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).
Of the estimated 135 million women suffering from POP worldwide, 28 percent live in Europe.
And about half of all women who have given birth may be affected by these dysfunctions, which can cause serious health issues including pain, discomfort, discharge, infections and the inability to have intercourse.
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Furthermore, there has been no innovation in this area for more than 20 years, leaving millions of patients in pain and distress.
Notwithstanding these alarming facts, women with pelvic floor dysfunctions have long been ignored and disregarded by legislators and practitioners worldwide.
Medical solutions, ranging from drugs, surgery, prolapse mesh devices and pessaries have so far been only partially satisfactory and in some cases have caused serious adverse effects.
Despite reports of serious complications since the 1990s, practitioners and legislators have long ignored women’s pain induced by invasive treatments, which were approved on the basis of weak evidence and in the absence of much-needed innovation.
But it seems women’s health is slowly but surely climbing up the agenda.
Last year the UK introduced a ban on transvaginal mesh for stress urinary incontinence.
“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)”
This was subsequently followed by a US ban on a group of prolapse mesh devices over safety and efficacy concerns in response to billions of dollars in damages claimed by thousands of women in America, Australia and Europe.
Alongside policymakers, researchers in the EU and its neighbourhood are making a move in the right direction by developing better solutions for patients.
Such an innovative solution was found in Israel, which participates in the EU’s Horizon 2020 Programme in the field of research and innovation.
Dr Elan Ziv, a urogynaecologyst with a long-standing interest in the non-invasive treatment of pelvic floor dysfunctions, has developed new types of devices that could lessen the burden for women with this condition.
His company has patented novel non-surgical and disposable management options for woman with various pelvic floor dysfunctions.
They consist of disposable vaginal devices with a lifespan of a week that users can insert themselves at home thanks to an applicator without the intervention of any practitioner or the need to go to hospital.
The first device developed by the Israeli scientist for stress urinary incontinence in women was acquired by an American company and is already available on the North American market.
“Market estimates predict FemTech could be “the next big phenomenon in the women’s health market”, and generate in excess of $50 billion USD (€44.6 billion) by 2025”
A second device for POP is ready for market with a CE marking indicating conformity with health, safety, and environmental standards in Europe as well as its American equivalent 510(k) clearance from FDA.
This promising and revolutionary solution could improve life quality for millions of women by allowing patients to manage their own condition.
The adoption of the Health Technology Assessment proposal may help the EU and its partners to boost innovation in areas such as women’s health, where research, clinical trials and data sharing have been limited.
But this should not prevent EU policymakers from considering the health needs of women and from encouraging more innovation in this area.
Only by paying more attention to women’s health can gender equality genuinely be achieved.
Market estimates predict that FemTech could be “the next big phenomenon in the women’s health market” and generate in excess of $50 billion USD (€44.6 billion) by 2025.
The EU must not miss out on this opportunity to improve women’s health across Europe.