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Ten-year Core Study Data for Sientra’s Food and Drug Administration–Approved Round and Shaped Breast Implants with Cohesive Silicone Gel

Stevens, W., Grant, MD; Calobrace, M., Bradley, MD; Alizadeh, Kaveh, MD; Zeidler, Kamakshi, R., MD; Harrington, Jennifer, L., MD; d’Incelli, Rosalyn, C., BA

Plastic and Reconstructive Surgery: April 2018 - Volume 141 - Issue 4S - p 7S–19S
doi: 10.1097/PRS.0000000000004350
Original Articles
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Background: In March 2012, the United States Food and Drug Administration approved Sientra’s application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra’s Core Study at the conclusion of 10 years.

Methods: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra’s breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction.

Results: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0–11.5%] compared with smooth devices (17.5%; 95% CI, 14.9–20.4%). There were no cases of breast implant–associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons.

Conclusion: The 10-year results of Sientra’s Core Study support a comprehensive safety and effectiveness profile of Sientra’s portfolio of round and shaped breast implants.

Marina del Rey, CA; Louisville, KY; New York, NY; Campbell, CA; Minneapolis, MN; and Santa Barbara, CA

From the Division of Plastic Surgery, University of Southern California School of Medicine; Division of Plastic Surgery, University of Louisville, and Division of Plastic Surgery, University of Kentucky; Division of Plastic and Reconstructive Surgery, Westchester Medical Center and New York Medical College; Private Practice; Division of Plastic and Reconstructive Surgery, University of Minnesota, and North Memorial Hospital; and Clinical and Medical Affairs, Sientra, Inc.

Received for publication June 22, 2017; accepted December 21, 2017.

Disclosure: Drs. Stevens, Calobrace, Alizadeh, Zeidler, Harrington are clinical study investigators for Sientra and receive standard research support for conducting their studies. The authors have no financial interest to declare in relation to the content of this article and received no financial support in the preparation of this article. R. d’Incelli is a Sientra employee.

W. Grant Stevens, MD, Marina Plastic Surgery Associates, 4644 Lincoln Boulevard, Suite 552, Marina del Rey, CA 90292, drstevens@hotmail.com

The first generation of silicone gel breast implants was developed by Cronin and Gerow1 and dates back to 1962. Over the last 50 years, there have been several iterations of silicone and saline-filled implants including changes in device shapes, projections, texture surface types, and dimensions.2–5 The most recent, fifth generation of silicone gel breast implants includes a highly cohesive gel fill.3 , 4 Along with progression in the device technologies, surgical practices and treatment of postoperative complications have continually evolved. In recent years, a more in-depth understanding of the relationship between bacterial biofilm and capsular contracture and potentially breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) has caused a reexamination of the best surgical methods to reduce bacteria contamination of the surface of breast implants at the time of placement.6 The safest and best outcomes for patients will come from putting the best implant options in the hands of highly trained surgeons. This 10-year study of Sientra’s silicone gel breast implants, exclusively placed by board-certified plastic surgeons, demonstrates the safety and efficacy of these implants for all surgical indications.

The American Society of Plastics Surgeons reported that there were 290,467 breast augmentation procedures performed in 2016 in the United States and silicone gel–filled implants were used in 84% of the cases (16% saline).7 In addition, there were 88,606 breast reconstruction procedures reported by American Society of Plastics Surgeons member surgeons, and silicone gel–filled implants were used in 94% of the cases (6% saline). In total, nearly 400,000 breast procedures were performed in the United States last year. Such large numbers of breast implant procedures being performed each year underscores the importance of plastic surgeons having access to long-term, core clinical study data to make device choices and formulate evidence-based decisions.

In the wake of the 1992 moratorium by the U.S. Food and Drug Administration (FDA) and the initiation of the pivotal trials, surgeons finally have access to large, prospective, 10-year clinical study results from all 3 U.S. manufacturers.8–12 Since approval in March 2012, Sientra has continued to publish results from their large pivotal and continued access studies to put this information in the hands of surgeons and highlight Sientra’s key differentiating features and advantages.13–20 The long-term safety and effectiveness of Sientra silicone gel implants for augmentation, reconstruction, and revision patients is presented through 10 years from the complete data set collected in the FDA Core Study.

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PATIENTS AND METHODS

Patients

The Sientra Core Study is a controlled, prospective, multicenter clinical trial that started enrollment in 2002 at investigational sites in the United States that obtained institutional review board approval. To assess the safety and efficacy of the Sientra round and shaped silicone gel breast implants, all patients in the study were required to have follow-up office visits at 6–10 weeks and annually through year 10. In addition, a cohort of patients received regular magnetic resonance imaging (MRI) to assess for ruptures. The study enrolled 1,788 patients and 3,506 implants across 4 cohorts, including, 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction patients. The MRI cohort contained 571 patients from the 4 indications. As a condition of approval, all remaining eligible patients were provided the opportunity to undergo MRI.21

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Device Description

The Sientra round and shaped study devices were the first FDA-approved fifth-generation implants featuring the High-Strength Cohesive (HSC) and the High Strength Cohesive Plus (HSC+) gel fills (Fig. 1).3 , 4 The HSC+ is a slightly more crosslinked silicone gel fill. Sientra’s round devices are currently available in both HSC and HSC+ gel fills, smooth and textured surface options, and a variety of projections. Shaped products feature HSC+ gel fill, a textured surface, and are available in round, classic, or oval base footprints.

Fig. 1

Fig. 1

All Sientra-textured devices are manufactured with a process that involves volatilization of ammonium carbonate with heat.22 The process does not use sodium chloride, rinse, wash, sugar, soak, scrub, or pressure stamping.15 , 23 Review of surface texturing on a scanning electron microscope indicates that Sientra’s texture is different from the other 2 U.S. manufacturers textured product in that it falls in-between and looks to combine characteristics from both of the other textured products in terms of appearance (Fig. 2).

Fig. 2

Fig. 2

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Data Collection

Study patients underwent preoperative and follow-up examination visits at 6–10 weeks and then annually through 10 years. Examination information was collected on standardized Case Report Forms and underwent double data entry into a 21 Code of Federal Regulations Part 11 compliant clinical database, which has documented procedures and controls to ensure authenticity, integrity, and confidentiality. At each visit, adverse events (when present) were collected on the Case Report Forms to assess safety. For each adverse event, physicians provided a severity rating of 1 (very mild) to 5 (severe). To assess effectiveness, bra size and patient satisfaction were collected.

To identify silent rupture, a subgroup of 571 patients underwent periodic MRI screenings without contrast. The MRI screenings began at year 3 and were performed on even years through 10 years. The scans were reviewed by both a local radiologist and an expert central radiologist. If the scan was interpreted as indeterminate or definitive rupture by either radiologist, local or central, the device was reported as ruptured.

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Statistical Analysis

The Sientra Core Study collected annual follow-up data and biannual MRI procedures through year 10.

Kaplan–Meier risk rates were the primary method of analysis. These were calculated for all breast implant–related adverse events (eg, infection, asymmetry). Complications with severities rated as very mild or mild (severity 1 or 2) were not included as events/failures in the analysis. The rates and 95% confidence intervals were produced using PROC LifeTest in SAS (SAS Institution, Inc., Cary, N.C.) and calculated as: 1 minus the complication-free survival rate.

Other analyses were performed with descriptive frequency analyses. These included an evaluation of by-surgeon rupture and capsular contracture rates and reasons for reoperation.

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RESULTS

Patient and Surgical Characteristics

A total of 1,788 patients (3,506 implants) were enrolled across all 4 cohorts in Sientra’s Core Study. Patient demographics are summarized in Table 1, and device and surgical characteristics are reported in Table 2. The use of smooth (53%) and textured (47%) devices revealed a relatively even distribution among the patients enrolled across all cohorts. The majority of study sites performed pocket irrigation (Table 2), and this was consistent across all 4 cohorts with a range of 91–96% of enrolled patients receiving pocket irrigation at the time of surgery. The favored incisional approach for primary augmentation (62%) and revision-augmentation (61%) patients was the inframammary fold. While for both the primary reconstruction (45%) and revision-reconstruction (55%) cohorts, it was the mastectomy scar.

Table 1

Table 1

Table 2

Table 2

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Safety Experience

The rates of local complications through 10 years are presented in Table 3. The overall risk of capsular contracture through 10 years was 13.5%. Baker grade III/IV capsular contracture was the most common complication reported in the primary augmentation, revision-augmentation, and primary reconstruction cohorts (12.9%, 13.7%, 15.8%, respectively). While the rate of capsular contracture in the revision-reconstruction cohort was similar (14.3%) to the other 3 cohorts, the most commonly reported complication in the revision-reconstruction cohort was asymmetry (16.9%). The overall risk of rupture across all patients in the MRI cohort through 10 years was 8.6%.

Table 3

Table 3

The Kaplan–Meier risk of reoperation and explantation with or without replacement through 10 years is presented in Table 4. Across all cohorts, there were 642 reoperations in 500 patients through 10 years, and the overall rate of reoperation was 31.5% [95% confidence interval (CI), 29.2, 33.9%]. Over half (50.6%) of all reoperations were due to cosmetic reasons (n = 325) versus noncosmetic reasons (49.4%; Fig. 3). Cosmetic reasons for reoperation included style/size change, asymmetry, malposition, and ptosis, whereas noncosmetic reasons for reoperation included capsular contracture, rupture, healing-related complications, and other infrequently occurring noncosmetic reasons such as infection, nipple-related, skin-related.

Table 4

Table 4

Fig. 3

Fig. 3

In the primary augmentation cohort, the most common reasons for reoperation were capsular contracture (24.7%) and style/size change (20.6%). In the revision-augmentation cohort, the most common reasons for reoperation were style/size change (17.4%) and capsular contracture (16.3%).

The highest rates of reoperation were seen in the primary reconstruction and revision-reconstruction cohorts (48.2% and 56.7%, respectively). Size/style change was the most common reason for reoperation in the reconstruction cohort, and the third most common in the revision-reconstruction cohort. The majority of the reconstruction patients underwent their first reoperations within the first 2 years after implantation (66.3% in the reconstruction and 57.1% in the revision-reconstruction cohort), whereas less than the majority of the reoperations occurred within the first 2 years after implantation among the augmentation cohorts (46.8% in the augmentation and 49.6% in the revision-augmentation cohort; Fig. 4).

Fig. 4

Fig. 4

Figure 5 presents the long-term trending of the risk of capsular contracture, rupture (MRI cohort), and reoperation for the overall population. Across all cohorts through 10 years, the Kaplan–Meier risk of rupture in the MRI cohort was 8.6% (95% CI, 6.2–11.8%). The capsular contracture rate was 13.5% (95% CI, 11.8–15.4%), and the reoperation rate was 31.5% (95% CI, 29.2–33.9%).

Fig. 5

Fig. 5

Within the overall study population through 10 years, the occurrence of rotation and double capsule was assessed. Rotation occurred in 2 patients across all cohorts (0.1%), and there were no reports of double capsule.

Reviewing postoperative reports of cancer and connective tissue disease through 10 years, 15 patients reported breast cancer (0.8%). Other types of reported cancers included skin cancer (0.8%), metastatic cancer (0.6%), and lung cancer (0.2%). There were no cases of BIA-ALCL in the Sientra Core clinical study. The following rates were calculated for connective tissue diseases, rheumatoid arthritis (0.3%), Reynaud’s Phenomenon (0.1%), and fibromyalgia (0.2%); all others were reported ≤ 0.2%.

In the combined augmentation cohorts, migraine and dry eyes were the most commonly reported neurologic/rheumatic symptoms at 10 years postimplantation. For migraines, the percentage decreased from baseline (from 13.7% to 9.3%), and for dry eyes the percentage increased after baseline (from 3.7% to 5.2%). In the combined reconstruction cohorts, migraine, dry eyes, and low back pain were the most commonly reported neurologic/rheumatic symptoms at 10 years postimplantation. For migraines, the percentage decreased from baseline (from 15.4% to 10.8%); dry eyes and low back pain percentage increased after baseline (from 4.9% to 5.8% for dry eyes, and from 5.4% to 5.8% for back pain). Skin and fatigue symptoms were reported by < 1% of augmentation patients at baseline and at 10 years after implantation, and no reconstruction patients reported these symptoms at 10 years.

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Additional Safety Analysis: Capsular Contracture

The impact of implant surface type on the occurrence of capsular contracture was analyzed in the primary augmentation population (n = 1,116 patients, 2,230 implants) by comparing the number of patients who were implanted with smooth implants (n = 1288, 58%) versus textured implants (n = 942, 42%). A risk factor analysis showed reduced risk of capsular contracture with textured devices (P = 0.0007) and submuscular placement (P ≤ 0.0001). This reduction is further demonstrated across all cohorts via the Kaplan–Meier rates reported in Table 5.

Table 5

Table 5

The timing of capsular contracture events was investigated across the 4 cohorts. Figure 6 reports how over half of all capsular contracture events in the primary and revision-reconstruction cohorts occurred within the first 2 years after implantation (54% and 67%, respectively). Whereas in the augmentation cohorts, it took 3–4 years for over 50% of the events in the primary and revision-augmentation cohorts to occur. Despite this differentiation during the initial years following implantation, Figure 6 consistently reports that within the first 6 years at least 80% of all capsular contracture events across all cohorts were reported.

Fig. 6

Fig. 6

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Additional Safety Analysis: Capsular Contracture and Rupture Results by Surgeon

A by-site analysis was performed for 2 key complications: capsular contracture and rupture. Three sites enrolled 18% of the total study patients and accounted for 42% of capsular contracture through 10 years. The Kaplan–Meier rate for capsular contracture excluding the 3 sites was 9.6% at 10 years, by-patient. For rupture, 3 sites enrolled 16% of total study patients and accounted for 41% of rupture occurrences. The Kaplan–Meier rate for suspected/confirmed rupture excluding the 3 sites was 5.8% at 10 years, by patient.

In assessing how the 3 highest contributors compare to the rest of the study surgeons, they enrolled 329 patients and reported 82 capsular contracture events through 10 years. All other sites enrolled 1,459 patients and reported 112 capsular contracture events. It is interesting to note that the highest contributing sites account for over double the percentage of capsular contracture (25%) compared with all other sites (8%). With regard to rupture, the 3 highest contributors enrolled 293 patients and reported 26 ruptures. All other sites enrolled 1,495 patients and reported 37 ruptures. This corresponds to over triple the percentage of rupture at the 3 highest contributing sites (9%) compared with all other sites (2%; Fig. 7).

Fig. 7

Fig. 7

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Effectiveness

Surgeon satisfaction with implant surgery results was high across all 4 cohorts at 99.5%. When comparing the bra cup size in the primary augmentation cohort, 60% of the patients increased their bra cup size by at least 1.5 cup sizes.

Patient-reported satisfaction measures are presented in Figure 8. The primary augmentation patients ranked the highest in satisfaction for “Patient agrees that her breasts look natural and feel soft” at 91%, while the highest patient satisfaction reported in the revision-augmentation cohort was “Patient thinks her breast implants make her clothes fit better” at 90%. In the reconstruction cohorts, patients ranked “Patient thinks breast implants make her feel more feminine” at 78% for primary reconstruction and 91% for revision-reconstruction.

Fig. 8

Fig. 8

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DISCUSSION

The completion of 10 years of follow-up in Sientra’s Core Study, the largest gel breast implant pivotal trial to-date, continues to confirm the long-term safety and effectiveness of Sientra’s silicone gel breast implants consistent with previously published study results.14 , 18 , 20 , 24 , 25

Throughout the duration of this 10-year study, Sientra’s implants have continued to perform safely with relatively low rates of key complications and are comparable with or below industry standards at similar timeframes (Tables 6, 7).9 , 11 The Sientra primary augmentation MRI cohort rupture rate was 8.5% and was the lowest compared with the 9.3% and 24.2% rupture rates of the other U.S. manufacturers (Table 6).9 , 11 Regarding capsular contracture, the Sientra primary augmentation 10-year rate was 12.9% and was comparable with the other U.S. manufacturers ranging between 12% and 19%. Reoperation rates were similar across manufacturers with Sientra again having the lowest rate at 24.0% compared with a range of 25–36%.9 , 11

Table 6

Table 6

In the primary reconstruction cohort, Sientra reported the lowest rates in these key categories: MRI Cohort Rupture (16.5%) compared to 35.4% and 32.7%; capsular contracture (15.8%) compared 24.6% and 20.5%; and reoperation (48.2%) compared to 71.5% and 49.0% (Table 7).9 , 11

Table 7

Table 7

In the overall study, one of the most common reasons for reoperation was style/size change (19.3%; Fig. 3). Cosmetic reasons, including style/size change, asymmetry and ptosis, continue to account for over half of the reoperations (50.6%). As surgeons gain access to preoperative sizers, sizing systems and device-specific surgical training, reoperations due to size and style change have and will continue to decrease while improving patient satisfaction.

The overall incidence of cancer and connective tissue disease remains low through the 10-year time point. These results are consistent with the large body of literature that indicates no proven correlation between silicone gel breast implants and these disease occurrences, including a comprehensive literature review published in 2015.26

Connective tissue disease signs and symptoms were reviewed through 10 years, and it is interesting to note that the percentage of patients reporting migraines decreased from baseline (from 13.7% to 9.3%). In the United States, 17% of the female population is affected by migraines.27 It would be interesting to see if further analysis revealed similar decreases in the signs and symptoms of other conditions especially when comparing the study population with the general population.

Given the current industry focus on BIA-ALCL, this endpoint was assessed, and there were no cases reported in this study at 10 years postplacement. To date, 2 cases of BIA-ALCL have been reported with Sientra implants in primary augmentation patients with textured round devices implanted by the same surgeon. Both patients were symptomatic at approximately 8 years postimplantation, received full capsulectomy and explantation and remain disease free. The leading theories on the etiology pathogenesis of BIA-ALCL include macro-textured devices with increased surface area, specific bacterial biofilm, and genetic predisposition.28–31 A wealth of evidence has demonstrated a correlation between chronic inflammation and bacterial biofilm in suggesting a role in the pathogenesis of both capsular contracture and BIA-ALCL, especially with textured devices where the increased surface area can result in an increased amount of bacterial biofilm.28 , 29 , 32

The long-term review of capsular contracture by surface type continues to provide evidence of the protective effect of Sientra’s texture in the development of capsular contracture. A previous multivariate regression analysis found that surgical techniques including textured surface, submuscular placement, and inframammary incision were shown to reduce the occurrence of capsular contracture in breast augmentation using Sientra implants.15 It is important to note that the Core Study patients were all enrolled prior to more recent “minimal touch” techniques, such as the use of an insertion sleeve, nipple shields, and bloodless dissection, as well as appropriate incision length, which are all shown to contribute to a decreased capsule formation.33–35 It has also been suggested that the increased cohesiveness in fifth-generation devices may impact the development of capsular contracture whereby the increased firmness creates more resistance to the mechanical forces of capsular contracture, thus minimizing the progression from a grade 2 (firmness) to a grade 3 (deformity) capsular contracture; however, further research is needed.36 Results from the other 2 U.S. manufacturers revealed similarly lower rates of capsular contracture in their fifth-generation shaped devices compared with fourth-generation devices.10 , 12 It has been proposed that these lower rates may be due to the texture on the shaped devices or the resistance to deformation afforded by the firmer silicone gel, but more studies are needed.

The by-investigator analysis of capsular contracture and rupture continues to show strong evidence of a correlation between surgical technique and the occurrence of complications. The 3 highest contributing surgeons accounted for over 2 times the percentage of capsular contracture events in comparison with all other study surgeons (25% and 8%, respectively). Similarly, the 3 highest contributors were attributed to over triple the percentage of rupture rate compared with all other study surgeons (9% and 2%, respectively). It is clear from these data that not only the device itself but also the surgical techniques employed can affect the complication and reoperation rates associated with these devices. In considering capsular contracture, plastic surgeons have made significant progress in recent years in the understanding of capsular contracture etiology and preventative measures. The 14 Point Plan for reduction of bacterial biofilm directly addresses points of potential contamination at the time of implant placement that may contribute to development of capsular contracture.6

European plastic surgeons predominately use textured devices36 and adopted highly cohesive shaped implants earlier than U.S. surgeons due to factors including the U.S. FDA 1992 breast implant moratorium and differences in postgraduate training programs. As a result, European clinical data are more extensive and reflective of clinical experience with textured implants compared with the U.S. especially with regard to reduction in capsular contracture seen with textured devices.37–39 According to an extensive European multicenter based study, textured shaped form-stable gel breast implants reported low complication rates, including rupture, capsular contracture, and wrinkling/rippling, up to 11 years postsurgery. The majority of subjects reported high satisfaction with their implants.40 With the majority of breast implants used in Europe being textured, it is interesting to note that there have been relatively few BIA-ALCL cases (58 cases) collected by the European Competent Authority from Italy, France, England, Belgium, Denmark, and Switzerland.41 The authors of the cited article postulated that some cases may not be reported or were excluded and/or unavailable.

In addition to the strong safety profile reported here, results through 10 years indicated there were continued high satisfaction results among surgeons and patients across all cohorts. Primary augmentation, revision-augmentation, and revision-reconstruction patients reported over 90% satisfaction in key satisfaction assessments, and primary reconstruction patients reported close to 80% satisfaction. Similarly, in Spear 2014 and Maxwell 2015, over 90% of round and shaped patients in the primary augmentation, primary reconstruction, and revision-reconstruction cohorts reported being either satisfied or very satisfied at 10 years.8 , 42 Postoperative case demonstrating long-term outcomes for augmentation results are presented in Figure 9.

Fig. 9

Fig. 9

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CONCLUSIONS

The 10-year follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirms the very strong safety profile as well as continued patient satisfaction. Based on the authors’ collective experience, preoperative surgical planning and operative approach can significantly impact the success of breast surgery utilizing Sientra implants. Based on the data collected in this study, strong consideration should be given to utilizing textured implants when it is deemed appropriate. This is especially important when placing the implants in the subglandular or subfascial plane. Placement of the implant in the submuscular pocket and the use of the inframammary incision seem prudent when clinically appropriate, as this may also contribute to lower capsular contracture rates. The ultimate operative decisions and approach must balance the desire to minimize these risks with the approach that will optimize the aesthetic outcome. The information gleaned from this study provides guidance to patients and board-certified plastic surgeons in making an informed decision regarding their breast implant options.

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ACKNOWLEDGMENTS

The authors thank Maggi Beckstrand, PhD, for biostatistical assistance. M. Beckstrand is a Sientra consultant.

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