Litigation Arising From Minimally Invasive Cosmetic Procedures: A Review of the Literature.

BACKGROUND: Minimally invasive cosmetic procedures are on the rise. To meet this rising demand, increasing numbers of physicians and nonphysicians are performing these procedures. Understanding malpractice trends and reasons for litigation in cosmetic medicine is important to establish safeguards for patient care and minimize liability. OBJECTIVE: Perform a comprehensive review of the literature on litigation associated with minimally invasive cosmetic procedures and discuss strategies to avoid facing a lawsuit. MATERIALS AND METHODS: The authors searched PubMed databases using a variety of keywords to identify studies of lawsuits arising from minimally invasive cosmetic procedures through December 2020. RESULTS: A total of 12 studies of litigation meeting inclusion criteria were identified: botulinum toxin (1), soft tissue fillers (3), lasers (5), body contouring/liposuction (1), chemical peels/dermabrasion (1), and sclerotherapy (1). Principle factors associated with litigation included negligence, lack of informed consent, vicarious liability for action of delegates, lack of communication, poor cosmetic result, failure to inform of risks, inappropriate treatment or dose, and failure to recognize or treat injury. CONCLUSION: Understanding malpractice trends and reasons for litigation in minimally invasive cosmetic procedures can strengthen the patient-provider relationship, establish safeguards for patient care, and may minimize future risk of a lawsuit.

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.

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.

Midurethral slings: evidence-based medicine vs the medicolegal system.

Midurethral sling procedures are minimally invasive surgeries for stress urinary incontinence that use a trocar system to place a narrow ribbon of polypropylene mesh under the midurethra. The peer-reviewed scientific literature on these procedures is abundant and midurethral slings are the most well-studied incontinence procedure ever. Systematic reviews of the literature demonstrate that midurethral slings are safer and more (or equally) effective as traditional procedures. The midurethral sling is the worldwide standard for the treatment of female stress urinary incontinence and >3 million procedures have been performed. The Food and Drug Administration and international scientific review agencies have consistently differentiated transvaginal mesh for stress urinary incontinence from transvaginal mesh for prolapse. In the recruitment of patients to participate in transvaginal mesh litigation, plaintiff lawyers have not made the distinction between stress urinary incontinence and prolapse procedures because more women have received midurethral slings than transvaginal mesh for prolapse by an order of magnitude. The litigation costs of defending their products have forced several companies that manufactured midurethral slings to leave the marketplace. It is not inconceivable that midurethral slings could become absent from the US market. If that happens, then US women with stress urinary incontinence will be harmed because they will not have access in this country to the best and safest stress urinary incontinence surgical procedure ever developed. It may be time for the Institute of Medicine or another comparable national agency to provide evidence-based recommendations on the midurethral sling.

The role of the U.S. Food and Drug Administration in device evaluation and monitoring.

The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported complications of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through October 2009 for articles and references related to devices and the U.S. Food and Drug Administration by using the keywords "FDA" and "devices." In addition, the Web was searched using the same keywords. The U.S. Food and Drug Administration website was also thoroughly reviewed. Practitioners should continue to monitor the medical literature for subsequent data about these issues. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.

[(section sign) 115 b SGB V threatens outpatient treatment for inguinal hernia. Analysis of outcome and economics]. / Das Aus für die minimal-invasive Leistenhernienversorgung durch (section sign) 115 b SGB V. Eine Analyse zu Patientenoutcome und Okonomie.

BACKGROUND: Current German legislation ( (section sign) 115 b SGB V) allows groin hernia inpatient treatment only under particular circumstances. That allows the operative technique of first choice for outpatient groin hernia repair to be determined by basic market principles. The aim of this paper was to study the feasibility of outpatient minimally invasive hernia surgery with regard to complication rates, patient satisfaction, and economic considerations. METHODS: For 1 year, a total of 571 patients with inguinal hernias (131 male, eight female, mean age 46 years, all ASA I) were treated at two surgical centers. Twenty-four percent (139/571) underwent outpatient total extraperitoneal repair (TEP). Complication rates were recorded. Patient satisfaction with the procedure was evaluated by a standard questionnaire. Cost calculations were compared with revenues according to the EBM2000plus. RESULTS: Of the patients, 96.4% were discharged on the day of operation without subsequent rehospitalization, 84% had no fears of complications at home, 54% went back to work in less than 14 days, and 88.7% were willing to undergo TEP a second time if necessary. Calculated average total cost of euro 709 exceeded the revenue of euro 565 by 20%. CONCLUSION: For a carefully selected group, outpatient TEP is patient-friendly and safe. Despite these advantages, it still remains economically unattractive to hospital management because of the 20% cover shortage. Improvements in the current legislation are urgently desired.

[Future of endoscopic surgery--German health law and minimal access surgery in an university hospital]. / Zukunft der endoskopischen Chirurgie--GSG-Probleme der MIC in einer Universitätsklinik.

The future development of endoscopic surgery depends on a medical and economical benefit. Medical advantages are demonstrated under professional conditions of practice in a retrospective study: endoscopical repair of the groin (TEP n = 44) vs. conventional Shouldice- (n = 17) and Lichtenstein (n = 19) method, laparoscopical hemifundoplication (n = 7) vs. traditional Nissen-Rosetti procedure (n = 3) and also resection of the sigmoid (lap. n = 26) vs. open surgery (n = 12). The overall hospital stay is shortend dramatically (primary hernia of the groin 8.8 (Shouldice) and 7.4 (Lichtenstein) vs. 3.1 days (TEP); (hemi-) fundoplication 11.1 (open) vs. 5.0 days (lap.); resection of sigmoid 19.0 (open) vs.17.0 days (lap.)) At the same time quality of care is held or improved. Comparison of real cost analysis revealed a better economical result (593-970 DM lower cost for TEP, 1.256 DM lower costs for lap. hemifundoplication, and 1.918 DM in case of lap. resection of sigmoid) for minimal-access-surgery (MAS), although particular costs for the endoscopic surgical procedure are increasing up to 100%, especially at the beginning (learning curve). The German payment-system does not regard the special conditions of MAS. There is no case-related payment for MAS due to the lower overall costs. Therefore the financial result is worse than for conventional treatment.