Responsible Off-Label Device Use in Surgical Innovation: A Review and LABEL Framework

Why Surgeons Use Devices Off-Label

Off-label device use in surgery appears to arise from five recurrent drivers: anatomical specificity, evidence lag, technical constraints, rescue necessity, and diffusion through professional networks. Anatomical specificity refers to the mismatch between product labelling and the specific tissue or operative field encountered in practice. Evidence lag occurs because device labels often change more slowly than surgical practice, especially when early evidence emerges through case series, technical reports, videos, or expert adoption. Technical constraints create additional pressure because limited access, loss of tactile feedback, and difficult intracorporeal suturing may make a device attractive even when conventional alternatives exist. Rescue necessity may justify the need to solve an unexpected intraoperative problem when standard options are unavailable or more harmful. Finally, professional diffusion through peer practice may normalize a use before the IFU or evidence base has caught up.

A Working Vocabulary

Precise vocabulary is needed because ‘off-label’ is often used too broadly. Table 1 proposes a practical taxonomy synthesized from regulatory guidance and professional statements.^1-3,11

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Table 1.

Definitions Relevant to Surgical-Device Use

Term	Working definition	Governance implication
On-label use	Use consistent with indication, contraindications, and warnings.	Routine governance.
IFU-silent use	The IFU does not address the exact anatomical or procedural context; the use may still fall within the device’s broad intended purpose.	Clarify intended purpose, check the evidence, and document when material.
Off-label use	Use outside the labelled or registered intended purpose, indication, population, anatomical site, or mode of use.	Patient-specific rationale, consent if material, and documentation.
IFU-discordant use	Off-label use that conflicts with an explicit warning, contraindication, or “not recommended” statement.	Highest justification threshold; institutional review for repeated or high-risk use.
Modified use	Physical alteration, non-standard deployment, or combination with non-approved accessories; Modified use may overlap with IFU-silent, off-label, or IFU-discordant use.	Documentation and institutional review may be needed.
Investigational use	Systematic use to evaluate safety or effectiveness.	Ethics review necessary.
Unapproved device use	Use of a device not lawfully approved in that jurisdiction.	Regulatory pathway is essential.
Expired-device use	Use after the manufacturer’s expiry date or after expiry of sterility/material assurance.	Distinct sterility, packaging, and governance issue.
Reuse/reprocessing	Reuse of a device intended for single use, or reprocessing before reuse.	Infection-control, accountability, and regulatory issue.
Repurposing	Redirection of an existing drug, device, or technology to a new disease or clinical problem.	Evidence-generation and emergency-governance issue.

Among the label-related categories, governance generally escalates from IFU-silent use to off-label use and is highest when use is IFU-discordant. IFU-silent use usually requires clarification of intended purpose, an evidence check, and documentation when material. Off-label use requires a patient-specific rationale and consent when relevant, while repeated or high-risk IFU-discordant use should prompt institutional review. Modified use should be assessed separately according to the extent of alteration, reversibility, device permanence, and available rescue options.

What Off-Label Use is Not

Off-label device use should not be conflated with expired-device use, reuse or reprocessing of single-use devices, or repurposing. Expired-device use raises separate concerns about sterility, packaging integrity, material stability, and manufacturer assurance, especially in humanitarian missions or medical-device donations to lower-resource settings. World Health Organization (WHO) guidance on medical-device donations emphasizes appropriateness to recipient needs, local policy, technical capacity, training, maintenance, and safe device management, rather than indication status alone. ¹² Reuse or reprocessing of a single-use device is also distinct. It concerns cleaning, disinfection, sterilization, device integrity, infection prevention, and accountability after the manufacturer’s single-use assurance has ended; FDA guidance treats reusable-device reprocessing and reprocessed single-use devices as separate regulatory and safety issues.^13,14 Unplanned reuse of a device during an intraoperative emergency is different from routine reprocessing for later use. It remains a high-risk rescue decision requiring immediate assessment of device integrity, sterility, available alternatives, and documentation, and should not become a routine local practice. Repurposing redirects an existing drug, device, or technology to a new disease or clinical problem. The COVID-19 experience with chloroquine and hydroxychloroquine illustrates how repurposing may begin under urgent clinical pressure but require rapid evidence correction when benefit is not confirmed or risk becomes unacceptable. ¹⁵

Barbed Sutures

Barbed sutures illustrate the value and hazard of IFU-sensitive surgical adaptation. Their practical appeal is obvious in minimally invasive surgery: knotless closure, even tension distribution, reduced intracorporeal knot tying, and shorter suturing time. Systematic reviews in gastrointestinal surgery report that barbed sutures can reduce suturing or anastomotic time without a clear overall increase in complications.^16,17 Published series have reported feasibility of barbed sutures for laparoscopic common bile duct exploration and primary choledochorrhaphy. ¹⁸ The critical issue is that broad soft-tissue use does not automatically establish safety for every luminal or intraperitoneal application. Published warnings and case-based literature describe small-bowel obstruction when barbed suture ends hook onto adjacent bowel or mesentery. ¹⁹ Barbed sutures should therefore not be described as unsafe or prohibited. Their responsible use requires attention to tissue context, exposed tails, burying or trimming ends, case selection, and documentation when the use is outside local standard practice. This example also shows why short-term series may be falsely reassuring: a device can reduce operative time and appear safe in routine outcomes, yet still create rare delayed mechanical complications that require longer follow-up to detect.

Lumen-Apposing Metal Stents

LAMS show a different pattern: rapid expansion from defined endoscopic purposes into adjacent and off-label indications. LAMS were developed for transluminal drainage and have become central to interventional endoscopic ultrasound. Published experience includes approved and off-label indications, including pancreatic fluid collections, gallbladder drainage, gastroenterostomy, biliary drainage, gastrointestinal strictures, and temporary access procedures.^20,21 One series of 303 patients reported that 190 patients, or 62.7%, received LAMS for off-label indications. ²¹ In selected patients, LAMS may avoid surgery or provide palliation. However, LAMS use is highly operator-dependent and requires expertise and fluoroscopic support. Adverse events such as bleeding or perforation may be serious. Off-label LAMS use should therefore be limited to operators with formal interventional endoscopy training, institutional credentialling, and access to endoscopic, radiological, and surgical rescue. Introduction of a new indication should include appropriate proctoring or peer review and prospective audit of outcomes. LAMS therefore shows how off-label use can evolve into accepted practice, but only when supported by expertise, audit, and outcome reporting.

Sealants and Haemostats

Fibrin sealants, glues, and topical haemostatic agents are often underestimated because they appear simple. Glue may function as a haemostat, adhesive, or sealant, and each use may have a different evidence base. Mandell and Gibran noted that fibrin sealants are used for a wide variety of off-label indications. ²² A broad systematic review of fibrin sealant in non-emergency surgery found use across multiple surgical contexts, while also highlighting uncertainty around benefits and harms in several settings. ²³ The literature is difficult to interpret because endpoints differ: bleeding, drain output, seroma, fistula, leak, transfusion, reoperation, and cost are not interchangeable. The safety concern is not always failure but overuse. This therefore requires professional restraint. Familiarity is not evidence, and local habit is not the same as indication-specific benefit. This category illustrates ‘indication creep’: a product initially used for one biological purpose may gradually be applied to adjacent problems without each new use being supported by the same level of evidence.

Mesh in Contaminated Fields

Mesh use in contaminated or infected fields is label-sensitive rather than categorically off-label, because product-specific IFU cautions, wound contamination, evolving evidence, and patient factors may not align neatly. However, clinical evidence has challenged older assumptions. A randomized clinical trial in contaminated ventral hernia repair found lower 2-year recurrence with synthetic mesh than biologic mesh, with similar safety profiles. ²⁴ The PRICE randomized trial found higher recurrence with biologic mesh compared with synthetic mesh, with similar postoperative complications. ²⁵ This example highlights the difference between product labelling, clinical evidence, standard of care, and patient values. A use may be supported by emerging literature but still cautionary in a specific IFU. Conversely, broad labelling does not remove the need to assess wound class, bacterial burden, patient risk factors, mesh type, likelihood of explantation, and patient preferences. Patient preferences may also include material-specific concerns, such as religious or moral objections to porcine-derived biological mesh; such issues are not captured by recurrence or infection outcomes but may be decisive for ethically acceptable surgical care. ²⁶ Mesh in contaminated fields is therefore best described as label-sensitive and evidence-evolving rather than simply off-label.

Modified Devices

Modified device use is the most ethically sensitive category because the surgeon may alter a device in a way the manufacturer did not test. Cutting, reshaping, combining, or using third-party accessories can change strength, sterility, deployment, compatibility, and failure mode. Such practices may be reasonable in selected circumstances, particularly rescue situations, but they require a higher threshold of justification. The greater the modification, the less the surgeon can rely on the manufacturer’s assurance of performance. This is where off-label use approaches surgeon-created innovation. Documentation and governance should increase accordingly. A single rescue modification may be defensible as patient-specific judgement. Repeated modified use becomes a local practice and should be audited, discussed, and, where appropriate, studied. Departments could maintain a simple modification register recording the device, nature and reason for alteration, alternatives considered, operator, patient outcome, and any adverse event. Repeated entries involving the same modification should trigger departmental review and consideration of formal evaluation.

The selected examples show that off-label and IFU-sensitive device use is not a single problem but a spectrum of evidence, risk, and governance challenges. Table 2 summarizes the main evidence signal, limitation, and governance lesson for each category.

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Table 2.

Evidence Map of Selected Surgical-Device Examples

Device category	Main evidence signal	Main limitation	Governance lesson
Barbed sutures	Reduced suturing difficulty and time; reported feasibility in gastrointestinal and biliary closure	Rare delayed mechanical complications may be missed in short-term series	Technical safeguards and adverse-event surveillance matter
Lumen-apposing metal stents	Expanding evidence for approved and off-label endoscopic indications	Outcomes are highly operator- and infrastructure-dependent	Off-label diffusion should be linked to expertise, rescue capability, and audit
Sealants and haemostats	Broad use across surgical contexts	Heterogeneous products, indications, and endpoints	Avoid indication creep and routine unmeasured use
Mesh in contaminated fields	Randomized trials support selected synthetic mesh use	Product IFU may remain cautionary; patient selection is crucial	Evidence and label must both be checked
Modified devices	Useful in rescue or constrained situations	Manufacturer testing may no longer apply	Higher documentation and institutional oversight threshold

When Off-Label Use Is Reasonable

Off-label use can be reasonable when it is patient-centred, evidence-informed, and proportionate. It may be justified when no suitable labelled alternative exists, when the off-label option avoids a more invasive procedure, when the anatomical problem is unusual, or when published evidence supports the practice. The clinical rationale should be stronger when the use is further from the IFU, when the device is implanted permanently, or when harm would be difficult to reverse. Off-label use should also be distinguished from research. Individual clinical use for patient care is not the same as systematic investigation. However, repeated use to generate generalizable safety or effectiveness data should move toward ethics review, registry, or formal evaluation.^1,27-29 This approach is consistent with the Declaration of Helsinki’s guidance on unproven interventions in clinical practice, which permits carefully justified patient-specific use when approved options are inadequate or ineffective, but emphasizes expert advice, risk–benefit assessment, informed consent, and subsequent evaluation of safety and efficacy. ³⁰

When Off-Label Use Becomes Unsafe

Off-label use becomes unsafe when the reason for using the device is weak or commercially shaped. Red flags include use despite lack of patient-specific rationale; failure to consider standard alternatives; repeated use without audit; undisclosed financial or training relationships; and failure to tell the patient when the information is material. “Everyone uses it,” “it works in my hands,” or “the representative said it is fine” are not evidence. They may be starting points for enquiry, but they cannot replace IFU review, literature review, local audits, or independent professional judgement. The greater the departure from the IFU, the greater the burden of justification.

Ethics and Professionalism

Off-label device use is a test of surgical professionalism. The surgeon’s first duty is to the patient. ³¹ A device may make an operation faster or easier, but convenience is not the same as benefit. The professional question is simple: is this device being used because it is better for this patient, or because it is familiar, fashionable, available, reimbursed, or promoted? Beneficence may justify off-label use when it provides a reasonable patient-specific advantage. Non-maleficence requires avoidance of preventable harm from untested use. Respect for autonomy requires disclosure when off-label status, IFU caution, additional cost, or uncertainty would reasonably matter to the patient. Justice requires attention to resource use and unequal access to expensive technologies. Professional integrity requires independence from industry influence and willingness to stop or modify practice when complications emerge. The most dangerous form of off-label use may be silent normalization. This drift is not rare in modern surgical learning. YouTube is widely used for surgical preparation, yet surgical videos often lack peer review, validated quality indicators, and transparent disclosure of conflicts or commercial influence. ³² In off-label device use, such videos may normalize a technique before the viewer understands whether it is on-label, evidence-supported, or reproducible locally. Professional societies and hospitals can reduce this risk by requiring video authors to identify the device, state whether the demonstrated use is on-label or IFU-sensitive, disclose sponsorship and conflicts, and describe patient selection, technical limitations, and complications. Institutional teaching libraries should preferentially host clinically reviewed material rather than rely on view counts, likes, or other popularity measures. ³² A device is demonstrated at a conference, used by a respected colleague, stocked by the hospital, and gradually becomes “how we do it,” without anyone checking the IFU, auditing outcomes, or discussing material uncertainty with patients. Professionalism requires surgeons to resist this drift.

Consent

Not every off-label device use requires a long consent discussion. Surgery involves many intraoperative choices that patients reasonably entrust to the surgeon. However, disclosure becomes important when the device use materially affects risk, alternatives, uncertainty, cost, postoperative expectations, or the patient’s ability to choose. Consent should be more explicit when the device use is clearly outside the IFU, when the IFU contains a relevant warning, when a labelled alternative exists, when evidence is limited, when the use is new to the surgeon or institution, when industry influence is present, or when the use is part of innovation, audit, registry, or research.^2,3,11 Subject to local law and institutional policy, a verbal explanation documented in the clinical record may be sufficient for low-risk IFU-silent use when the departure does not materially change risk, alternatives, or cost. Explicit written consent should generally be obtained for IFU-discordant or modified use, permanent implantation, substantial uncertainty, important additional cost, or use that is new to the operator or institution. Investigational use requires formal research consent and ethics oversight. The purpose of disclosure is not to frighten the patient with regulatory language, but to explain facts honestly. Plain-language disclosure may be more useful than technical regulatory terminology. For example:

This device is used by some surgeons for this type of problem, but this exact use is not specifically described in the manufacturer’s instructions. I think it is reasonable here because [reason]. The alternative is [alternative]. The specific uncertainty is [uncertainty].

This explanation respects autonomy without turning consent into a technical manual. Patients may accept uncertainty when it is explained; they are less forgiving when uncertainty is hidden.

Law, Governance and Audit

The main legal and governance risk in off-label device use usually lies not in clinician-directed judgement itself, but in poor surrounding conduct: promotional influence, concealment, inadequate oversight, failure to understand IFU limitations, poor documentation, or failure to disclose material uncertainty. Clinician-directed off-label use is different from manufacturer promotion, but it still requires professional discipline. Surgeons should therefore separate independent clinical judgement from commercial messaging and document the patient-specific rationale. Governance should not make surgeons afraid to innovate, but courageous to embrace it professionally and adopt it responsibly. Departments could maintain a short list of commonly used IFU-sensitive devices, document the reason for material off-label or IFU-silent use, review device-related complications at morbidity and mortality conferences, and report serious or repeated adverse events. Singapore’s Health Sciences Authority describes adverse-event reporting as part of post-market risk assessment, with the objective of reducing the likelihood or consequences of repeated adverse events. ³³ FDA’s MAUDE database houses medical-device reports from mandatory reporters and voluntary reporters, including healthcare professionals, patients, and consumers. ³⁴ These systems are imperfect and under-reporting is common, but the principle is important: device-related harm should enter a learning system. The aim is not to punish surgeons for adapting devices, but to prevent repeated unrecognized harm.

Surgical Innovation and the LABEL Framework

Surgical innovation has established evaluation frameworks. IDEAL describes stages of surgical innovation from idea to development, exploration, assessment, and long-term study.^27,28 IDEAL-D extends this thinking to device innovation and preclinical evaluation. ²⁹ Governance studies have shown variation in institutional policies for innovative invasive procedures, supporting the need for clearer local processes. ³⁵ To translate these principles into a practical point-of-care approach, we propose the LABEL framework, summarised in Table 3. The LABEL framework is not intended to replace IDEAL, regulatory review, IRB review, or institutional innovation committees. These systems operate at different levels. LABEL supports the surgeon’s patient-level decision at the point of care. Repeated or planned adoption should move into institutional governance and, where appropriate, IDEAL-based evaluation, while systematic use intended to generate generalizable evidence requires IRB or ethics review. LABEL is therefore a front-end clinical decision aid rather than an alternative regulatory or research pathway.^27-29 It is a practical decision aid for surgical-device use. It asks five questions before, during, and after off-label or IFU-silent use.

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Table 3.

The LABEL Framework for Responsible Off-Label Device Use

Element	Key question	Professional standard
Label	What does the IFU actually say?	The surgeon knows the indication, warning, and limitation before relying on the device.
Alternatives	What else could be used?	Off-label use is easier to justify when labelled alternatives are unavailable, more invasive, or more harmful.
Basis	What supports this use?	The basis may be literature, local audit, expert consensus, or rescue necessity. Weak evidence requires stronger caution.
Explain	Would this matter to the patient?	Material uncertainty, added risk, cost, conflict of interest, or non-standard use should be disclosed.
Log/Learn	How will practice improve?	Rationale, outcome, complications, and adverse events should be documented, reviewed, and actively reported through institutional and regulatory pathways when appropriate.