Understanding the Legal Essentials of a Bowel Injury Lawsuit in Minimally Invasive Gynecologic Surgery.

Bowel injury is a known inherent complication of minimally invasive gynecologic surgery; however, it does not automatically signify medical malpractice. Plaintiff attorneys representing patients seeking legal recourse from a bowel injury typically allege claims of intraoperative negligence, delay in diagnosis, or lack of informed consent in an effort to circumvent the assertion that it is a known inherent complication. In addition, damage awards in bowel injury lawsuits can easily exceed the amount covered by the policy limits of a medical malpractice insurance plan, leaving the gynecologist financially responsible for the difference. Therefore, it is crucial to understand when it may be appropriate to consent to a settlement offer, which can relieve the gynecologist from financial liability for amounts awarded above the medical malpractice policy limits. The purpose of this medical-legal review is to make minimally invasive gynecologic surgeons more aware of the legal strategies used by plaintiff attorneys representing patients who have incurred bowel injuries, and how to limit liability in lawsuits.

Management of the Jehovah's Witness in Obstetrics and Gynecology: A Comprehensive Medical, Ethical, and Legal Approach.

IMPORTANCE: Obstetricians and gynecologists frequently deal with hemorrhage so they should be familiar with management of patients who refuse blood transfusion. Although there are some reports in the literature about management of Jehovah's Witness patients in obstetrics and gynecology, most of them are case reports, and a comprehensive review about these patients including ethicolegal perspective is lacking. OBJECTIVE: This review outlines the medical, ethical, and legal implications of management of Jehovah's Witness patients in obstetrical and gynecological settings. EVIDENCE ACQUISITION: A search of published literature using PubMed, Ovid Medline, EMBASE, and Cochrane databases was conducted about physiology of oxygen delivery and response to tissue hypoxia, mortality rates at certain hemoglobin levels, medical management options for anemic patients who refuse blood transfusion, and ethical/legal considerations in Jehovah's Witness patients. RESULTS: Early diagnosis of anemia and immediate initiation of therapy are essential in patients who refuse blood transfusion. Medical management options include iron supplementation and erythropoietin. There are also some promising therapies that are in development such as antihepcidin antibodies and hemoglobin-based oxygen carriers. Options to decrease blood loss include antifibrinolytics, desmopressin, recombinant factor VII, and factor concentrates. When surgery is the only option, every effort should be made to pursue minimally invasive approaches. CONCLUSION AND RELEVANCE: All obstetricians and gynecologists should be familiar with alternatives and "less invasive" options for patients who refuse blood transfusions.

Enmeshed in Controversy: Use of Vaginal Mesh in the Current Medicolegal Environment.

UNLABELLED: Vaginal mesh has been a valuable tool in the treatment of stress urinary incontinence and pelvic organ prolapse. As our knowledge of the long-term outcomes and complications of this product has evolved, however, vaginal mesh has become the subject of legal scrutiny. Therefore, it is imperative that physicians understand pertinent litigation techniques to optimize their informed consent and documentation processes and protect themselves. OBJECTIVES: Our objective is to familiarize physicians who use vaginal mesh with how law suits involving transvaginal mesh are construed. We also describe the current medicolegal environment surrounding the use of these products. METHODS: The food and drug administration public safety communications, food and drug administration Manufacturer and User Facility Device Experience database, and LexisNexis legal search engine were used to review data relevant to current vaginal mesh litigation. This information was used to create a medicolegal review. RESULTS: Litigation involving transvaginal mesh follows 3 paths. The first consists of claims against the manufacture of transvaginal mesh with allegations, such as design defects, failure to warn, and misrepresentation. The second is a defensive legal strategy called the learned intermediary doctrine, used by manufacturers to shift liability from themselves to surgeons. The manufacturers claim that the duty to inform patients of potential complications lies with the surgeon. The third involves claims by patients against surgeons for lack of informed consent, alleging that they were not sufficiently informed of potential complications associated with transvaginal mesh before insertion. CONCLUSIONS: To lessen the liability, a surgeon using transvaginal mesh should inform patients of potential complications associated with the products and document informed consent in their medical records.

A medical-legal review of power morcellation in the face of the recent FDA warning and litigation.

Minimally invasive gynecologic surgeons who perform laparoscopic intraperitoneal morcellation should be aware of the recent US Food and Drug Administration (FDA) warning and litigation arising from use of morcellation devices with claims of intraperitoneal dissemination of cancerous cells. On November 24, 2014, the FDA issued a statement warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids. Despite the best intentions in regards to their patients, gynecologists who continue to use power morcellation devices expose themselves to liability. This article is not meant to further deter gynecologists from using laparoscopic power morcellators, but rather to provide an interpretation of the FDA statement as to the patients for whom the use of power morcellation may still be permitted under the FDA guidelines. This article also offers protective measures from a legal perspective for those who choose to continue to use power morcellation in the face of the recent FDA warning and litigation.

Liability exposure for surgical robotics instructors.

Surgical robotics instructors provide an essential service in improving the competency of novice gynecologic surgeons learning robotic surgery and advancing surgical skills on behalf of patients. However, despite best intentions, robotics instructors and the gynecologists who use their services expose themselves to liability. The fear of litigation in the event of a surgical complication may reduce the availability and utility of robotics instructors. A better understanding of the principles of duty of care and the physician-patient relationship, and their potential applicability in a court of law likely will help to dismantle some concerns and uncertainties about liability. This commentary is not meant to discourage current and future surgical instructors but to raise awareness of liability issues among robotics instructors and their students and to recommend certain preventive measures to curb potential liability risks.

Transvaginal hydrolaparoscopy.

Transvaginal hydrolaparoscopy (THL) is being performed regularly in Europe and China, but rarely in the United States. The reasons may be physicians' unfamiliarity with the procedure and their uneasiness over potential rectal puncturing due to the proximity of the rectum to the vaginal trocar insertion site. THL has the advantage over hysterosalpingography (HSG) in that it allows for direct visualization of the tubal mucosa in addition to determining tubal patency. THL has advantages over traditional laparoscopy in that it does not require an abdominal incision and has the capability of being conducted in an outpatient office setting with local anesthesia. Studies have shown that THL has comparable accuracy to laparoscopy with 96.1% concordance between THL and laparoscopic findings. THL may be combined with chromopertubation and salpingoscopy. In addition to diagnostic purposes, THL may be used for operative intervention including adhesiolysis, endometriosis ablation, and ovarian drilling. Studies from France and China report the occurrence of rectal injury from 0% to1%. Despite the advantages of THL and low reports of rectal injury, THL has not gained popularity in the United States. The purpose of this article is to familiarize gynecologists in the United States with THL.

Comparison of Perioperative Outcomes of Total Laparoscopic and Robotically Assisted Hysterectomy for Benign Pathology during Introduction of a Robotic Program.

Study Objective. Prospectively compare outcomes of robotically assisted and laparoscopic hysterectomy in the process of implementing a new robotic program. Design. Prospectively comparative observational nonrandomized study. Design Classification. II-1. Setting. Tertiary caregiver university hospital. Patients. Data collected consecutively 24 months, 34 patients underwent laparoscopic hysterectomy, 25 patients underwent robotic hysterectomy, and 11 patients underwent vaginal hysterectomy at our institution. Interventions. Outcomes of robotically assisted, laparoscopic, and vaginal complex hysterectomies performed by a single surgeon for noncancerous indications. Measurements and Main Results. Operative times were 208.3 ± 59.01 minutes for laparoscopic, 286.2 ± 82.87 minutes for robotic, and 163.5 ± 61.89 minutes for vaginal (P < .0001). Estimated blood loss for patients undergoing laparoscopic surgery was 242.7 ± 211.37 cc, 137.4 ± 107.50 cc for robotic surgery, and 243.2 ± 127.52 cc for vaginal surgery (P = 0.05). The mean length of stay ranged from 1.8 to 2.3 days for the 3 methods. Association was significant for uterine weight (P = 0.0043) among surgery methods. Conclusion. Robotically assisted hysterectomy is feasible with low morbidity, a shorter hospital stay, and less blood loss. This suggests that robotic assistance facilitates a minimally invasive approach for patients with larger uterine size even during implementing a new robotic program.

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 ethical challenges of providing fertility care to patients with chronic illness or terminal disease.

The field of fertility is rapidly evolving, bringing opportunities for improvement in our patients' quality of life as well as bringing new ethical dilemmas. As medical science continues to advance, significant numbers of the reproductive-aged population are living with chronic and/or terminal conditions but have reasonable odds of lengthy survival and wish to have children. Likewise, there are adolescents diagnosed with cancer who are increasingly expected to achieve an improved, if not normal, life expectancy after treatment. Oftentimes these children are told they must sacrifice their ability to later have genetically related offspring; however, technologies to preserve fertility are changing this prognosis. Patients with chronic infection are living longer, more normal lives and are increasingly seeking reproductive assistance. Moreover, there is an increasing number of patients' families desiring posthumous use of gametes, which also raises ethical and legal issues. This article discusses ethical principles of bioethics and then highlights specific ethical issues through four plausible cases that may be seen in a fertility practice providing medical care to patients with chronic illness or terminal disease. It concludes that prompt referral of patients to the reproductive endocrinologist, along with a multidisciplinary approach to care, provides increased chances of successful treatment of this group of patients.

Use of vaginal mesh in the face of recent FDA warnings and litigation.

Choosing to use mesh in vaginal reconstructive surgery for pelvic organ prolapse or stress urinary incontinence is perplexing in the face of recent US Food and Drug Administration (FDA) warnings. In October 2008, the FDA alerted practitioners to complications associated with transvaginal placement of surgical mesh. Litigation is another concern. A Google search of "transvaginal mesh" results in numerous hits for plaintiff attorneys seeking patients with complications related to use of mesh. In light of a recent decision by the US Supreme Court and strategies by manufactures of medical devices to escape liability, it is imperative that gynecologic surgeons using transvaginal mesh document proper informed consent in the medical records. The purpose of this commentary is not to deter gynecologic surgeons from using transvaginal mesh when appropriate, but to provide an overview of current medical-legal controversies and stress the importance of documenting informed consent.

Prevalence of infraumbilical adhesions in women with previous laparoscopy.

BACKGROUND AND OBJECTIVE: The aim of this study is to evaluate the prevalence of intraabdominal adhesions to the umbilicus following gynecologic laparoscopy through an umbilical incision. METHODS: A retrospective review was performed of all gynecologic laparoscopic procedures in a private practice setting to identify patients with a repeat laparoscopy who had a history of a previous laparoscopy through an umbilical incision. Patients with a history of other surgeries were excluded. All repeat laparoscopies used a left upper quadrant entry technique where the abdominal cavity was surveyed for adhesions. We also reviewed adverse events attributable to the left upper quadrant entry approach. RESULTS: We identified 151 patients who underwent a second laparoscopy and had a previous umbilical scar. Thirty-two of the 151 (21.2%) patients with a history of a laparoscopy had evidence of adhesions to the umbilical undersurface. No adverse events or injuries were attributed to the left upper quadrant entry technique. CONCLUSIONS: Adhesions to the umbilical undersurface occur in 21.2% of patients who have undergone a prior laparoscopy through an umbilical incision. For this reason, we recommend an alternate location for entry in patients with an umbilical scar from a previous laparoscopy.

Laparoscopic vaginal vault suspension using uterosacral ligaments: a review of 133 cases.

The objective of our study was to describe the surgical technique of laparoscopic vaginal vault suspension using the uterosacral ligaments. In addition, we performed a retrospective analysis of this laparoscopic technique on 133 patients with advanced symptomatic vaginal vault prolapse to evaluate the efficacy and durability of this laparoscopic technique. Efficacy and anatomic outcome were assessed by the Baden-Walker halfway scoring system before and after the surgical procedure. Preoperatively, all patients showed evidence of grade 2 or greater prolapse (descent to the level of the hymen). Fifty-one patients (38.4%) had uterovaginal prolapse, and 82 patients (61.6%) had vaginal vault prolapse. The patients were reevaluated at 1, 6, and 12 months postoperatively and yearly thereafter. The postoperative follow-up ranged from 2.0 to 7.3 years. Postoperatively, 116 patients (87.2%) had no recurrence of prolapse, and 17 patients (12.8%) had recurrence of prolapse. The major complication rate was 2.25%. We conclude that laparoscopic vaginal vault suspension is a safe, efficacious, and durable alternative for the management of vaginal vault prolapse.

Laparoscopic suburethral sling procedure.

STUDY OBJECTIVE: To describe the technique of laparoscopic suburethral sling and discuss patient satisfaction and subjective continence rates over 7 years. DESIGN: Retrospective analysis (Canadian Task Force classification III). SETTING: Private practice. PATIENTS: Sixty-three consecutive patients. INTERVENTION: Laparoscopic sling procedure using either autologous or donor fascia. MEASUREMENTS AND MAIN RESULTS: The space of Retzius is entered laparoscopically. Then from a vaginal approach, a small midline vertical incision is made below the urethra, and vaginal epithelium is dissected off underlying periurethral and paravesical fascia. Material for the sling is passed underneath the urethra and secured laparoscopically to Cooper's ligaments bilaterally. Over 7 years, 63 laparoscopic suburethral sling procedures were performed. Overall, patients reported 88.9% satisfaction rate and 81.0% subjective continence rate. CONCLUSION: The laparoscopic approach is an acceptable alternative to other suburethral sling procedures.