Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the US Post-Approval Study.

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. post-approval study. We 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 receiving breast augmentation, reconstruction, and revision in the post-market 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 percent (3.9 percent with submuscular placement and 6.7 percent with subglandular placement), the risk of reoperation was 11.6 percent, and the risk of implant removal was 7.8 percent (5.9 percent with implant replacement and 2.0 percent without replacement). The primary reason (over 50 percent) for reoperation was aesthetic (e.g., style/size change). The Kaplan-Meier risk of rupture, calculated for patients who underwent explantation or MRI for rupture evaluation, was 5.8 percent. Overall, 82.6 percent of patients were highly satisfied/happy with their implant. No cases of breast implant-associated anaplastic large cell lymphoma were reported. CONCLUSIONS: Six-year results of the post-approval study were consistent with the 10-year core study and provide additional evidence in a large dataset supporting the comprehensive safety and effectiveness profile of the Sientra implants.

Intravitreal antisense oligonucleotide sepofarsen in Leber congenital amaurosis type 10: a phase 1b/2 trial.

CEP290-associated Leber congenital amaurosis type 10 (LCA10) is a retinal disease resulting in childhood blindness. Sepofarsen is an RNA antisense oligonucleotide targeting the c.2991+1655A>G variant in the CEP290 gene to treat LCA10. In this open-label, phase 1b/2 ( NCT03140969 ), 12-month, multicenter, multiple-dose, dose-escalation trial, six adult patients and five pediatric patients received ≤4 doses of intravitreal sepofarsen into the worse-seeing eye. The primary objective was to evaluate sepofarsen safety and tolerability via the frequency and severity of ocular adverse events (AEs); secondary objectives were to evaluate pharmacokinetics and efficacy via changes in functional outcomes. Six patients received sepofarsen 160 µg/80 µg, and five patients received sepofarsen 320 µg/160 µg. Ten of 11 (90.9%) patients developed ocular AEs in the treated eye (5/6 with 160 µg/80 µg; 5/5 with 320 µg/160 µg) versus one of 11 (9.1%) in the untreated eye; most were mild in severity and dose dependent. Eight patients developed cataracts, of which six (75.0%) were categorized as serious (2/3 with 160 µg/80 µg; 4/5 with 320 µg/160 µg), as lens replacement was required. As the 160-µg/80-µg group showed a better benefit-risk profile, higher doses were discontinued or not initiated. Statistically significant improvements in visual acuity and retinal sensitivity were reported (post hoc analysis). The manageable safety profile and improvements reported in this trial support the continuation of sepofarsen development.

Durable vision improvement after a single treatment with antisense oligonucleotide sepofarsen: a case report.

Leber congenital amaurosis due to CEP290 ciliopathy is being explored by treatment with the antisense oligonucleotide (AON) sepofarsen. One patient who was part of a larger cohort (ClinicalTrials.gov NCT03140969 ) was studied for 15 months after a single intravitreal sepofarsen injection. Concordant measures of visual function and retinal structure reached a substantial efficacy peak near 3 months after injection. At 15 months, there was sustained efficacy, even though there was evidence of reduction from peak response. Efficacy kinetics can be explained by the balance of AON-driven new CEP290 protein synthesis and a slow natural rate of CEP290 protein degradation in human foveal cone photoreceptors.

Effect of an intravitreal antisense oligonucleotide on vision in Leber congenital amaurosis due to a photoreceptor cilium defect.

Photoreceptor ciliopathies constitute the most common molecular mechanism of the childhood blindness Leber congenital amaurosis. Ten patients with Leber congenital amaurosis carrying the c.2991+1655A>G allele in the ciliopathy gene centrosomal protein 290 (CEP290) were treated (ClinicalTrials.gov no. NCT03140969 ) with intravitreal injections of an antisense oligonucleotide to restore correct splicing. There were no serious adverse events, and vision improved at 3 months. The visual acuity of one exceptional responder improved from light perception to 20/400.

Results of the Postmarket Clinical Study of the Sientra 207 Highly Cohesive Gel Breast Implants in Primary and Revision Augmentation.

BACKGROUND: Board-certified plastic surgeons utilizing the Sientra 207 Highly Cohesive Gel breast implants provided their initial satisfaction with usage and postoperative results on primary and revision augmentation patients, and study participants provided their satisfaction with surgical result. METHODS: Up to 15 participating investigators at institutional review board-approved sites enrolled up to 180 women who received Sientra 207 implants for primary augmentation or revision augmentation procedures. Investigator and participant assessments were performed preoperatively and postoperatively at 3, 6, and 12 months. RESULTS: All participating surgeons found the implants to be easy or very easy to implant, and 92 percentage reported satisfaction with surgical results. Patients receiving these implants reported similarly high rates of satisfaction (94%). CONCLUSION: With this combination of high satisfaction and low complication rates, the Sientra 207 silicone breast implants now provide a welcome addition to plastic surgeons' breast implant options.

Long-Term Safety of Textured and Smooth Breast Implants.

In this review, the authors provide a 20-year review and comparison of implant options and describe the evolution of breast implant surface textures; compare available implant surfaces; present long-term safety data from the 10-year US-based Core clinical studies; list the key benefits and risks associated with smooth and textured implants; and provide perspectives on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The authors explore the key benefits and risks associated with all available devices so that optimal and safe patient outcomes can be achieved.

Evidence-Based Medicine: Breast Augmentation.

LEARNING OBJECTIVES: After reading this article, the participant should be able to: 1. Understand the key decisions in patient evaluation for cosmetic breast augmentation. 2. Cite key decisions in preoperative planning. 3. Discuss the risks and complications, and key patient education points in breast augmentation. SUMMARY: Breast augmentation remains one of the most popular procedures in plastic surgery. The integral information necessary for proper patient selection, preoperative assessment, and surgical approaches are discussed. Current data regarding long term safety and complications are presented to guide the plastic surgeon to an evidence-based approach to the patient seeking breast enhancement to obtain optimal results.

Sientra high-strength cohesive shaped technique: roundtable discussion.

UNLABELLED: A panel of board-certified plastic surgeons chaired by Dr Michael Schwartz convened to discuss their respective experiences with the Sientra High-Strength Cohesive (HSC+) shaped silicone gel breast implants (Sientra, Inc., Santa Barbara, CA). The authors have implanted a combined total of over 700 patients. Preoperative planning, surgical techniques, and practice integration tips are among the topics reviewed. The surgeons also present breakthrough cases and describe how the HSC+ textured implants helped them achieve a successful outcome. LEVEL OF EVIDENCE: 5Therapeutic.

Algorithm and techniques for using Sientra's silicone gel shaped implants in primary and revision breast augmentation.

With the 2006 Food and Drug Administration approval of round silicone gel breast implants in the United States, there still remained a lack of versatility in implant options. The approval of Sientra's shaped cohesive implants in 2012 brought with it the innovations needed to address varying patient needs. Because access to shaped devices is still fairly recent in the United States, some surgeons remain uncomfortable with implementing shaped cohesive gel implants into their practice. The author outlines surgical techniques and algorithms from experience with the Sientra shaped device, covering the preoperative stage, measurements (base diameter, sternal notch to nipple, tissue pinch, and nipple to inframammary fold), ideal first candidates, operative techniques, and complication avoidance, as well as important factors for shaped-implant selection, including chest base diameter, implant height, implant volume, and implant projection for the patient's desired outcome. With experience, surgeons will find new utility with shaped implants for a variety of patients in their practices.

Sientra portfolio of Silimed brand shaped implants with high-strength silicone gel: a 5-year primary augmentation clinical study experience and a postapproval experience-results from a single-surgeon 108-patient series.

BACKGROUND: The Sientra portfolio of silicone gel breast implants was approved by the Food and Drug Administration on March 9, 2012, and included the first approved shaped implants in the United States. The 5-year results from Sientra's Core Gel and Continued Access Study and the results of a single surgeon are presented. METHODS: This analysis used the data of 640 shaped implants in 321 primary augmentation patients implanted by 16 study surgeons through 5 years. The Kaplan-Meier method was used to analyze safety endpoints. In addition, analysis is presented for a single surgeon's results of 213 shaped implants in 108 postapproval patients through up to 16 months of follow-up (9-month mean) using a separate frequency analysis. RESULTS: The overall risk of rupture for primary augmentation patients through 5 years was 0.4%, the risk of infection was 1.4%, and the risk of capsular contracture (Baker grade III/IV) was 3.9%. Reported surgeon satisfaction was 100%, and patient satisfaction remained high. In the separate single-surgeon analysis, after 16 months, 4 of the 108 patients experienced a complication (3.7%) and 3 underwent a reoperation (2.8%). Complications included infection, ptosis (0.9%, each), and capsular contracture (1.9%). CONCLUSIONS: The results of Sientra's large clinical study and the postapproval data from a single surgeon demonstrate the safety and effectiveness of Sientra's shaped implants. The review of the data and author's experience illustrate the ease of incorporating shaped implants into any surgical practice.