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Morcellation is a surgical technique used to reduce the size of the uterus or myomas by creating smaller pieces to allow the tissue to be removed through small incisions or with laparoscopic instruments. Open (uncontained) morcellation of the uterus and myomas has been scrutinized because of the possible spread of an unsuspected leiomyosarcoma while using a power morcellator during a hysterectomy or myomectomy for presumed symptomatic uterine leiomyomas. Before considering open morcellation of the uterus, a woman should be evaluated to determine if she is at increased risk of malignancy of the uterine corpus...

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Background Current strategies for ensuring the postmarket safety of medical devices are limited by small sample size and reliance on voluntary reporting of adverse events. Prospective, active surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety but has not been demonstrated in national clinical data registries. Methods and Results The CathPCI DELTA (Data Extraction and Longitudinal Trend Analysis) study was designed to assess the feasibility of prospective, active safety surveillance of medical devices within a national cardiovascular registry...

BACKGROUND: Gasketless laparoscopic insufflator systems are marketed for the ability to prevent desufflation of pneumoperitoneum during laparoscopy. However, surgeons raised concern for possible introduction of non-absorbable room air, including oxygen (O2 ), with these systems. A community-university collaborative was created to test this hypothesis. METHODS: An artificial abdomen, calibrated to equivalent compliance and volume of an average abdomen, was connected to a flow meter, oxygen concentration sensor, and commercially available laparoscopic gasketless cannula system...

The purpose of this study was to develop a searchable system to confirm magnetic resonance (MR) safety information of implantable medical devices (IMDs) to safely perform magnetic resonance imaging examinations. We labeled MR safety information for IMDs based on package insert descriptions and then categorized allowed MR conditions for IMDs. Finally, a searchable system was developed to use the database via the internet. This system enables efficient and accurate confirmation of MR safety information for IMDs...

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are a well-established therapy for patients at risk of life-threatening ventricular arrhythmias. With rising implant rates, the risk of a rescuer performing chest compressions during discharge is increasing, leading to concerns over rescuer safety from the resultant leakage current. More recently, subcutaneous ICDs (S-ICD) have been developed, which utilise a higher energy and more superficial electrodes compared with transvenous ICDs (T-ICD), raising safety concerns further...

BACKGROUND: Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. OBJECTIVES: The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. METHODS: Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm)...

The surgical mesh material used in the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women is associated with significant complications in some women. This has recently become a public health issue with involvement of national parliaments and regulatory bodies. The occurrence of mesh complications is thought to be a result of multifactorial processes involving problems related to the material design, the surgical techniques used and disease, and patient-related factors...

INTRODUCTION: Silicone breast implants (SBI) may induce systemic autoimmune disease as part of autoimmune syndrome induced by adjuvants (ASIA). This syndrome bears similarities to fibromyalgia and chronic fatigue syndrome (CFS). We sought to determine whether there are any associations between SBI and depression, fibromyalgia and CFS in a rheumatology clinic population. METHODS: The electronic files of rheumatology clinic patients at the Royal Adelaide Hospital between 2000 and 2017 were searched for patients who had received SBI prior to rheumatological diagnosis...

OBJECTIVE: The objective of this study is to compare quality of life and success rates of repeat midurethral slings (RMUS) using retropubic (RP) and transobturator (TO) routes. MATERIALS AND METHODS: Multicenter retrospective cohort with prospective follow-up of patients undergoing RMUS from 2003 to 2016. Prospective Urinary Distress Inventory (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected by phone. Primary outcome was success of repeat sling by approach (RP vs TO), defined as responses of no to UDI-6 number 3 and very much better or much better on PGI-I...

AIMS: Energy-based devices using radiofrequency and laser technologies have gained popularity as therapies for vaginal atrophy, urinary incontinence, and vaginal prolapse. They have been promoted by cosmetic and aesthetic industries for vaginal "laxity" and vaginal "rejuvenation," both of which are undefined conditions and terms. This article aims to review the current available literature and its quality on this emerging technology. METHODS: An international panel of gynaecologists, urogynaecologists, and urologists undertook a review of the available published literature, identifying articles, guidance, and society statements on the use vaginal energy-based devices...

PURPOSE: To evaluate mini-sling long-term results and correlate them to failure predictors. Many studies show comparable results among different single-incision slings developed as an attempt to reduce complications while keeping good results, but there is a lack of evidence about mini-slings outcomes in the long term. METHODS: This prospective, single-center study evaluated 40 patients for long-term outcomes after mini-sling placement. Objective cure was defined as leakage of less than 1 g in 1-hour pad-test and no leakage at Valsalva maneuver...

AIMS: The number of percutaneous edge-to-edge mitral regurgitation valve repairs with MitraClip implantation has increased during recent years. Published studies showed promising safety outcomes in relatively small cohorts, while results from large samples are sparse. Thus, we aimed to evaluate trends and safety outcomes in the German nationwide in-patient sample. METHODS AND RESULTS: We analysed data on patients' characteristics and in-hospital safety outcomes for all percutaneous mitral valve repairs using the MitraClip technique in Germany between 2011 and 2015...

BACKGROUND: Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction-breast reconstruction with implants or expanders at the time of mastectomy-but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques...

BACKGROUND: Spinal cord stimulation (SCS) is an established therapy for refractory neuropathic pain. To ascertain the balance between treatment benefits and risks, the French National Authority for Health requested a post-market registry for real-world evaluation of the long-term effectiveness and safety of the therapy. METHODS: A total of 402 patients undergoing implantation with a Medtronic SCS device as either a primo-implant (n = 264) or replacement implant (n = 138) were enrolled across 28 representative sites in France...

PURPOSE: As cardiovascular implantable electronic devices (CIEDs) are increasingly indicated in older patients, and the burden of cancer is rising with the aging population, the management of patients with CIEDs who require radiotherapy (RT) is a timely concern. The objective of the study was to evaluate the management of, and malfunctions in, patients with CIEDs undergoing RT. METHODS: A retrospective study of patients with CIEDs receiving RT at Kingston Health Sciences Center from March 2007-April 2018 was conducted...

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Purpose: We assess the safety and effectiveness of intranasal neurostimulation to promote tear production via the nasolacrimal pathway in subjects with dry eye disease. Methods: A multicenter, randomized, controlled, double-masked pilot study was conducted in adults with dry eye diagnosis and at least one eye with corneal fluorescein staining ≥2 in at least one region or a sum of all regions ≥5 (National Eye Institute grading), basal Schirmer test score ≤10 mm, a cotton-swab stimulated Schirmer score ≥7 mm higher, and an Ocular Surface Disease Index score ≥23...

OBJECTIVE: The treatment of genitourinary syndrome of menopause (GSM) includes prescription hormone therapy, nonhormonal over-the-counter products, and most recently, laser treatment. Although the Food and Drug Administration has cleared fractional carbon dioxide (CO2) laser for a variety of dermatologic and gynecologic indications, lasers have not to date, been approved for use for vulvar/vaginal atrophy, or sexual dysfunction. METHODS: Four case studies that were referred to a tertiary sexual medicine center regarding laser treatment complications for GSM are reported...

OBJECTIVE: With the increasing use of flow diversion as treatment for intracranial aneurysms, there is a concomitant increased vigilance in monitoring complications. The low porosity of flow diverters is concerning when the origins of vessels are covered, whether large circle of Willis branches or critical perforators. In this study, the authors report their experience with flow diverter coverage of the lenticulostriate vessels and evaluate their safety and outcomes. METHODS: The authors retrospectively reviewed 5 institutional databases of all flow diversion cases from August 2012 to June 2018...