The Importance of Patient Advocacy: When the System Fails the Patient

When the Patient Becomes Their Own Advocate

“The nose is the central landmark of the face” (Hohman et al., 2024).
At 27, I underwent what I was told would be a routine nasal procedure with a highly respected surgeon. What I was not told, and what many patients are never told, is that the nose is not a cosmetic afterthought. It is a complex framework of cartilage, bone, and soft tissue engineered by the body for structural and respiratory function. When one part changes, everything changes.

After my cast was removed, it became clear something was very wrong. The surgeon had removed much of the bone and cartilage providing structural support. What followed was a journey thousands of patients know all too well: repeated surgeries, donor-site procedures, compounding complications, and a search for a surgeon who could help.

I travelled across the United States, consulting with some of the top reconstructive surgeons in the country. One by one, they described proposals that all converged on the same hard
truth.

“We will have to take rib. You only have a small amount of bone left. The rest is scar tissue.”

I was shocked that my only option involved removing healthy tissue from my chest to rebuild my nose. I chose a surgeon who offered cadaver tissue instead. My body rejected it. I then underwent rib-graft surgery at one of the top university medical centres in the world, a procedure costing $50,000, on top of $20,000 already spent. After 18 months, the graft began to warp and my breathing worsened.

I sought out what I believed to be one of the best reconstructive surgeons in the field. He quoted me $70,000 for another surgery: a second rib removal, ear cartilage harvest, and banked tissue behind the ear for future use. I moved forward, scared but hopeful. That surgery also failed.

A CT scan eventually revealed that my turbinates, critical structures responsible for regulating airflow, humidifying air, and supporting normal nasal function, had been significantly or completely removed. This was despite my explicit instructions to my surgeons not to touch them, and despite being repeatedly told by my most recent surgeon that my inability to breathe was simply the result of allergies. I knew that wasn’t true. That moment fundamentally changed how I viewed medicine. I quickly realised that patients were not always being prioritised. Instead, many of us were being forced to become our own medical experts, our own advocates, and the only people willing to relentlessly search for answers when our concerns were dismissed.

My story is not unusual. It is one version of a pattern that repeats across thousands of cases, and the scale of that pattern is worth laying out plainly.

The Growing Need for Nasal Reconstruction

Children born with congenital craniofacial anomalies. Veterans returning home with devastating facial injuries sustained in combat. Individuals living with Empty Nose Syndrome, a debilitating condition that profoundly affects breathing and quality of life. Cancer survivors facing the loss of part of their nose following tumour removal. Although these patients arrive through very different paths, they ultimately share the same challenge: the need for complex nasal reconstruction.

Today several of these conditions continue to grow in number. One of the most common reasons for nose removal is skin cancer. As skin cancer rates rise alongside an aging population, dermatologists and plastic surgeons are caring for an increasing number of patients requiring nasal reconstruction after oncologic resection. The nose is the most common site of non-melanoma skin cancer on the face, and its intricate three-dimensional anatomy, combined with its essential aesthetic and functional role, makes reconstruction one of the most technically demanding procedures in reconstructive surgery. In 2024, U.S. plastic surgeons performed more than 361,000 tumour-removal reconstructive procedures alone, with skin cancer among the leading indications, part of a broader and ever-expanding population of patients in need of reconstructive care.

The demand for nasal reconstruction extends far beyond oncologic surgery. Cosmetic rhinoplasty remains one of the most performed facial plastic procedures in the United States, with nearly 45,000 operations performed in 2022 alone. Published revision rates for rhinoplasty range from roughly 5% to 15% depending on technique and patient population, with one of the larger single-practice series reporting a 9.8% revision rate. Among patients requiring complex tertiary reconstruction using autologous costal cartilage grafts, revision rates approach 24%. Trauma, congenital craniofacial anomalies, and autoimmune diseases such as granulomatosis with polyangiitis further expand this patient population, creating a substantial and continually growing demand for reconstructive solutions.

Many of these patients did not initially seek reconstructive surgery. They began as cosmetic patients but became reconstructive ones after structural cartilage was over-resected, the nasal framework collapsed, or functional breathing was compromised. What began as an elective procedure evolved into a lifelong reconstructive condition requiring multiple operations to restore anatomy that had been permanently altered.

The distinction matters. This is not a market driven by cosmetic demand or patient preference. It is a growing population of individuals whose anatomy has been altered by disease, trauma, congenital conditions, or prior surgery, and who require reconstructive options that current medicine still struggles to provide.

The Limitations of Current Reconstruction

Despite remarkable advances across modern medicine, the fundamental principles of nasal reconstruction have changed surprisingly little over the past century. Reconstructive surgeons continue to rely primarily on borrowing healthy tissue from one part of the body to repair another. Cartilage is harvested from the ear or rib, skin is transferred through forehead flaps or other locoregional flaps, and cadaveric grafts are used when autologous tissue is unavailable.

Septal cartilage has traditionally been the first-choice graft material in rhinoplasty; surgeons turn to costal (rib) cartilage when a larger volume of graft material is needed than the septum can supply. Rib cartilage can come either from the patient’s own body (autologous) or from a donor source that has been sterilised through irradiation (homologous). However, harvesting a patient’s own rib cartilage introduces donor-site morbidity, including risk of lung puncture (pneumothorax), postoperative pain, thickened scarring, and longer operative time. Donor rib cartilage avoids the harvesting-related injury, but the high radiation doses used to sterilise it, typically above 25 kGy, accelerate the graft’s breakdown in the body, often making a second corrective surgery necessary.

These procedures have restored form and function for countless patients and remain indispensable within modern reconstructive surgery. Yet each carries significant limitations. Harvesting rib as a source of cartilage can result in significant donor-site morbidity, and clinical evidence confirms that pain and clicking of the chest wall represent the most common complaints following costal cartilage harvest, peaking in the first week after surgery and diminishing slowly over three months. Beyond acute postoperative discomfort, rib cartilage grafts carry well-documented risks of warping and
resorption over time, compromising the structural integrity of the reconstruction long after the initial procedure. Ear cartilage harvested from the concha, tragus, or scapha provides limited structural support for complex nasal defects and introduces measurable short- and long-term morbidity at the donor site, requiring the patient to sacrifice otherwise healthy tissue from a second anatomical location to address a problem at the first. Cadaveric cartilage eliminates the need for donor-site harvest, and a 2025 systematic review and meta-analysis of fresh frozen cadaveric rib grafts in rhinoplasty, pooling five studies and 440 patients, found comparatively low complication rates overall, though complications were more frequent in studies with
longer follow-up and in cases combining primary and revision surgery.

Even so, that review drew on a small pool of studies, and cadaveric grafting more broadly continues to be limited by a lack of long-term outcome data sufficient to support fully informed surgical decision-making. Taken together, the autologous, irradiated homologous, and fresh frozen cadaveric options each carry their own profile of trade-offs, and no single approach has emerged as a universally reliable solution for cartilage reconstruction in rhinoplasty. What unites these approaches is a shared fundamental constraint: each solves one wound by creating another, or trades one set of risks for a different one.

As reconstructive complexity increases, so too does the likelihood that patients will require multiple operations. Rather than resolving a single defect, many patients enter years of sequential procedures as surgeons attempt to improve function and appearance while managing the limitations of available tissues. The result is a cycle in which reconstruction repeatedly introduces new donor-site injuries in the attempt to address the original one.

These procedures remain the clinical standard not because they are without limitations, but because no regenerative alternative has yet reached routine clinical practice. It is precisely this absence of a reliable, non-invasive reconstructive option that has directed scientific attention toward tissue engineering, three-dimensional bioprinting, and regenerative medicine as the next frontier in nasal reconstruction.

The Economic Burden of Reconstruction

The financial burden reflects the scale of this unmet need. Patients requiring complex nasal reconstruction frequently undergo multiple operations over many years. Forehead flap reconstruction commonly requires two to six staged procedures depending on defect complexity, while revision rhinoplasty patients often undergo anywhere from one to seven reconstructive operations throughout their treatment journey. Importantly, surgical complexity and cost increase with each successive revision as scar tissue accumulates, native anatomy becomes increasingly distorted, and available donor tissue becomes more limited.

Complex revision rhinoplasty performed at leading United States hospitals and private practices routinely costs between $30,000 and $60,000 per procedure, with fees at internationally recognised centres frequently exceeding those amounts. My own reconstructive surgery exceeded $70,000 for a single operation, not as an exceptional case, but as a reflection of the financial reality many patients face after exhausting conventional options and seeking highly specialised expertise.

For many individuals, each operation represents another substantial out-of-pocket financial gamble. Patients invest tens of thousands of dollars with no guarantee that their issues will improve, breathing will be restored, or additional surgeries will not become necessary. The cumulative economic burden of reconstructive failure remains largely invisible within healthcare innovation despite affecting thousands of patients each year.

These financial and physical costs are what have pushed a growing field of researchers toward a different approach altogether: regenerating tissue rather than borrowing it.

While rib cartilage harvesting, ear cartilage grafting, and staged forehead flap
reconstruction remain standard practice, a growing body of researchers, clinicians, and companies are actively working to eliminate the donor-site morbidity and multi-stage burden these techniques impose. At the University of Basel, Ivan Martin’s Department of Biomedicine has demonstrated that cartilage can be engineered from a patient’s own nasal chondrocytes, cells taken through a minimally invasive biopsy rather than a rib incision, and used successfully to repair cartilage defects in a first-in-human clinical trial published in The Lancet. At Utrecht University and UMC Utrecht, Jos Malda’s bio fabrication group has tackled one of the central limitations of
engineered cartilage: its lack of structural durability once implanted. In a large-animal orthotopic (equine) study, Malda’s team found that structural reinforcement of cartilage implants matters more for long-term success than pre-culturing the tissue before implantation , a finding with direct implications for whether lab grown cartilage can ultimately replace grafts taken from a patient’s rib or ear.

At Johns Hopkins, Warren Grayson’s Laboratory for Craniofacial and Orthopedic Tissue Engineering is pursuing a parallel goal for bone. His team uses 3D-printed, biodegradable scaffolds seeded with a patient’s own stem cells to create anatomically precise, “ready-to implant” facial bone that gradually dissolves as living tissue takes its place, sidestepping the pain, scarring, and pneumothorax risk of rib harvesting entirely. In the UK, Iain Whitaker’s ReconRegen group at Swansea University has focused specifically on regenerating auricular cartilage, the same tissue currently harvested from the ear for nasal grafting, through tissue-engineered alternatives designed to overcome the structural weaknesses and donor-site complications documented in conventional ear-cartilage grafts. These academic efforts are beginning to translate into industry: T&R Biofab, a South Korean bioprinting company founded on research from Pohang University of Science and Technology (POSTECH), has already commercialised a Korean-regulatory
approved, 3D-printed craniofacial bone scaffold used in reconstructive nasal and facial surgery, and is developing a bioprinted cartilage construct that has shown efficacy in a rabbit knee joint model and remains in preclinical development. Together, this research signals a broader shift in reconstructive medicine, away from harvesting healthy tissue from one part of the body to repair another, and toward regenerating tissue directly, potentially eliminating the pain, scarring, staged procedures, and psychological burden that patients currently endure under conventional reconstructive techniques.

It’s clear the problem is not a lack of innovation. The problem is that these innovations are struggling to reach patients. There is a structural disconnect between the laboratory, the clinic, regulators, investors, and the people living with these conditions every day, and patients, the very people these technologies are designed to help, have little to almost no voice in shaping their development or their path to market.

Even when a regenerative therapy clears the scientific hurdle of proving in the lab that it works, it faces an entirely separate barrier before it can ever reach a patient: manufacturing it at scale, safely, and affordably. Tissue engineering remains, by and large, a “laboratory bench process,” reliant on labour-intensive, hands-on techniques that are simply not built for mass production. Translating a laboratory-scale success into large-scale, reproducible, commercially viable manufacturing remains one of the field’s most significant obstacles. Unlike a conventional pharmaceutical pill, living tissue is difficult to standardise, sterilise, and quality-control at volume.

This isn’t a minor logistical detail. It is a primary reason regenerative products stay locked in small clinical trials for years, and why, when they do reach market, they are often prohibitively expensive, limiting patient access and market penetration even after the science has been proven. In other words, the innovation exists; what’s missing is the industrial infrastructure to turn that innovation into something a hospital can order and a patient can afford.

This is precisely the gap the Advanced Regenerative Manufacturing Institute (ARMI) was created to close. ARMI is a member-driven non-profit operating in partnership with the U.S. Department of Defense through its BioFabUSA program. It brings together more than 170 companies, universities, and research institutions with a singular focus: building the scalable, cost-effective manufacturing infrastructure that regenerative medicine has been
missing. Rather than developing a single therapy, ARMI is building the industrial backbone the entire field depends on, automated, FDA-compliant production systems capable of turning engineered tissues and cell-based products from one-off lab experiments into technologies that can actually be manufactured, distributed, and delivered to patients at scale. Since 2017, this effort has attracted roughly $500 million in combined federal funding and in-kind investment, reflecting a growing recognition that the bottleneck holding back regenerative medicine isn’t just scientific, it’s industrial. If organisations like ARMI succeed in solving the manufacturing and cost side of this
equation, they won’t just accelerate a handful of products to market. They will help close the very gap driving patients toward unproven state-level pathways and overseas care in the first place.

Patients Are Changing the Market

Frustrated by the slow pace of conventional reconstructive and regenerative options, a growing number of patients are beginning to bypass the traditional medical system altogether. The standard of care still means harvesting a patient’s own rib, ear cartilage, or skin, techniques that carry documented risks of pain, scarring, and repeat surgery, while genuinely regenerative alternatives remain 10 to 20 years away from FDA approval. Patients increasingly feel that the system is asking them to wait for a future that may never arrive in time to help them.

This erosion of trust is not merely anecdotal. It is now visible in state legislation designed explicitly to route around the FDA’s traditional approval timeline. Montana’s Senate Bill 535 (2025), for example, amends the state’s existing Right to Try Act to license “experimental treatment centres” and permits patients to access experimental treatments, including those still under investigation, based on informed consent rather than full federal
approval, provided the treatment has completed Phase 1 of a clinical trial. Florida has taken a parallel, and in some respects more permissive, approach: its Stem Cell Therapy Act (SB1768), effective July 1, 2025, allows licensed physicians to administer non-FDA-approved stem cell therapies for orthopaedic conditions, wound care, and pain management, explicitly
citing the need to give patients a legal, in-state alternative to traveling abroad for treatment.

Both laws are a direct legislative response to the same underlying pressure: patients who feel that regenerative medicine’s slow, incremental march through preclinical models and small trials cannot restore what they have already lost, and who are consequently seeking care overseas in countries with faster regulatory pathways, or through emerging domestic frameworks that prioritise patient choice over the traditional, multi-decade approval
process.

This shift is not without risk, however. Removing FDA oversight also removes the evidentiary safeguards that oversight is designed to provide. Legal commentators reviewing both the Montana and Florida frameworks have raised concerns that patients may not be fully informed that a treatment lacks FDA approval in substance, not just in name, and that loosened state-level rules could open the door to exploitation by clinics offering unproven or even harmful products under the banner of “innovation”. The tension, then, is not simply between an overly cautious FDA and impatient patients. It is between
two legitimate but competing goods: patient autonomy and access to hope on one hand, and protection from unproven, potentially unsafe treatment on the other.

As a foundation, we have made it a priority to centre the patient voices at the heart of this tension while working to advance regenerative medicine responsibly.

One of the most formative experiences in this work has been direct engagement with the U.S. Food and Drug Administration. Many founders in this space treat regulatory affairs as a compliance exercise. I came to understand it as one of the most important conversations in medicine.

In two separate engagements with the FDA, our team raised issues that are rarely surfaced by industry: the cumulative patient burden of repeated donor-site surgeries, the lack of long-term outcome data on autologous tissue failure, and the case for a clearer translational pathway for tissue-engineered nasal and craniofacial constructs. These conversations are not adversarial. They are necessary. Regulators are not obstacles to innovation, they are partners who, until recently, rarely had patient advocates in the room.
That is changing. The FDA’s Breakthrough Device Designation (U.S. FDA, 2023) and Regenerative Medicine Advanced Therapy (RMAT) pathways (U.S. FDA, 2025) were not created in a vacuum. They were created in part because patient advocacy groups demonstrated, with data and lived experience, that the standard regulatory timeline was incompatible with the urgency of unmet clinical need. That is what patient-informed advocacy has already changed, not through sentiment, but through structured engagement with the evidence.

For too long, patients have been expected to accept the limitations of current medicine. We are told to be grateful for what exists, even when those options leave us with significant physical, emotional, and financial consequences. The evidence bears this out. Postoperative traumatic stress affects roughly one in five surgical patients, with rates climbing higher among those who face complications, repeated procedures, or a loss of control over their
own care. This is compounded by the grief of repeated failed procedures and the financial trauma of uninsured reconstructive cycles. None of this is
background context. It is central to the argument for why innovation must move faster, and why the people most affected must be at the table.

The future of medicine will not be built solely by scientists, clinicians, regulators, or investors, not because those voices are insufficient, but because the pipeline has already demonstrated that without patient input, critical problems remain invisible. The gap between what the laboratory can produce and what reaches the clinic is not primarily a scientific gap. It is a coordination gap, a funding gap, and an advocacy gap.

What Needs to Change

What emerges from this landscape, the real but underdiscussed risks of conventional grafting and flap techniques, the promising but still-early work of regenerative researchers, and the legislative scramble to give patients faster access, is a single underlying gap: patients are consistently the last voice consulted, not the first.

It is encouraging to see small steps in the right direction, from state Right to Try expansions to the FDA’s own Patient-Focused Drug Development (PFDD) initiative, which since 2012 has pushed to ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. But small steps are not the same as structural change, and structural change is what this moment calls for.

Patient advocacy cannot remain a late-stage checkbox, added once a treatment is nearly ready for market. It needs to be embedded at every stage, from the earliest design of a regenerative therapy through its clinical testing, regulatory review, and eventual delivery.

In practice, this means patient input should be a requirement, not an invitation: patients belong in the room when research priorities are being set, not just when consent forms are being signed.

This is especially urgent at the start-up level, where the foundational decisions about a technology’s direction are made and where patient representation is still the exception rather than the rule. A small number of companies, such as Amicus Therapeutics with its dedicated patient and professional advocacy team, are held up in the industry as models precisely because so few others have built anything comparable. Most biotech and medtech start-ups developing reconstructive and regenerative technologies still have no patient, or patient advocate, on their board or advisory council at all. That absence is not a minor oversight. It means the people who understand a condition’s real burdens, trade-offs, and unmet needs are structurally excluded from the decisions that will determine whether a new technology meets those needs.

If the healthcare industry wants to earn back the trust it is currently losing, trust that is visibly driving patients overseas and into legislative workarounds, it cannot treat patient inclusion as optional or aspirational. It needs to become a requirement: every start-up, research lab, and treatment centre working in this space should be expected to have a patient voice built into its governance from day one, not brought in after the fact to validate decisions that have already been made.

Concretely, that means: a patient or patient advocate seated on the board or advisory council of every regenerative-medicine start-up from its founding; patient input built into FDA engagement and trial design before protocols are finalised; and public reporting of long-term, patient-reported outcomes, not just procedural success rates, for every reconstructive and regenerative technique that reaches the market. These are not aspirational values. They are structural requirements, and the industry should be held to them.

Endnote

As a patient, this is an exciting time to be part of healthcare. For decades, the conversation happened around us, in boardrooms, in labs, in regulatory hearings, while we waited to be told what was possible. That is beginning to change. There are more avenues now than ever before for patients to share their stories, to be heard, and to hold the systems meant to serve us accountable to what we need.

The researchers building tissue-engineered alternatives, the legislators drafting new pathways to access, the clinicians rethinking what reconstruction should look like: all of it is happening because patients pushed, questioned, and refused to stay silent. That is proof of what happens when patients stop waiting for permission to be part of the conversation.

Patients are no longer waiting for innovation. We are helping create it.

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