Sientra primary and revision augmentation rupture trending and analysis with magnetic resonance imaging.

BACKGROUND: Rupture of silicone gel breast implants is a rare occurrence but remains one of the key surgical concerns. The objective of this article was to provide visibility and information on trends for the impact that patient and surgical characteristics play in the occurrence of rupture. OBJECTIVES: Examine trends in surgical techniques to better understand the etiology of implant rupture. METHODS: Analysis was based on Sientra's prospective, open-label, U.S.-based clinical study of High-Strength Cohesive silicone breast implants. Patient and surgical characteristics were compared between ruptured and intact implants. RESULTS: The subset of data used for this analysis included 1792 implants in 935 primary and revision augmentation patients implanted by 31 plastic surgeons, with an average follow-up of 6.6 years. The results confirm that rupture remains a rare adverse event. Overall, the rupture prevalence for this study was 2.4%. Rupture prevalence was lower among textured devices (0.8%) compared to smooth devices (3.8%). The prevalence of rupture was 7.8% among devices placed with a transaxillary incision site compared to 1.6% and 3.0% when placed with an inframammary or periareolar incision site, respectively. Rupture was reported in 5.5% of the devices that received steroid pocket irrigation, compared to 1.8% of the devices that did not. CONCLUSIONS: Although ruptures in the Sientra study with the High-Strength Cohesive silicone gel implants were an uncommon occurrence, the authors were able to identify strong trends for the association of certain surgical factors and characteristics. The results show among other factors that an inframammary approach and a textured device were found to be protective against rupture. LEVEL OF EVIDENCE: 2 Therapeutic.

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.

Myalgic Encephalomyelitis-Chronic Fatigue Syndrome Common Data Element item content analysis.

INTRODUCTION: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a multisystem chronic disease estimated to affect 836,000-2.5 million individuals in the United States. Persons with ME/CFS have a substantial reduction in their ability to engage in pre-illness levels of activity. Multiple symptoms include profound fatigue, post-exertional malaise, unrefreshing sleep, cognitive impairment, orthostatic intolerance, pain, and other symptoms persisting for more than 6 months. Diagnosis is challenging due to fluctuating and complex symptoms. ME/CFS Common Data Elements (CDEs) were identified in the National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element Repository. This study reviewed ME/CFS CDEs item content. METHODS: Inclusion criteria for CDEs (measures recommended for ME/CFS) analysis: 1) assesses symptoms; 2) developed for adults; 3) appropriate for patient reported outcome measure (PROM); 4) does not use visual or pictographic responses. Team members independently reviewed CDEs item content using the World Health Organization International Classification of Functioning, Disability and Health (ICF) framework to link meaningful concepts. RESULTS: 119 ME/CFS CDEs (measures) were reviewed and 38 met inclusion criteria, yielding 944 items linked to 1503 ICF meaningful concepts. Most concepts linked to ICF Body Functions component (b-codes; n = 1107, 73.65%) as follows: Fatiguability (n = 220, 14.64%), Energy Level (n = 166, 11.04%), Sleep Functions (n = 137, 9.12%), Emotional Functions (n = 131, 8.72%) and Pain (n = 120, 7.98%). Activities and Participation concepts (d codes) accounted for a smaller percentage of codes (n = 385, 25.62%). Most d codes were linked to the Mobility category (n = 69, 4.59%) and few items linked to Environmental Factors (e codes; n = 11, 0.73%). DISCUSSION: Relatively few items assess the impact of ME/CFS symptoms on Activities and Participation. Findings support development of ME/CFS-specific PROMs, including items that assess activity limitations and participation restrictions. Development of psychometrically-sound, symptom-based item banks administered as computerized adaptive tests can provide robust assessments to assist primary care providers in the diagnosis and care of patients with ME/CFS.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Essentials of Diagnosis and Management.

Despite myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) affecting millions of people worldwide, many clinicians lack the knowledge to appropriately diagnose or manage ME/CFS. Unfortunately, clinical guidance has been scarce, obsolete, or potentially harmful. Consequently, up to 91% of patients in the United States remain undiagnosed, and those diagnosed often receive inappropriate treatment. These problems are of increasing importance because after acute COVID-19, a significant percentage of people remain ill for many months with an illness similar to ME/CFS. In 2015, the US National Academy of Medicine published new evidence-based clinical diagnostic criteria that have been adopted by the US Centers for Disease Control and Prevention. Furthermore, the United States and other governments as well as major health care organizations have recently withdrawn graded exercise and cognitive-behavioral therapy as the treatment of choice for patients with ME/CFS. Recently, 21 clinicians specializing in ME/CFS convened to discuss best clinical practices for adults affected by ME/CFS. This article summarizes their top recommendations for generalist and specialist health care providers based on recent scientific progress and decades of clinical experience. There are many steps that clinicians can take to improve the health, function, and quality of life of those with ME/CFS, including those in whom ME/CFS develops after COVID-19. Patients with a lingering illness that follows acute COVID-19 who do not fully meet criteria for ME/CFS may also benefit from these approaches.

Diagnosis of mast cell activation syndrome: a global "consensus-2".

The concept that disease rooted principally in chronic aberrant constitutive and reactive activation of mast cells (MCs), without the gross MC neoplasia in mastocytosis, first emerged in the 1980s, but only in the last decade has recognition of "mast cell activation syndrome" (MCAS) grown significantly. Two principal proposals for diagnostic criteria have emerged. One, originally published in 2012, is labeled by its authors as a "consensus" (re-termed here as "consensus-1"). Another sizable contingent of investigators and practitioners favor a different approach (originally published in 2011, newly termed here as "consensus-2"), resembling "consensus-1" in some respects but differing in others, leading to substantial differences between these proposals in the numbers of patients qualifying for diagnosis (and thus treatment). Overdiagnosis by "consensus-2" criteria has potential to be problematic, but underdiagnosis by "consensus-1" criteria seems the far larger problem given (1) increasing appreciation that MCAS is prevalent (up to 17% of the general population), and (2) most MCAS patients, regardless of illness duration prior to diagnosis, can eventually identify treatment yielding sustained improvement. We analyze these proposals (and others) and suggest that, until careful research provides more definitive answers, diagnosis by either proposal is valid, reasonable, and helpful.

Access Planning and Resource Coordination for Clinical Research Operations.

This research creates an operations engineering and management methodology to optimize a complex operational planning and coordination challenge faced by sites that perform clinical research trials. The time-sensitive and resource-specific treatment sequences for each of the many trial protocols conducted at a site make it very difficult to capture the dynamics of this unusually complex system. Existing approaches for site planning and participant scheduling exhibit both excessively long and highly variable Time to First Available Visit (TFAV) waiting times and high staff overtime costs. We have created a new method, termed CApacity Planning Tool And INformatics (CAPTAIN) that provides decision support to identify the most valuable set of research trials to conduct within available resources and a plan for how to book their participants. Constraints include (i) the staff overtime costs, and/or (ii) the TFAV by trial. To estimate the site's metrics via a Mixed Integer Program, CAPTAIN combines a participant trajectory forecasting with an efficient visit booking reservation plan to allocate the date for the first visit of every participant's treatment sequence. It also plans a daily nursing staff schedule that is optimized together with the booking reservation plan to optimize each nurse's shift assignments in consideration of participants' requirements/needs.

A Capacity Allocation Planning Model for Integrated Care and Access Management.

The prevailing first-come-first-served approach to outpatient appointment scheduling ignores differing urgency levels, leading to unnecessarily long waits for urgent patients. In data from a partner healthcare organization, we found in some departments that urgent patients were inadvertently waiting longer for an appointment than non-urgent patients. This paper develops a capacity allocation optimization methodology that reserves appointment slots based on urgency in a complicated, integrated care environment where multiple specialties serve multiple types of patients. This optimization reallocates network capacity to limit access delays (indirect waiting times) for initial and downstream appointments differentiated by urgency. We formulate this problem as a queueing network optimization and approximate it via deterministic linear optimization to simultaneously smooth workloads and guarantee access delay targets. In a case study of our industry partner we demonstrate the ability to (1) reduce urgent patient mean access delay by 27% with only a 7% increase in mean access delay for non-urgent patients, and (2) increase throughput by 31% with the same service levels and overtime.

Neurological and immunological dysfunction in two patients with Bartonella henselae bacteremia.

Recently, BAPGM enrichment culture has documented Bartonella bacteremia in previously healthy, "nonimmunocompromised" patients following arthropod exposures. Neurobartonellosis should be among the differential diagnoses for patients with persistent or recurrent neurological symptoms of undetermined etiology. Microbiological and immunological testing should be concurrently pursued to determine whether defective immune function accompanies Bartonella bacteremia.

Somatic instability of the NF2 gene in schwannomatosis.

CONTEXT: Schwannomatosis is a newly described form of neurofibromatosis of unclear pathogenesis. PATIENT AND METHODS: We studied the NF2 locus on chromosome 22 in 7 tumor specimens resected from a 36-year-old man with schwannomatosis of the right ulnar nerve. RESULTS: Unrelated truncating NF2 gene mutations were detected in 4 tumor specimens. None of the NF2 mutations were present in the blood specimen. Loss of heterozygosity at the NF2 locus was seen in all tumors, and in every case the same allele was lost. Loss of distal chromosome 22 markers was variable. Fluorescence in situ hybridization results were consistent with monosomy 22 in 4 tumors and mitotic recombination or nondisjunction in 1. CONCLUSIONS: Molecular analysis of tumor specimens distinguishes schwannomatosis from other forms of neurofibromatosis. Further work is needed to understand the natural history and molecular biology of this condition.

Evolving practices in augmentation operative technique with Sientra HSC round implants.

As of 2012, breast augmentation surgery continues to be the most commonly performed aesthetic surgical procedure in the United States. Surgeons consider a multitude of factors when choosing the type and style of breast implant for a patient. With the continuous evolution of breast implant designs, there are a variety of breast implant options for plastic surgeons to choose from; however, round implants remain the implant of choice for breast augmentation. This article discusses preoperative planning, implant selection, surgical techniques, and postoperative management using Sientra's Silimed brand smooth and textured round implants.