Replacement of Shaped Textured Implants with Round Smooth Implants in Breast Reconstruction: Long-Term Outcomes

Abstract

Background:

The number of patients undergoing exchange of textured implants for smooth devices has greatly increased due to concern over BIA-ALCL. The authors examine long-term patient- and surgeon-reported outcomes in terms of aesthetics, comfort, and complications.

Methods:

Patients who underwent reconstruction with shaped, textured implants replaced with round, smooth implants between 1994–2022 with a minimum follow-up of 1 year were included. Patient-reported outcomes were collected using the BREAST-Q Reconstruction Module as well as a survey evaluating aesthetics and comfort. Surgeon-reported outcomes included evaluation of aesthetics and capsular contracture.

Results:

530 patients were reviewed, and 307 patients were included. Pairwise comparison of BREAST-Q data demonstrated psychosocial well-being (72.68 to 76.45; p=0.0075) and physical well-being (78.79 to 81.88; p=0.0078) significantly increased. Overall breast satisfaction (61.94 to 67.27; p=0.0082) and sexual well-being (53.89 to 57.98; p=0.0002) were also significantly higher in parallel with a clinically meaningful increase in BREAST-Q score of 5.33 and 4.09 points, respectively. Most patients felt they looked better (56.4%) or similar (27.3%) and were more comfortable (54.4%) or similar (39.4%) after the exchange procedure. The senior surgeon rated 40.1% of patients as a better aesthetic grade after replacement and 50.3% as the same. 36.8% of patients were rated as having a decrease in Baker capsular contracture grade. 2.9% of patients experienced a peri-operative complication and there were no reconstructive failures.

Conclusion:

Exchange of textured to smooth implants is safe, does not sacrifice aesthetic outcome, and provides a more comfortable and satisfactory outcome for patients with minimal complications.

Introduction

Implant-based breast reconstruction is the most popular form of breast reconstruction, increasing at a rate of 11% per year in the setting of the re-approval of silicone gel implants in 2006 by the US Food and Drug Administration (FDA).¹ Textured, shaped implants gained traction in the United States in the last decade due to wide utilization internationally and data suggesting these devices reduced capsular contracture, increased pocket control, offered better aesthetics, and increased patient comfort.^2,3 Out of 10 million women with breast implants in the United States, 3 million are estimated to be textured implants.⁴

Currently, there is considerable debate regarding the advantages of textured implants following the discovery of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Although the pathogenesis and etiology are not completely understood, studies suggest that the malignancy is almost exclusively associated with the texturing of implant surfaces,⁵ resulting in a recall of certain implant models.⁶ The reported incidence of BIA-ALCL in the literature varies widely but is reported to be as high as 1 in 355 patients and the risk of development appears associated with prolonged exposure.⁷ While there is no current recommendation for removal of textured implants in asymptomatic patients, there is a significant concern about the risk of developing BIA-ALCL and no guidelines on shared decision-making regarding explantation of textured implants and exchange to a smooth implant. As textured implants are thought to have decreased rate of capsular contracture and shaped “teardrop” models attributed an increased aesthetic benefit, there is apprehension that exchange of implants for the sole purpose of risk mitigation for future BIA-ALCL may downgrade aesthetic results and patient satisfaction.

There are few studies comparing long term outcomes between patients undergoing reconstruction with smooth implants vs textured implants,⁸ and no studies report outcomes in patients following replacement of textured shaped for smooth round silicone implants. The objective of this study is to examine long term surgeon and patient-reported outcomes in terms of aesthetics, comfort, and complications.

Methods

Data Collection

All patients who underwent post-mastectomy reconstruction with shaped textured implants by the senior author (P.G.C.) between 1994–2022 which were then replaced with round smooth implants were identified. No patients with textured implants were exchanged for textured implants. All surgeries were performed in the same facility by the same surgeon using comparable technique and with similar post-operative care. Demographics (age, BMI, history of radiation) and surgical details including procedure laterality and implant fill (saline or silicone) were retrospectively collected from prospectively maintained clinic visits and electronic medical record. Patients presenting for exchange based on implant rupture were excluded. Institutional Review Board approval was obtained.

Patient-reported outcomes were collected using two modalities: the BREAST-Q Reconstruction Module as well as an additional survey measure. The BREAST-Q is a patient-reported outcomes measure that is administered to all patients undergoing breast reconstruction at our institution at 3 months, 6 months, 1 year, and 2 years post-operatively. Patients who had scores at least one year post-operatively were included. The following domains are included in the module and were evaluated in this study: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-Being (Chest), and Sexual Well-Being. Values were converted to summary scores ranging from 0–100, and a difference of 4 points was considered clinically significant.⁹ BREAST-Q scores were compared between smooth and textured groups using the t-test for continuous variables and statistical significance was set at p<0.05 (GraphPad Prism version 9.1 for Mac).

Patients were also administered a two-question survey inquiring satisfaction with the outcome (yes/no) and if the patient would undergo the operation again (yes/no) as well as a 5-point Likert scale surveying the patient’s aesthetic outcome and comfort level.

Surgeon-reported outcomes included evaluation of capsular contracture grade (modified Baker classification for reconstructed breasts) and aesthetic grade using a 5-point categorical Likert scale (1=poor, 2=fair, 3=good, 4=very good, and 5=excellent).

Surgical Technique

All patients initially underwent two-stage breast reconstruction with a total submuscular tissue expander exchanged to permanent shaped, textured silicone implant. At the time of implant exchange, partial capsulectomy was completed and capsulorraphy performed as needed. All specimens were sent to pathology. Fat grafting was not routinely performed as all patients were total submuscular. No pocket changes or plane changes were performed and acellular dermal matrix was not utilized. Drains are used routinely for postoperative wound suction and left in place until the first follow-up visit.

Results

Demographics, Clinical Characteristics

Out of 530 patients, 307 patients (534 implants) who underwent exchange of shaped, textured breast implants to round, smooth implants with a minimum of one-year follow-up were included. The mean patient age was 46 (σ 11.75) and BMI 23.25 (σ 6.38); average follow-up was 1.5 years and median follow-up 1.2 years. A subset of patients had a history of radiation therapy (70, 22.8%) and the majority underwent bilateral reconstruction (227, 73.94%) (Table 1). Almost all textured implants used were manufactured by Allergan, including Natrelle Style 410 (187, 60.9%), Style 468 (53, 17.3%), and Style 363 (48, 15.6%). All shaped, textured implants were exchanged to Allergan smooth round silicone (184, 60%) or saline (123, 40%) implants. 16 (5.2%) patients switched from saline to silicone implants and 33 (10.7%) switched from silicone to saline. All other patients kept their initial fill preference upon exchange. The average volume difference was 40 cc and median volume difference 15 cc with projection matched as closely as possible. On pathologic examination, no specimens had any evidence of malignancy, and no implants were reported to be ruptured. No implants after exchange were noted to be displaced or flipped at last follow-up.

Table 1:

Demographics and Clinical Characteristics

Characteristic	Total (SD or %)
No. patients	307
Mean age	45.79 (11.75)
Mean BMI	23.25 (6.38)
Textured Implant
Fill
Saline	108 (35.2)
Silicone	199 (64.8)
Smooth Implant
Fill
Saline	123 (40)
Silicone	184 (60)
Laterality
Unilateral	80 (26)
Bilateral	227 (74)
Radiation	70 (22.8)
Median Follow-up Time	14.4 months (12–56)

Patient-Reported Outcomes

Pairwise comparison of BREAST-Q data demonstrated statistically significant, long-lasting improvement in all domains. At one-year follow-up after exchange of shaped, textured implants to round, smooth implants, psychosocial well-being (72.68 to 76.45; p=0.0075) and physical well-being (78.79 to 81.88; p=0.0078) significantly increased. Overall breast satisfaction (61.94 to 67.27; p=0.0082) and sexual well-being (53.89 to 57.98; p=0.0002) were also significantly higher in parallel with a clinically significant increase in BREAST-Q score of 5.33 and 4.09 points, respectively (Figure 1).

Figure 1:

Patient-Reported Outcomes (BREAST-Q)

167 (55.6%) patients felt more or much more comfortable after exchange, 121 (40.3%) felt the same, and only 12 (4%) felt less comfortable. 173 (57.6%) of patients expressed they looked better or much better, 84 (28%) the same, and 43 (14.3%) felt they looked better prior to exchange. 279 (98.6%) of patients responded they were satisfied with the exchange and 275 (98.6%) would make the same decision to undergo exchange (Table 2). There was no significant difference between patient-reported outcomes in the radiated vs non-radiated cohorts.

Table 2:

Patient-Reported Outcomes (PGC Questionnaire)

Outcome	1-year post-exchange (%)
Satisfied
Yes	279 (98.6)
No	4 (1.4)
Did not answer	24
Would do again
Yes	275 (98.6)
No	4 (1.4)
Did not answer	28
Aesthetic
Much better	106 (35.3)
Better	67 (22.3)
Same	84 (28)
Worse	43 (14.3)
Much Worse	0 (0)
Did not answer	7
Comfort
Much better	109 (36.3)
Better	58 (19.3)
Same	121 (40.3)
Worse	12 (4)
Much Worse	0 (0)
Did not answer	7

Surgeon-Reported Outcomes

Following exchange, 122 (40.9%) patients were rated aesthetically better or much better, 150 (50.3%) were the same, and only 26 (8.7%) were rated as worse. 110 (36.8%) had improvement in capsular contracture grade, 176 (58.9%) were the same, and only 13 (4.3%) experienced worsened contracture (Tables 3). There was no significant difference between surgeon-reported outcomes in the radiated vs non-radiated cohorts.

Table 3:

Surgeon-Reported Outcomes (Variance)

Outcome	# Patients (%)
Aesthetic
Three categories better	2 (0.67)
Two categories better	33 (11.1)
One category better	87 (29.2)
Same	150 (50.3)
One category worse	21 (7)
Two categories worse	5 (1.7)
Capsular contracture
Three grades better	25 (8.4)
Two grades better	78 (26)
One grade better	7 (2.3)
Same	176 (58.9)
One grade worse	4 (1.3)
Two grade worse	9 (3)

^*Categories: poor, fair, good, very good, excellent

^*Grades: 1, 2, 3, 4

Complications

9 patients (2.9%) experienced a peri-operative complication (hematoma/seroma requiring drainage or cellulitis requiring antibiotics) and there were no reconstructive failures (Table 4).

Table 4:

Complications Post-Exchange

Complication	# Patients (%)
Hematoma	5 (1.6)
Seroma	0 (0)
Cellulitis	3 (0.98)
Implant Deflation	1 (0.48)

Discussion

Textured, shaped implants were initially popularized in the United States as they were thought to stimulate less capsular formation and result in less malposition, leading to decreased re-operation rates and better aesthetic outcomes compared to their smooth, round counterparts.^2,10,11 However, there is little evidence that surgical or patient-reported outcomes are improved when comparing a smooth to a textured shell.^12,13 Additionally, results are often heterogenous with data confounded by multiple variables, including multiple surgeons incorporating different techniques and variable pocket selection. This is the first study analyzing a large series of patients undergoing a previously described two-stage breast reconstruction technique¹⁴ followed by elective implant exchange by the same surgeon, in which confounding covariates are reduced as each patient served as their own control.

Therefore, the BREAST-Q reconstructive module was utilized to determine the overall well-being and satisfaction of the patient before and after the exchange procedure. A major strength of this study is that the validated BREAST-Q module was administered to the same patient at consistent time points after each procedure, and therefore the pre-and post- exchange cohort of patients were exactly matched with any significant difference clearly only related to the exchange. Our results are only further supported by these patient-reported outcomes subset analysis. There was statistically significant improvement in every domain of the BREAST-Q Reconstruction Module (Satisfaction with Breasts, Physical Well-Being, Sexual Well-Being, and Psychosocial Well-Being). To give clinical meaning to these health measures, a “minimal important difference” has been defined in the literature as a difference of 4 points out of 100.⁹ In this cohort of patients, exchanging shaped textured implants to round smooth implants resulted in clinically significant and meaningful increases in overall breast satisfaction (5.33 points) and sexual well-being (4.09 points).

Historically, textured implants were thought to significantly reduce capsular contracture.^15,16 Pollock et al in 1992 described his series of 197 patients in which smooth-surface implants were 7.22 times as likely as the textured-surface implants to have a Baker score >1.¹⁶ In 2006, a meta-analysis of randomized controlled trials looking at textured surface breast implants in the prevention of capsular contracture among breast augmentation patients found contracture to occur five times more frequently in smooth surface implants compared with textured surface implants. However, there was no significant difference in contracture rates when implants were placed in the sub-muscular plane.² The idea that capsular contracture is dependent on shell texturing is now largely falling out of favor. More recent studies have proven that rates of capsular contracture are similar between textured and smooth implants regardless of plane, possibly because newer generation breast implants with higher gel cohesiveness have a low incidence of gel bleed.¹⁷ The mechanism behind development of capsular contracture is not fully understood, but thought to be a combination of immunobiological as well as patient-, surgery-, and implant-specific risk factors. In this study, 110 patients (36.8%) had improvement in capsular contracture grade, 176 (58.9%) were the same, and only 13 (4.3%) experienced worsened contracture over an average follow-up of 18 months. The authors have previously demonstrated that contracture usually develops within the first year.¹⁸ Thus, these data likely represent stable long term outcomes, which have been similarly identified in other studies.¹⁹ All patients were compared against themselves and therefore patient-specific covariates such as history of radiotherapy were controlled for and were not confounding factors in the development of capsular contracture.

Patients undergoing implant-based post-mastectomy breast reconstruction have unique needs when considering shaped or round implants, as they may be undergoing unilateral reconstruction requiring a prosthetic as symmetric as possible to their native contralateral breast. The “tear-drop” shape of a shaped implant has been thought to produce a more natural upper-pole slope than a round implant and attempt to recreate the ideal breast aesthetic according to four previously described objective criteria: proportion of upper to lower pole in a 45:55 ratio, linear or slightly concave upper pole, nipple angulation upward by 20 degrees, and a convex lower pole.^20–22 These implants have traditionally been considered aesthetically superior, especially in women with a relatively low body mass index, thin mastectomy flaps, and unilateral reconstructions. Shaped devices have a similar complication profile to those of round implants and have similar rates of rupture and rotation.^20,23 On the basis of previous literature and excellent outcomes, the senior author began to use exclusively shaped, textured implants in his reconstructive breast practice to provide consistent aesthetic results¹⁸. With the increasing concern and mounting evidence that BIA-ALCL was associated with these devices, the senior author believed risk reduction was of greater importance than the potential downgrade in aesthetic result when swapping the shaped for a round implant. Interestingly, upon rating and comparing aesthetic outcomes in this series of patients, 122 (40.1%) patients were rated aesthetically better or much better, 150 (50%) were the same, and only 26 (8.7%) were rated as worse. In addition, patients were given the opportunity to rate their own new aesthetic result compared to their first experience with the previous device. Over half of this patient cohort expressed they looked better or much better, and almost a third felt their aesthetic outcome remained the same, with only 43 (14.3%) expressing they looked better prior to exchange. There were no differences in surgeon or patient reported outcomes in terms of aesthetics when comparing those undergoing bilateral vs unilateral reconstruction. Almost every patient felt satisfied with the exchange and would make the same decision to undergo the exchange procedure.

Ultimately, consultation between a surgeon and an asymptomatic patient regarding elective removal of her shaped, textured implants must be a result of shared decision-making. While there are no official guidelines on whether these implants must be removed, the risk of potentially developing a malignancy must be balanced with the risks of exchanging implants, including potential implant failure, capsular contracture, infection, and sacrifice of aesthetic result. The authors have found complication rates to be low and contracture rates as well as patient and surgeon reported aesthetic outcomes to be largely improved. While confounding factors have been eliminated due to the crossover nature of this study, patients may have better aesthetic results due to the opportunity for revision during the exchange procedure. Patients underwent varying degrees of capsulotomies and capsulectomies for contracture release, with those with worse contractures undergoing more extensive pocket revision. In most patients, the inframammary fold was revised and reset, and the new implant re-positioned. Patients were also given the opportunity to upsize or downsize their implants or switch their fill type and any asymmetries were addressed at the time of exchange.

Though this is the first study to evaluate long-term patient and surgeon reported outcomes after exchange from shaped, textured implants to smooth round implants in asymptomatic patients to mitigate risks of BIA-ALCL, we recognize certain limitations of this data set. Patients underwent exchange for possible risk mitigation but there may have been a subset who also wanted a reconstruction revision. There may be selection bias as patients returning for follow-up may overall have had a more positive reconstructive outcome, and we did not capture those patients who underwent revision procedures or converted to autologous reconstruction. While some view a single-surgeon, single-institution study as a limitation, we find this to be a strength in this case as technical preferences remained uniform across all patients. In addition, all patients were compared in an intra-patient fashion rather than between two separate cohorts or against historical standards.

Conclusions

In our analysis of 534 implants exchanged from a shaped, textured implant to a round, smooth implant, both surgeon-reported and patient-reported outcomes improved. Aesthetic outcomes from both a surgeon and patient reported standpoint are superior, capsular contracture grades decreased, and patients overall felt more comfortable with their new implants and satisfied with their decision to undergo exchange. These results should be given strong consideration when counseling patients with textured implants and can aid in making an informed decision regarding exchange.