig. 1.

Fig. 1.

Complication rates (presented as number of breasts).

Fig. 2.

Fig. 2.

Indication for revision surgery.

The subgroups with and without complications were first compared. This analysis demonstrated that bra band and cup size (P = 0.03 and P < 0.01, respectively), smoking status (P = 0.016), manufacturer (P < 0.01), texture (P = 0.015), type of surgery performed (P < 0.01) and method of placement (P < 0.01) were significantly different between patients with and without complications, demonstrating that the groups were heterogenous. On univariate regression analysis, bra band size (P = 0.006), bra cup size (P = 0.004), manufacturer (P ≤ 0.001), texture (P = 0.02), type of surgery (P < 0.001) and placement method (P = 0.003) were found to be statistically significant. These results are summarized in Table 3.

Table 3.

Univariate Logistic Regression of Potential Confounders for Complications

Overall Complication
(P)
Age 0.492
BMI 0.287
Bra band size 0.006
Bra cup size 0.004
Smoking status 0.870
Comorbidities 0.513
Parity 0.195
Manufacturer <0.001
Type 0.465
Texture 0.02
Shape 0.933
Surgery <0.001
Plane 0.448
Placement 0.003

Accordingly, these variables were included in the multivariate regression models of implant volume and implant volume/BMI ratio, implant volume/height, and height/BMI ratio regarding overall and specific complications. These results are summarized in Table 4. Implant volume did not significantly increase the risk of overall complication rates [Odds ratio (OR) = 0.988, 95% confidence interval (CI): 0.996–1.000, P = 0.116]. When grouped by volume, the general trend observed was that as implant size increased by 100 mL, the odds of developing an overall complication decreased. However, the results were not significant (Table 5). Moreover, increased implant volume alone, and implant volume/BMI ratio were associated with a significant increase in risk of implant rupture (OR = 1.012 [1.006–1.018], P < 0.001 and OR = 1.282 [1.141–1.439], P < 0.001 respectively). Both variables were also associated with a significant increase in risk of asymmetry (OR = 1.005 [1.001–1.008], P = 0.004 and OR = 1.151 [1.081–1.225], P < 0.001).

Table 4.

Multivariate Logistic Regression of Implant Volume, Implant Volume/BMI Ratio, Implant Volume/Height Ratio and Height/BMI Ratio

Implant Volume Implant Volume/BMI Ratio Implant Volume/Height Ratio Height/BMI Ratio
OR [95% CI] P OR [95% CI] P OR [95% CI] P OR [95% CI] P
Overall complications 0.998 [0.996–1.000] 0.116 0.980 [0.934–1.028] 0.403 0.857 [0.565–1.299] 0.467 0.960 [0.752–1.225] 0.742
 Dehiscence/exposure 0.994 [0.986–1.002] 0.123 0.912 [0.778–1.069] 0.255 0.327 [0.060–1.782] 0.196 1.231 [0.484–3.127] 0.663
Hematoma 0.995 [0.984–1.006] 0.346 1.009 [0.816–1.248] 0.933 1.696 [0.139–20.739] 0.679 2.103 [0.580–7.631] 0.258
    Infection 0.989 [0.978–1.000] 0.054 0.787 [0.631–0.982] 0.034 0.115 [0.011–1.240] 0.075 0.946 [0.237–3.783] 0.938
     Laxity 1.005 [0.993–1.017] 0.405 1.025 [0.816–1.288] 0.831 0.046 [0.001–12.096] 0.279 0.563 [0.13–23.751] 0.763
    Rotation 1.008 [0.994–1.022] 0.251 1.313 [1.012–1.703] 0.041 2.028 [0.128–32.168] 0.615 1.158 [0.227–5.897] 0.860
    Rupture 1.012 [1.006–1.018] <0.001 1.282 [1.141–1.439] <0.001 4.722 [1.412–15.796] 0.012 1.029 [0.476–2.225] 0.942
    Seroma 1.008 [0.997–1.019] 0.171 1.164 [0.938–1.444] 0.168 2.840 [0.194–41.593] 0.446 1.724 [0.385–7.718] 0.476
   Asymmetry 1.005 [1.001–1.008] 0.004 1.151 [1.081–1.225] <0.001 1.356 [0.703–2.616] 0.364 1.028 [0.699–1.512] 0.888
Capsular contracture (grade 1) 0.999 [0.987–1.010] 0.803 1.034 [0.830–1.288] 0.765 1.302 [0.174–9.722] 0.797 1.069 [0.331–3.452] 0.911
Capsular contracture (grade 2) 1.000 [0.993–1.006] 0.928 0.960 [0.842–1.095] 0.543 0.614 [0.129–2.918] 0.540 0.992 [0.403–2.446] 0.986
Capsular contracture (grade 3) 0.999 [0.990–1.007] 0.744 0.902 [0.762–1.069] 0.234 4.281 [0.525–34.900] 0.174 1.736 [0.510–5.907] 0.377
Hypertrophic scarring 0.993 [0.988–0.997] 0.002 0.876 [0.795–0.964] 0.007 0.245 [0.088–0.686] 0.007 5.731 [2.028–16.192] <0.001
Nipple areolar complex asymmetry 0.999 [0.992–1.006] 0.683 0.883 [0.765–1.021] 0.092 0.208 [0.026–1.654] 0.138 0.170 [0.34–0.845] 0.030
     Ptosis 0.994 [0.990–0.997] 0.001 0.857 [0.794–0.924] <0.001 0.448 [0.175–1.149] 0.095 0.533 [0.290–0.979] 0.043

Pertinent results are highlighted in bold.

Table 5.

Volume Logistic Regression (Per 100 cm3 Interval) for Complications

Volume (mL) n Overall Complications
OR (95% CI) P
0–99 0
100–199 22 0.571 (0.067–4.875) 0.609
200–299 744 0.380 (0.053–2.718) 0.335
300–399 1061 0.302 (0.042–2.154) 0.232
400–499 196 0.333 (0.046–2.430) 0.278
500–599 7 0.167 (0.009–2.984) 0.224
600–699 4

Implant volume/height ratio was also found to predict complication rates. Those with higher implant volume/height ratios were found to have almost five times the odds of rupture (OR = 4.722 [95% CI: 1.142–15.796], P = 0.012). Additionally, height/BMI ratio was found to have increased odds for developing hypertrophic scarring (OR = 5.731 [95% CI: 2.028–16.192], P < 0.001).

DISCUSSION

This single-surgeon retrospective cohort study explores the relationship between implant volume and postoperative complications in 1017 women (2034 breasts) undergoing primary breast augmentation and/or augmentation-mastopexy. Rates of implant rupture and asymmetry were associated with increased implant volumes. Dehiscence/exposure, hematoma, implant rotation, seroma (late), capsular contracture, nipple areolar complex asymmetry, excess skin laxity, and reoperation rate were not significantly affected by implant volumes. When looking at grouped analysis results, there was no significant increase in overall complication rates per 100 cm3 of volume increase. This said, no definitive conclusion can be drawn from these results due to the heterogenicity in sample size between the different volume categories. Unfortunately, there were not enough events per variable (outcomes) to analyze the relationship between implant volumes and each specific complication individually. Other studies have addressed the relationship of implant size to complications; however, none have provided an in-depth analysis of implant size as an independent risk factor.

The literature regarding the relationship of implant size to complications in breast augmentation is heterogeneous. Henriksen et al8 demonstrated that implants larger than 350 cm3 confer an increased risk of complications from capsular contracture requiring surgery, and Pitanguy et al13 showed that large implants seem to increase the risk of postoperative sensory alterations of the breast. This said, Huang et al14 demonstrated that implants between 300 and 350cc actually required more secondary procedures compared with implants greater than 350 cm3. In a 10-year prospective study of 784 augmentations, Swanson15 demonstrated no significant correlation between implant volume and complications. Unfortunately, our study did not identify a single implant volume or volume/BMI ratio above which risks of complications significantly increased but we were able to show an increasing trend in complication rates that was significant with increased implant volume to height ratio and increased implant volume to BMI ratio.

The etiologies behind implant rupture rates have been studied and identified as swelling of the implant surface, manufacturing defects, a flaw of the fold, and surgical instrumentation with the later contributing to 51% to 64% of implant ruptures.1618 This said, nobody to date has identified volume as an independent risk factor for implant rupture. Our study demonstrated a consistent increased risk of rupture across all implant volume related variables including implant volume alone, implant volume/height ratio, and implant volume/BMI ratio. Based on the current available literature the authors hypothesize that this could be due to the increased level of difficulty associated with the insertion of larger implants in the breast pocket. The discrepancy in size between the incision and the implant as well as between the implant and breast pocket could lead to more prolonged manipulation in order to obtain adequate placement of the implant. This would therefore subject the implant to more trauma resulting in perioperative micro implant fractures that worsen over time or a general weakening of the implant envelope, putting the implant at higher risk of rupture later on.

Almost all studies suggest that implant volume should be determined based on patients’ preoperative body morphology. More specifically, the breast width, breast type, anterior pull skin stretch, nipple-to-inframammary fold distance, and parenchyma to stretched envelope fill are ways to assess morphology preoperatively.1922 The present study did not report such measurements, as these are often used purely for planning purposes rather than documentation. In replacement of such, BMI was used as inferences of body morphology. Our statistical analyses demonstrate that this variable followed similar trends in terms of complication rates as that of just implant size.

Limitations and Future Directions

The main limitation of this review lies in its retrospective and single-surgeon nature, which may limit its generalizability. In addition to this, one might argue that unsatisfied patients may have sought care else-where, therefore underestimating the true rate of complications amongst our population. Finally, the predominant use of textured implants at the time may render our results less applicable to current practices in North America, as the use of this type of implant is now discouraged due to its association with breast implant-associated anaplastic large cell lymphoma. Future studies looking at implant volumes should also include breast base width and implant profile, which are considered important measures for implant selection and likely have a large role to play in determining appropriate implant size.23

CONCLUSIONS

The literature is unclear as to the exact role of implant volume regarding complications in primary breast augmentations. The present study establishes that implant volume does play a role in the development of complications in the context of primary augmentation mammaplasty. This is particularly true in the context of increased implant size to BMI ratios as well as increased implant volume to patient height ratios. Based on the results of this study, surgeons should be more wary of implant rupture and postoperative asymmetries with larger implants. The authors hope such a study can help both surgeons and their patients be more cognizant of the role of implant size as an independent predictor of complications, and can encourage better individualized, patient morphology-based approaches to such a decision.

Footnotes

Published online 8 March 2023.

Presented at the 2022 Canadian Society of Plastic Surgeons Annual Meeting, June 28, 2022, Quebec City, Canada – Winner of First Prize for Poster Competition.

Disclosure: The authors have no financial interests to declare in relation to the content of this article.

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