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Appeals court upholds $19m Boston Scientific loss in pelvic mesh case

Boston Scientific (NYSE:BSX) has lost another bid as it looked to overturn an $18.5 million loss in a product liability suit over alleged injuries caused by its Obtryx pelvic mesh. A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based company to pay each of the 4 women damages ranging from $3.25 million to $4.25 million (the 4th plaintiff later settled her case out of court and it was dismissed). In its appeal, Boston Scientific argued that the court’s decision to consolidate the four cases into a single trial created potential prejudice and confusion amongst the jury. The appeals court disagreed, saying that “BSC lacks evidence that the district court’s safeguards were inadequate or that consolidation in fact resulted in any prejudice or jury confusion.” “Instead, it asks us to infer jury confusion based on the similarities of the damages awarded to each plaintiff. Attempting to reverse engineer the jury’s thought processes based on its verdicts is always a dangerous enterprise, because we have no way of knowing what really happened during jury deliberations,” the court wrote, according to official documents. “Here, there is little reason to be suspicious of the verdicts given that BSC had a chance to fully develop its defenses and that the judge properly instructed the jury through...
Source: Mass Device - Category: Medical Devices Authors: Tags: Legal News Product Liability Wall Street Beat Women's Health Boston Scientific Source Type: news

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Conclusions Among ambulatory women with urgency urinary incontinence, poor sleep quality is common and greater frequency of incontinence is associated with a greater degree of sleep dysfunction. Women seeking urgency urinary incontinence treatment should be queried about their sleeping habits so that they can be offered appropriate interventions.
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
Objective The aim of this study was to evaluate the associations between type and route of hormone use and urinary incontinence (UI) and pelvic organ prolapse (POP) in premenopausal and postmenopausal women. Methods The authors used the National Health and Nutritional Examination Survey database for data from 2005–2006, 2007–2008, 2009–2010, and 2011–2012. Seven thousand sixty-six of the women included were premenopausal, and 5387 were postmenopausal. Premenopausal women were younger than 51 years and reported menstrual periods in the last 12 months. Postmenopausal women reported being in natur...
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
Conclusions Most PCPs do not routinely screen for PFDs, and fewer feel comfortable treating. The majority is unaware of FPMRS and American Urogynecologic Society and more commonly refers PFD patients to other specialists.
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
The objective of this study was to determine if weight loss surgery is associated with decreased prevalence of urinary incontinence (UI) and pelvic organ prolapse (POP) symptoms. Methods A survey was conducted among previously morbidly obese women who underwent bariatric surgery at Brigham and Women's Hospital, Boston from 2007 to 2015. In addition to the Pelvic Floor Distress Inventory 20, we collected demographic and clinical data including symptoms of and treatment for UI and POP before surgery. Participants were divided into 4 quartiles based on self-reported postsurgical weight loss: less than 26.1 kg, 26.1 to 36.2...
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
Conclusions Most studies regarding frailty among women with PFDs did not define frailty as recommended in the ACS NSQIP/AGS guidelines. The evidence regarding PFDs and frailty is of very low quality. This is the first systematic review regarding frailty assessments specifically among women with PFDs. Paucity of data regarding frailty in women with PFDs, particularly with regard to surgical choice and surgical counseling, highlights the need for further study in this area.
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
Conclusions At present, it remains uncertain whether postpartum PFMT improves POP symptoms because of very low-quality evidence, and more high-quality RCTs are needed in this area. The POP staging will likely not change with postpartum PFMT. The PFMT may result in improved postpartum sexual function compared to watchful waiting, and may provide benefit for AI in women with anal sphincter injuries. Postpartum PFMT likely reduces the risk of UI, particularly stress urinary incontinence symptoms. There is currently little evidence about postpartum PFMT and long-term pelvic floor function.
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
The objective of this study was to compare disposable pads to Icon™ reusable underwear for the management of urinary incontinence on dimensions of quality of life and product performance. Methods This randomized cross-over trial included women with mild to moderate urinary incontinence as defined by baseline responses to the International Consultation on Incontinence Questionnaire—Short Form. Excluded were patients who had fecal incontinence or an active urinary tract infection. Participants were randomized to 2 days of Icon™ underwear or disposable pads use and then completed another 2 days using the ...
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
Conclusions Practice variability in catheterization after pelvic reconstructive and incontinence surgery is high. Distribution of catheterization type by specialty varies significantly, with clean-intermittent straight catheterization most prevalent. Future studies are necessary to establish a consensus on optimal catheterization management technique for patients with acute postoperative voiding dysfunction.
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: AUGS Conference Submissions Source Type: research
We present unusual cases of cutaneous mucormycosis that resulted from penetration of the perineum region by mucorales species in stool that was associated with fecal incontinence and progression to a black necrotic ulcer. These lesions look similar to ecthyma gangrenosum, atypical cutaneous herpes lesions, and decubitus ulcers. It is difficult to differentiate on a clinical basis alone. Early diagnosis and treatment are crucial steps to prevent complications of cutaneous mucormycosis infection.
Source: Infectious Diseases in Clinical Practice - Category: Infectious Diseases Tags: Review Articles Source Type: research
Conclusions The Advance® and AdvanceXP® system are effective over time in terms of urinary continence and patient satisfaction.
Source: Actas Urologicas Espanolas - Category: Urology & Nephrology Source Type: research
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