For women with frequent urine leakage, a newer and simpler “sling” surgery works as well as the standard version, according to a new clinical trial. The study involved women with stress urinary incontinence, where movement that puts pressure on the abdomen — such as running, lifting, coughing or laughing — causes urine leakage. When the condition is severe, surgery may be recommended. Read more.
Source: UPI, April 1, 2022
For women with frequent urine leakage, a newer and simpler “sling” surgery works as well as the standard version, according to a new clinical trial. The study involved women with stress urinary incontinence, where movement that puts pressure on the abdomen — such as running, lifting, coughing or laughing — causes urine leakage. When the condition is severe, surgery may be recommended. Read more.
Source: HealthDay News, March 31, 2022
One of the most commonly performed surgeries to treat stress urinary incontinence in women may have better long-term results than another common surgical technique, according to a study led by Mayo Clinic researchers. The retrospective study of more than 1,800 cases at Mayo Clinic from 2002 to 2012 found that the need for additional surgery was twice as high after a transobturator sling surgery compared with a retropubic sling procedure. Reoperation rates within eight years after surgery were 11.2 percent for patients in the transobturator group compared with 5.2 percent in the retropubic group, according to the study, which will be published in the journal Obstetrics and Gynecology in August. Read more.
Source: Austin Daily Herald, July 16, 2019
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
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
Boston Scientific (NYSE:BSX) this week released three-year data from a study of its Solyx single incision sling system intended to treat stress urinary incontinence, touting that the trial met all primary and secondary endpoints. Boston Scientific said it presented the full results from the trial yesterday at the annual scientific symposium of the American Urogynecologic Society. The Marlborough, Mass.-based company said it enrolled a total 281 patients in the trial at 21 sites looking to compare efficacy and adverse events for non-inferiority of the Solyx system versus the gold-standard transobturator mid-urethral sling procedure. The study was part of a post-market surveillance trial required by the FDA to be performed by all manufacturers of mesh products, Boston Scientific said. The company touted it as the first of three such studies it will complete, with remaining data expected to be released next year. Read more.
Source: Mass Device, October 12, 2018
Women who need treatment for urinary incontinence should only be offered mesh surgery as a last resort, new draft guidelines for the NHS advise. The National Institute for Health and Care Excellence (NICE) says non-surgical options, like pelvic muscle exercises, are the first to turn to. The NHS in England has already put restrictions on mesh operations after safety concerns. Many women say the implants cause agony by cutting into tissue. It is estimated that more than 100,000 UK women have had a mesh fitted. The net-like fabric can be attached into the wall of the vagina to act as a scaffold to support organs, such as the bladder, to keep them in the right place to help manage incontinence or another condition called prolapse. Read more.
Source: BBC News, October 9, 2018
The [UK] government has accepted a recommendation to temporarily ban vaginal mesh implants for women with urinary incontinence. The Independent Medicines and Medical Devices Safety Review concluded there must be an immediate pause in the use of surgical mesh to treat stress-urinary incontinence (SUI) – a condition where urine leaks out when the bladder is under pressure. It comes after the National Institute for Health and Care Excellence (NICE) ruled last year against vaginal mesh as a treatment for pelvic organ collapse, but stated devices could still be used to treat SUI and to repair hernias in men or women. Read more.
Source: Independent, July 9, 2018
Scientists from the University of Sheffield have developed a material that could be used as an alternative to the current vaginal mesh material, polypropylene, used to treat pelvic organ prolapse and stress urinary incontinence. The use of these current meshes, in particular surgical procedures, has led to severe complications for millions of women across the world and is now banned in Australia. The research conducted by the University of Sheffield, published today in the journal Neurourology and Urodynamics, provides evidence which supports the use of a softer and more elastic material better suited for use in the pelvic floor and one that releases oestrogen into the surrounding pelvic tissue to form new blood vessels and ultimately speed up the healing process. Read more.
Source: EurekAlert, February 13, 2018
New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today. The agency said the product’s removal was the outcome of a recent regulatory action on surgical mesh products, specifically those designed for treating pelvic organ prolapse via transvaginal implantation and one mini-sling product designed to treat stress urinary incontinence. Medsafe said that last December it requested safety information from four surgical mesh suppliers in New Zealand, following action taken by Australia’s TGA as it looked to review meshes used for urogynaecological use. The earlier TGA’s investigation ended in regulatory actions to remove the devices from the market, MedSafe said, and similarly resulted in their removal from New Zealand’s market. Read more.
Source: +Mass Device, January 31, 2018