Uterine transplantation: legal and regulatory implications in England.

Uterus transplantation (UTx) is fast evolving from an experimental to a clinical procedure, combining solid organ transplantation with assisted reproductive technology. The commencement of the first human uterus transplant trial in the United Kingdom leads us to examine and reflect upon the legal and regulatory aspects closely intertwined with UTx from the process of donation to potential implications for fertility treatment and the birth of the resultant child. As the world's first ephemeral transplant, the possibility of organ restitution requires consideration and is discussed herein. TWEETABLE ABSTRACT: Uterine transplantation warrants a closer look at the legal frameworks on fertility treatment and transplantation in England.

Review of Malpractice Litigations Involving Vesicovaginal and Rectovaginal Fistulas Following Elective Hysterectomy for Benign Indications in the United States From 1970 to 2020.

OBJECTIVE: The aims of this study were to review malpractice litigations involving vesicovaginal and rectovaginal fistulas after elective hysterectomy for benign indications in the United States and identify the most common themes in allegations by the plaintiffs and defenses by the defendants. METHODS: Using the Lexis Nexis legal database, we searched for and reviewed all U.S. malpractice litigations pertinent to this question between 1970 and 2020. RESULTS: Out of 82 cases that were identified and reviewed, 17 cases met our inclusion and exclusion criteria. These cases were decided between 1973 and 2019. Nine cases involved total abdominal hysterectomies, 1 involved total laparoscopic hysterectomy (TLH), 1 involved total vaginal hysterectomy (TVH), and the rest were not specified. Fifteen cases involved vesicovaginal fistulas and 2 involved rectovaginal fistulas. Three cases were ruled in favor of the plaintiffs, with monetary compensation ranging from $250,000 to $753,722 (approximately $364,120 to $1.8 million when adjusted for inflation), whereas 14 cases were ruled in favor of the defending surgeons. Common allegations were negligence in 15 cases and lack of informed consent in 2 cases. Factors that strengthened the defendants' arguments were thorough documentation, informed consent, and prompt referral to specialists. Intraoperative cystoscopy may have benefited in some cases. CONCLUSIONS: Thorough documentation, informed consent, and prompt referral to specialists strengthened the defendants' legal arguments. Intraoperative cystoscopy may also be beneficial.

Medicolegal Issues in Power Morcellation: Cautionary Rules for Gynecologists to Avoid Unfavorable Outcomes.

Power morcellation in laparoscopic surgery enables specialists to carry out minimally invasive procedures such as hysterectomies and myomectomies by cutting specimens into smaller pieces using a rotating blade and removing pieces through a laparoscope. Unexpected uterine sarcoma treated by surgery involving tumor disruption could be associated with poor prognosis. The current study aims to shed light on power morcellation from a medicolegal perspective: the procedure has resulted in adverse outcomes and litigation, and compensation for plaintiffs, as published in various journals cited in PubMed and MEDLINE, Cochrane Library, EMBASE, and GyneWeb. Considering the claims after the US Food and Drug Administration warnings on morcellation, the current study broadens the scope of research by including search engines, legal databases, and court filings (DeJure, Lexis Nexis, Justia, superior court of New Jersey, and US district court of Minnesota) between 1995 and 2019. Legal records show that courts determine professional responsibility regarding complications, making it essential to document adherence to safety protocols and specific guidelines, when available. Sound medical practices and clearly stated institute best practices result in better patient outcomes and are important when unfavorable clinical outcomes occur; adverse legal decisions can be avoided if there are grounds to prove professional conformity with specific guidelines and the unpredictability of an event.

Ethical Controversy About Hysterectomy for a Minor.

One of the most complicated ethical issues that arises in children's hospitals today is the issue of whether it is ever permissible to perform a procedure for a minor that will result in permanent sterilization. In most cases, the answer is no. The availability of good, safe, long-acting contraception allows surgical options to be postponed when the primary goal of such surgical options is to prevent pregnancy. But what if a minor has congenital urogenital anomalies or other medical conditions for which the best treatment is a hysterectomy? In those cases, the primary goal of therapy is not to prevent pregnancy. Instead, sterility is an unfortunate side effect of a medically indicated treatment. Should that side effect preclude the provision of a therapy that is otherwise medically appropriate? We present a case that raises these issues, and asked experts in law, bioethics, community advocacy, and gynecology to respond. They discuss whether the best option is to proceed with the surgery or to cautiously delay making a decision to give the teenager more time to carefully consider all of the options.

Impact of the Food and Drug Administration Safety Communication on the Use of Power Morcellator in Daily Clinical Practice: An Italian Survey.

STUDY OBJECTIVE: To assess the impact of the Food and Drug Administration (FDA) warning about power morcellation use on the daily clinical practice of Italian gynecologists. DESIGN: Electronic survey mailed to the main gynecologic centers (Canadian Task Force Classification type III). SETTING: Unit of Obstetrics and Gynecology, IRCCS - Arcispedale S. Maria Nuova di Reggio Emilia (Italy). PATIENTS: The study did not include patient data. INTERVENTION: There was no intervention. MEASUREMENTS AND MAIN RESULTS: From 490 surveys sent out, 426 replies were included in the final analysis (return rate = 86.9%). Four hundred of the 426 (93.9%) gynecologists were aware of the FDA warning. One hundred fifty of 302 (49.7%) of experienced gynecologists and 176 of 349 (50.4%) of oncology gynecologists considered laparoscopy the best approach for myomectomy. The FDA communication was considered overly restrictive by experienced and oncology gynecologists who declared that they had no intention of changing their surgical approach. Two hundred fifty of the 426 (58.7%) gynecologists declared that they would change their surgical approach only to prevent legal litigation. CONCLUSION: The FDA warning also affected Italian gynecologists. Particularly, less experienced gynecologists and those without oncologic practice seem to be more interested in avoiding legal litigation rather than a real clinical risk of upstaging an unexpected leiomyosarcoma. Fear of undiagnosed sarcoma could increase the number of laparotomies.

Medically necessary sterilization of a minor with intellectual disability: a case report and historical perspective.

Medical necessity may lead to secondary sterilization of individuals with intellectual disabilities, but legal statutes mandate that certain procedures be followed in these cases. In this article, we present a case of medically necessary sterilization of an individual with intellectual disability, and we discuss important legal statutes that guide this practice in North Carolina.

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.

Surgery without consent or miscommunication? A new look at a landmark legal case.

Schloendorff v Society of New York Hospital is regarded widely as a landmark in the history of informed consent because it is thought to have established individual self-determination as the legal basis of consent and respect for patient autonomy as the ethical basis of consent. For a century, it has been understood as a laparotomy done without consent when a pelvic mass was discovered unexpectedly in an anesthetized patient after an examination. We believe it was a case of surgeons failing to communicate properly with each other and their patient. To support this reinterpretation, we present evidence from the original medical and surgical records, letters of key participants in the case, and the trial court record. We also consider the case from the perspective of the modern culture of safety in gynecologic surgery. Contrary to what is commonly assumed, Ms Schloendorff lost her legal case, and her surgery might not have been performed at all had her clinicians known, understood, communicated, documented, and reaffirmed what the patient actually wanted. This new perspective on Schloendorff is important for gynecologic surgeons because it vividly documents the perils of implicit consent, delegating the obtaining of consent, and miscommunication among clinicians. The Schloendorff case underscores the constant need for continuous quality improvement to reduce medical errors and the risk of litigation by improving communication among surgeons.

Revisiting the legal standards that govern requests to sterilize profoundly incompetent children: in light of the "Ashley Treatment," is a new standard appropriate?

This Note discusses the recent controversy surrounding a six-year-old girl named Ashley, whose parents chose to purposefully stunt her growth and remove her reproductive organs for nonmedical reasons. A federal investigation determined that Ashley's rights had been violated because doctors performed the procedure, now referred to as the "Ashley Treatment," without first obtaining a court order. However, the investigation did not make any conclusions regarding whether the "Ashley Treatment" could present a legally permissible treatment option in the future. After discussing the constitutional rights that the "Ashley Treatment" implicates and the current legal standards in place, this Note examines how courts have applied these legal standards to cases involving extreme requests. Drawing upon legal commentators, this Note concludes that a court could approve a request for the "Ashley Treatment" in appropriate and limited cases where the parents have presented clear and convincing evidence before a court that the benefits that the "Ashley Treatment" would provide to the child and her family outweigh the risks associated with the procedure. This Note argues that those benefits may include extrinsic considerations, but courts should remain cautious when considering such evidence and be sure that the evidence as a whole supports their conclusions.

[Medico-legal aspects of hysterectomy].

INTRODUCTION: Understanding the lawful implementations of surgical procedures, such as hysterectomy, raises practical questions concerning legal relations between a doctor and his patient, and consequences of this relationship, which may be legally relevant. The modern legal theory and practice consider doctors and patients to be partners. CONSENT AND INFORMATION: Medical practitioners performing surgical procedures are obliged to obtain informed consent. They are also required to inform their patients about indications, course of the operative procedure, postoperative treatment, possible complications during and after the procedure, and quality of life after the operation. Informed conversation should take into account the age, mental status and patient's intellectual abilities. Legal consequences ofsurgical procedures Malpractice litigation mostly concers medical error and negligence. Medical errors should not be confused with ineffective outcome, or complicated postoperative course. Even if the surgical procedure was followed correctly and uneventful outcome took place, there might be some problems. CONCLUSION: A patient has a right to receive complete information from a physician about the specific nature of a proposed treatment. A physician has an obligation to elucidate and justify, treatment he proposes. Certain codification of all operative procedures may facilitate this task. Codification instructions about procedures, in this case hysterectomy, must include indications for a certain type of hysterectomy (subtotal, total, radical), as well as for the operative technique (abdominal, vaginal, laparoscopic). Patient information brochures should be available in print, and include information about indications and potential risks associated with the proposed surgical procedure. In this way, it is possible to prevent the inconveniences which may arise from insufficient knowledge and information about surgical procedures.