Insight
The hidden cost of “business as usual” in gynecologic surgery
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.
News
From Hologic to Ark Surgical: Why Joseph LaBruzzo is betting on the future of women’s surgical innovation
After more than two decades leading organisations at some of the world’s most respected medical device companies, including Hologic, SenoRx Breast Care, and BTL Industries, Joseph B. LaBruzzo is embarking on a new chapter as President & CEO of U.S. Operations and Board Member at Ark Surgical.
We sat down with Joseph to discuss what drew him to Ark Surgical, why he believes women’s surgical innovation is entering a transformative era, and what it takes to bring meaningful technologies from concept to standard of care.
You have held leadership positions at some of the biggest names in MedTech. What attracted you to Ark Surgical?
Throughout my career, I’ve been fortunate to work with organisations that developed technologies capable of changing the standard of care.
What attracted me to Ark Surgical is the opportunity to help address a meaningful unmet need in gynecologic surgery with an innovation that has the potential to improve patient outcomes while preserving the benefits of minimally invasive surgery.
Opportunities like that don’t come along very often.
FemTech World recently highlighted that many women remain unaware of gynecologic cancers and that unexpected diagnoses continue to have a profound impact on patients and families.
How has your own experience shaped the way you think about innovation in women’s health?
Earlier in my career, I witnessed many women receive life-changing cancer diagnoses.
Those experiences stayed with me and reinforced my belief that if there’s an opportunity to reduce risk through better innovation, it’s one worth pursuing.
That’s one of the reasons I was drawn to Ark Surgical.
The vast majority of minimally invasive gynecologic procedures are performed for conditions believed to be benign. Unfortunately, in rare cases, pathology later reveals an unexpected malignancy.
LapBox was designed with a proprietary dual-wall tissue containment system to help facilitate contained specimen retrieval and minimise the risk of tissue spillage during laparoscopic procedures.
I believe innovations like this can help surgeons manage the unexpected while preserving the many benefits of minimally invasive surgery for women.
Women’s health has gained significant momentum in recent years, yet surgical innovation often receives less attention than diagnostics or therapeutics. Why do you think that is?
Women’s health has historically been underfunded and underserved across many areas of medicine, and surgery is no exception.
While we’ve seen tremendous advances in diagnostics and pharmaceuticals, there are still important opportunities to improve the surgical experience for both physicians and patients.
Innovation that enhances safety, efficiency, and outcomes has the potential to make a lasting impact.
What excites you most about LapBox?
LapBox addresses a very real challenge that gynecologic surgeons face during minimally invasive procedures.
It was thoughtfully designed to integrate seamlessly into the surgical workflow while providing an added layer of confidence when tissue retrieval is required.
I believe technologies that solve real clinical challenges in a practical way have the greatest potential to become part of the standard of care.
What do you see as the biggest unmet needs in minimally invasive gynecologic surgery today?
The future of surgery isn’t simply about making procedures less invasive. It’s about making them smarter and safer.
Surgeons need technologies that integrate seamlessly into their workflow while helping them navigate increasingly complex clinical situations.
Every advancement that helps reduce risk while preserving the benefits of minimally invasive surgery has the potential to improve outcomes for both physicians and patients.
That’s where I believe the greatest opportunities for innovation exist.
As you take on this new role, what are your priorities over the next 12 months?
Our focus over the next 12 months is to build a strong foundation for growth. That means expanding physician partnerships, driving early clinical adoption, growing our team, and ensuring that more surgeons have access to technologies like LapBox.
At the same time, we’re focused on building strategic relationships with investors, healthcare systems, and industry partners that support our long-term vision.
What advice would you give entrepreneurs building the next generation of women’s health companies?
Start with a real clinical problem and never lose sight of the patient.
Great technology alone isn’t enough. You also need strong clinical evidence, physician advocates, and a clear market strategy. The companies that succeed are the ones that bring all of those pieces together while remaining focused on improving patient care.
About Joseph B. LaBruzzo
As President & CEO of U.S. Operations and Board Member, Joseph LaBruzzo is leading Ark Surgical’s U.S. growth strategy, physician partnerships, strategic investment initiatives, and organisational expansion, supporting the company’s mission to advance safer minimally invasive gynecologic surgery through innovative technologies.
Cancer cells may hijack a fertility protein to repair damaged DNA and survive chemotherapy, research suggests.
The findings could point to a way of making existing cancer treatments more effective.
SYCP1 is a protein normally involved in producing sperm and eggs.
Researchers at the University of Liverpool found that the protein, previously thought to work only in reproduction, can be reactivated in cancer cells, where it helps tumours survive and grow.
SYCP1 usually helps chromosomes pair during meiosis, the form of cell division that produces reproductive cells.
In cancer cells, however, the protein appears to take on another role. It enters the nucleus, the cell’s control centre, binds directly to DNA and regulates genes involved in cell division and DNA repair.
DNA repair is how cells fix damage to their genetic code. In cancer, this process can help tumour cells survive treatment.
The researchers found that removing SYCP1 made cancer cells much more sensitive to chemotherapy drugs that damage DNA.
The findings suggest cancers may use SYCP1 to repair damage caused by treatment and continue growing.
Dr Urszula McClurg, lecturer in biochemistry, cell and systems biology at the University of Liverpool, said: “Our findings show that cancer cells can hijack proteins that normally exist only in reproductive tissues and give them completely new jobs.
“Understanding these unexpected functions opens up exciting opportunities to develop new treatments that make existing cancer therapies more effective.”
The work challenges the long-held belief that proteins active only in fertility have no biological relevance outside the reproductive system.
Researchers say these specialised proteins could provide new treatment targets across many types of cancer.
The study also offers a new view of how cancers evolve by repurposing developmental and reproductive processes.
The findings highlight SYCP1 as a candidate for future precision cancer therapies, which are treatments based on the specific biology of a patient’s cancer.
Women’s health has become one of the most searched and shared topics online, from cycle syncing and cortisol management to menopause hacks, supplements, hormone testing and clinician-creator content.
That surge in attention, sometimes dubbed “healthmaxxing,” is changing how women find, evaluate and act on health information, and it is starting to reshape the relationship between patients, clinicians and the companies building products for this market.
For providers, the shift means patients are arriving better informed but also more exposed to unverified claims, putting pressure on clinicians to engage with online narratives rather than dismiss them.
For femtech and pharma companies, it opens a route to reach and educate consumers at scale, but also raises the stakes on credibility: products and messaging that ride the trend without clinical grounding risk eroding the trust the industry has spent years building.
Investors are watching the same dynamic from a different angle.
Attention-driven demand can be a signal of where the next wave of femtech growth will come from, but distinguishing genuine clinical need from viral momentum is increasingly part of due diligence.
The net effect is a widening gap between companies that treat cultural attention as a distribution channel for credible, evidence-based care, and those that risk being swept up in trends with little clinical substance behind them.
How that gap plays out will shape patient trust, clinical relationships and commercial opportunity across the women’s health industry for years to come.
These themes will be explored in more depth in an upcoming webinar, “Women’s Healthmaxxing: The Opportunity & Risks of Cultural Attention for the Women’s Health Industry,” hosted by the Women’s Health Innovation Summit (WHIS), featuring Ellen Wilcox (Listen Ventures), Jessica Bell van der Wal (Frame Fertility), Dr. Tosin Sotubo-Ajayi (NHS, BBC and more) and Nora Lansen (Elektra Health).
Register free for the webinar on 23 July 2026 at https://events.virtualpro.com/womens-health-series-webinar-july-2026/registration
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