Historical and Ethical Perspectives on Vulvoplasty.

INTRODUCTION: Surgical and other procedures to alter the shape of the female external genitalia, especially the labia minora, are increasingly popular and controversial worldwide. OBJECTIVES: This article aims to delineate and complicate the medical and moral controversy around these vulvoplasty procedures, by describing how female genital aesthetics, their interpretation, and alteration vary over time, space, and culture. METHODS: The history of the Hottentot Venus is used as a pivot about which to consider current biomedical, anthropological, and ethical literatures regarding female genital appearance and its manipulation. Intersectionality describes how different systems influence each other to affect the agency of certain individuals or groups, and is therefore an ideal analytic method for biopsychosocial concerns of sex and informed consent. RESULTS: The 19th century anatomic study and display of Sarah "Saartjie" Baartman, the Hottentot Venus, defined a European vulvar ideal by demonstrating its opposite. Today, the ideal appearance of the labia minora is variable across cultures and nationalities, and various mechanical and surgical manipulations are sought or imposed upon women to bring their bodies into conformity with these ideals. CONCLUSION: For European audiences, Baartman exemplified a stereotypical association between genital appearance, sexual availability, and accessibility as a biomedical subject. These logical linkages were a by-product of sexist, racist, and colonial ideologies that have since fallen out of favor. However, their genital effects continue to influence bioethical considerations of genitoplasty into the present day. Chubak B. Historical and Ethical Perspectives on Vulvoplasty. Sex Med Rev 2020;8:542-547.

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.

ACOG Committee Opinion No. 759 Summary: Ethical Considerations for Performing Gynecologic Surgery in Low-Resource Settings Abroad.

Global surgical care programs present obstetrician-gynecologists with important opportunities to address disparities in women's health and health care worldwide. However, these programs also present a unique set of practical and ethical challenges. Obstetrician-gynecologists are encouraged to participate in surgical care efforts abroad while taking the necessary steps to ensure that their patients can make informed decisions and receive benefit from and are not harmed by their surgical care. In this document, the Committee on Ethics highlights some of the ethical issues that may arise when providing surgical care in low-resource settings to help guide obstetrician-gynecologists in providing the best care possible. This document has been updated to broaden its focus beyond the example of obstetric fistulae, to address issues pertinent to medical trainees, and to include new information to guide physicians' return home from participation in global surgical care programs. Although clinical research has an important role in the surgical care of patients in global settings, a complete discussion of the conduct of ethical research in global settings is beyond the scope of this document.

ACOG Committee Opinion No. 759: Ethical Considerations for Performing Gynecologic Surgery in Low-Resource Settings Abroad.

Global surgical care programs present obstetrician-gynecologists with important opportunities to address disparities in women's health and health care worldwide. However, these programs also present a unique set of practical and ethical challenges. Obstetrician-gynecologists are encouraged to participate in surgical care efforts abroad while taking the necessary steps to ensure that their patients can make informed decisions and receive benefit from and are not harmed by their surgical care. In this document, the Committee on Ethics highlights some of the ethical issues that may arise when providing surgical care in low-resource settings to help guide obstetrician-gynecologists in providing the best care possible. This document has been updated to broaden its focus beyond the example of obstetric fistulae, to address issues pertinent to medical trainees, and to include new information to guide physicians' return home from participation in global surgical care programs. Although clinical research has an important role in the surgical care of patients in global settings, a complete discussion of the conduct of ethical research in global settings is beyond the scope of this document.

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.

Hymenoplasty and Muslim Patients: Islamic Ethico-Legal Perspectives.

BACKGROUND: Hymenoplasty, commonly called "revirginization," is a controversial procedure that pushes the scope of medical practice to satisfy cultural and/or religious "needs." AIM: To outline the sociocultural contexts underlying patient requests for hymenoplasty and present Islamic juridical views on the moral status of hymenoplasty for Muslim patients. METHODS: Narrative review of the extant bioethics literature and leading Islamic ethico-legal verdicts. OUTCOMES: We identified "Western" and Islamic bioethical debates on hymenoplasty and the critical concepts that underpin ethical justifications for and against the procedure. RESULTS: From a Western-ethics perspective, the life-saving potential of the procedure is weighed against the role of the surgeon in directly assisting in a deception and in indirectly promoting cultural practices of sexual inequality. From an Islamic bioethical vantage point, jurists offer two opinions. The first is that the surgery is always impermissible. The second is that although the surgery is generally impermissible, it can become licit when the risks of not having postcoital bleeding harm are sufficiently great. CLINICAL IMPLICATIONS: Patient requests for hymenoplasty should be approached by surgeons with a willingness to understand patients' social contexts and reasons for pursuing the procedure and are ethically justified by leading Islamic jurists in particular circumstances. STRENGTHS AND LIMITATIONS: This article presents emic and etic perspectives on hymenoplasty in Muslim patients, although our review of the Islamic bioethical stances might have missed some juridical opinions and important considerations. Further, Muslims, even devout ones, might not be beholden to Islamic juridical views on medical procedures and thus physicians should not make assumptions about the rationale for, and ethical views of, patients seeking hymenoplasty. CONCLUSION: This article provides critical insight into how Muslim patients, and Islamic jurists, evaluate the moral contexts of hymenoplasty. Bawany MH, Padela AI. Hymenoplasty and Muslim Patients: Islamic Ethico-Legal Perspectives. J Sex Med 2017;14:1003-1010.

Informed consent checklists for midurethral slings: a common-sense approach.

INTRODUCTION AND HYPOTHESIS: Following the US Food and Drug Administration's (FDA's) warning about the use of transvaginal mesh to treat pelvic organ prolapse (POP) and the use of single-incision slings to treat incontinence, the number of lawsuits for medical negligence regarding the use of any polypropylene mesh in the vagina has increased tremendously. METHODS: This same FDA document did not question the use of polypropylene midurethral slings and polypropylene for sacrocolpopexies. Surprisingly, despite all the evidence and recommendations from respected international scientific societies, we are constantly being called upon by our patients to defend the use of midurethral slings. The most common reasons for the new rash of medicolegal proceedings involving midurethral slings has to do with "breach of duties" resulting from undisclosed postoperative complications on the consent form and/or the lack of information in the medical records confirming that all possible alternative treatment options were presented to and discussed with the patient. RESULTS: One response to these lawsuits involves the addition of preoperative checklists when performing informed consent with patients electing surgical correction of stress urinary incontinence (SUI). CONCLUSIONS: This clinical opinion provides an expert clinician's perspectives and legal point of view on this controversial topic and discusses the role of a preoperative checklist supplementary to the standard informed consent form.

Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014.

BACKGROUND: Interest in medical malpractice and areas of medicolegal vulnerability for practicing obstetricians and gynecologists has grown substantially, and many providers report changing surgical practice out of fear of litigation. Furthermore, education on medical malpractice and risk management is lacking for obstetrics and gynecology trainees. Recent obstetric and gynecologic malpractice claims data are lacking. We report on recent trends in malpractice claims for obstetrics and gynecology procedures, and compare these trends to those of other medical specialties. OBJECTIVE: We sought to evaluate recent trends in malpractice claims for obstetrics and gynecology procedures and compare these to other medical specialties. STUDY DESIGN: A search was performed on all medicolegal claims data for obstetrics and gynecology procedures from Jan. 1, 2005, through Dec. 31, 2014, using the Physician Insurers' Association of America data-sharing project, which was created to identify medical professional liability trends. Data from 20 insurance carriers were reviewed based on a search using International Classification of Diseases, Ninth Revision codes and unique database-specific codes. RESULTS: Of the 10,915 total claims closed from 2005 through 2014, the majority (59.5%) were dropped, withdrawn, or dismissed. The average indemnity of the remaining paid claims (31.1%) was $423,250. The most frequently litigated procedure was operative procedures on the uterus; 27.8% of cases were paid with an average indemnity of $279,384. The procedure associated with the highest proportion of paid claims was vacuum extraction. The average indemnity for paid obstetrics and gynecology procedural claims was 27% higher than that for all medical specialties combined. Obstetrics and gynecology procedural claims had the second highest average indemnity payment and the fifth highest paid-to-closed ratio of all medical specialties. CONCLUSION: Litigation claims for obstetrics and gynecology procedures have higher average indemnity payments and higher paid-to-closed ratios than most other medical specialties. Claims most frequently relate to gynecologic surgery, but obstetric procedures are more expensive. Possible factors may include procedural experience and unique perioperative complications. We encourage efforts addressing procedures, litigation, and quality interventions to improve outcomes, mitigate risk, and potentially lower indemnity payments.

[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.

Analysis of Surgical Outcomes and Determinants of Litigation Among Women With Transvaginal Mesh Complications.

OBJECTIVES: To identify litigation predictors among women with complications of transvaginal mesh. METHODS: Chart review and patient survey were conducted among women who had undergone a complication-related explant of a transvaginal prolapse or incontinence sling mesh. Trained study personnel administered a 57-question survey addressing subjective complaints related to bowel, bladder, sexual dysfunction, and development of pain or recurrent prolapse. These data were analyzed with respect to the subject's reported pursuit of litigation related to the mesh complication. Categorical and continuous variables were analyzed using the χ test and the t test as indicated. RESULTS: Ninety-five (68%) of 139 women completed the surveys with 60% of the patients pursuing litigation at the time of the survey. Individual risk factors for pursuing litigation included development of vaginal pain after mesh placement (P = 0.01); dyspareunia after mesh placement (P = 0.01); persistence of dyspareunia, suprapubic pain, and groin pain after mesh excision (P = 0.04, P = 0.02, and P = 0.001, respectively); unsuccessful attempts at conservative management of pelvic pain using pelvic floor rehabilitation (P = 0.002). CONCLUSION: There is an association between a higher likelihood of pursuing litigation and new-onset or persistent pain symptoms attributable to transvaginal mesh.

[Litigation in gynecological surgery: A retrospective study in the French university hospital of Lille between 1997 and 2015]. / Sinistralité en chirurgie gynécologique : expérience de 1997 à 2015, au sein du CHRU de Lille.

OBJECTIVE: Analysis of litigation in gynecological surgery in the French university hospital of Lille. METHODS: It is a longitudinal and retrospective study. We collected all cases of complaints between November 1997 and August 2015 concerning the department of gynecological surgery, university hospital of Lille. Medical data were obtained using electronic medical record and hospital's legal unit gave data about the complaints. RESULTS: Forty cases were identified during the reporting period. Thirty-three records concerned medical injuries and seven cases failing to provide information or lack of communication. Eleven complaints were reviewed by the French "commission de conciliation et d'indemnisation". Five cases were brought to administrative court. Finally, Lille high court examined two records. Most of complaints concerned perforation during endoscopic procedures, nosocomial infections and forgotten foreign bodies. It was not observed any increasing number of complaints during the whole period. It was noticed a decreasing number of legal action in favor of "commission de conciliation et d'indemnisation". CONCLUSION: This study evaluated specifically litigation in gynecological surgery. It is necessary to conduct this type of study so as to improve medical care and to provide information for practitioner about consequences of their exercise.

The Role of Social Networks, Medical-Legal Climate, and Patient Advocacy on Surgical Options: A New Era.

The dissemination of information online and resultant public discourse through social media and other online channels has influenced the practice of medicine in dramatic ways. Physicians have historically worked to develop new techniques and devices for the benefit of their patients. It is only a more recent phenomenon, however, that these tools are either removed or their use is curtailed largely driven by anecdotal reports; passionate, vocal, often media-savvy advocates; and plaintiff attorneys. The use of power morcellation, hysteroscopic tubal sterilization, and mesh in urogynecologic procedures all have been victims of these societal pressures. It is important for health care professionals to be involved in the debate to ensure that public outcry does not unduly influence what we, as clinicians, are able to safely offer our patients. By being better advocates for our field, our instruments, and our patients, we can ensure medical decision-making is driven by good science and not public fervor.

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.

When Bleeding Is Vital: Surgically Ensuring the "Virginal" State.

A young woman called me to ask for a referral to a physician who provided hymen reconstruction surgery. She had had premarital intercourse and came from a cultural background in which it was very important to "prove virginity" on the wedding night. This article deals with my internal struggle whether or not to provide the referral. I felt that providing it would have made me complicit in supporting gender inequality, as men are not required to "prove virginity" to get married. At the same time, I was concerned about the repercussions of not being able to "prove virginity" would have on the caller. I had no explicit guidance on what to do in such a situation--it was not covered by the professional responsibilities I had as a research assistant.