Sylvia Health takes on a global women’s health crisis

Pelvic organ prolapse is a common but often stigmatised condition in which one or more of the organs in the female pelvis descend into, or out of, the vagina. It can cause pain, discomfort, and significant emotional distress, disrupting women's ability to fully engage in work, social life, and family activities. 

An estimated 1 in 12 women experience symptomatic prolapse, amounting to more than 200 million women worldwide.

Due to underreporting and stigma, the true number is likely even higher, and incidence is expected to grow by a staggering 46 per cent in the US alone by 2050.

Danish healthtech startup Sylvia Health is pioneering a revolutionary medical device to empower women suffering from pelvic organ prolapse.

I spoke to CEO Andrew Stretton to learn more. 

Stretton has lived in Denmark for five years. Before that, he completed a PhD in biotechnology at the University of Cambridge, finishing in January 2020 — just before the pandemic. He started working for a couple of startups here that were connected to his PhD.

Sylvia Health came out of the Novo Nordisk Foundation BioMedical Design Fellowship Programme, a needs-based innovation programme at the University of Copenhagen in Denmark.

During four months of clinical observations at the obstetrics and gynaecology departments of Slagelse Hospital, the team encountered many problems within women's health and witnessed the profound impact of pelvic organ prolapse on women's lives. 

"The first part of the program involved four months of clinical observation. I spent that time with a notebook in a gynaecology and obstetrics department," shared Stretton.

He admits, "I'm not a doctor, and as a man, it was an unusual but incredible opportunity to observe and learn in that environment."

A hidden epidemic of shocking need

Throughout the program, participants observed numerous unmet needs in women's health. Prolapse emerged very quickly as a major one. 

According to Stretton, the scale and impact of prolapse shocked the team, sparking a deepening interest that persisted throughout the programme.

"We met with and interviewed patients and clinicians from six countries, delving into disease fundamentals, prevalence, risk factors, stigma, and treatment options. 

If you start with the patient population, the numbers are striking: one in twelve women has symptomatic pelvic organ prolapse."

The two biggest risk factors for vaginal prolapse are vaginal delivery and age. It can also be influenced by menopause, heavy lifting and genetic or hereditary factors. 

He realised there was not only a lack of societal knowledge of the issue but a lack of meaningful solutions, describing the options as "innovation light." 

"When you look at existing solutions, you have surgery — often invasive and not always viable for women who are family planning. Then there are pessary devices, but over half of women discontinue using them within 3–12 months."

 A medical scandal is hidden explained away by gender stigma

Another solution for vaginal prolapse is transvaginal mesh, a surgical implant used to support weakened pelvic tissues, primarily for treating conditions like pelvic organ prolapse and stress urinary incontinence in women. It is a net-like device inserted through the vagina to help hold pelvic organs in place. 

However, since the 2000s, tens of thousands of women with mesh insertions have complained of severe side effects, including chronic pain, infection, organ perforation and other debilitating conditions.

As a post by the Lawsuit ínformation Centre asserts, in US depositions, lawyers have uncovered internal documents showing mesh manufacturers were hearing complaints about mesh tension and material degradation as far back as 2009. Doctors flagged these issues, but they were not shared with regulators. And patients received no warning prior to surgery.

The post asserts:

"A lot of these women were told their symptoms were unrelated. That their pain was normal. That they were just getting older. Some were told it was in their head. It went on for years, in many cases, with most everyone paying lip service to the pain and suffering."

According to Stretton, the mesh debacle set back innovation in this area for a long time.

And, the themes experienced by women suffering as a result of the vaginal mesh represent the broader issues around stigmatisation and vaginal prolapse. 

Medical misogyny lives in everyday consultations

There's also a lot of normalisation of women's suffering in these contexts. According to Stretton:

"We spoke with women in their 40s who, after finally working up the courage to see a doctor, were told, "Well, you've had kids, you're in your forties now—this is normal." 

That kind of normalisation can be incredibly confusing and disheartening.

"Even in Denmark, with free healthcare and strong equality measures, women reported these experiences. If this is happening here, you can imagine what it's like elsewhere. It reflects a broader pattern."

Further, the underlying clinical need remains unchanged — especially for certain subtypes of prolapse. For example, in the rectocele, where the rectum descends into the vagina, the standard pessaries sit too high and don't really match the anatomy.

"It's surprising that something so fundamental hasn't been addressed, but it's a stigmatised area," shared Stretton.

"Many of the basic needs simply haven't been studied in detail."

Anatomy-first innovation with global market potential 

I was interested in how Sylvia Health approached R&D for something so sensitive and anatomical. Andrew explained that the team started by looking at the anatomy of rectocele. 

"Because existing devices like pessaries sit high, but the prolapse bulges lower down, we asked: what kinds of devices are already used in that part of the body? Menstrual cups and tampons.

So we thought: what if we take something like a menstrual cup and modify its function—not to collect fluid, but to provide support? That was the core idea."

The team sketched out concepts, shared them with gynaecologists and physiotherapists, and got encouraging feedback. Then it created simple silicone prototypes, refined them, and developed medical-grade versions suitable for clinical testing.

Sylvia Health developed its first medical-grade prototypes in Autumn 2023, following the end of the BioMedical Design Programme.

Since then, it's been focused on testing and improving its products. Together with expert pelvic health physiotherapists, its done over 40 functional tests with women with prolapse.  

It was surprisingly easy to recruit participants — because so many women are affected and current options are limited. "Early on, we interviewed and surveyed women affected by prolapse to understand their daily experiences," explained Stretton. 

"If you show that you understand the impact on their lives, they're often eager to participate. And crucially, we listened.

Many medical consultations are only ten minutes long; there's no time to unpack everything. Having someone sit down and truly listen was validating for them. A lot of women with prolapse experience a loss of dignity in their interactions with healthcare systems.

Restoring that dignity is core to our approach." 

This user-centred design approach has enabled Sylvia Health to iteratively improve its designs, so much so that towards the end of its functional testing phase, many women asked to take the prototype home with them. 

Sylvia Health has since begun clinical trials at Herlev Hospital in the Copenhagen region, where it will recruit around 40 participants and measure quality of life changes from baseline to the end of the study.

Stretton explained that it's a simple, non-comparative study because pessaries are already well-established and silicone is highly biocompatible. If adverse effects occur, they typically resolve upon removal of the device.

"If we can show a meaningful quality-of-life improvement and acceptable safety, that data will go into our regulatory submission."

The device is patent-pending, but Sylvia Health aims for the device to become a prescribed medical device—essentially the go-to option for rectocele prolapse.

Stretton explained: 

"First, we need to prove clinical efficacy. Then we'll focus on commercialisation—starting in Denmark and likely one large European market. Once we have proof of business, we can bring in a strategic partner, raise a Series A, or consider an exit.

We're realistic that our founding team may not be the ones to scale it globally. If the product works—and we believe it does — it needs to reach as many women as possible."

Currently, Sylvia Health is actively engaging with partners in the UK and EU to enable us to provide devices in those regions as soon as possible, followed by the rest of the world.