Abstract
Background:
After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. postapproval study. The authors present results from the first 6 years of this study.
Methods:
An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients undergoing breast augmentation, reconstruction, and revision in the postmarket environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015 (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022).
Results:
Across all cohorts who received an implant, the Kaplan-Meier risk of investigator-reported Baker grade III/IV capsular contracture was 4.1% (3.9% with submuscular placement and 6.75%with subglandular placement), the risk of reoperation was 11.6%, and the risk of implant removal was 7.8% (5.9% with implant replacement and 2.0% without replacement). The primary reason (>50%) for reoperation was aesthetic (eg, style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8%. Overall, 82.6% of patients were highly satisfied/happy with their implant. No cases of breast implant–associated anaplastic large cell lymphoma were reported.
Conclusion:
Six-year results of the postapproval study were consistent with the 10-year core study and provide additional evidence in a large data set supporting the comprehensive safety and effectiveness profile of the Sientra implants.
Silicone breast implants have been used since the 1960s.1,2 In January of 1992, after a highly publicized class-action lawsuit against Dow Corning,3 the U.S. Food and Drug Administration (FDA) placed a temporary moratorium on silicone breast implants for augmentation.4 At that time, data demonstrating the long-term safety and efficacy of silicone breast implants were unavailable. Research in the following years into the safety of these devices found no associations between increased risk of breast cancer or connective tissue diseases and silicone breast implants,5–8 and the moratorium was lifted in November of 2006.1 Although the first case of breast implant–associated anaplastic large cell lymphoma was reported in 1997,9 it was not until 2011 that an FDA alert was publicized.10 Since then, more cases have been reported in patients with macrotextured (>50 µm) implants.11,12 New labeling and restriction of use imposed by the FDA emphasized the need for long-term clinical data on safety and effectiveness of breast implants. Mentor (n = 1008 patients), Allergan (n = 715), and Sientra (n = 1788) have published the results of 10-year core studies, which supported premarketing approval.13–16 However, few large multicenter studies showing real-world data have been published.17,18
The Sientra silicone gel breast implants were approved in the United States in 2012 for breast augmentation in women at least 22 years old and for breast reconstruction.19 The implants range from 60 to 700 cc in volume and are available in smooth round, textured round, and textured anatomically shaped options.19 The Sientra textured implant is unique because of the proprietary microtextured surface, per ISO14607:2018.13,20 Data from the pivotal 10-year core-study13 support the safety and effectiveness of the Sientra breast implant portfolio.
Here, we report the results of the first 6 years of the postapproval study, which was designed to evaluate the long-term clinical performance of Sientra silicone gel breast implants in patients undergoing augmentation, reconstruction, or revision under general conditions of use in the postmarket environment. This large 10-year study includes more than 5000 patients, expanding the real-world evidence in Sientra breast implants.
PATIENTS AND METHODS
Study Design
This open-label, prospective, multicenter clinical study was initiated on June 1, 2012, at 148 sites across the United States and was conducted in accordance with FDA guidance for postapproval studies.21 The protocol was developed in compliance with the International Council for Harmonisation guidelines. All study sites received institutional review board approval, and informed consent was obtained from all patients. Enrollment was completed on March 6, 2015. The 6-year data cutoff date for this article was January 24, 2022. The expected date of the postapproval study completion is May 18, 2025, which includes the 10-year duration, and the target window for patient follow-up.
Patients
Women undergoing primary or revision breast augmentation or primary or revision breast reconstruction with Sientra high-strength silicone gel breast implants (aged 18 years or older in the reconstruction cohort and 22 years or older in the augmentation cohort) were eligible for inclusion. Patients were enrolled into 4 cohorts by indication: primary augmentation, revision-augmentation, primary reconstruction, and revision-reconstruction.
Device Description
The Sientra high-strength silicone gel breast implants are single-lumen devices composed of a barrier-type, silicone elastomer shell and filled with a high-strength silicone gel.19 The implants are available in various shapes, profiles, and sizes, with either a smooth or textured shell surface.
Endpoints and Assessments
The primary safety outcomes included 3 local complications reported by the investigators: capsular contracture, rupture (suspected by means of magnetic resonance imaging [MRI] or ultrasound), and infection, and explantation and reoperation (any revisions after implant exchange were captured as a reoperation). Data on clinically assessed malposition were also collected. Systemic outcomes were reported and defined as diseases or conditions with an incidence of greater than 10 per 10,000 according to FDA recommendation for inclusion in a postapproval study.21 The common systemic outcomes evaluated were rheumatoid arthritis, rheumatic polymyalgia, chronic fatigue syndrome, breast implant-associated anaplastic large cell lymphoma, lung cancer, breast cancer, suicide/attempted suicide, anxiety, depression, and fibromyalgia. Rheumatologic and neurologic signs and symptoms were also evaluated. The secondary outcomes included reasons for reoperations, analyses of adverse event risk factors, and effectiveness (patient satisfaction and quality of life).
Data Collection
Investigator evaluations were conducted at baseline and at years 1 and 5. Participants received e-mail reminders at set intervals to schedule follow-up visits and complete study questionnaires. Multiple attempts were made to reach participants who did not comply with the study by e-mail or phone call to minimize loss to follow-up.
Patients were screened for rupture at years 1, 3, and 5, based on its presentation as silent (no symptoms but suspected by means of MRI, found at explantation or intraoperatively, or found by means of other source) or symptomatic (symptoms of rupture are present) according to FDA guidelines. Only patients with suspected rupture underwent MRI. The censored group for rupture risk calculation were patients who either underwent explantation or MRI for suspected rupture.
Local complications and common systemic outcomes were recorded on the investigator local complications and secondary procedures form (see Document, Supplemental Digital Content 1, which shows investigator complication report, which investigators use to report any complications, http://links.lww.com/PRS/G756) or the participant interim complications form (see Document, Supplemental Digital Content 2, which shows the participant complication report, which participants use to report any complications, http://links.lww.com/PRS/G757). Additional follow-up data were obtained by means of questionnaires designed to be completed online, but alternative methods were available (eg, paper form in investigator’s office, telephone interview). Patients completed a baseline questionnaire, a condensed follow-up questionnaire at years 1 and 5 (when they also received a physical evaluation), and a standard follow-up questionnaire at year 3. At years 2, 4, and 6, they completed quality-of-life and signs/symptoms questionnaires to assess suicide/attempted suicide, satisfaction with implant, and rheumatologic and neurologic signs and symptoms. Patient satisfaction with breast implants and quality of life were measured using a previously validated instrument, the BREAST-Q augmentation and reconstruction modules (version 1.0).22
Statistical Analysis
For the 6-year follow-up, Kaplan-Meier analyses were used for the primary study endpoints (ie, investigator reports of 3 local complications—capsular contracture, rupture, and infection—and reoperations and implant removals) in patients who received an implant. The Kaplan-Meier risk of the event was calculated based on length of implantation. For patients who experienced the event, person-years were calculated as the date of the event minus implantation date. For patients who did not experience the event, person-years were calculated as the last follow-up date (or death) minus the implantation date.
The study was powered to detect a two-fold increase with a one-side significance level of 0.05. The adverse event risk factor analysis was performed using a Cox proportional hazard model to assess whether specific patient, device, or surgical characteristics were associated with the incidence of capsular contracture, infection, rupture, and reoperation. In the risk factor regression analysis, P value interpretation was adjusted using the Bonferroni correction.
Changes from baseline in quality-of-life scales were analyzed using generalized linear modeling with adjustment for age and length of follow-up. Adjusted means (least squared means) at baseline (preimplantation) and at 6 years (postimplantation) were calculated with a P value to test for effect. SAS software (version 9.4; SAS Institute, Inc., Cary, NC) was used for all statistical analyses.
RESULTS
Patients
A total of 5197 patients participated in the study: 4046 primary augmentation (including augmentation mastopexy), 895 revision-augmentation (including revision-augmentation mastopexy), 149 primary reconstruction, and 107 revision-reconstruction. At 6 years, 131 institutional review board–approved sites were actively participating in the study, and 361 participants had discontinued the study. The reasons for study discontinuation were explantation (n = 245), participant request (n = 76), death (n = 19), loss to follow-up (n = 18), and unavailability (n = 3). The percentage of patients who actively continued compliance to visits and forms per study protocol at 6 years was 67%, calculated as number seen (n = 3306) divided by number expected (n = 4933, treated patients minus the number of discontinuations because of explantation and death). Compliance was lower than anticipated, likely because of the challenges of the COVID-19 pandemic.
At baseline, participants were aged from 22 to 73 years in the augmentation cohorts and from 19 to 77 years in the reconstruction cohorts (Table 1). In total, 10,327 devices were implanted (smooth, 5857 [56.7%]; textured, 4470 [43.3%]).
Table 1.
Participant Demographics, by Indication (Patient-Based Analysis)
| Primary Augmentation (n = 4046) (%) | Revision-Augmentation (n = 895) (%) | Primary Reconstruction (n = 149) (%) | Revision-Reconstruction (n = 107) (%) | |
|---|---|---|---|---|
| Age, yr | ||||
| Median | 32 | 43 | 48 | 53 |
| Range | 22–72 | 22–73 | 19–77 | 19–72 |
| Height | ||||
| Median | 5’5” | 5’5” | 5’5” | 5’5” |
| Range | 4’4”–6’6” | 4’4”–6’1” | 4’11”–6’0” | 4’11”–6’2” |
| Weight, lb | ||||
| Median | 130 | 130 | 140 | 142 |
| Range | 84–278 | 73–230 | 95–260 | 105–278 |
| Race/ethnicity | ||||
| White | 3131 (77.4) | 737 (82.3) | 118 (79.2) | 78 (72.9) |
| Black | 95 (2.3) | 13 (1.5) | 10 (6.7) | 19 (17.8) |
| Hispanic | 346 (8.6) | 73 (8.2) | 12 (8.1) | 3 (2.8) |
| Asian | 196 (4.8) | 32 (3.6) | 3 (2.0) | 2 (1.9) |
| Hawaiian/other Pacific Islander | 21 (0.5) | 1 (0.1) | 2 (1.3) | 0 |
| American Indian/Alaskan Native | 37 (0.9) | 7 (0.8) | 0 | 0 |
| Mixeda | 220 (5.4) | 32 (3.6) | 4 (2.7) | 5 (4.7) |
ND, not determined.
The category “mixed” indicates participants who reported more than one race/ethnicity in their baseline questionnaire.
Device and surgical characteristics for the implants are shown in Table 2. For the primary augmentation and revision-augmentation groups, most patients received the smooth round implants (59.7% and 51.8% of devices implanted, respectively), whereas for the primary reconstruction and revision-reconstruction cohorts, most patients received the textured shaped implants (65.7% and 59.1% of devices implanted, respectively). Across all cohorts, most incisions were 3.1 to 6.0 cm in length (71.5% primary augmentation, 61.8% revision-augmentation, 46.5% primary reconstruction, and 61.8% revision-reconstruction). Submuscular implantation placement was the most common across all cohorts (92.6% primary augmentation, 88.5% revision-augmentation, 90.8 primary reconstruction, and 96.2% revision-reconstruction). For the augmentation cohorts, the incisions were primarily at inframammary sites (72.0% primary augmentation and 53.7% revision-augmentation); in the reconstruction cohorts, most implants had incisions at the mastectomy scar (55.0% primary reconstruction and 37.1% revision-reconstruction) or inframammary sites (37.6% primary reconstruction and 49.5% revision-reconstruction). Almost all implants (>98%) received pocket irrigation.
Table 2.
Implant Device and Surgical Characteristics, by Indication (Implant-Based Analysis)
| Primary Augmentation (n = 4046) (%) | Revision-Augmentation (n = 895) (%) | Primary Reconstruction (n = 149) (%) | Revision-Reconstruction (n = 107) (%) | |
|---|---|---|---|---|
| No. of implants | 8090 | 1780 | 271 | 186 |
| Device distribution | ||||
| Smooth round | 4832 (59.7) | 922 (51.8) | 67 (24.7) | 36 (19.4) |
| Textured round | 2194 (27.1) | 687 (38.6) | 26 (9.6) | 40 (21.5) |
| Textured shaped | 1064 (13.2) | 171 (9.6) | 178 (65.7) | 110 (59.1) |
| Device placement | ||||
| Subglandular (prepectoral) | 596 (7.4) | 205 (11.5) | 25 (9.2) | 7 (3.8) |
| Submuscular (subpectoral) | 7492 (92.6) | 1575 (88.5) | 246 (90.8) | 179 (96.2) |
| Not provided | 2 (<0.1) | 0 | 0 | 0 |
| Incision site | ||||
| Periareolar | 899 (11.1) | 323 (18.1) | 6 (2.2) | 6 (3.2) |
| Inframammary | 5826 (72.0) | 956 (53.7) | 102 (37.6) | 92 (49.5) |
| Mastopexy incision | 1030 (12.7) | 450 (25.3) | 13 (4.8) | 15 (8.1) |
| Mastectomy scar | N/A | N/A | 149 (55.0) | 69 (37.1) |
| Transaxillary | 334 (4.1) | 50 (2.8) | 1 (0.4) | 4 (2.2) |
| Not provided | 1 (<0.1) | 1 (<0.1) | 0 | 0 |
| Incision size | ||||
| 0.0–3.0 cm | 1509 (18.7) | 296 (16.6) | 14 (5.2) | 5 (2.7) |
| 3.1–6.0 cm | 5785 (71.5) | 1100 (61.8) | 126 (46.5) | 115 (61.8) |
| 6.1–9.0 cm | 562 (6.9) | 240 (13.5) | 83 (30.6) | 54 (29.0) |
| >9.0 cm | 232 (2.9) | 144 (8.1) | 48 (17.7) | 12 (6.5) |
| Not provided | 2 (<0.1) | 0 | 0 | 0 |
| Pocket irrigation | ||||
| No | 34 (0.8) | 9 (1.0) | 2 (1.3) | 0 |
| Yes | 4012 (99.2) | 886 (99.0) | 147 (98.7) | 107 (100) |
| Types of irrigationa | 4012 | 886 | 147 | 107 |
| Anesthetic (eg, Marcaine) | 2510 (62.6) | 537 (60.6) | 51 (34.7) | 16 (15.0) |
| Antibiotic (eg, Ancef, Neomycin, Bacitracin) | 2810 (70.0) | 680 (76.7) | 111 (75.5) | 82 (76.6) |
| Betadine | 1477 (36.8) | 274 (30.9) | 42 (28.6) | 42 (39.3) |
| Epinephrine | 783 (19.5) | 191 (21.6) | 8 (5.4) | 5 (4.7) |
| Saline/NaCl | 1782 (44.4) | 372 (42.0) | 58 (39.5) | 30 (28.0) |
| Steroid (eg, Kenalog) | 68 (1.7) | 29 (3.3) | 0 | 0 |
| Other antiseptic (other than povidone-iodine) | 129 (3.2) | 41 (4.6) | 2 (1.4) | 5 (4.7) |
N/A, not applicable.
The sum is greater than 100% because a combination of irrigation types were used in some instances.
Safety Outcomes
Outcomes for the primary study endpoints (ie, investigator reports of 3 local complications [capsular contracture, rupture, and infection] and reoperations and implant removals) are shown in Table 3. (See Figure, Supplemental Digital Content 3, which shows the Kaplan-Meier curves for primary local complications [n = 5197]. [Above, left] Capsular contracture. [Above, right] Confirmed/unconfirmed rupture. [Center, left] Infection. [Center, right] Reoperation. [Below] Implant removal, http://links.lww.com/PRS/G758.)
Table 3.
Primary Local Complications, Reoperation, and Implant Removal through Year 6, by Indication (Patient-Based Analysis, Investigator Reported)
| No. (Kaplan-Meier Risk %) | Primary Augmentation (n = 4046) (%) | Revision-Augmentation (n = 895) (%) | Primary Reconstruction (n = 149) (%) | Revision-Reconstruction (n = 107) (%) | Total (n = 5197) (%) |
|---|---|---|---|---|---|
| Capsular contracture | |||||
| No. | 113 (3.1) | 58 (7.4) | 12 (10.2) | 11 (12.6) | 194 (4.1) |
| 95% CI | 2.5–3.7 | 5.8–9.5 | 5.9–17.4 | 7.2–21.8 | 3.6–4.7 |
| Confirmed/unconfirmed rupturea | |||||
| No. | 12 (5.7) | 3 (4.9) | 2 (9.7) | 1 (6.3) | 18 (5.8) |
| 95% CI | 3.2–9.9 | 1.6–14.5 | 2.3–35.8 | 0.9–36.8 | 3.6–9.1 |
| Infection | |||||
| No. | 22 (0.6) | 7 (0.8) | 2 (1.6) | 2 (2.1) | 33 (0.7) |
| 95% CI | 0.4–0.9 | 0.4–1.7 | 0.4–6.2 | 0.5–8.0 | 0.5–1.0 |
| Reoperation | |||||
| No. | 342 (9.1) | 138 (16.9) | 47 (33.6) | 33 (34.4) | 560 (11.6) |
| 95% CI | 8.2–10.1 | 14.5–19.7 | 26.4–42.2 | 25.8–44.9 | 10.8–12.6 |
| Implant removal | |||||
| No. | 218 (5.8)b | 92 (11.5) | 34 (24.5) | 29 (30.4) | 373 (7.8) |
| 95% CI | 5.1–6.6 | 9.4–13.9 | 18.1–32.6 | 22.2–40.8 | 7.1–8.6 |
| With replacement | |||||
| No. | 167 (4.5) | 67 (8.3) | 26 (19.5) | 23 (24.5) | 283 (5.9) |
| 95% CI | 3.9–5.2 | 6.6–10.5 | 13.7–27.4 | 16.9–34.6 | 5.3–6.6 |
| Without replacement | |||||
| No. | 53 (1.5) | 25 (3.4) | 8 (6.1) | 6 (7.9) | 92 (2.0) |
| 95% CI | 1.1–1.9 | 2.3–5.0 | 3.1–12.0 | 3.6–16.8 | 1.7–2.5 |
| Rate | |||||
| Malposition (by patient) | 105 (2.6) | 31 (3.5) | 10 (6.7) | 5 (4.7) | 151 (2.9) |
The Kaplan-Meier risk calculations exclude patients who have been censored. For the rupture endpoint, patients were censored on the last date that the device was known to be intact which is either the last MRI or the date of implant explantation (or the date of initial implant placement if the patient never underwent MRI and never underwent explantation). Therefore, not all patients are included in these analyses.
Number of implant removals may not equal the total because some participants had multiple events in both categories of “with or without replacement.”
For all implant cohorts combined, the Kaplan-Meier risk of reoperation was 11.6%; all other Kaplan-Meier risks for the primary study endpoints were less than 10%. Overall, 560 of 5197 patients had a reoperation. When analyzed per cohort, the Kaplan-Meier risks of reoperation were 9.1% for primary augmentation, 16.9% for revision-augmentation, 33.6% for primary reconstruction, and 34.4% for revision-reconstruction. Excluding reoperation and rupture (which was calculated in a subset of patients), the complication with the next highest risk in all cohorts was Baker grade III/IV capsular contracture, with an overall risk of 4.1% (3.1%, 7.4%, 10.2%, and 12.6 % for the cohorts, respectively). The risk of infection was less than 1% overall.
At year 6, of the 10,327 devices implanted in 5197 patients, the total number of ruptured implants was 18 (12 primary augmentation, 3 revision-augmentation, 2 primary reconstruction, and 1 revision-reconstruction). Risk of rupture was calculated in a subset of patients who had undergone either explantation or MRI for rupture evaluation as required by the FDA for reporting. In these patients, the Kaplan-Meier risk of rupture, suspected through MRI or ultrasound, was 5.8% for all cohorts combined, 5.7% for primary augmentation, 4.9% for revision-augmentation, 9.7% for primary reconstruction, and 6.3% for revision-reconstruction.
In this study, implant removal (with or without replacement) was classified as a reoperation procedure. The Kaplan-Meier risk of implant removal was 7.8% for all cohorts (5.8% for primary augmentation, 11.5% for revision-augmentation, 24.5% for primary reconstruction, and 30.4% for revision-reconstruction). Most implant removals (283 of 373) were followed by replacement. The risks of implant removal without replacement were 1.5% for primary augmentation, 3.4% for revision-augmentation, 6.1% for primary reconstruction, and 7.9% for revision-reconstruction. The rate of malposition across all cohorts was 2.9% (2.6% for primary augmentation, 3.5% for revision-augmentation, 6.7% for primary reconstruction, and 4.7% for revision-reconstruction).
Primary reasons for reoperations through year 6 are shown in Table 4 and Figure 1. Over half (57.4%) of all reasons for reoperation were aesthetic. The most common reasons for reoperation were capsular contracture (18.8%), malposition (13.5%), and size/style change (11.8%).
Table 4.
Primary Reason for Reoperations through Year 6, by Indication (Patient-Based Analysis, Investigator Reported)
| Characteristica | Primary Augmentation (n = 4046) (%) | Revision-Augmentation (n = 895) (%) | Primary Reconstruction (n = 149) (%) | Revision-Reconstruction (n = 107) (%) | Total (n = 5197) (%) |
|---|---|---|---|---|---|
| Reoperations | 372 | 150 | 53 | 33 | 608 |
| Most common reasons for reoperation | |||||
| Capsular contracture | 62 (16.7) | 35 (23.3) | 7 (13.2) | 10 (30.3) | 114 (18.8) |
| Implant malpositionb | 51 (13.7) | 26 (17.3) | 4 (7.5) | 1 (3.0) | 82 (13.5) |
| Size/style changeb | 55 (14.8) | 15 (10.0) | 2 (3.8) | 0 | 72 (11.8) |
| Asymmetryb | 32 (8.6) | 15 (10.0) | 13 (24.5) | 4 (12.1) | 64 (10.5) |
| Patient request for implant removalb | 28 (7.5) | 10 (6.7) | 1 (1.9) | 3 (9.1) | 42 (6.9) |
| Other reasons | |||||
| Breast cancer | 4 (1.1) | 1 (0.7) | NR | NR | 5 (0.8) |
| Breast pain | 6 (1.6) | 3 (2.0) | 1 (1.9) | 1 (3.0) | 11 (1.8) |
| Delayed wound healing | 4 (1.1) | 2 (1.3) | 0 | 2 (6.1) | 8 (1.3) |
| External trauma/injury to breast area | 1 (0.3) | NR | NR | NR | 1 (0.2) |
| Extrusion | 2 (0.5) | 2 (1.3) | 2 (3.8) | 0 | 6 (1.0) |
| Hematoma | 14 (3.8) | 2 (1.3) | 0 | 0 | 16 (2.6) |
| Hypertrophic or other abnormal scarring | 13 (3.5) | 3 (2.0) | 2 (3.8) | 0 | 18 (3.0) |
| Implant palpabilityb | 2 (0.5) | NR | NR | NR | 2 (0.3) |
| Implant rotationb | 3 (0.8) | NR | 1 (1.9) | NR | 4 (0.7) |
| Implant visibilityb | 1 (0.3) | 1 (0.7) | 1 (1.9) | NR | 3 (0.5) |
| Infection | 20 (5.4) | 7 (4.7) | 2 (3.8) | 2 (6.1) | 31 (5.1) |
| Irritation/inflammation | 0 | 1 (0.7) | 0 | 0 | 1 (0.2) |
| Mass/lump | 24 (6.5) | 1 (0.7) | 3 (5.7) | NR | 28 (4.6) |
| Nipple related | 4 (1.1) | 1 (0.7) | 0 | 0 | 5 (0.8) |
| Pocket related | 1 (0.3) | 1 (0.7) | 1 (1.9) | NR | 3 (0.5) |
| Ptosisb | 20 (5.4) | 4 (2.7) | 0 | 0 | 24 (3.9) |
| Recurrent/metastatic cancer | NR | NR | 1 (1.9) | 2 (6.1) | 3 (0.5) |
| Rupture or suspected rupture | 7 (1.9) | 1 (0.7) | 0 | 1 (3.0) | 9 (1.5) |
| Seroma | 9 (2.4) | 5 (3.3) | 0 | 1 (3.0) | 15 (2.5) |
| Skin related | 2 (0.5) | 3 (2.0) | 3 (5.7) | 2 (6.1) | 10 (1.6) |
| Swelling | 1 (0.3) | 1 (0.7) | NR | NR | 2 (0.3) |
| Tissue or skin necrosis | 0 | 0 | 2 (3.8) | 0 | 2 (0.3) |
| Upper pole fullnessb | NR | 1 (0.7) | NR | 1 (3.0) | 2 (0.3) |
| Wrinkling/ripplingb | 6 (1.6) | 9 (6.0) | 6 (11.3) | 3 (9.1) | 24 (3.9) |
| Other | 0 | 0 | 1 (1.9)a,c | 0 | 1 (0.2) |
NR, not reported.
The number of reoperations is greater than the number of participants reported on the risk table because some participants underwent multiple reoperations.
Indicates an aesthetic reason for reoperation.
One patient had next-stage breast reconstruction.
Fig. 1.
Top 5 reasons for reoperations.
Other systemic outcomes are reported in Table 5. Events through year 6 were rare, with incidences reported at less than 1%. The Kaplan-Meier risk of anxiety was 2.1%. No cases of breast implant-associated anaplastic large cell lymphoma, squamous cell carcinomas, or other lymphomas were reported.
Table 5.
Systemic Outcomes through Year 6 by Indication (Patient-Based Analysis)
| Primary Augmentation (n = 4046) (%) | Revision-Augmentation (n = 895) (%) | Primary Reconstruction (n = 149) (%) | Revision-Reconstruction (n = 107) (%) | Total (n = 5197) (%) | |
|---|---|---|---|---|---|
| No. | 4046 | 895 | 149 | 107 | 5197 |
| Breast cancer | 14 (0.3) | 2 (0.2) | 0 | 0 | ND |
| Lung or bronchus cancer | 0 | 3 (0.3) | 0 | 1 (0.9) | ND |
| Chronic fatigue syndrome | 0 | 2 (0.2) | 0 | 0 | ND |
| Fibromyalgia | 15 (0.4) | 0 | 0 | 0 | ND |
| Rheumatic polymyalgia | 2 (<0.1) | 0 | 0 | 1 (0.9) | ND |
| Rheumatoid arthritis | 8 (0.2) | 4 (0.4) | 0 | 0 | ND |
| Considered and planned to commit suicidea | 30 (0.7) | 12 (1.3) | 0 | 1 (0.9) | ND |
| Attempted suicidea | 9 (0.2) | 4 (0.4) | 0 | 0 | ND |
| No. (Kaplan-Meier risk %) | |||||
| Anxiety disorder | 79 (2.2) | 11 (1.5) | 2 (1.8) | 4 (5.4) | 96 (2.1) |
| Depression or other mood disorder | 82 (2.3) | 11 (1.4) | 0 | 2 (2.1) | 95 (2.1) |
ND, not determined.
Patient reported.
Risk factor regression analysis in the primary and revision-augmentation cohorts showed reduced risks of capsular contracture with smooth devices (P = 0.0005) and submuscular placement (P = 0.0015). (See Table, Supplemental Digital Content 4, which shows the risk factor regression analysis for capsular contracture in the primary and revision augmentation cohorts, http://links.lww.com/PRS/G759.) No statistically significant associations between specific patient, device, or surgical characteristics and the risk of capsular contracture (see Table, Supplemental Digital Content 5, which shows the risk factor regression analysis for capsular contracture in the primary and revision reconstruction cohorts, http://links.lww.com/PRS/G760), infection, rupture, reoperation, or explantation were found in the primary and revision-reconstruction cohorts. Risks of capsular contracture and malposition by implant surface and placement are shown in Tables 6 and 7. Overall for all cohorts, the risk of capsular contracture was 3.9% with submuscular placement and 6.7% with subglandular placement. For patients with smooth implants, the risk of capsular contracture was 3.1% in the submuscular space and 6.1% in the subglandular space. For patients with textured implants, the risks of capsular contracture were 5.0% and 7.0% (Table 6), respectively. No trend related to implant surface or placement was observed for malposition (Table 7).
Table 6.
Risk of Capsular Contracture through Year 6, by Implant Surface and Placement (Patient-Based Analysis, Investigator Reported, Kaplan-Meier Risk % [95% CI])
| Surface | Placement | Primary Augmentation (n = 4046) | Revision-Augmentation (n = 895) | Primary Reconstruction (n = 149) | Revision-Reconstruction (n = 107) | Total (N = 5197) |
|---|---|---|---|---|---|---|
| Smooth | Overall | (n = 2415) 2.7 (2.1–3.5) |
(n = 463) 5.4 (3.6–8.1) |
(n = 37) 7.2 (1.8–26.0) |
(n = 21) 12.5 (3.3–41.4) |
(n = 2936) 3.2 (2.6–4.0) |
| Subglandular | (n = 108) 5.2 (2.2–12.2) |
(n = 21) 10.8 (2.8–36.9) |
0 | 0 | (n = 129) 6.1 (3.0–12.4) |
|
| Submuscular | (n = 2306) 2.6 (2.0–3.4) |
(n = 441) 5.2 (3.4–7.9) |
(n = 37) 7.2 (1.8–26.0) |
(n = 21) 12.5 (3.3–41.4) |
(n = 2805) 3.1 (2.5–3.9) |
|
| Textured | Overall | (n = 1629) 3.5 (2.7–4.6) |
(n = 431) 9.5 (7.0–13.0) |
(n = 112) 11.2 (6.1–20.0) |
(n = 86) 12.6 (6.8–23.0) |
(n = 2258) 5.3 (4.4–6.4) |
| Subglandular | (n = 190) 3.1 (1.3–7.3) |
(n = 82) 14.8 (8.4–25.1) |
(n = 13) NR |
(n = 5) NR |
(n = 290) 7 (4.5–10.9) |
|
| Submuscular | (n = 1439) 3.6 (2.7–4.7) |
(n = 348) 8.3 (5.7–12.1) |
(n = 98) 10.4 (5.3–19.9) |
(n = 81) 11.8 (6.1–22.4) |
(n = 1966) 5 (4.1–6.1) |
|
| Overall | Subglandular | (n = 298) 3.9 (2.1–7.1) |
(n = 103) 14.0 (8.3–22.9) |
(n = 13) NR |
(n = 5) NR |
(n = 419) 6.7 (4.6–9.8) |
| Submuscular | (n = 3747) 3.0 (2.5–3.6) |
(n = 790) 6.6 (4.9–8.7) |
(n = 135) 9.5 (5.2–17.1) |
(n = 102) 12.0 (6.6–21.2) |
(n = 4774) 3.9 (3.4–4.5) |
NR, not reported.
Table 7.
Risk of Malposition through Year 6, by Implant Surface and Placement (Patient-Based Analysis, Investigator Reported, No. [Kaplan-Meier Risk %])
| Surface | Placement | Primary Augmentation (n = 4046) | Revision-Augmentation (n = 895) | Primary Reconstruction (n = 149) | Revision-Reconstruction (n = 107) | Total (N = 5197) |
|---|---|---|---|---|---|---|
| Smooth | Overall | (n = 2415) 39 (1.7) |
(n = 463) 13 (3.2) |
(n = 37) 4 (13.2) |
(n = 21) 0 |
(n = 2936) 56 (2.1) |
| Subglandular | (n = 108) 0 |
(n = 21) 1 (5.0) |
0 | 0 | (n = 129) 1 (0.8) |
|
| Submuscular | (n = 2306) 39 (1.8) |
(n = 441) 12 (3.1) |
(n = 37) 4 (13.2) |
(n = 21) 0 |
(n = 2805) 55 (2.1) |
|
| Textured | Overall | (n = 1629) 21 (1.4) |
(n = 431) 14 (3.6) |
(n = 112) 2 (2.1) |
(n = 86) 2 (3.5) |
(n = 2258) 39 (1.9) |
| Subglandular | (n = 190) 3 (1.8) |
(n = 82) 1 (1.5) |
(n = 13) 1 (8.3) |
(n = 5) 0 |
(n = 290) 5 (2.0) |
|
| Submuscular | (n = 1439) 18 (1.3) |
(n = 348) 13 (4.1) |
(n = 98) 1 (1.0) |
(n = 81) 2 (3.6) |
(n = 1966) 34 (1.9) |
Efficacy Outcomes
Patient-reported satisfaction measures are presented in Figure 2. Overall satisfaction among all cohorts was 82.6% and was highest in the primary augmentation cohort (85.5%). Patients in the primary augmentation cohort reported high satisfaction (93%) with “breast appearance in the mirror clothed,” whereas patients in the revision-augmentation cohort reported high satisfaction (86.2%) with “bra fit.” In the reconstruction cohorts, the highest satisfaction score for primary reconstruction (89%) and revision-reconstruction (86%) was “feels normal in clothes.”
Fig. 2.
Patient satisfaction measures through year 6 based on questionnaire responses (includes only nonmissing responses for primary implants) by overall satisfaction (above) and patient satisfaction by specific outcomes (below), where satisfied includes responses of “very satisfied” and “somewhat satisfied.”
Patient-reported quality of life was assessed for physical well-being, psychosocial well-being, and satisfaction with breast implants (Fig. 3), and reported for those with nonmissing valid scale-specific scores at both baseline and the 6-year follow-up. Statistically significant improvements were observed at year 6 compared with baseline for psychosocial well-being and satisfaction with breasts for the primary augmentation, revision-augmentation, and revision-reconstruction cohorts. Physical well-being decreased for the primary augmentation cohort and increased for the revision-augmentation cohort. No statistically significant changes were observed in any category for the primary reconstruction cohort.
Fig. 3.
Patient-reported quality-of-life change at year 6 (* < 0.05) (participants with nonmissing valid scale-specific scores at both baseline and follow-up).
DISCUSSION
In this analysis of the 10-year postapproval study, the clinical performance of the Sientra silicone breast implants was studied through 6 years of follow-up in over 5000 patients who had augmentation, reconstruction, or revision surgery under general conditions of use in the postmarket environment. The 6-year safety and efficacy results were consistent with the core study13,23 (Table 8) and provide additional evidence from a large data set supporting the comprehensive safety and effectiveness profile of the Sientra smooth round and textured round and shaped breast implants.
Table 8.
Comparison of Primary Local Complications between Postapproval Study and Core Studya (Patient-Based Analysis)
| Kaplan-Meier Risk % | Postapproval Study at 6 Yr | Core Study at 5 Yr23 | Core Study at 10 Yr13 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Aug (95% CI) | Revision Aug (95% CI) | Primary Recon (95% CI) | Revision Recon (95% CI) | Primary Aug (95% CI) | Revision Aug (95% CI) | Primary Recon (95% CI) | Revision Recon (95% CI) | Primary Aug (95% CI) | Revision Aug (95% CI) | Primary Recon (95% CI) | Revision Recon (95% CI) | |
| No. | 4046 | 895 | 149 | 107 | 1116 | 363 | 225 | 84 | 1116 | 363 | 225 | |
| Capsular contracture | 3.1 (2.5–3.7) | 7.4 (5.8–9.5) | 10.2 (5.9–17.4) | 12.6 (7.2–21.8) | 8.8 (7.2–10.8) | 7.9 (5.4–11.6) | 10.6 (7.0–16.0) | 10.9 (5.1–22.6) | 12.9 (10.8–15.2) | 13.7 (10.2–18.4) | 15.8 (11.0–22.5) | 14.3 (7.5–26.4) |
| Ruptureb | 5.7 (3.2–9.9) | 4.9 (1.6–14.5) | 9.7 (2.3–35.8) | 6.3 (0.9–36.8) | 4.2 (2.6–6.7) | 2.8 (0.9–8.4) | 2.4 (0.3–15.7) | — | 8.5 (5.8–12.4) | 6.8 (3.1–14.7) | 16.5 (6.3–39.1) | — |
| Any reoperation | 9.1 (8.2–10.1) | 16.9 (14.5–19.7) | 33.6 (26.4–42.2) | 34.4 (25.8–44.9) | 16.6 (14.4–19.0) | 29.7 (24.9–35.0) | 42.7 (36.0–50.0) | 47.8 (36.8–60.2) | 24.0 (21.4–26.8) | 38.8 (33.6–44.6) | 48.2 (41.5–55.4) | 56.7 (45.4–68.5) |
Aug, augmentation; NR, not reported; Recon, reconstruction.
Study designs were not identical and not designed to be compared head-to-head.
Confirmed/unconfirmed for postapproval study; confirmed by MRI for core study. The Kaplan-Meier risk calculations exclude patients who have been censored. For the rupture endpoint, patients were censored on the last date that the device was known to be intact, which is either the last MRI or the date of explantation (or the date of initial implant placement if the patient never underwent MRI or explantation). Therefore, not all patients are included in these analyses.
Overall, the data demonstrate a low risk of adverse events, including rupture, capsular contracture, and reoperation, and high rates of patient satisfaction with real-world use of the Sientra breast implants. For the primary study endpoints, Kaplan-Meier risk rates varied by cohort, but were generally low. The risk of reoperation for all cohorts combined was 11.6%, with the highest risk reported in the reconstruction cohorts, in which approximately one-third of patients had reoperation, primarily for aesthetic reasons or capsular contracture. Of note, for total reoperations, there was a low Kaplan-Meier risk of implant removal without replacement (ranging from 1.5% in primary augmentation to 7.9% in revision-reconstruction), suggesting that patients were largely happy with their implants.
Furthermore, the data showed a low overall rate of malposition (2.9%), highlighting the long-term stability of Sientra’s smooth and textured implants. Previous studies with smooth and nanotextured implants have reported the need to change technique to ensure a satisfactory outcome with these types of implants.24,25 In contrast, the postapproval study data showed stability of the Sientra implant using traditional surgical techniques.
The overall Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8% and ranged from 4.9% to 9.7% by cohort. These findings are consistent with the low risk of rupture observed at 5 years in the Sientra core study23 (Table 7) and are comparable with or below the Kaplan-Meier risks of rupture reported by cohort in the 10-year core studies of other silicone gel implants, including Allergan (5.4% to 35.4%) and Mentor (7.5% to 43.9%).14,16
Compared with the 10-year core study,13 participants enrolled in the postapproval study were of similar age but had greater racial diversity. We also noted an expanded use of textured devices and of placement in the submuscular pocket in the postapproval study, reflecting the practices of U.S. surgeons at a large number of investigator sites. Note that the enrollment period was from 2012 to 2015, when textured implants were still at the peak of use. Textured devices were used in 75.3% and 80.6% of the primary reconstruction and revision-reconstruction cohorts, respectively, in the postapproval study, compared with 54.1% and 59.7%, respectively, in the core study. The rates of submuscular placement were higher in all cohorts (range, 88.5% to 96.2%) compared with those in the 10-year core study (range, 57.1% to 89.9%),13 and, as demonstrated in the literature, placement into the submuscular pocket was protective against capsular contractures.13,26 As expected, the change in placement from subglandular to submuscular led to fewer events of capsular contracture (Table 6), with the Kaplan-Meier risks in the postapproval study ranging from 3.1% to 12.6% (Table 8) versus 10% to 14.5% in the core study at 6 years.13 In the core study, a textured surface was shown to be protective against capsular contracture when used with subglandular placement (subglandular placement had a capsular contracture risk of 11.3% with a textured implant and 35.4% with a smooth implant). However, data from the postapproval study show a reduced risk of capsular contracture with submuscular placement, regardless of implant surface, reducing the risks to 5.0% and 3.1% with textured and smooth implants, respectively).
These data highlight the importance of communicating risk factors for complications and how this information can be used to lower risks for patients. The increased use of the submuscular pocket for implants in the postapproval study improved the capsular contracture rates, whether a smooth or textured device was used. Furthermore, even though there was an increase in the use of textured implants, no cases of breast implant-associated anaplastic large cell lymphoma have been reported to date in the postapproval study.
Breast implant illness is an emerging area of concern, and based on the literature, anxiety/depression, fibromyalgia, chronic fatigue, irritable bowel syndrome, Sjögren syndrome, rheumatologic/autoimmune disease, and rheumatoid arthritis may all possibly be symptoms of this illness.27 Of these systemic events, only a few were explicitly measured in this study. Anxiety disorder and depression were both reported at 2.1% through year 6, whereas Sjögren syndrome, autoimmune diseases including lupus/systemic lupus erythematosus, and multiple sclerosis were reported at less than 0.1%. In addition, in 2022, the FDA issued a safety communication about reports of squamous cell carcinomas and various lymphomas related to breast implants.28 At the 6-year follow-up, no cases of squamous cell carcinomas or other lymphomas had been reported in patients who received a Sientra breast implant in the postapproval study.
Patient-reported satisfaction rates were generally high through 6 years of follow-up, with improvements in quality of life for psychosocial well-being from baseline. Of note, in the primary augmentation cohort, physical well-being decreased by year 6. Interpretation of this finding is purely speculative. This effect may have been secondary to increased social media attention over the period of the postapproval study that has led to increased safety concerns, especially in the primary augmentation group. These quality-of-life data will be further analyzed at the 10-year follow-up of this study.
SUMMARY
Over 5000 patients across 131 clinical sites were included in this large postapproval study, providing real-world evidence regarding the use of the Sientra implants in both augmentation and reconstruction procedures. Data from this robust study are comparable to the core study, which not only validates the core study, but provides strong evidence that the device performs in a safe and effective way in the real world. In addition, no large disparities in outcomes were found between the core study and the postapproval study, indicating that stable, precise, and reliable data points can be defined and used in a stringent real-world evidence study. As Sientra breast implants are only supplied to board-certified and board-eligible skilled plastic surgeons for implant surgery, the data from this study are supportive of clinical practice showing that the right device in the right hands reduces the risk of complications. Given the increased scrutiny of the safety of silicone breast implants, there is a need for transparency in the reporting of safety data so that both patients and board-certified plastic surgeons can make informed choices about the devices selected. Long-term follow-up is critical to facilitate understanding of these devices and their use in the real world. In this postapproval study, we have collected data on safety and levels of patient satisfaction for the Sientra breast implants. This report of 6-year data highlights the importance of the continuous flow of data collected in a rigorous and reliable way to increase transparency for patients and surgeons.
DISCLOSURE
All investigators were compensated by Sientra for all patient visits, including enrollment/baseline and follow up at years 1, 5, and 9. Dr. Calobrace has been a speaker for Mentor, Allergan, Sientra, SIA, and Galatea (with no financial disclosures) and receives royalties from QMP Publishing (video series) and Springer (textbook). Dr. Gordon is a speaker for and shareholder in Sientra, Inc.; an investor in Revance, Engage Media, and Brijjit Medical; and a speaker for Brijjit Medical and Revelle Aesthetics. Dr. Cohen is a speaker for Sientra, Inc. Dr. Dajles is an employee at and shareholder in Sientra, Inc. Dr. Zeidler is a medical consultant for Allergan/AbbVie and Bimini Healthtech and a clinical researcher for Alastin/Galderma. Drs. Schwartz, Kaufman, and Harrington have no financial interest to disclose in relation to the content of this article.
ACKNOWLEDGMENTS
This study was funded by Sientra, Inc. The authors would like to thank the patients, their families and caregivers, and all the sites, study nurses, and clinicians involved in this study. They thank Margie B. Rose of Sientra, Inc., for statistical support and data verification. Medical writing support, which was in accordance with Good Publication Practice guidelines, was provided by Lauren D. Van Wassenhove, PhD, of Parexel (Hackensack, NJ) and was funded by Sientra, Inc.
Supplementary Material
Footnotes
This trial is registered under the name “Sientra Postapproval Study,” ClinicalTrials.gov identification no. NCT01639053 (https://clinicaltrials.gov/study/NCT01639053).
Disclosure statements are at the end of this article, following the correspondence information.
Related digital media are available in the full-text version of the article on www.PRSJournal.com.
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