Artigo Original
CRIMINAL LIABILITY AND SYSTEMIC FAILURES IN THE PRESCRIPTION OF IMPLANTABLE MEDICAL DEVICES
Como citar: Cançado DFD. Responsabilidade criminal e falhas sistêmicas na prescrição de dispositivos médicos implantáveis. Persp Med Legal Pericia Med. Vol. 10, 2025; 251257
https://dx.doi.org/10.47005/251257
Recebido em 01/12/2025
Aceito em 27/12/2025
The authors report no conflict of interest.
CRIMINAL LIABILITY AND SYSTEMIC FAILURES IN THE PRESCRIPTION OF IMPLANTABLE MEDICAL DEVICES
Resumo
INTRODUÇÃO: A crescente judicialização da saúde e o aumento dos custos assistenciais trouxeram à tona a complexidade das relações entre médicos e fornecedores de Dispositivos Médicos Implantáveis (DMI). O objetivo deste estudo é analisar a responsabilidade criminal médica e as falhas sistêmicas de controle que permitem fraudes na prescrição de DMI. MATERIAL E MÉTODO: Estudo qualitativo documental forense, baseado na análise de denúncias do Ministério Público Federal (Operações "Fatura Exposta" e "Máfia das Próteses"), inquéritos policiais e relatórios de auditoria de Tribunais de Contas, triangulados com a legislação médica vigente (Lei do Ato Médico e Resoluções CFM). RESULTADOS: A análise evidenciou que as fraudes dependem da autonomia técnica do prescritor, cooptado por comissões ilegais para indicar cirurgias desnecessárias ou materiais superfaturados. Identificou-se a violação sistemática da vedação de vínculos comerciais e a ausência de rastreabilidade efetiva dos implantes. DISCUSSÃO: A legislação atual é insuficiente para coibir conflitos de interesse ocultos. A fragilidade do controle reside na falta de um registro universal compulsório, impedindo a auditoria retrospectiva e favorecendo a impunidade. CONCLUSÃO: É necessária a implementação mandatória do Registro Nacional de Implantes (RNI) e comissões de auditoria independentes para garantir a integridade do ato médico e a segurança do paciente.
Palavras Chave: Medicina Legal; Responsabilidade Penal; Próteses e Implantes; Legislação de Dispositivos Médicos
Abstract
INTRODUCTION: The growing judicialization of healthcare and the increase in assistance costs have brought to light the complexity of relationships between physicians and suppliers of Implantable Medical Devices (IMDs). The objective of this study is to analyze criminal medical liability and the systemic control failures that allow fraud in the prescription of IMDs. MATERIAL AND METHOD: A forensic qualitative documentary study, based on the analysis of indictments from the Federal Public Ministry (Operations "Fatura Exposta" and "Prosthesis Mafia"), police inquiries, and audit reports from Courts of Auditors, triangulated with current medical legislation (Medical Act Law and CFM Resolutions). RESULTS: The analysis evidenced that frauds depend on the technical autonomy of the prescriber, co-opted by illegal commissions to indicate unnecessary surgeries or overpriced materials. The systematic violation of the prohibition of commercial ties and the absence of effective traceability of implants were identified. DISCUSSION: Current legislation is insufficient to curb hidden conflicts of interest. The fragility of control lies in the lack of a mandatory universal registry, preventing retrospective auditing and favoring impunity. CONCLUSION: The mandatory implementation of the National Implant Registry (RNI) and independent audit committees is necessary to ensure the integrity of the medical act and patient safety.
Keywords (MeSH): Forensic Medicine; Criminal Law; Prostheses and Implants; Medical Device Legislation
INTRODUCTION
The incorporation of new health technologies, such as Implantable Medical Devices (IMDs), has revolutionized surgical practice, offering solutions for conditions previously considered intractable. However, this advancement has brought with it an exponential growth in healthcare costs and a complex web of commercial relationships between the industry and prescribing professionals. In this scenario, the “judicialization of healthcare” often camouflages serious distortions, where the demand for high-cost materials may not reflect a real clinical need, but rather hidden economic interests.
Recent scandals with national repercussions, such as the so-called “Prosthesis Mafia” (Máfia das Próteses) and “Operation Exposed Invoice” (Operação Fatura Exposta), have exposed the fragilities of this system. Police investigations revealed sophisticated corruption schemes involving physicians, hospitals, and suppliers, in which the indication of orthoses and prostheses was motivated by the receipt of illegal commissions, directly violating medical ethics and criminal law. The severity of these cases transcends financial loss, affecting the physical integrity of patients subjected to unnecessary or unsafe procedures.
Given this context, this study aims to analyze, from a medico-legal and forensic perspective, the criminal liability of the physician in the prescription of IMDs. It seeks to identify, through the analysis of inquiries and audits, the systemic mechanisms that allow the perpetuation of these frauds and to propose concrete compliance and regulatory measures, aiming to mitigate conflicts of interest and restore the safety of medical practice.
MATERIAL AND METHOD
The present work was designed as a qualitative, exploratory, and descriptive study. The research focused on the identification and categorization of deviant medical conduct in the context of healthcare fraud, utilizing available public documents originating from investigations with national repercussions as the object of study, specifically the “Prosthesis Mafia” and “Fatura Exposta” operations, conducted by the Federal Police and the Federal Public Ministry.
For data collection, primary sources of information were selected, including indictments offered by the Public Ministry, final reports of police inquiries, and technical audit rulings from Courts of Auditors. The selection of documents prioritized those describing the materiality of medical participation in illicit acts, excluding purely administrative or procedural documents without clinical or forensic probationary value.
Data analysis was performed through the triangulation between the conduct described in the case files and the current regulatory framework. The focus of the investigation fell specifically on the actions of the medical professional, segregating irregularities into three main axes: technical indication (pertinence versus unnecessity of Implantable Medical Devices – IMDs), commercial relationship (existence of hidden financial ties between prescribers and suppliers), and ethical violation (confrontation of actions with the Medical Act Law and Resolutions of the Federal Council of Medicine).
It is emphasized that the research exclusively used public domain data, respecting the confidentiality of personal information and the guidelines of the General Data Protection Law (LGPD), thus waiving the need for submission to a Research Ethics Committee.
RESULTS
The analysis of documents referring to the “Fatura Exposta” and “Prosthesis Mafia” operations evidenced the existence of an alignment between the medical device industry and prescribing professionals. It was identified that the modus operandi of the frauds was not limited to administrative overpricing but depended intrinsically on the technical autonomy of the physician. In the analyzed cases, it was verified that the choice of the brand and model of the Implantable Medical Device (IMD) was conditioned upon the receipt of undue advantages, constituting a direct conflict of interest. The inquiries demonstrated that supplier companies, such as those led by the core group investigated in Operation Fatura Exposta, paid “commissions” that varied as a percentage of the value of the implanted material, incentivizing the indication of high-cost devices to the detriment of more conservative or economical therapeutic alternatives.
In the axis of technical indication, the documentary analysis revealed the performance of unnecessary surgical procedures or the excessive use of materials in a single intervention, a practice known as “overuse.” In situations described in the Public Ministry indictments, patients were subjected to complex surgeries, such as spinal arthrodesis with multiple levels of instrumentation, without robust clinical justification in the medical records. The documentation of medical expert examinations attached to the proceedings indicated that, in several cases, the clinical severity of patients was overestimated in request reports, aiming to force the authorization of imported materials, whose costs were artificially inflated.
Regarding the violation of governing norms, non-compliance with the prohibition of direct commercial interaction between physicians and suppliers was observed. The police investigation mapped financial flows where payments to surgeons were not made as official medical fees, but rather through fictitious consultancies, lectures not delivered, or cash transfers operated by shell companies. This structure allowed for the concealment of financial ties, violating the Code of Medical Ethics and legislation prohibiting physicians from obtaining advantages from the commercialization of orthoses and prostheses. The “cartelization” of suppliers, in collusion with the heads of specialty services in public hospitals, eliminated legal competition, transforming the medical act of prescription into a tool for bid rigging.
DISCUSSION
The findings of this analysis corroborate the hypothesis that medical autonomy, when devoid of control and traceability mechanisms, becomes the primary vector for the consummation of systemic fraud in IMDs. Contrary to what is observed in common administrative infractions, the “Prosthesis Mafia” cases demonstrate that corruption in healthcare requires the technical validation of the prescriber. Current legislation, notably Law No. 12.842/2013 and CFM Resolution No. 2.318/2022, clearly establishes the prohibition of ties between physicians and pharmacies or industry; however, data indicate that the norm, by itself, is insufficient to curb illicit practices hidden under the guise of “consultancies” or “classes.”
Critical analysis of the inquiries reveals that the central vulnerability lies in the lack of traceability of the implanted device. Currently, the National Implant Registry (RNI) operates on a voluntary basis and is restricted to certain procedures (such as hip and knee arthroplasties). This gap allows high-cost devices to “disappear” in the logistical flow or be overpriced without an effective cross-check between the patient’s actual clinical need and the billed material. The absence of a mandatory universal registry prevents effective retrospective auditing, facilitating impunity for those involved.
In this context, the expansion of the RNI to a mandatory and comprehensive model, as suggested by the analyzed data, would act not only as a sanitary surveillance tool but as an instrument of criminal compliance. The mandatory linking of the surgeon’s Tax ID (CPF), the implant serial number, and the clinical record in a unified national database would create an “indelible digital trail.” This would allow for the early identification of standard deviations (such as a single surgeon indicating volumes of materials far superior to the average of their peers), serving as a preventive barrier against conflicts of interest and protecting the integrity of the medical act and patient safety.
CONCLUSION
The forensic analysis of the “Fatura Exposta” and “Prosthesis Mafia” operations allows for the conclusion that criminal medical liability in the prescription of IMDs is not an isolated event, but the result of a systemic control failure. It was demonstrated that professional autonomy, when exercised in an environment without traceability, is vulnerable to co-optation by economic interests, transforming the medical act into an instrument of fraud and resulting in direct damage to patient health and the public treasury.
Therefore, it is concluded that criminal prosecution, although necessary, is insufficient if not accompanied by preventive structural changes. The implementation of a mandatory and universal National Implant Registry (RNI), associated with the action of multidisciplinary audit committees, presents itself as the most effective measure to ensure the integrity of the system. Only through the total traceability of the device—from manufacturer to patient—will it be possible to mitigate conflicts of interest, ensuring that technological innovation serves exclusively for assistance, and not for illicit enrichment.
References
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