By Dr. Fernando Gómez Sancha, MD
Urologist & World Expert in En Bloc HoLEP | 10,000+ Procedures | 50 Countries
"If a treatment exists with a 4.4% retreatment rate at five years, and another exists with a 14-17% retreatment rate at the same timepoint, why are patients not always offered the choice? The answer has less to do with medicine than with money."
Introduction: A Question Worth $30 Billion
Imagine you are told you need surgery for benign prostatic hyperplasia (BPH) — the non-cancerous enlargement of the prostate that eventually affects the majority of men over 60. Your urologist presents you with two broad categories of treatment. One group of procedures has a retreatment rate of 14-17% within five years, meaning roughly one in six patients will need another operation. The other approach carries a retreatment rate of just 4.4% — three to four times more durable.
The question is not which you would choose if given full information. The question is: why are so many patients never given that full information?
After performing more than 10,000 en bloc holmium laser enucleation of the prostate (HoLEP) procedures and training urologists in over 50 countries, I have watched the same patterns repeat across healthcare systems — from the United States to Japan, from Germany to Brazil. The issue is not individual bad actors. It is a structural misalignment built into the medical device industry, and patients deserve to understand it.
This is not a conspiracy theory. It is a documented, multi-layered system of influence that shapes what treatments get recommended, what research gets funded, what gets taught at congresses, and ultimately what options patients are offered in the consulting room. The data tells this story better than I can.
The Economic Context: Follow the Money
The global BPH device market is worth more than $30 billion annually and is growing. Within that market, a striking divide exists between two business models: those that generate recurring revenue per procedure, and those that do not.
The Recurring Revenue Model
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Rezum (Boston Scientific, market cap ~$16.7 billion): Uses water vapour thermal therapy delivered through single-use needle cartridges. Every procedure requires new disposable components, generating direct per-case revenue for the manufacturer.
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UroLift (Teleflex, ~$3.05 billion): Uses permanent implants — small titanium devices that hold the enlarged prostate tissue aside. Each procedure requires multiple implants, each one a revenue event. In a telling development, Teleflex announced in 2026 the divestiture of its entire Interventional Urology portfolio — including UroLift, Barrigel, and related products — to Intersurgical, citing declining procedure volumes. When the manufacturer itself exits, the market has spoken.
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Aquablation (PROCEPT BioRobotics, ~$224 million market cap but growing at +65% annually): Requires a robotic system purchase and ongoing disposables for every procedure. High upfront capital cost, then recurring revenue.
The Non-Recurring Model
- HoLEP / Laser Enucleation: Requires a holmium laser — a capital purchase that, properly maintained, lasts years and serves thousands of patients. There are no significant proprietary consumables. Once the laser is purchased, the manufacturer's revenue relationship with that hospital is essentially over.
The financial implication is stark: HoLEP is structurally unprofitable for the medical device industry. There is no business incentive to promote it, fund studies of it, or cultivate opinion leaders around it. The absence of commercial pressure does not make HoLEP better medicine — but the presence of commercial pressure around competing technologies absolutely shapes how they are marketed, studied, and ultimately recommended.
Pull Quote: "The medical device industry spends billions ensuring physicians hear about treatments that generate recurring revenue. Treatments that don't — like HoLEP — are left to promote themselves on merit alone."
20 Mechanisms of Industry Influence
The influence of commercial interests on medical practice is well-documented in the literature. What follows is not speculation — each mechanism has been described in peer-reviewed publications, regulatory filings, or confirmed by industry insiders. They are organized into five categories.
Category A: Direct Financial Relationships
1. Consulting fees and advisory boards. Device companies pay surgeons — often among the most respected in their fields — to sit on advisory boards, provide "input" on product development, and attend annual meetings. These relationships create a durable, if subtle, sense of loyalty and alignment.
2. Speaker honoraria. Paid speaking engagements at congresses and CME events place commercially motivated information in the mouths of credible physicians. The content may be factually accurate while being curated to emphasize benefits and minimize risks.
3. Proctoring fees. This is perhaps the most insidious mechanism. Device companies pay expert surgeons to travel and teach their technique at other institutions. The surgeon is compensated. The institution receives "training." But the entire programme exists to drive adoption of a revenue-generating procedure. It is sales, dressed as education.
4. Research grants with strings attached. Industry-funded research is not inherently corrupt — but the terms of funding agreements frequently include provisions that give sponsors influence over publication, data access, and framing of results. A surgeon who accepts device company funding for a study is not automatically biased, but the structural pressures are real.
5. Stock options and equity stakes. Some KOLs (Key Opinion Leaders) hold equity in the companies whose devices they champion. In the US, these relationships must be disclosed; in many other countries, they need not be.
Category B: Shaping the Evidence
6. Industry-funded trials designed to support the product. A 2020 study in the Journal of Sexual Medicine (Bouhadana et al., funded by PROCEPT BioRobotics) concluded that ejaculation preservation is patients' number one priority when choosing BPH treatment. This finding — legitimate in isolation — happens to be precisely Aquablation's commercial differentiator. The study was designed to produce a finding that served a marketing purpose, then published in a peer-reviewed journal, lending it scientific credibility.
7. "Data torture" — choosing favorable endpoints. Defining a "responder" as any patient who improves by just 3 points on the IPSS (International Prostate Symptom Score) sounds rigorous. But a 3-point improvement — from 23 to 20 — represents a clinically marginal change. When industry-funded studies use such lenient thresholds, "response rates" of 80-90% become possible for treatments that provide minimal functional improvement.
8. Professional medical writers who know which endpoints to select. A sophisticated body of commercial medical writing exists specifically to present clinical data in the most favorable light. Statistical significance is achieved by choosing the right subgroups, timepoints, and comparators. This is legal, peer-reviewed, and largely invisible.
9. Short follow-up periods. A 12-month result is not a treatment outcome — it is a snapshot. BPH is a chronic condition. Patients live with the consequences of their treatment for decades. Industry trials routinely follow patients for 12-24 months and publish results during this window, before retreatment rates become apparent.
10. The iTind example. The temporary implantable nitinol device (iTind) was marketed with the headline: "safe and effective up to 12 months." At 48 months, the surgical retreatment rate was 11.1%. Those who received the device at 12 months were told it worked. At four years, one in nine needed another procedure. The 12-month data was not false — it was selectively true.
11. Cherry-picking. A Rezum marketing flyer has cited a "4.4% surgical retreatment rate" compared to "13% for TURP." What the same flyer did not mention: the objective flow rate (Qmax) improvement after Rezum is significantly lower than after HoLEP — matched pair analysis shows HoLEP achieving a mean Qmax of 22.1 ± 7.2 ml/s versus Rezum at 16.82 ± 2.27 ml/s at 12 months (PMID 40263139). Symptom scores may improve while objective flow remains inadequate. Both pieces of information are in the literature — only one appeared in the marketing.
Category C: Controlling the Narrative
12. Ghost-written papers and reviews. The practice of ghost-writing — where industry-employed writers produce manuscripts that are then signed by academic physicians — has been documented in multiple medical specialties. In urology, the opportunity exists wherever a new device requires rapid evidence generation.
13. KOL development programs. This is long-term investment in influence. Companies identify promising young surgeons early in their careers — often trainees or early-career faculty — and cultivate them through early adoption programs, grants, speaking opportunities, and inclusion in advisory boards. By the time these surgeons become department heads, they have spent fifteen years building a relationship with a device brand. Their advocacy feels authentic because, from their perspective, it is.
14. Industry-funded "patient advocacy groups." Organisations that appear to represent patients independently are sometimes substantially funded by device manufacturers. These groups produce "patient education" materials, influence policy discussions, and lobby payers — all while presenting as independent voices.
15. Social media influencer programs for urologists. Device companies increasingly offer grants, travel, and recognition to physicians who are active on social media, in exchange for content that showcases their devices. These relationships are not always disclosed.
16. Sponsored symposia disguised as independent education. At every major urology congress — EAU, AUA, ESOU — a parallel universe of satellite symposia runs alongside the scientific programme. These are funded by industry, staffed by paid speakers, and often indistinguishable to attendees from independent scientific sessions. They are, functionally, advertising.
Category D: Institutional Capture
17. "Centers of Excellence" as sales certificates. Rezum, UroLift, and GreenLight laser all offer "Centers of Excellence" designations to high-volume adopting institutions. The criteria are almost invariably volume-based: perform enough procedures with our device to qualify. There is no outcome requirement, no independent quality audit, no patient satisfaction threshold. These programmes are sales incentives with medical-sounding names. Hospitals display them proudly; patients assume they represent clinical quality.
18. Conflicts of interest in guideline panels. An analysis of financial conflicts of interest across AUA clinical practice guidelines (Carlisle A et al., Eur Urol 2018) found that 59.3% of AUA guideline authors received at least one industry payment — across 13 guidelines evaluated, not limited to BPH. Guidelines carry enormous weight — a "Grade B recommendation" can shift practice nationally within months of publication. When the people writing those recommendations have financial ties to the companies whose products they are evaluating, the potential for bias is structural, not theoretical.
19. Industry funding of professional societies. Medical societies depend on industry for much of their operating budget — through sponsorship of annual meetings, educational grants, and advertising in journals. This does not make societies corrupt, but it does create an environment where openly challenging major sponsors is institutionally uncomfortable.
20. Device rep relationships with hospital purchasing. In many institutions, procurement decisions about which devices to stock are influenced by the relationships between device company representatives and hospital purchasing managers. Clinical effectiveness may be secondary to negotiated pricing, bundled contracts, and long-standing commercial relationships.
Pull Quote: "A 'Center of Excellence' for a medical device is not a quality award. It is a sales milestone. Patients deserve to know the difference."
The Evidence They Don't Want You to See
In 2025, a landmark study was published in European Urology Focus using the Epic Cosmos database — the largest real-world administrative dataset in American healthcare, encompassing 420,611 BPH procedures performed across diverse clinical settings.
This was not a randomised controlled trial with carefully selected patients, industry-defined endpoints, and 12-month follow-up. This was the real world: all patients, all surgeons, all institutions, tracked over five years.
The results were unambiguous:
| Treatment | 5-Year Retreatment Rate |
|---|---|
| HoLEP / ThuLEP (enucleation) | 4.4% |
| TURP / Open Prostatectomy | 7.1% |
| MISTs (Rezum, UroLift, Aquablation, etc.) | 14-17% |
(Reference: PMID 41558957, European Urology Focus 2026)
The durability gap is not small. Compared to enucleation, MISTs carry a 3-4× higher retreatment rate at five years. For a patient making a once-in-a-lifetime treatment decision, this is not a marginal difference — it is clinically decisive.
The same Epic Cosmos dataset (PMID 41558957) also illuminates what happens when MIST procedures fail: managing post-MIST failures is not straightforward. Anatomical distortion from implants (UroLift) or scarring (Rezum, iTind) makes subsequent enucleation more technically demanding. The retreatment burden falls on patients and healthcare systems that were never informed it was coming.
The common thread: when industry controls the research agenda, short follow-up hides long-term failure. When real-world data emerges at five years and beyond, the durability advantage of enucleation becomes undeniable.
The Ejaculation Trade-Off: An Honest Discussion
It would be intellectually dishonest to dismiss the ejaculation argument. It is real, and it matters to many patients.
HoLEP, like TURP, results in retrograde ejaculation (ejaculate entering the bladder) in a majority of patients — rates vary by technique and experience, but typically range from 70-90%. Many MISTs, by contrast, preserve antegrade ejaculation. For sexually active patients who are not yet resigned to this outcome, this is a meaningful difference.
The question — and this is precisely where informed consent becomes crucial — is whether that difference justifies a 3-4× increase in retreatment risk.
The PROCEPT BioRobotics-funded study (Bouhadana et al., J Sex Med 2020) found that ejaculation was patients' top priority. But consider how the study was framed: patients were asked to rank priorities before receiving detailed information about retreatment rates, durability, and the consequences of repeat surgery. When patients understand that choosing ejaculation preservation with a MIST gives them a roughly 1-in-6 chance of needing another procedure within five years — potentially a more complex procedure due to post-MIST anatomy — many make different choices.
Informed consent for BPH treatment should sound something like this:
"Option A preserves ejaculation but carries approximately a 15% chance of requiring further surgery within five years. Option B results in retrograde ejaculation in approximately 80% of cases but has a less than 5% chance of requiring retreatment."
In my experience, across thousands of consultations in dozens of countries, when patients are given all the data — not the curated version — a substantial proportion choose durability. They were not anti-MIST; they were simply never offered the complete picture.
Pull Quote: "The informed consent conversation for BPH should include: 'With this treatment, you have a 1-in-6 chance of needing another surgery within five years.' How many patients hear those words today?"
Fernando's Own Experience: What the Data Shows from Thousands of Cases
My own published work provides a reference point from which to evaluate the current landscape.
In 2019, our group published the technique of en bloc HoLEP with early apical release in World Journal of Urology — Saitta G, Becerra JEA, Del Álamo JF, Llanes González L, Reinoso Elbers J, Suardi N, Gómez-Sancha F. "'En Bloc' HoLEP with early apical release in men with benign prostatic hyperplasia." World J Urol 2019;37:2451-2458. PMID 30734073. This described a systematized approach to complete anatomical enucleation along the capsular plane that provides consistent, reproducible outcomes. More recently, Iscaife A, Rodríguez Socarrás M, Talizin TB, Nahas WC, Fernandez Del Alamo J, Cuadros Rivera V, Gómez Sancha F. published "Contemporary results of En Bloc HoLEP for large prostates" (2025, PMID 40586952), demonstrating that the technique delivers durable outcomes even in the most challenging anatomical scenarios.
The capsular plane does not change with commercial trends. Anatomy is constant. What changes is whether the surgical community is taught to access it — and who funds that teaching.
What Should Change: A Call for Transparency
This is not a call to abandon innovation. New technologies deserve evaluation. Some MISTs have genuine roles — in patients with specific anatomical or clinical profiles, or in healthcare settings where enucleation expertise is genuinely unavailable.
But the current system is failing patients by allowing commercial interests to dominate the information environment. Concrete changes would help:
1. Mandatory disclosure of ALL industry payments at scientific presentations. Not buried in a conflict-of-interest slide shown for three seconds, but prominently declared, in writing, in all congress materials.
2. Five-year minimum follow-up before guideline inclusion. BPH is a chronic condition. A treatment that looks good at 12 months but fails at 48 is not an advance — it is a deferral. Guidelines should require long-term durability data.
3. Independent funding for comparative effectiveness research. The BPH evidence base is disproportionately funded by device companies. Public funding bodies — NIH, NIHR, European Commission — should prioritise head-to-head, long-term comparison studies with no industry involvement.
4. Patient decision aids that include retreatment rates. Every shared decision-making tool for BPH treatment should present 5-year retreatment rates prominently, alongside ejaculation and continence outcomes.
5. "Centers of Excellence" based on outcomes, not volume. If these programmes continue, their criteria should include independent outcome audits, patient satisfaction measures, and complication rates — not procedure counts.
6. Conflict-of-interest thresholds for guideline panel membership. Physicians with declared financial relationships to companies whose products are under guideline review should be excluded from voting on those recommendations — or at minimum, their declarations should be published alongside each specific recommendation they influenced.
Conclusion: The Capsular Plane Doesn't Lie
I am not writing this to condemn innovation, criticise colleagues who use MISTs, or suggest that device companies are uniformly malign. The medical device industry has delivered extraordinary advances. Some of my closest professional relationships are with industry scientists and engineers.
But after more than 10,000 en bloc HoLEP procedures, after training urologists on five continents, after reviewing every major dataset on BPH treatment durability, I have an obligation to say what the evidence shows clearly:
The most durable surgical treatment for BPH — by the largest real-world dataset ever assembled — is laser enucleation. Its retreatment rate at five years is 4.4%. The next best option, TURP, is 7.1%. The MISTs that dominate current marketing and commercial investment carry rates of 14-17%.
These numbers are not industry estimates. They are not cherry-picked from favourable trials. They are drawn from 420,611 real procedures, in real hospitals, in real patients.
I should be transparent: my career is built on enucleation. I have every professional incentive to advocate for HoLEP. I invite the reader to set aside my perspective entirely and examine the data independently. The Epic Cosmos database was not compiled by enucleation advocates — it is a neutral, administrative dataset of 420,611 procedures. The numbers speak without me.
Every patient deserves to know these numbers before they make their decision. Every surgeon has an obligation to present them — regardless of which company paid for last year's CME programme, which device rep sends the holiday gifts, or which "Center of Excellence" plaque hangs in the waiting room.
The capsular plane is a consistent anatomical boundary. Navigate it correctly, and you restore function durably. It does not care about business models, quarterly earnings calls, or marketing slogans.
That's the $30 billion question, answered honestly.
References
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PMID 41558957 — Epic Cosmos 420,611 procedures: 5-year BPH retreatment rates by modality — European Urology Focus, 2026
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Bouhadana D et al. — Patient-reported outcomes and ejaculation as primary priority in BPH treatment — Journal of Sexual Medicine, 2020 (PROCEPT BioRobotics-funded)
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Amparore D et al. — "Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results." Minerva Urol Nephrol 2023;75(6):743-751. PMID 37350585
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McVary KT, Roehrborn CG et al. — "Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study." Urology 2019;126:171-179. PMID 30677455
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Roehrborn CG et al. — "Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study." Can J Urol 2017;24(3):8802-8813. PMID 28646935
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Carlisle A et al. — "Financial Conflicts of Interest Among Authors of Urology Clinical Practice Guidelines." Eur Urol 2018;74(3):427-429. PMID 29747945
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PMID 40263139 — Matched pair analysis: HoLEP vs. Rezum — objective flow rate (Qmax) outcomes at 12 months
About the Author
Dr. Fernando Gómez Sancha is a urologist and Medical Director of ICUA (Instituto de Cirugía Urológica Avanzada) at Clínica CEMTRO, Madrid, Spain. He is internationally recognised as one of the world's leading experts in en bloc holmium laser enucleation of the prostate (HoLEP), with more than 10,000 procedures performed. He has trained surgeons in over 50 countries and has published extensively on laser enucleation technique, outcomes, and the learning curve. Disclosures: Dr. Gómez Sancha is a consultant and proctor for Quanta System (laser manufacturer), has a collaborative agreement with Richard Wolf (endoscopy), and holds stock options in Andromeda Surgical (robotic HoLEP). These relationships are disclosed in the interest of full transparency — the same standard this article calls for across the field.
Twitter/X: @fgomsan
This article represents the author's independent clinical and scientific perspective. All claims are referenced to peer-reviewed literature or public data sources. The author welcomes critical engagement and correction of factual errors.
© 2026 Dr. Fernando Gómez Sancha. Reproduction for educational purposes permitted with attribution.
