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pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women

The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products.  The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.” Read more.

Source: HealthDay News, April 16, 2019

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INNOVO Transcutaneous Electrical Stimulator for Urinary Incontinence Coming to U.S.

Atlantic Therapeutics, a company out of Galway, Ireland, will soon be releasing its INNOVO transcutaneous electrical stimulator to treat stress urinary incontinence in women. The device was FDA approved late last year as the first transcutaneous stimulator with such an indication. It delivers electric current through the body toward muscles that control the pelvic floor, which in turn can help maintain continence.  The technology provides women a non-invasive option that, in a clinical trial, demonstrated that 87% of women were dry or nearly so after a three month treatment. 80% of the women studied had results after only a month or therapy.  Read more.

Medgadget, April 11, 2019

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InControl Medical Wins FDA Clearance for Attain: The First Over-the-Counter, At-Home Device for the Treatment of Urinary and/or Fecal Incontinence in Women

InControl Medical wins FDA clearance for new Attain, the first over-the-counter (OTC) non-implantable muscle stimulator designed for at-home use to help treat the approximately 60 million women in the U.S. suffering with stress, urge, mixed urinary incontinence and/or bowel incontinence.  This is good news for all those affected by urinary and/or involuntary bowel leakage that can increase with age: 20% -30% of young women, 30%-40% of middle-aged women, and up to 50% of older women suffer from incontinence.  It’s time to talk about this taboo topic before diapers become the newest accessory in the Nike store. So, strengthen your calves and abs, but don’t forget to strengthen your pelvic floor muscles too, says Lauren Streicher, M.D., Medical Director of the Northwestern Medicine Center for Sexual Health and Menopause and Clinical Professor of Obstetrics and Gynecology at Northwestern University. All kidding aside, many of my patients who suffer with urinary incontinence, can also have leaky bowel, and truly suffer in silence and embarrassment. Post-partum, anal or rectal cancer, and the natural aging process can cause incontinence. Thankfully, many patients respond well to pelvic-floor electrical stimulation and biofeedback as a first-line treatment, before considering surgery or medication. Attain is a small, painless, easy to use medical device for women to self-treat in the privacy of their own home, reducing or eliminating the need for pads or diapers. Read more.

Source: Global Banking & Finance Review, March 26, 2019

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Behavioral Therapy Superior to Drugs Alone for Urinary Incontinence

Behavioral therapies relieve stress, urgency, and mixed urinary incontinence (UI) more effectively than drug monotherapies in nonpregnant women.  In a new systematic review and network meta-analysis (NMA) of 84 randomized trials published in theAnnals of Internal Medicine, most interventions including combination therapies improved or resolved women’s symptoms better than no treatment, whether sham or watchful waiting, Ethan Balk, MD, MPH, of Brown University in Providence, Rhode Island, and colleagues reported. Hormones and periurethral bulking agents appeared less than effective, however. Read more.

Source: Renal & Urology News, March 20, 2019

drugs for overactive bladder (OAB)

First Big Test Approaches for Urovant

Investors who backed Urovant’s $140m flotation last September will soon find out whether the money was well spent. Before the end of March the company will release topline pivotal data on the overactive bladder project vibegron, a β3-adrenergic receptor agonist licensed from Merck & Co, and a positive result should allow regulatory filings to follow.  It seems likely that the trial will hit: Merck successfully conducted a large phase IIb study of vibegron a few years ago, and a similar compound is already on the market in the shape of Myrbetriq, which has been sold by Astellas since 2011. This well-established product has only four years of US patent life left, so if Urovant has any chance of building vibegron into a similarly large product it needs to prove that its contender is both safer and more effective.   Read more.

Source: Evaluate, March 12, 2019

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

BD withdraws surgical mesh products for SUI and POP

A spokesperson said: “BD has decided to discontinue the manufacture and sale of pelvic organ prolapse and stress urinary incontinence products in all remaining markets worldwide. While thousands of women over many years have benefited from the safe use of these products, we have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements.”  The government website says there is no need for implanted devices to be removed and no additional follow-up is required for patients implanted with such devices but anyone who has any concerns about their implanted device should contact their GP. Read more.

Source: Medical Plastics News, March 7, 2019