Revolutionizing Women's Pelvic Health: From One-Size-Fits-All Surgeries to Personalized Solutions

Every minute, another hysterectomy is performed in the United States. For decades, women facing pelvic health issues like pelvic organ prolapse or incontinence have often been presented with two daunting options: undergo invasive surgery (such as a hysterectomy or a mesh implant repair) or manage symptoms with decades-old devices known as pessaries. Both paths exemplify a one-size-fits-all approach to problems that are anything but uniform. The result has been high complication rates, inconsistent outcomes, and millions of women left without satisfactory solutions.

In a recent episode of talk is biotech!, a podcast hosted by Guru Singh (Founder and CEO of Scispot), these issues took center stage. Scispot, recognized for providing a comprehensive AI stack for life science labs, uses its platform to spotlight biotech innovators tackling big challenges.

In Episode 2, Singh sat down with Negin Ashouri, CEO of FemTherapeutics, to discuss why current surgical treatments for women's pelvic health are falling short and how personalized, tech-enabled alternatives could change the game.

This report builds on insights from that conversation, backed by broader research and industry data, to explore the limitations of the status quo and the emerging opportunities for innovation in women's pelvic health.

An Overlooked Women's Health Crisis

Pelvic floor disorders, which include pelvic organ prolapse (POP) and urinary incontinence, are exceedingly common and increase with age and childbirth. Estimates vary, but roughly one-quarter to one-third of women will experience a pelvic floor disorder in their lifetime. In the case of POP alone (where organs like the uterus or bladder slip out of place and bulge into the vagina), one U.S. medical center notes it "affects nearly one-third of all women, usually as they age or after childbirth". Globally, even a conservative estimate finds POP impacts about 1 in 10 women, representing a significant patient population in need.

Despite this prevalence, female pelvic health has historically been underfunded and overlooked in medical innovation. "Unfortunately, women's health has been neglected in the area of urogynecology. The technology is under-developed, leaving plenty of room for us to expand in the future," says Negin Ashouri. For over half a century, there were virtually no major advances in non-invasive treatments, a reality that biotech entrepreneurs like Ashouri are now determined to change.

The Standard Treatments: Hysterectomy, Mesh, and Pessaries

Given the lack of innovation, the standard-of-care for serious pelvic floor disorders has remained heavily weighted toward surgery or antiquated support devices:

Hysterectomy (Uterus Removal)

Hysterectomy is one of the most common surgeries for women, with about 600,000 procedures performed annually in the U.S. In fact, roughly one in three American women will have had a hysterectomy by age 60. The vast majority (around 90%) of these surgeries are done for non-cancerous conditions, including fibroids, abnormal bleeding, and uterine prolapse. In cases of severe prolapse, removing the uterus is seen as a definitive solution.

While hysterectomy can indeed resolve certain issues and many women report improved quality of life post-surgery, it is a major operation with inherent risks and downsides. Recovery can take weeks, and complications such as infection, bleeding, or organ damage are possible. Moreover, it's an irreversible step that may be disproportionate for women who might have benefited from a less invasive fix.

Pelvic Reconstructive Surgery with Mesh Implants

In the early 2000s, synthetic transvaginal mesh emerged as a surgical innovation to repair POP and stress incontinence. Surgeons would implant a mesh device to reinforce the weakened pelvic tissues. Initially marketed as an easy, long-term fix, mesh implants quickly grew popular. However, they soon led to widespread complications.

Mesh erosion (where the mesh cuts into vaginal tissues or organs) became the most commonly reported issue, along with chronic pain, infection, painful intercourse, and organ perforation. Thousands of women suffered serious injuries, sparking numerous lawsuits and a public health outcry. In 2019, after years of mounting evidence, the U.S. FDA banned the sale of transvaginal mesh products for prolapse repair due to safety concerns. A 36-month postmarket study confirmed that the risks of transvaginal mesh often outweighed the benefits.

While some mesh-based sling procedures (for incontinence) remain in use, "mesh" has become a four-letter word in women's health. The mesh saga underscored that a supposedly "off-the-shelf" solution for all patients could end up harming many, especially when anatomical variation and long-term biocompatibility weren't fully accounted for.

Vaginal Pessaries

For women who wish to avoid surgery, the primary non-surgical option is a vaginal pessary, a medical-grade device (often silicone) inserted into the vagina to support prolapsed organs. Pessaries have been around for over half a century with little change in design. They come in a limited range of standardized shapes and sizes (typically ring- or dish-shaped devices that clinicians fit by trial-and-error).

In theory, a well-fitted pessary can relieve symptoms and allow women to manage prolapse or incontinence without surgery. In practice, however, traditional pessaries are notorious for discomfort and fitting difficulties. Women must often remove, clean, and reinsert them regularly (often monthly) to prevent infection. Many find this maintenance regimen inconvenient or unsanitary, especially older women with limited mobility or those who feel uneasy handling the device.

Worse, a poor fit can lead to constant irritation or even pressure ulcers in vaginal tissue. It's no surprise that more than half of women prescribed pessaries abandon their use within the first year due to pain, discomfort or inadequate symptom relief. Studies report that 20 to 50% of women discontinue pessary use within one year, with side effects (like discharge, pain, or ulceration) being the main reason.

As Negin Ashouri summarizes, "today's products are not working well for patients."

The consequence of these limitations is a cascade of suboptimal outcomes. When a pessary fitting fails, and Ashouri notes it happens "40% of the time" in current practice, the patient is "left with no option but to seek invasive reconstructive surgical procedures instead". In other words, women who hoped to avoid surgery often end up needing it after all.

Yet surgeries have their own high failure rates: roughly 20% of women will undergo pelvic floor surgery (for prolapse or incontinence) and many will need repeat operations; prolapse surgeries have a recurrence rate of up to 30%, meaning nearly one in three cases require reoperation for prolapse that returns. In sum, the current standard-of-care is often too generic and too risky: a one-size-fits-all set of solutions for a problem that varies greatly from woman to woman.

Why "One-Size-Fits-All" Isn't Working

Several factors explain why these standard approaches remain inadequate for many patients:

Lack of Personalization

Perhaps the biggest issue is that anatomical diversity is not sufficiently accounted for. Every woman's pelvic anatomy and prolapse condition is unique, yet pessaries come in a few predetermined shapes, and surgical implants were mass-produced devices. "When we learned that the design of pessaries hasn't changed in more than 50 years, and that today's products are not working well for patients, we decided to do something about it," says Ashouri.

The trial-and-error fitting of a handful of pessary sizes often fails to find a perfect fit, leading to that 40 to 50% failure rate in practice. Similarly, rigid mesh implants did not adapt to individual variations, which contributed to erosions and chronic pain. In essence, women have been forced to adapt to the device or surgery rather than having the solution adapt to them.

High Complication and Failure Rates

The standardized solutions carry significant risks. Hysterectomy, though common, is major surgery with potential complications like any surgery (bleeding, infection, anesthesia risks) and longer-term effects (early menopause if ovaries are removed, pelvic floor weakening in some cases once the uterus, a support structure, is gone). Mesh implants introduced new, mesh-specific complications that were devastating for some patients.

Even native tissue surgeries (no mesh) for prolapse can fail over time; roughly 30% of prolapse surgeries fail within a few years, leading to prolapse recurrence. Each repeat surgery tends to be more complex and less effective. Pessaries, while safer, commonly cause irritation, discharge, or discomfort, and often do not adequately relieve symptoms, prompting many women to give up on them.

One-Dimensional Approaches

The standard-of-care options address the anatomical symptom (organ out of place) but often don't holistically address the patient's needs and preferences. A hysterectomy removes the prolapsing organ but doesn't strengthen pelvic muscles or tissues (prolapse can sometimes recur at the vaginal vault even after the uterus is removed). A mesh physically supports the organs but doesn't integrate with the body's natural movement and can provoke immune responses.

Pessaries provide support but don't rehabilitate the underlying muscles; plus, as inert objects, they don't adjust to changes in a patient's body or condition over time. Essentially, these solutions are static and "one-size-fits-all", while the problem is dynamic and personal.

Historical Underestimation

Women's pelvic health issues have long been under-prioritized in research and device development. Ashouri points out that urogynecological innovation lagged for decades because of neglect in women's health funding. As a result, the field hasn't benefited from the kind of cutting-edge R&D seen in other domains.

Until recently, few startups or major medtech companies focused on improving things like pessaries or prolapse surgery tools, despite the clear demand from millions of patients. This gap is only now starting to be addressed, which is why current solutions feel stuck in the past.

Traditional vs. Personalized Approaches

To summarize the contrast between legacy treatments and new personalized interventions, consider the following comparison:

Aspect	Traditional Surgical Approach	Personalized Tech-Enabled Approach
Nature of Solution	Invasive surgery: removal of organ (hysterectomy) or implantation of synthetic mesh to support organs	Non-surgical or minimally invasive: patient-specific device (like custom 3D-printed pessary) supports organs without major surgery
Personalization	One-size-fits-all. Standardized procedure and device; little accommodation for individual anatomy	Tailored to the individual. Uses patient-specific measurements, AI modeling, and 3D printing to achieve optimal fit. Millions of possible device configurations vs. ~100 in conventional pessaries
Complication Risk	Significant. Surgical risks include infection, bleeding, organ injury; mesh implants risk erosion and chronic pain. Reoperation rates up to 30% for prolapse surgery indicate frequent failures	Potentially lower. Custom-fit device avoids major surgery and may reduce tissue irritation (no sharp edges or pressure points). Early data suggests improved comfort
Recovery & Maintenance	Weeks of recovery for surgery (hospital stay, anesthesia). Mesh complications often required additional surgeries. Pessary use demands frequent cleaning/removal and doctor visits for refitting	Minimal downtime. Custom devices can often be fitted in outpatient setting; no general anesthesia needed. Maintenance is user-friendly; designs like FemTherapeutics' are biodegradable and disposable
Patient Comfort & Quality of Life	Variable. Many women report improved symptoms post-surgery or with well-fitted pessary, but significant subset experience ongoing discomfort, sexual dysfunction, or dissatisfaction	Prioritizes comfort and adherence. Personalized fit aims to maximize comfort and symptom relief. Early pilots of custom pessaries report higher patient compliance due to better comfort and results

The Promise of Personalized Solutions

Recognizing these challenges, a new wave of innovators is bringing the tools of modern technology from artificial intelligence to 3D printing to the realm of women's pelvic health. The goal is straightforward but ambitious: create interventions that fit the patient, rather than forcing the patient to fit the intervention.

As Guru Singh noted during the talk is biotech! podcast, this convergence of biotech and personalized medicine could be "game-changing for life science labs and patients alike," aligning perfectly with Scispot's ethos of using advanced technology to solve real lab and clinical problems.

FemTherapeutics: Leading Personalized Pessary Innovation

Montreal-based FemTherapeutics, led by CEO Negin Ashouri, is one such pioneer. The company has developed what it calls the world's first adaptable, personalized vaginal pessary. Their approach combines precise 3D anatomical data, AI-powered design algorithms, and 3D printing of medical-grade silicone to produce a pessary uniquely tailored to each patient's anatomy.

"We mirrored the same 3D printing process used in the dental industry for custom-fit orthodontic devices," Ashouri explains, referring to how modern dentistry creates personalized Invisalign braces. In FemTherapeutics' process, a woman's pelvic measurements (taken via exam or imaging) are fed into proprietary software, which then generates an optimal pessary design for her specific needs.

The design is printed as a one-off device in biocompatible silicone. Importantly, the team decided to make their pessaries biodegradable and single-use, meaning a woman can discard and replace it monthly, rather than endure the unpleasant cleaning routine. This seemingly simple tweak addresses a key patient pain point (hygiene and convenience) that the legacy products never solved.

Cosm Medical: FDA-Cleared Personalized Solutions

FemTherapeutics is not alone. Another startup, Cosm Medical, uses ultrasound-based measurements, machine learning, and 3D printing to create custom pessaries on-demand. Cosm reports that its system can generate nearly 10 million possible shape configurations to find the perfect fit for each patient, compared to the roughly 100 sizes/shapes available off-the-shelf today.

Cosm's personalized pessary earned FDA clearance in early 2024, a major validation that personalized devices can meet regulatory standards of safety and efficacy. FemTherapeutics, for its part, has been conducting pilot studies and working toward Health Canada and FDA approvals.

Beyond Pessaries: The Future of Personalized Pelvic Health

Beyond pessaries, the personalized medicine wave is also influencing how we think about surgical interventions for pelvic health. Researchers are exploring patient-specific surgical planning (using 3D pelvic models to practice and tailor prolapse surgeries to the individual) and even bioengineered grafts that could one day replace synthetic mesh with a patient's own regenerated tissue.

While such advances are in early stages, they underscore a broader trend: the era of "one-size-fits-all" in women's health is giving way to an era of personalization. This aligns with trends seen across medicine, from oncology (personalized cancer therapies) to orthopedics (custom 3D-printed implants), and now to gynecology.

Crucially, personalized solutions need to prove not just that they can be made, but that they deliver better outcomes. Early indications are encouraging. A pilot study of custom-fit pessaries showed high retention and satisfaction rates, as women reported greater comfort and symptom relief than with standard devices.

"Most women who have this condition are above the age of 40," Ashouri notes from her experience. Many of these patients, she says, "are uncomfortable removing, washing and inserting [traditional] devices" and thus delay or avoid care. By offering a more user-friendly solution, personalized approaches could prompt more women to seek help earlier for pelvic floor issues, rather than suffering in silence.

Market and Scientific Context

The drive toward personalized pelvic health solutions comes at a time of growing recognition of the "femtech" market and the unmet needs in women's health. Pelvic floor disorders may not always grab headlines, but the numbers are striking. In the U.S. alone, an estimated 300,000+ prolapse surgeries are performed each year, and about one in five women will undergo some form of pelvic floor surgery in her lifetime. Hysterectomies add another 600,000 cases per year on top of that.

The direct healthcare costs and lost productivity associated with these conditions run into billions of dollars. One analysis pegged the global market for prolapse treatment (devices and surgeries) at around $1.2 billion USD, and it is poised to grow as populations age. Meanwhile, the global market for pessaries, a device category that barely saw innovation for decades, is now expected to climb toward $600 to 800 million within the next 5 to 10 years, according to various industry forecasts.

Scientific and Technological Enablers

From a scientific standpoint, the renewed focus on pelvic health has been enabled by advancements in related fields. Biomedical engineering and materials science have given us 3D-printable, medical-grade silicones and other polymers that can be safely used in the body and tailored to custom shapes. Artificial intelligence allows rapid iteration and optimization of device designs: for example, AI algorithms can predict which pessary shape will likely be most effective for a given patient's MRI or ultrasound data, without lengthy manual trial-and-error.

Digital health platforms are emerging to complement the devices. Cosm, for instance, offers a digital app for patients to track symptoms and report issues, making it easier to personalize care over time. All these developments create a fertile ground for innovation that simply did not exist a generation ago.

Regulatory Support and Clinical Acceptance

Importantly, regulators and clinicians are increasingly on board. The FDA's 2019 mesh ban, while removing a product from the market, also served as a clear signal: patient safety and personalization matter, and the old paradigms weren't cutting it. In the aftermath, professional societies and health authorities have emphasized the need for alternatives.

Urogynecologists at leading centers now often stress non-surgical treatments and call for better pessary design, especially for patients who either cannot undergo surgery or prefer not to. The entry of new tech-enabled solutions is therefore met with both caution and optimism: caution, because after the mesh saga, any new device will be scrutinized closely; optimism, because the status quo left a lot to be desired.

Ashouri's company and others like it have had to navigate intense regulatory hurdles to bring their products to market. "Bringing a medical device to market is no small feat, especially for startups," Ashouri told Guru Singh during the talk is biotech! episode, highlighting the need for meticulous testing and collaboration with experienced regulatory advisors.

Implications and Opportunities for Biotech Founders

For early-stage biotech startup founders or aspiring entrepreneurs, the saga of pelvic health solutions offers several key lessons and opportunities:

Huge Unmet Needs Can Be Huge Opportunities

Pelvic floor disorders affect millions of women, yet for decades the solutions were stagnant. This kind of scenario, a prevalent condition with outdated treatments, is ripe for innovation. Startups like FemTherapeutics and Cosm saw the disconnect between what patients needed and what was available, and seized the opportunity.

The market is substantial and hungry for better options, meaning a well-designed product can quickly gain traction. As Ashouri's journey shows, even a niche that was long ignored can become a viable business when you bring fresh thinking and technology to it.

Personalization is a Winning Value Proposition

We live in an age where personalization is expected in many consumer experiences, and healthcare is moving the same way. Whether it's personalized medicine (tailoring drug treatments to a patient's genetic profile) or personalized medical devices, solutions that acknowledge individual variability are likely to outperform one-size-fits-all approaches in outcomes and patient satisfaction.

Biotech founders should ask: how can we leverage data and technology to tailor our product to each user or patient? In lab research, this might mean AI-driven analysis for custom formulations; in medtech, it can mean modular or bespoke device designs. The success of early personalized pessary trials suggests that patients highly value solutions made specifically for them, and they'll stick with those solutions.

Technology Plus Domain Expertise Equals Innovation

The pelvic health breakthroughs happened at the intersection of new technology (AI, 3D printing) with deep domain knowledge in gynecology. One without the other might not have succeeded. For aspiring entrepreneurs, the takeaway is to combine cutting-edge tech skills with partnerships or expertise in the target medical domain.

Ashouri herself exemplifies this blend: a computer science background applied to a women's health problem, in collaboration with clinicians. Similarly, Scispot's role as an AI and data platform for labs underlines how important tech integration is in biotech development.

Navigate Regulatory and Clinical Hurdles Early

The road to market in healthcare is challenging: regulatory approval, clinical trials, and physician adoption can make for a long journey. Biotech founders should plan for this from the outset. Engaging with regulatory experts, designing rigorous studies to demonstrate safety and efficacy, and gathering clinical champion support (doctors who believe in the product) are all critical.

As discussed during the talk is biotech! podcast, startups may face skepticism and stricter scrutiny than established players, so preparation and persistence are key. However, when you solve a pressing problem, the pay-off, both in patient impact and business success, can be significant.

The Rise of FemTech and Social Impact

There's a broader momentum now behind women's health innovation. FemTech (female technology) has grown into a recognized sector, attracting dedicated investors and initiatives. Founders tackling women's health issues often find a passionate user base and, increasingly, support from public agencies or grants.

The social impact angle, improving quality of life for women and addressing inequalities in healthcare, can galvanize teams and open doors to non-traditional funding. Biotech entrepreneurs should not shy away from "taboo" or under-discussed health topics; those areas might be exactly where innovation is most overdue.

Conclusion: Toward a New Standard of Care

The conversation between Guru Singh and Negin Ashouri on talk is biotech! highlights a critical inflection point in women's pelvic health. We are moving from an era where women's only options were highly invasive surgeries or antiquated devices, into an era of precision gynecology where solutions are smarter, safer, and centered on the individual patient.

It's a change that is both technical and cultural. As Ashouri's success shows, when entrepreneurs listen to patients and apply modern science to long-standing problems, the outcomes can be transformative. For the millions of women suffering pelvic floor disorders, these innovations can't come soon enough.

A future where a prolapse or incontinence diagnosis doesn't automatically mean a hysterectomy, where a young woman can avoid losing her uterus and instead use a custom-tailored device to manage her condition, is a future within reach. And for biotech founders, this is a case study in how challenging the status quo, armed with data, technology, and empathy for the patient, can create not just a thriving company, but a new standard of care.

As the field continues to evolve, it holds the promise of ensuring that women's pelvic health is no longer relegated to one-size-fits-all solutions, but instead benefits from the full power of personalized, 21st-century medicine.