Robotic urologic surgery: trends in litigation over the last decade.

There is a lack of information regarding malpractice claims and indemnity payments associated with robotic cases in surgery. Malpractice claims and indemnity payouts will elucidate and mitigate harms of future adoption of new technology into surgery. We analyzed claims filed against Intuitive Surgical, Inc. from 2000 to 2017. A law librarian identified product liability claims from 2000 to 2017 with the defendant "Intuitive Surgical, Inc." using the Bloomberg Law database. We reviewed all available legal documents pertaining to identified claims, and extracted data points including filing date, surgery date, surgery type, robot type, instrument type, complications, and case outcomes. Since 2000, 123 claims were filed; 108 met criteria for inclusion. Gynecologic surgeries comprised the majority of claims (62%, 67 claims), followed by urologic surgeries (20%, 22 claims). Number of claims filed peaked in 2013 (30%, 32 claims) and then decreased each year, with 6% (7 claims) filed in 2016, and only 1% (1 claim) filed in 2017. Of the 22 claims regarding robotic urologic surgeries, 19 claims (86%) pertained to prostatectomy. Commonly alleged injuries in urologic cases were bowel injury (8 claims), erectile dysfunction (5 claims), bowel fistulas (4 claims), and incontinence (4 claims). Device failure was cited in only 2 claims. Early adopters of robotic surgery were at highest risk of litigation. This risk subsequently decreased despite the wide spread adoption of this technology. Almost all claims were secondary to surgical complications and not device failure, thus demonstrating a need for more systematic training for novel devices and early adopters.

Pathological findings in explanted vaginal mesh.

In light of the legal issues and the shortage of data on histopathological findings, we summarized our experience on how explanted vaginal mesh specimens were managed in a surgical pathology practice during the last 5 years. Clinical history and pathology reports were collected from 155 women undergoing transvaginal tape excision. The degree of chronic inflammation, fibrosis, foreign-body giant cell reactions, the number of capillary vessels and nerve fibers, and the presence or absence of adipose tissue were recorded. Among the 155 patients, 65 (41.9%) were active medicolegal cases, with a significant increase in recent years. The main medical indications for mesh excision were pelvic pain, mesh erosion, voiding dysfunction, genital organ prolapse, and vaginal bleeding. In most cases, mild to moderate chronic inflammation with a mild degree of foreign-body giant cell reaction and minimal to mild fibrosis were found in explanted mesh specimens. The specimens were well vascularized without any evidence of nerve abnormality. Patient age correlated negatively with vaginal pain (P = .007) but positively with erosion (P = .005). In addition, the presence of adipose tissue within the explanted mesh correlated significantly with pelvic pain (P = .016). Overall, there was good tissue integration in all specimens. Considering the significant increase in the number of lawsuits in recent years, we recommend that all explanted vaginal mesh specimens be examined microscopically as well as grossly. A list of microscopic findings, including the presence or absence of adipose tissue, is suggested.

Analysis of closed medical litigation in urology.

PURPOSE: The objective of this study was to provide a descriptive understanding of the characteristics of malpractice litigation related to urology by examining court cases. MATERIALS AND METHODS: A total of 6,074 court cases related to medical malpractice litigation filed between 2005 and 2010 were received from the Lower Courts, the Appellate Courts, and the Supreme Court of Korea. Of the received cases, 34 urology-related civil proceedings were analyzed. The following information was compiled and investigated from the cases: background, age and sex of patient, categorization of the defendant, opinion of the court, amount claimed and awarded in damages, type of medical treatment involved, and negative effects resulting from the medical accident. RESULTS: The average amount in damages paid out to plaintiffs in this research was 27,186,504±32,371,008 Korean won (KRW) (range, 1,000,000-100,000,000 KRW). A total of 9 of the 34 analyzed cases (26.5%) ruled in favor of the plaintiff, with all 9 cases involving a surgery. An analysis of the surgery sites further revealed that the penis was the most frequently litigated over site of surgery, making up 14 of the 35 sites (40.0%). CONCLUSIONS: Information regarding urology malpractice lawsuits should be made available to help prevent further disputes and litigation. Continuous efforts must be expended in the prevention of accidents and disputes, alongside research into urology-related cases beyond 2010. Extensive cause analysis and recurrence prevention methods must also be researched to enhance overall patient safety.

[Urogynecologycal surgery : Informed consent and other medicolegal aspects]. / Urogynäkologische Eingriffe : Ärztliche Aufklärung und andere medizinrechtliche Aspekte.

With regard to jurisdiction, the Patients' Rights Act and the Medical Association's professional code of conduct in Germany, correct informed consent in a timely manner has to be assured by the physician. Omissions concerning informed consent may lead to conviction including compensation for damages and for pain and suffering if the patient is able to prove such omissions. Mistakes during treatment or gaps of the informed consent must not to be told to the patient, but facts must be correctly answered.

[Urological diseases most frequently involved in medical professional liability claims]. / Patologías urológicas más frecuentemente implicadas en las reclamaciones por responsabilidad profesional médica.

Clinical safety and medical professional liability are international major concerns, especially in surgical specialties such as urology. This article analyzes the claims filed at the Council of Medical Colleges of Catalonia between 1990 and 2012, exploring urology procedures. The review of the 173 cases identified in the database highlighted the importance of surgical procedures (74%). Higher frequencies related to scrotal-testicular pathology (34%), especially testicular torsion (7.5%) and vasectomy (19.6%), and prostate pathology (26 %), more specifically the surgical treatment of benign prostatic hyperplasia (17.9%). Although urology is not among the specialties with the higher frequency of claims, there are special areas of litigation in which it is advisable to implement improvements in clinical safety.

Patologías urológicas más frecuentemente implicadas en las reclamaciones por responsabilidad profesional médica / Urological diseases most frequently involved in medical professional liability claims

La seguridad clínica y la responsabilidad profesional médica son prioridades en el ámbito internacional, especialmente en lo referente a especialidades quirúrgicas como la urología. El presente artículo analiza las reclamaciones por presunto defecto de praxis interpuestas ante el Consejo de Colegios de Médicos de Cataluña entre los años 1990 y 2012, y se exploran los procedimientos correspondientes a la especialidad de urología. La revisión de los 173 casos identificados en la base de datos subrayó la importancia de los actos quirúrgicos (74%). Las frecuencias más elevadas de reclamación correspondieron a la patología escrototesticular (34%), especialmente la torsión testicular (7,5%) y la vasectomía (19,6%), y a la patología prostática (26%), más específicamente el tratamiento quirúrgico de la hiperplasia benigna de próstata (17,9%). Si bien la urología no es una de las especialidades de mayor frecuencia de reclamación, hay áreas especialmente litigiosas en las que resulta recomendable implementar mejoras en materia de seguridad clínica (AU)

Clinical safety and medical professional liability are international major concerns, especially in surgical specialties such as urology. This article analyzes the claims filed at the Council of Medical Colleges of Catalonia between 1990 and 2012, exploring urology procedures. The review of the 173 cases identified in the database highlighted the importance of surgical procedures (74%). Higher frequencies related to scrotaltesticular pathology (34%), especially testicular torsion (7.5%) and vasectomy (19.6%), and prostate pathology (26 %), more specifically the surgical treatment of benign prostatic hyperplasia (17.9%). Although urology is not among the specialties with the higher frequency of claims, there are special areas of litigation in which it is advisable to implement improvements in clinical safety (AU)

Outpatient urologic surgery office conducted by nursing staff. A process integrated in a total quality strategy.

OBJECTIVES: To create an innovative process to care for urological outpatient surgery patients in an outpatient clinic basis conducted by nursing staff. METHODS: Our centre covers a population of 153,266 inhabitants. A differentiated process for urological outpatient surgery patients has been implemented, conducted by nursing staff trained for the attendance of urologic patients ("phimosis","short penile frenulum",and "vasectomy request" sent from Primary Care units). Planning and implementation phases have been carried out. In the control phase, a questionnaire was given after surgical procedures with 9 different items, in order to assess different issues of the process. RESULTS: A total of 224 patients were attended during the study period, and 175 valid questionnaires were collected (78.1%). The procedures performed were circumcision (11.7%), frenuloplasty (14.6%), and vasectomy (73.7%), with a median patient age of 36 years. Satisfaction level was high for all items of the questionnaire, with 98.2% of patients" very satisfied" or "rather satisfied" when asked for the overall quality of attention of the whole process. The lowest scores were obtained in items that assessed delay from the appointment to attendance date (5.1% of patients "little satisfaction or not satisfied"), and the perception of information supplied (2.3% "little satisfaction or not satisfied"). A lower satisfaction score was observed (in the delay from appointment to attendance) in younger patients (p=0.001) and in patients who underwent circumcision (p=0.004). No complaints with regard to this process were collected. No incorrect indications for interventions were observed. CONCLUSIONS: The attendance of urological outpatient surgery patients can be safely and effectively performed by nursing staff trained for the care of urologic patients, without observing a decrease of the level of user satisfaction. Focusing on a process strategy allows the identification of areas for improvement and makes possible total quality management.

Mesh sling in an era of uncertainty: lessons learned and the way forward.

Following transvaginal mesh, synthetic slings to correct stress urinary incontinence have been put under further scrutiny. Since the recent FDA website update, we reviewed the latest developments and then reflected on the lessons learned by applying this process and the way forward.

[Current state, challenges and prospects for the development of the Russian urological service].

The present study was dedicated to the analysis of the incidence, prevalence and mortality from diseases of the urogenital system. The data on the effectiveness of the hospital bed usage, the patient profile at hospital, the treatment timing and outcomes, surgical activities in urological hospitals, the state of staff assistance in urological service, the efficacy of usage of working time of urologist and human resource of Russian urological service were analyzed. Data analysis revealed a number of issues of administrative and legal nature, which cause modest efficiency of activity of urological service. The ways for solutions of these problems are presented.

Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the society of urologic robotic surgeons.

PURPOSE: With the exponential growth of robotic urological surgery, particularly with robot assisted radical prostatectomy, guidelines for safe initiation of this technology are a necessity. Currently no standardized credentialing system exists to our knowledge to evaluate surgeon competency and safety with robotic urological surgery performance. Although proctoring is a modality by which such competency can be evaluated, other training tools and guidelines are needed to ensure that the requisite knowledge and technical skills to perform this procedure have been acquired. We evaluated the current status of proctoring and credentialing in other surgical specialties to discuss and recommend its application and implementation specifically for robot assisted radical prostatectomy. MATERIALS AND METHODS: We reviewed the literature on safety and medicolegal implications of proctoring and the safe introduction of surgical procedures to develop recommendations for robot assisted radical prostatectomy proctoring and credentialing. RESULTS: Proctoring is an essential mechanism for robot assisted radical prostatectomy institutional credentialing and should be a prerequisite for granting unrestricted privileges on the robot. This should be differentiated from preceptoring, wherein the expert is directly involved in hands-on training. Advanced technology has opened new avenues for long-distance observation through teleproctoring. Although the medicolegal implications of an active surgical intervention by a proctor are not clearly defined, the role as an observer should grant immunity from malpractice liability. CONCLUSIONS: The implementation of guidelines and proctoring recommendations is necessary to protect surgeons, proctors, institutions and, above all, the patients who are associated with the institutional introduction of a robot assisted radical prostatectomy program. With no current guidelines we anticipate this article will serve as a catalyst of interorganizational discussion to initiate regulatory oversight of surgeon certification and proctorship.

[Legal aspects of injuries due to positioning of the patient in urology]. / Juristische Aspekte bei Lagerungsschäden in der Urologie.

Each positioning of the patient has method specific risks and risk increasing factors which depend on the type of surgery carried out. The causes of damage during positioning are pressure and strain when the protective reflexes are out of action, as well as a reduction of the shielding muscle tone through anaesthesia. The surgeon is responsible for the positioning of the patient, and the anaesthetist for the "infusion arm". For this interdisciplinary cooperation, the principles of horizontal work division are required: strict role boundaries, trust without reciprocal direction, close coordination and reciprocal respect for the specialist requirements of the partner, resolution of conflicts taking these requirements into consideration and the final decision of the surgeon. Legally, the damage caused by the positioning of the patient is considered to be fully under control. It can only be reduced by medical care but can not be eliminated. For compensation, the medical practitioner must prove that the appropriate amount of care was taken in the positioning of the patient as well as in the medical cooperation.

[Remarks on the introduction of the German Diagnosis-Related Groups (DRGs) for the specialty of urology]. / Anmerkungen zur Einführung der Deutschen Diagnosis-related Groups (G-DRGs) für das Fach Urologie.

In January 2003 a new system to charge inpatient treatment was established in Germany: the G-DRGs. This system is based on the thought that equal medical service causes equal costs all over Germany. Hospitals offering a broad spectrum of diagnostics and therapies and being unable to select their patients according to economical aspects are put at disadvantage: Despite a perfect documentation the G-DRGs reflect their medical service only in an insufficient way. Tools for an optimized coding must be a coding manual created for the specific needs of urologists and an infrastructure that allows a permanent quality control for all persons involved.