pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Study Shows Advantages for Stress Urinary Incontinence Surgery

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

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

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

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Boston Scientific Touts 3-year Solyx Stress Urinary Incontinence Mesh Trial Data

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

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Mesh ‘Last Option’ for Incontinence

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

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Government Agrees to Temporarily Ban Vaginal Mesh Implants for Women with Urinary Incontinence

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

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

New Vaginal Mesh Material Could Help Thousands of Women Affected By Life Changing Complications

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

surgeons perform pelvic organ prolapse surgery

New Zealand’s Medsafe regulatory body removes pelvic mesh products from market

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

surgeons perform pelvic organ prolapse surgery

Australia Bans Use of Vaginal Mesh Implants for Prolapse

An Australian watchdog has banned the use of controversial vaginal mesh implants for prolapse after a review found “the benefits do not outweigh the risks these products pose to patients”.  The Therapeutic Goods Administration has decided to remove the use of mesh products in the treatment of pelvic organ prolapse and single incision mini-slings which is used to treat urinary incontinence. This move follows the news that NICE, the health watchdog in the UK, will recommend that mesh should be banned as a routine treatment for prolapse, a condition when organs such as the vagina, uterus or bowel fall down or slip out of place. The draft guidance, seen by Sky News and due to be published next month, states that mesh implants for prolapse should now only be used for research purposes. It does not affect the use of mesh for incontinence which accounts for the majority of operations. Read more.

Source: Sky News, November 29, 2017

surgeons perform pelvic organ prolapse surgery

Women Damaged by Surgical Mesh to Treat Incontinence Are Furious at Report

Women damaged by surgical mesh used to treat post-childbirth incontinence have reacted with fury to a Government report investigating the problem.  At least 7,800 women say they’ve suffered lacerations and nerve damage because the mesh has broken into tiny fragments.  The report, which is unpublished but has been seen by Good Health, is the result of a three-year investigation by NHS England. It confirms that many more women have complained of injuries than previously suggested and calls for a helpline to support victims.  But it did not look at the safety of the mesh and rejects calls for a ban. Instead, it says hospitals should ensure that surgeons be trained to implant it; at the moment any gynaecologist can perform the procedure. Read more.

Source: Daily Mail, July 25, 2017