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The hidden cost of “business as usual” in gynecologic surgery

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A Common Surgery with Outsized Consequences

Hysterectomy and myomectomy are among the most frequently performed surgeries worldwide.

Minimally invasive and robotic approaches have delivered clear benefits at the point of care, including shorter hospital stays, faster recovery, and fewer complications.

To remove the uterus or fibroids through small incisions, surgeons use a technique known as morcellation, in which tissue is cut into smaller pieces for extraction during surgery.

However, when tissue is cut without containment, those short-term gains can be offset by downstream harm.

The risks fall into three interconnected categories:

  • dissemination of undiagnosed malignancy
  • spread of benign tissue, including endometriosis and parasitic fibroids
  • legal and financial exposure linked to off-label device use

Crucially, these costs often surface years after the original procedure and rarely where the original cost savings were realized.

Cancer Dissemination: A Known and Preventable Risk

The risk of occult uterine malignancy in women undergoing surgery for presumed benign fibroids is well documented.

The U.S. Food and Drug Administration has estimated this risk at approximately 1 in 350 women, prompting repeated safety communications recommending tissue containment during morcellation.

When morcellation is performed without containment, undiagnosed cancer will be dispersed throughout the abdominal cavity, effectively upstaging disease from localised to disseminated.

The clinical implications are profound, and so are the economic consequences.

Treatment costs for early-stage uterine cancer typically range from $40,000 to $60,000. Once disease becomes disseminated, costs can exceed $150,000 to $300,000, excluding indirect costs such as lost productivity, long-term disability, and caregiver burden.

Beyond treatment expenses, litigation related to morcellation-associated cancer spread has resulted in multi-million-dollar settlements, particularly during the power morcellation litigation wave of the mid-2010s. Several cases explicitly tied disease progression to tissue dissemination during surgery.

From a system perspective, a single preventable dissemination event can negate the cost savings of hundreds of minimally invasive procedures.

Benign Tissue Seeding: The Long Tail of Surgical Cost

Cancer is not the only concern.

Uncontained morcellation has also been associated with the spread of benign tissue, including parasitic fibroids and iatrogenic endometriosis, conditions that may present years after the index surgery.

Endometriosis alone represents one of the most expensive chronic gynecologic conditions. Multiple health economic studies estimate annual per-patient costs of $12,000 to $16,000, with lifetime costs exceeding $100,000, driven by repeat surgeries, chronic pain management, hormonal therapy, and fertility interventions.

While the financial impact may surface years later, downstream harm is increasingly traced back to the index procedure, including the choice between FDA-cleared containment and off-label alternatives used during tissue extraction.

Off-Label Use and the Quiet Accumulation of Liability

One of the least visible, but most consequential, dimensions of morcellation risk lies in off-label device use.

Many tissue bags currently used during morcellation are not FDA-cleared for prevention of tissue spillage during organ cutting and removal. While off-label use is common in medicine, it carries distinct legal and financial implications when complications occur.

Risk management guidance from MedPro Group, one of the largest medical malpractice insurers in the United States, has repeatedly warned that off-label use increases professional liability exposure in three key ways:

1. Burden of justification

When an FDA-cleared alternative exists, the legal burden shifts to the surgeon to prove that off-label use met the standard of care.

2. Informed consent vulnerability

Standard consent language may be insufficient for off-label device use, increasing exposure to failure-to-warn claims if complications arise.

3. Changed liability dynamics

Off-label use alters traditional liability dynamics, increasing scrutiny on clinical decision-making at the hospital and surgeon level.

Legal scholarship published in Clinical Orthopaedics and Related Research has echoed these concerns, noting that courts increasingly allow off-label status to be considered in malpractice cases, particularly when patient harm occurs and safer alternatives were available.

Recent U.S. court decisions have further reinforced that while off-label use is generally permitted, it is not immune from civil liability and, in rare but serious circumstances, criminal consequences when tied to demonstrable patient harm.

FDA Guidance Exists, Adoption Lags Behind

Regulatory expectations around morcellation are no longer ambiguous. The FDA has consistently called for tissue containment during tissue cutting to mitigate the risks of cancer and tissue dissemination.

Yet real-world adoption remains inconsistent.

A 2025 survey reported by News-Medical found widespread gaps in safe tissue containment during laparoscopic gynecologic surgery.

Respondents cited variability in training, institutional protocols, and access to FDA-cleared containment systems. Many surgeons reported reliance on improvised or non-cleared solutions despite growing awareness of regulatory and legal risk.

The result is a widening gap between guidance and practice, one that is increasingly visible to regulators, insurers, and hospital leadership.

Who Ultimately Pays?

The economic impact of uncontained morcellation does not fall on a single stakeholder.

  • Hospitals face litigation exposure, rising malpractice premiums, re-operations, and reputational risk.
  • Surgeons shoulder personal liability, heightened scrutiny around informed consent, and evolving standards of care.
  • Payers absorb downstream oncology costs, chronic disease management, and repeat interventions.
  • Patients bear the heaviest burden, including preventable morbidity, fertility loss, financial toxicity, and erosion of trust.

Taken together, these costs far exceed the price of prevention.

From Clinical Risk to Market Response

This growing recognition of risk has begun to reshape the market.

Before regulatory scrutiny intensified, power morcellation was widely adopted because it saved time, reduced operating room burden, and supported high procedural throughput.

It represented a multi-billion-dollar global market, supported by major surgical device manufacturers and deeply embedded in minimally invasive gynecologic practice.

The withdrawal of power morcellation from many hospitals did not eliminate the clinical need for efficient tissue extraction. Instead, it created a prolonged gap between surgical efficiency and acceptable risk.

That gap is now beginning to close.

With the emergence of FDA-cleared tissue containment systems designed specifically for morcellation, hospitals are reassessing whether power morcellation can be responsibly reintroduced in a manner aligned with regulatory guidance, patient safety, and liability mitigation.

This has significant implications for operating room efficiency, surgeon ergonomics, and system-wide cost management.

One example is Ark Surgical, a U.S.-focused surgical technology company advancing safety-first approaches to tissue extraction.

Its double-wall, airbag-like LapBox containment chamber was developed to support FDA-aligned morcellation while integrating into existing laparoscopic workflows, an increasingly important consideration as hospitals evaluate not just procedural efficiency, but long-term risk exposure.

Ark Surgical is currently in an active investment round, reflecting broader investor interest in technologies that address regulatory-driven risk while unlocking previously constrained markets.

More broadly, capital is flowing toward solutions that make it possible to restore clinical efficiency without reintroducing legacy risk.

The Cost Question Is No Longer “If,” but “When”

Healthcare systems already absorb the cost of uncontained morcellation through litigation, chronic disease management, repeat interventions, and loss of trust.

What has changed is visibility.

As clinical data, regulatory expectations, and market solutions converge, the question is no longer whether containment matters, but whether healthcare systems can afford to continue treating it as optional.

Diagnosis

Gender gap in treatment persists even when men and women have same condition

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Women with the same medical conditions as men were less likely to receive the same treatment across several specialties, a global research review found.

The review found differences in care for conditions including cardiovascular disease, kidney disease and Parkinson’s, with women less likely to receive some active treatments.

Of 38 studies analysed, 33 found women were less likely than men to be offered active treatment.

Researchers at the University of St Andrews found women with myocardial infarction, heart failure or an irregular heartbeat were more likely to receive medication, while men were more likely to undergo coronary bypass surgery, stenting or other surgical treatment.

Women were also less likely to be prescribed statins.

Men with Parkinson’s were more likely to be referred for deep brain stimulation.

Men with liver failure were more likely to receive a transplant, while women with kidney disease requiring dialysis were less likely to receive permanent access and spent longer using a catheter.

Women were also less likely to receive opioids for pain management.

The researchers found no significant difference between women and men in treatment for stroke or diabetes, while women were more likely to receive treatment for dementia.

None of the studies identified clinical guidelines recommending different treatment based on sex.

Researchers said this suggested the differences could not be explained by the need for different clinical approaches to women’s health.

Dr Andrew O’Malley, who co-led the study, said: “For clinicians, the findings are a prompt to check whether treatment is being offered on clinical grounds rather than assumption.”

He said studies showed doctors more often attributed women’s symptoms to anxiety and made more diagnostic errors with female patients, even when test results were positive.

Dr Miriam Veenhuizen, honorary lecturer in the School of Medicine at St Andrews, said: “While the direction of the findings was not a surprise, the consistency was. The same pattern appeared in cardiology, surgery, transplant medicine and emergency care, and it survived statistical adjustment in most studies.”

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Far from ‘boxed in’: The innovative design transforming at-home testing

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Alexander Parker is head of wellness at packaging design and manufacturing company, Burgopak.

Burgopak is a world leader in design innovation, with a 25-year-history spanning entertainment, consumer tech and now health diagnostics, including an expanding range of at-home hormone and fertility testing kits.

We speak to Alexander to discover what goes into designing robust, functional but engaging packaging and the sometimes surprising considerations that can make or break a product.

Hi Alexander. Please tell us about your role at Burgopak.

My role is about driving our growth and direction in the healthcare and wellness space, which in practice means everything from packaging to client engagement, to partnerships, to developing the team.

I also sit on the company management committee and help manage our IP portfolio.

Before stepping into this role, I spent 20 years as a designer, 15 of them as head of design – so I bring a hands-on understanding of what it takes to deliver great packaging.

At-home test kits require the user to perform a medical procedure alone, without professional support.

How does that inform your design approach?

It’s a key pillar of a project, heavily influenced by the product and its intended use.

In the case of a test kit being used to collect a sample specimen and return it to a lab, there’s often plenty of opportunity for packaging to help or hinder the process and experience.

There are layers to effective packaging.

●       Structure – Physical interventions through the packaging.

●       Artwork – The visual identity, messaging and instructions across the pack and instructions for use.

●       Signalling – Sometimes-undervalued but what signals are communicated through the packaging – how this makes the user feel about the product, the company behind it and the task at hand.

Careful design of the instructions for use is universally appreciated and often a regulatory requirement.

However, the pack structure and artwork should also work together to communicate a clear user journey.

This could include presenting components in the order they’re used, aligning the pack layout with the IFU steps (Prepare>Test>Return), making the IFU immediately visible as a hero component.

We can also introduce physical aids, like collection tube stands, to help during the sampling process.

The packaging is often used in the return of the sample to a lab so this needs to be considered and intuitively designed.

The structure, materials and artwork are all communicating something to the user.

You want to reassure the user by signalling care, efficacy, trust and in the case of a paid product, value.

In your mind, compare these two pack examples.

One a simple carton with a sea of components loosely filled and rattling around inside. Poor quality print and seemingly damaged in the post.

Contrast that with a suitably robust piece of packaging, with the components arranged and labelled into steps 1, 2, 3.

They might both work, but you can imagine the second building a reassured user experience.

How often do you encounter brands that haven’t thought about the emotional and potentially anxiety-inducing moment of opening a testing kit, and what’s the first thing you fix?

Thankfully it’s not too often, in our case at least.

I think we tend to attract customers who sense there’s more to packaging than just being a container or functionally driven.

The start of a project for us is building a brief with the customer and aligning on values for the packaging – what we want people to feel when opening or using it – as well as defining the technical requirements.

So, if there’s going to be an early fix it’ll probably be here, establishing the emotional intent.

How has the rise in social media ‘unboxing’ videos and product reviews changed what you do?

Is there a tension between designing for social media shareability and designing for the privacy women often want around health testing?

I don’t think there has to be a tension, provided everyone is clear on what the goals of the packaging are, and they are aligned with the product type and its use.

We can’t influence the results of a test or the positive or negative emotional significance it has in someone’s life.

What we can do is design packaging that offers the best possible user experience.

If there’s a shareable moment at the end, packaging might be a prop within a photo or video. But equally it might be a very private experience.

If it’s a test offering a diagnosis or insights into a health condition – you can conceive of a range of emotional outcomes. As you could imagine for certain fertility products too.

The design needs to acknowledge all these possibilities in its structural design, visual identity and the signals they communicate.

For women using a fertility or hormone test, perceived quality signals trust.

How do you stop sustainable choices from reading as cheap?

Do the essentials well, look for small interventions that add value and use attention to detail to signal that the care taken over the packaging, and sustainability, extends to the user.

Material choice is incredibly important.

In the case of paperboard quality can be a spectrum so it’s important to take the time to find and qualify the right one.

One that offers the necessary performance characteristics, is verifiably from responsibly managed forests such as through FSC/PEFC, and from a mill whose activities are aligned with your sustainability targets.

Take care over the design of each touch point and detail. A fitment that holds a device should neatly cradle it. A closure should be intuitive to open and work every time.

If the pack is meant to stand up, then the proportions should be optimised to facilitate that. It’s attention to the details that’s important.

Print quality will have a big impact on perception, not just the messaging or visual identity it renders. If the print quality is poor, then it devalues the product.

Doing it well doesn’t mean using material resources – it’s careful vendor selection and quality assurance.

For some responsible premiumisation you can introduce embossing or debossing details to the artwork, a tactile three-dimensional finish.

This details-led approach is valuable across all packaging but if sustainability is driving a reduction to the essentials, then there is a heightened importance to the execution of what is left.

As at-home health testing moves into NHS and public health contexts, what does good packaging look like when the brief is scale and cost rather than aspiration?

Scale and cost often feature very heavily in the success of projects outside of these settings, so there are parallels between the public and private, but with greater imperative to strip things back.

What is important to understand is success is not a piece of packaging in isolation. It’s efficiency, kitting, quality, distribution, tracking, data management across all activities and partners. Packaging is one part of the bigger picture.

Central to all of this is the need for it to reliably and consistently encourage the correct use of the kit through structure, artwork and instructions.

It is materially efficient and from a robust agile supply chain.

Assembly and kitting might be automated so it will be designed for those production lines or in conjunction with the equipment development.

It is compliant with all transport regulations and the most cost-efficient postal streams to the patient and from them back to the lab.

So, what does good packaging look like? It’s the design that efficiently offers the best patient user experience through a robust, reliable, scalable supply chain.

How do you make the business case for investing in packaging design before the product itself is ready to market?

There’s an opportunity cost.

Packaging has the potential to be a valuable asset when someone invests time and resources into coherent design and development. By starting too late or under resourcing the process you risk having packaging that’s a commercial pain point.

At the earliest opportunity, you at least want to be selecting your packaging partners and have a clear understanding of the development timeline and milestones – structural design, prototyping, stakeholder feedback, artwork/labelling development, regulatory milestones, transit testing, stability testing, wetproofing, manufacturing, delivery.

You must complete these steps before your product can go to market.

What’s the cost to you of delaying launch because you didn’t get packaging underway sooner?

You need to spend time creating packaging that elevates your brand and is a marketing asset that works across ecommerce, retail, advertising, social media.

Engage with the other supply chain stakeholders.

One example would be involving kitting partners in the process to validate and input on packaging improvements. If it’s expensive to kit, your cost of goods go up and if it’s slow to kit you might not have a scalable solution.

You may also find packaging insights influence product decisions.

If you are defining components for a test kit, factor in that larger devices might in turn increase pack size and eventually incur higher shipping costs.

You might work with a device manufacturer on how a USB cable is wound so the packaging volume can be decreased – another potential packaging and shipping cost reduction.

Transit testing and design improvements ensure that products arrive in acceptable condition – reducing costs associated with replacements, damaged reputation and potentially the loss of repeat purchases.

Packaging done well is that opportunity realised – it’s value demonstrated across sales, marketing and operations.

For a founding team approaching a packaging partner for the first time, what does a genuinely useful brief contain, what do most brands leave out, and how much does coming in underprepared add to the timeline and cost?

At Burgopak we build a brief together with the customer and that usually happens in a few stages.

The initial conversation is a chance to learn more about each other, make sure we’re a good fit for one another and the project.

We like to learn more about you, your product, how it’s used and some headline information around timelines, volumes, budget, your packaging ambitions and likes/dislikes.

We explain what we do and how we typically work. This really is the kick-off point – the goal at the end of this stage is being excited to be working together on a project that looks technically and commercially feasible.

In the next stage we build-out a brief capturing the technical and brand-led requirements of the packaging.

It will cover product details, brand & experience, sales & delivery channels, fulfilment and distribution, budget and timelines, compliance and regulations.

The exact questions will vary by product and project, but they span those areas.

From this we can build the project plan – and this might involve working towards answers that aren’t yet defined.

It seems obvious, but knowing exactly what needs to be packaged is fundamental – the product, peripherals – and this can be one of the common missing puzzle pieces.

You can design a container to hold ‘something’.

But when you know exactly what the product is – its size, shape, weight, how it’s used – you can design a piece of packaging that is maximally efficient and effective in elevating the total product experience.

The risk to a successful project is not so much under preparedness at the start – we’re here to help build the brief and a realistic project plan – it’s a loss of momentum through the process.

The packager and the client must work together.

We can be very efficient and agile in doing the work but there’s also the responsibility from the client to keep momentum through rounds of feedback, coordinating product samples or technical drawings and so on.

If there’s a finite timeline and repeated delays within it there can come a crunch point – when delivery dates are pushed out or potentially avoidable compromises made.

Come prepared to collaborate on the brief – but know that the founding teams who get the best outcomes are the ones who stay engaged and keep momentum through the whole process, not just the kick-off.

Learn more about Burgopak at burgopak.com

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Features

Elation Health acquires EHR startup Aster

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Elation Health has acquired Aster, a women’s health EHR startup created by sisters Fifi Kara and Dr Lailah Kara-Newton.

The deal, announced on 3 June 2026, will see Aster’s team join Elation Health as the company expands development of what it describes as the first agentic operating system for primary care.

An EHR, or electronic health record, is a digital system used by healthcare providers to store and manage patient information.

Aster was founded by Kara and Kara-Newton as an AI-native EHR platform for women’s health providers.

Elation Health said the acquisition would allow Aster to learn from its expertise in AI agents and support development of its agentic operating system for primary care.

Kyna Fong, co-founder and chief executive of Elation Health, said: “The Aster team impressed us with their vision and creative inventions to support independent practices.”

Fong said Elation, like Aster, was founded by siblings who wanted to change the healthcare system.

She added: “That shared north star means they understand what we’re building and why it matters. It was clear right away they would significantly add to our capabilities.”

Kara has spent 10 years creating consumer and business-to-business products across the UK, Europe and the US, and recently supported Meta’s Health & Fitness team, according to Aster’s website.

Kara-Newton previously worked as a hospital doctor in the NHS across medical and surgical specialties, including breast surgery, general surgery, emergency medicine and obstetrics and gynaecology.

Aster launched in 2023 after raising US$2.8m from Zeal Capital Partners, Cornerstone Ventures, Octopus Ventures and others.

Kara, Kara-Newton and Aster’s chief technology officer, Nacho Vazquez, will all join Elation.

Kara said: “From the moment we met Kyna Fong, Ashley Rogers, and the Elation leadership team, it was clear we were aligned on what matters most: that clinicians deserve truly incredible software that brings joy back to their practice. Together, we can now bring that vision to millions of primary care patients across the country.”

The sisters said their work was shaped by Kara-Newton’s first pregnancy, when undiagnosed pre-eclampsia led to an emergency caesarean section and neonatal intensive care admission for her son.

The founders said they wanted to build technology that could help prevent similar outcomes for other women.

The acquisition comes amid continued concern over maternal health inequalities in the US.

In the US, Black maternal mortality remains alarmingly high, with rates nearly double those of white women, and experts point to unequal access to care, implicit bias and fragmented approaches to care.

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