FemTech – Making strides for women

While EU Member States discuss the Health Technology Assessment proposal, an EU-wide research tool to support decision-making on health technologies and innovation in the “FemTech” sector (encompassing fertility, pregnancy and nursing care, women’s sexual wellness and e-health technologies) promises to revolutionise the treatment of pelvic floor dysfunctions for women across Europe and beyond. Over 50 percent of women worldwide suffer from at least one of the following three pelvic floor dysfunctions: Stress urinary incontinence, faecal incontinence, and pelvic organ prolapse (POP). Read more.

Source: The Parliament, July 23, 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

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

Analytica Expands Clinical Indication for Its Unique Pelvic Floor Exercise Technology

Analytica Limited (ASX:ALT) has received clearance from the Australian Therapeutic Goods Administration for the expanded clinical indication for its PeriCoach System to assist in the conservative treatment of Pelvic Organ Prolapse (POP). The PeriCoach system with its patent protected force sensing technology assists women to properly perform pelvic floor exercises. The expanded clinical indication for PeriCoach now includes targeted resolution of symptoms for mild to moderate POP, urinary incontinence and sexual wellness. Data suggests that 50% of women that have given birth have some degree of POP and half of women over 50 complain of prolapse symptoms. Estimates state women have a lifetime risk of up to 12% of undergoing a surgical intervention, with a re-operation rate of nearly 20%. Read more.

Source: Proactiveinvestors Australia, May 2, 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

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

New Report Indicates No Evidence AHT Pelvic Exercise Works

Abdominal hypopressive technique (AHT), an exercise method widely touted for 20 years as a way of controlling bladder leakage and pelvic organ prolapse, doesn’t work, according to a new report. AHT is a breathing exercise developed in the 1980s by Belgian physiotherapist Marcel Caufriez. Highly popular, it is taught by more than 1500 practitioners in 14 countries, including in Australia. But a report published last week in the British Journal of Sports Medicine finds no scientific evidence to support the claimed benefits of AHT. Authors Kari Bo, of the Norwegian School of Sport Sciences, in Oslo, and Saul Martín-Rodríguez, of the College of Physical Education, in Las Palmas, Spain, acknowledge the “worldwide huge interest” in AHT but say it “lacks scientific evidence to support its benefits. At this stage, AHT is based on a theory with 20 years of clinical practice.” Read more.

Source: Cosmos Magazine, October 18, 2017

Pelvic Organ Prolapse (POP) Surgery

Pelvic organ prolapse surgery should only be done by a highly qualified and skilled surgeon.

There are several different types of surgeries performed for the treatment of pelvic organ prolapse (POP). The kind of surgery used is dependent on the type of prolapse (bladder, womb or end of vagina, uterine, or bowel). Sometimes, when the patient is experiencing stress urinary incontinence, the surgeon can perform an anti-incontinence surgery, (most likely a loose sling under the neck of the bladder) during the prolapse surgery for treatment of stress urinary incontinence.Continue reading→

A Pessary for the Management of Urinary Incontinence in Women

A pessary may be used by a woman who is experiencing urinary incontinence and/or pelvic organ prolapse.

A pessary is a small device made of silicone, often shaped like a diaphragm or a cube, which is inserted into the vagina of a woman to help support her pelvic organs. Pessaries are used to treat pelvic organ prolapse (POP) and urinary incontinence. Continue reading→