Litigations Involving Ureteral Injury Related to Minimally Invasive Gynecologic Surgery: Lessons Learned from a Legal Literature Review

Ureteral injury is a known complication of minimally invasive gynecologic surgery. Despite being discussed preoperatively and included in consent forms, litigations that involve such injury continue to be prevalent. Our aim was to review all major litigations involving ureteral injuries related to minimally invasive gynecologic surgery to determine the most common allegations from plaintiffs and highlight factors that aided defendants. We used Lexis Nexis, a comprehensive legal database, to search all publicly available federal- and state-level cases on ureteral injury related to gynecologic surgeries. Fifty-nine cases resulted from our search. Of these cases, 19 were deemed pertinent to our question. These 19 cases occurred between 1993 and 2018. The most common allegations included medical negligence, lack of informed consent, and medical battery. Eight of 19 cases (42%) were decided in favor of the defendants, 3 of 19 cases (16%) in favor of the plaintiffs, and the remaining cases proceeded to further trial or are ongoing. The monetary compensation to a plaintiff was as high as $426,079.50. Meticulous documentation, comprehensive consent procedure, timely postoperative evaluation, and the use of immediate postoperative cystoscopy were the critical factors that aided the defendants. Meticulous documentation, a comprehensive consent procedure, timely postoperative evaluation, and the use of immediate postoperative cystoscopy can aid minimally invasive gynecologic surgeons involved in litigations involving ureteral injury.     

Medicolegal review of liability risks for gynecologists stemming from lack of training in robot-assisted surgery

The advances in robot-assisted surgery in gynecology evolved after most practicing gynecologists had already completed residency training. Postgraduate training in new technology for gynecologists in practice is limited. Therefore, gynecologists with insufficient training who perform robot-assisted surgery may potentially be at risk for liability. In addition to the traditional medical negligence claims, plaintiff attorneys are seeking causes of actions for lack of informed consent and negligent credentialing. Thus, it is essential that gynecologists be aware of these potential liability claims that arise in a robot-assisted malpractice suit. This commentary provides an overview of the current medicolegal liability risks originating from lack of training in robotic surgery and seeks to raise awareness of the implications involved in these claims. A better understanding of the doctrine of informed consent and seeking assistance of proctors or experienced co-surgeons early in robotics training are likely to reduce the liability risks for gynecologic surgeons.     

The role of mechanical bowel preparation in gynecologic laparoscopy

Various combinations of dietary restriction, antibiotic regimens, and mechanical preparations have become routine in preoperative surgical planning for elective colon surgery. This practice has also become commonplace in the field of gynecology, either for planned bowel surgery or in complex cases that are believed to be high risk for inadvertent bowel injury. As the trend in gynecologic surgery shifts toward more minimally invasive approaches, the complexity of cases being performed by laparoscopy and robotics continues to increase. In addition, laparoscopic surgical techniques have a different set of inherent risks and challenges as compared with open pelvic operations. This review summarizes the available data surrounding the use of mechanical bowel preparations, specifically with regard to gynecologic laparoscopy.     

Minimally invasive surgery in gynecologic practice.

The medical world is facing increasing demands for improvement of the quality of life of women of all ages. This is not possible without overall improvement of the healthcare of females, and, in particular, of the quality of surgical treatment for gynecologic pathology. Positive changes are ensured by the active introduction of minimally invasive technologies into all spheres of gynecologic practices. There are almost no medical, demographic or technical limits for the application of endoscopy in gynecology, while the benefits it provides are extraordinary. The process of positive change towards minimally invasive surgery in operative gynecology should be supported and promoted by the medical community in every possible way.     

The Effect of a Gynecologist–Interventional Radiologist Relationship on Selection of Treatment Modality for the Patient with Uterine Myoma

BackgroundOn the basis of consistent published scientific evidence, the American College of Obstetricians and Gynecologists has given uterine artery embolization (UAE) a level A recommendation as a viable alternative treatment for uterine myomas, describing it as a safe and effective option for appropriately selected women who wish to retain their uteri. Despite the growth of favorable clinical outcome information, many gynecologists do not routinely offer UAE as an alternative to abdominal hysterectomy or abdominal myomectomy. The percentage of laparoscopic hysterectomies in the United States remains less than 20%, reflecting the reluctance or inability of gynecologic surgeons to perform other minimally invasive procedures such as hysteroscopic myomectomy, laparoscopic myomectomy, laparoscopic hysterectomy, or even vaginal hysterectomy. Of great significance, many patients do not wish to have any kind of surgery, no matter how “minimally invasive.” As a result, patients seeking less invasive treatments may bypass the gynecologist and be referred directly to an interventional radiologist by their primary care physician, or they may self-refer. Little has been published on the referral relationship between gynecologists and the interventional radiologist who performs uterine artery embolization. The absence of a structured routine referral relationship causes some women to undergo treatments that potentially are not aligned with all of her treatment desires. This study was undertaken to gain insight into the interventional radiologist–gynecologist dynamic and the benefit to patients who are informed of all of their options for the treatment of myomas.Study ObjectivesInvestigate the course of myoma treatment in a cohort of patients either self-referred to an interventional radiologist or referred to the interventional radiologist by their gynecologist. Determine the effect of a cooperative referral network of interventional radiologists and gynecologists that informs patients about the options of UAE and minimally invasive surgical alternatives on the choice of myoma treatment.Study DesignProspective data acquisition of patient referral source, UAE evaluation, patient decision on treatment options, and continued follow-up with a network gynecologist.SettingHospital-based interventional radiologist and gynecologist both practicing in a large urban teaching setting.PatientsA total of 226 women, representing 73% of women presenting to an interventional radiologist in 2007 seeking UAE for symptomatic myomas. One hundred thirty-eight of these patients were referred to the interventional radiologist by a gynecologist, and 88 were self-referred. Patient outcome relative to referral was traced with 76 patients in the myoma surgery group treated from 2007–2008 by a gynecologist in the referral network.InterventionsEvaluation for suitability for UAE procedure, followed either by UAE procedure with return to referring gynecologist for follow-up, return to referring gynecologist for treatment, or referral to another gynecologist for minimally invasive surgical management when the primary gynecologist is unable to perform alternative treatment.Measurements and Main ResultsAll patients in the study initially evaluated by the interventional radiologist were referred to a gynecologist. Overall, 62% of patients were candidates for UAE, and 38% underwent the procedure during the study period. Patients who did not receive UAE were returned to the referring gynecologist for further evaluation and treatment. Patients who underwent UAE were referred to a gynecologist for ongoing care. In all, 70% of self-referred patients and 92% of gynecologist-referred patients expressed satisfaction with their original gynecologist and were referred back to that physician. Patients who did not have a gynecologist or who were dissatisfied with their original gynecologist were referred to a network gynecologist for continued gynecologic care. In our study 26 self-referred women were sent as new patients to gynecologists in the interventional radiologist's referral network, resulting in a 119% return on the original 138 gynecologist–to–interventional radiologist–referred patients. Among the 8% of gynecologist-referred women who switched to a different gynecologist within the referral network, the primary reasons for dissatisfaction were the gynecologist's failure to fully disclose treatment options or offer desired minimally invasive procedures. On follow-up with a network gynecologist, 8 newly referred patients underwent myoma surgery, and 8 newly referred patients continued to be seen by that gynecologist. Four patients referred to the gynecologist for treatment were originally referred by the gynecologist to the interventional radiologist for UAE evaluation. Ten patients switched from their named gynecologist to a different gynecologist willing to disclose all treatment options for uterine myomas and able to provide minimally invasive surgical treatment as medically indicated. Of the 10 women who switched to this network gynecologist, 8 underwent myoma surgery.ConclusionsEstablishing a referral relationship with an interventional radiologist for comprehensive uterine myoma treatment supports a trusting, collaborative, long-term, noncompetitive “win-win” relationship between the gynecologist and radiologist, meets the patient's desire for full disclosure of all myoma treatment options, improves the patient's overall medical care and physician/patient experience, and has been demonstrated to improve patient flow to a gynecologist practice. With the guidelines established in this study, no patients were inappropriately left to the gynecologist for post-UAE care. The authors acknowledge that this dynamic is dependent on the individual interventional radiologist and their relationships and open communication with the gynecologist. Finally, the study revealed that failure to fully disclose alternative treatment options, or offer minimally invasive surgical techniques may result in a loss of patients due to patient dissatisfaction.     

Legal aspects in obstetric medicine

Legal aspects in obstetrics concern in the first place all liabilities such as compulsory preoperative information of patients in respect of involved risks and of all risks involved in childbirth. In addition there is a liability in case of malpractice. A physician may also be held legally responsible by a court in case of absence of documentation or if the documentation is improper, faulty or incomplete. In conclusion, this overview also deals with the limits of medical obligation to treat a patient in case of a most severely damaged newborn and the limits of liability of the obstetrician in respect of the liability of the midwife. All legal aspects take topical court rulings in consideration.     

子宫内膜癌微创手术的研究进展

医学模式转变为微创外科的发展带来了机遇,随着科学及医疗技术的不断创新,近二十年来微创技术迅速发展,应用于妇科肿瘤领域并取得了满意的效果。其具有手术切口比较小、术中出血量少、并发症的发生率低及住院时间和恢复时间短等优点。不仅如此,与传统的开腹手术相比,子宫内膜癌微创手术的淋巴结切除数目、患者整体生存率、无瘤生存期等指标无明显差异。因此微创手术治疗子宫内膜癌是安全可行的。目前可用于治疗子宫内膜癌的微创技术包括传统腹腔镜、单孔腹腔镜、机器人手术系统以及机器人辅助单孔腹腔镜技术等。现对各种微创技术在子宫内膜癌中的应用及其优劣性作一介绍,希望能为临床工作者根据患者情况选择手术方式提供一定的帮助。     

Evaluation of Strategies to Prevent Urinary Tract Injury in Minimally Invasive Gynecologic Surgery: A Systematic Review

ObjectiveTo systematically review tools for the prevention of urinary tract injury in adult women undergoing minimally invasive gynecologic surgery.Data SourcesA medical librarian (M.P.H.) searched Ovid Medline 1946 to, Ovid Embase 1929 to, CINAHL 1965 to, Cochrane Library 1974 to, Web of Science 1926 to, and SCOPUS 1974 to present on April 2 and April 3, 2020.Methods of Study SelectionArticles evaluating strategies for the prevention of urinary tract injury at the time of minimally invasive gynecologic surgery were included. Articles that were nongynecologic, nonhuman, and nonadult were excluded. If a study did not describe the surgical approach or type of surgical procedures performed, it was excluded. If the study population was <50% gynecologic or <50% minimally invasive, it was excluded. Articles evaluating techniques for the diagnosis or management of injury, rather than prevention, were excluded.Tabulation, Integration, and ResultsThe search yielded 2344 citations; duplicates were removed, inclusion criteria were applied, and 9 studies remained for analysis. Three studies evaluated bladder catheters, and 6 evaluated ureteral catheters. In the 3 studies evaluating bladder catheters, there were no urinary tract injuries. Urinary tract infection was greater in women who received a bladder catheter. In the studies evaluating the use of ureteral catheters, we found inconsistent reporting and heterogeneity that precluded meta-analysis. The results of the available studies do not indicate that ureteral catheters decrease the risk of injury, and indicate that they increase morbidity.ConclusionThe evidence is insufficient to support the routine use of bladder catheters or ureteral catheters for the prevention of urinary tract injury at the time of minimally invasive gynecologic surgery.     

Enhanced Recovery after Minimally Invasive Gynecologic Procedures with Bowel Surgery: A Systematic Review

Enhanced recovery after surgery (ERAS) is an evidence-based approach to perioperative care of the surgical patient. A mounting body of literature in gynecologic surgery has demonstrated that ERAS improves postoperative outcomes, shortens hospital length of stay, and reduces cost without increasing complications or readmissions. Most of the existing literature has concentrated on open surgery, questioning if patients undergoing minimally invasive surgery also derive benefit. Our aim was to systematically review the literature on ERAS after minimally invasive gynecologic surgery (MIGS) with and without bowel surgery. Given the paucity of studies on ERAS in MIGS with bowel surgery (1 study), we expanded our search to include studies of ERAS in patients undergoing minimally invasive colorectal resections alone. Twelve studies were identified through an electronic database search of PubMed, Medline, and Ovid EMBASE. These studies included patients undergoing MIGS for benign and/or malignant indications and showed that ERAS pathways decreased length of stay and/or increased the proportion of same-day discharge surgeries, improved patient satisfaction, and reduced hospital costs while maintaining low postoperative complication and readmission rates. Although limited, data from a single study suggest that ERAS in MIGS with bowel surgery leads to shortened hospital stay, stable postoperative morbidity, and less readmissions. Although the variation between the published protocols underscores the need for standardization, existing literature supports the adoption of ERAS as safe and effective when planning MIGS.     

Penile Prostheses and the Litigious Patient: A Legal Database Review

IntroductionErectile dysfunction (ED) is a common problem with significant impact on patient quality of life. Penile prosthesis implantation provides an effective treatment for ED but as an invasive procedure carries with it an increased risk of medicolegal liability.AimTo investigate factors associated with malpractice litigation surrounding penile prosthesis implantation.MethodsThe Westlaw legal database was used to perform an advanced search for case reports using the term “medical malpractice” in combination with “penile” or “penis” and “prosthesis” or “implant” with dates between the January 1990 and December 2013.Main Outcome MeasuresEach report was examined for trial information including patient demographics, device model and indications, alleged breach of duty, alleged damages, progression to trial, case outcome, and plaintiff award(s).ResultsThe initial search yielded 76 cases that were narrowed to 40 after exclusions. There were 23 (57.5%) cases that were found in favor of the defendant, while 17 (42.5%) cases led to indemnity payment to the plaintiff including two cases (5.0%) that were settled out of court and 15 (37.5%) favoring the plaintiff in front of a jury. The mean settlement received was $335,500 compared with the mean indemnity award of $831,050 for verdicts decided in favor of the plaintiff (P = 0.68). The most common breach of duty was error in surgical decision making, present in 20 cases (48.8%). Informed consent was an issue in 13 filings (31.7%), and postoperative infection was seen in 13 cases (31.7%). In cases that identified the type of implant used, 58.3% were malleable implants, and 41.7% were inflatable devices.ConclusionsThe main issues involved in malpractice litigation for penile prosthesis implants included surgical performance, informed consent, and postoperative management. Urologists must be aware of these potential issues in order to minimize their malpractice liability. Sunaryo PL, Colaco M, and Terlecki R. Penile prostheses and the litigious patient: A legal database review. J Sex Med 2014;11:2589–2594.     

Disability and litigation from urinary tract injuries at benign gynecologic surgery in Canada

OBJECTIVES: To estimate the prevalence of urinary tract injury and the relative risk of litigation from an injury for benign gynecologic surgery in Canada and to analyze a subset of cases of litigation, determining independent risk factors that predicted medical and legal outcomes. METHODS: The prevalence of urinary tract injury and the relative risks of litigation from an injury were determined from the national hospital discharge abstract and the national physician malpractice databases. Multiple logistic regression was performed on a subset of litigation cases. RESULTS: The prevalence of urinary tract injury at benign gynecologic surgery was low (0.33%). If a patient sustained a urinary tract injury, there was a high relative risk of litigation (relative risk 91, 95% confidence interval [CI] 55-158). Patients had a higher chance of major disability after urinary tract injury from hysterectomy for abnormal uterine bleeding (odds ratio [OR] 6.16, 95% CI 1.13-39.01, P = .04), but a lower chance of this being a permanent disability (OR 0.23, 95% CI 0.05-0.96, P = .05). Permanent disability was more likely after an obstructed ureter compared with other types of urinary tract injuries (OR 4.54, 95% CI 1.55-14.88, P = .008). Only 18% of the injuries were recognized intraoperatively. An acute bladder injury was more likely to be recognized intraoperatively than other types of injury (OR 14.98, 95% CI 3.89-57.74, P < .001). No obstructed ureters or urinary tract fistulae were recognized intraoperatively. CONCLUSION: Urinary tract injuries are an uncommon but significant complication from benign gynecologic surgery. Such injuries are associated a high relative risk of litigation.     

Assisted reproduction on treacherous terrain: the legal hazards of cross-border reproductive travel

The growing phenomenon of cross-border reproductive travel has four significant legal dimensions. First, laws that ban or inhibit access to assisted reproductive procedures in one country lead patients and physicians to travel to other countries to acquire, to contribute to or to provide assisted reproductive services. Such laws may include provisions that criminalize those who assist or advise patients to undertake such travel. Second, the law may expressly criminalize crossing borders to obtain, to be a donor for or to perform certain procedures. Third, the law may interfere with the ultimate goal of reproductive travellers by refusing to recognize them as the parents of the child they have crossed borders to conceive. Finally, facilitating cross-border reproductive travel may expose physicians, attorneys and brokers to malpractice or other civil liability. This article explores these legal dimensions of cross-border reproductive care and uses the legal doctrines of proportionality, extraterritoriality and comity to assess the legality and normative validity of governmental efforts to curb or limit assisted reproductive practices.     

Robot-assisted laparoscopy, natural orifice transluminal endoscopy, and single-site laparoscopy in reproductive surgery

Minimally invasive gynecologic surgery is continuously pushing its limits by embracing ever more sophisticated technology. This is also true for reproductive surgery, arguably the birthplace of gynecologic endoscopy, where minimally invasive treatment of uterine, tubal, ovarian, and peritoneal pathology has long become the gold standard. This article describes in some detail three novel minimally invasive surgery approaches that have seen the light during the past decade: robot-assisted laparoscopic surgery, natural orifice transluminal endoscopic surgery, and single-incision laparoscopic surgery. These fascinating technologies, far from being widely adopted, are sure to generate scientific controversy for years to come. Nonetheless, they follow in the footsteps of the tradition of innovation that is a defining aspect of our specialty and hold the promise to potentially revolutionize the field of reproductive surgery.     

Die Organisation geburtshilflicher Versorgung unter juristischen Aspekten

For physicians the legal risk associated with professional duties has continuously increased over the last decade. In Germany it is estimated that more than 10,000 new civil procedures are instituted each year for alleged medical malpractice and more than 3,000 preliminary investigations by public prosecutors are initiated. In addition the increasing number of proceedings before expert commissions and arbitration boards must also still be considered. This development particularly affects obstetrics because due to the nature of the situation with respect to severely injured newborns it follows that high sums for compensation are always the center of discussion. Accusations of insufficient organization are often concealed behind these accusations of malpractice and insufficient informed consent. As a result of this organizational aspects become particularly significant especially in obstetric care.     

Penile Prosthesis Implantation Compares Favorably in Malpractice Outcomes to Other Common Urological Procedures: Findings from a Malpractice Insurance Database

IntroductionSome urologists choose not to offer penile prostheses because of concern over malpractice liability.AimThe aim of this study was to assess whether urologists performing penile prosthesis surgery are placed at a greater malpractice risk.Main Outcome MeasuresPercentage of malpractice suits from prosthesis surgery and other urological procedures that result in payment, average resulting payout from these cases, and category of legal issue that ultimately resulted in payout.MethodsA database from the Physician Insurers Association of America, an association of malpractice insurance companies covering physicians in North America, was analyzed to quantitatively compare penile implant surgery to other urological procedures in medicolegal terms.ResultsCompared to other common urological procedures, penile implant is comparable and on the lower end of the spectrum in terms of both the percentage of malpractice suits that result in payment and the amount ultimately paid in indemnity from those cases. Additionally, issues of informed consent play the largest role in indemnities for all urological procedures, whereas surgical technique is the most important issue for prosthesis surgery.ConclusionsUrologists who are adequately trained in prosthetic surgery should not avoid penile implant procedures for fear of malpractice suits. A focus on communication and informed consent can greatly reduce malpractice risk for urological procedures. Chason J, Sausville J, and Kramer AC. Penile prosthesis implantation compares favorably in malpractice outcomes to other common urological procedures: Findings from a malpractice insurance database. J Sex Med 2009;6:2111–2114.     

Same-Day Discharge in Minimally Invasive Surgery Performed by Gynecologic Oncologists: A Review of Patient Selection

ObjectiveTo review the literature about same-day discharge (SDD) in minimally invasive surgery performed by gynecologic oncologists and identify factors associated with SDD and admission to provide selection criteria.Data SourcesSystematic review of PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and SCOPUS between May 2007 and May 2019. The search included the following medical subject heading terms and keywords: “same day discharge,” “patient discharge,” “minimally invasive surgical procedures,” “hysterectomy,” “gynecologic malignancy,” “gynecologic neoplasm,” “cervical cancer,” “ovarian cancer,” and “endometrial cancer.”Methods of Study SelectionArticles published in English about women who underwent minimally invasive procedures for benign and malignant conditions of the reproductive tract performed by gynecologic oncologists (robotic or laparoscopic) and who received SDD or admission were included. The following were described: SDD and admission rate, readmission or unscheduled evaluation rates within 30 days after surgery, and associated factors for each one.Tabulation, Integration, and ResultsNine studies with a total of 16 423 patients were included. The complication rates in the studies were variable, with only 2 studies showing advantages in the SDD group with respect to intraoperative complications and wound complications. There were no statistically significant differences in postoperative complications in the first 30 days after the adoption of SDD. There were no higher readmission rates within the first 30 days in the group of patients who were discharged on the same day vs those admitted. The common factors associated with admission were as follows: age <70 years, surgery after 1 PM, duration of surgery more than 2 hours, and intraoperative complications. Other factors to consider were the presence of comorbidities that require follow-up within the hospital after surgery, adequate postoperative evaluation, and the patient accepting SDD.ConclusionSDD seems to be safe and feasible in minimally invasive surgery performed by gynecologic oncologists. The proposed selection criteria includes the following: younger than 70 years, surgery before 1 PM, procedure less than 2 hours, and no intraoperative complications.     

C-reactive protein should accelerate the diagnosis of bowel injury after gynecologic surgery

STUDY OBJECTIVE: To search for a marker that could aid in earlier diagnosis of bowel injury after gynecologic surgery. DESIGN: Retrospective case study with prospective controls (Canadian Task Force classification II-2). SETTING: University hospital. PATIENTS: Fourteen women with bowel injuries and 50 controls with no postoperative complications. MEASUREMENTS AND MAIN RESULTS: Bowel injury occurred in 14 (2.4/1000) of 5901 gynecologic procedures. Of these, eight were recognized intraoperatively and treated immediately. In six women C-reactive protein levels were markedly increased (>100 mg/L) relative to control patients (p <0.0001). CONCLUSION: Systematic postoperative assessment of C-reactive protein in patients at high risk for bowel injury may help identify this complication earlier in the postoperative period.     

Preoperative evaluation of the gynecologic patient: considerations for improved outcomes

The preoperative evaluation serves several purposes for the gynecologist. Patients with previously undiagnosed, or incompletely managed, medical concerns are identified and appropriate treatment initiated. In women with known medical concerns, the surgeon can anticipate problems and plan for appropriate postoperative care. In certain cases, the preoperative evaluation identifies medical conditions that are unstable enough to adversely affect the postoperative outcome, and appropriate referral for medical management can be made. One of the most important aspects of the evaluation is the identification of women at high risk for cardiovascular complications. A stepwise approach is useful to identify those women who may proceed to surgery and those who need further testing. Much of the preoperative evaluation of the woman with pulmonary disease can be done during the history and physical examination without additional testing. Deep venous thrombosis is a significant concern in gynecologic surgery; appropriate identification of the woman at risk is important, with initiation of prophylaxis occurring shortly after the surgery concludes. Many women undergoing gynecologic surgery have diabetes. Careful management of diabetes in the perioperative period has become more germane, with evidence of improved outcomes as tight control is achieved. Much of the preoperative evaluation falls easily into the purview of the gynecologist, with advice presented as to when medical consultation should be considered.     

Legal liability in the use of ultrasound by office-based obstetricians

Ultrasound has proved to be a valuable diagnostic tool in the practice of obstetrics. Its rapidly increasing use by the office-based obstetrician, however, has opened a potential new area of legal vulnerability. The malpractice liability that may arise from its use is reviewed and practical ways to avoid it are considered.