The Medical Device Applied to Uterine Fibroids Morcellation: Analysis of Critical Biological Issues and Drawbacks from A Medical-Legal Prospective

Following the FDA safety communication of 2014 increasing attention has been to the treatment of uterine fibroids, due to the suspicion of a potential leiomyosarcoma (ULM). FDA banned the use of power morcellation in the US, since this technique is likely to spread malignant cells from an unsuspected ULM. We criticized the medical legal consequences of this banning among gynecologists and patients, focusing on the drawbacks of biology and surgery. The authors analyzed literature data on one side, on the incidence, diagnosis and treatment of leiomyoma and ULM, and the other side, on the power morcellations and related critical issues, trying to highlight their main controversial aspects and to outline the possible impact on patients and on medical responsibility. The alternative methods to power morcellation are more invasive surgical solutions (as mini laparotomy or culdotomy), which inevitably involve associated risks with the surgical procedure as such and always request the containing bags. Although the in-bag morcellation is a promising technique, currently the used devices are largely off-label. This highlights the surgical risk, in case of complications, of suffering for malpractice claims both for not having used a containment system, favoring the spread of the neoplasm, and for its off-label use. Since the diagnosis of ULM is by histology after surgery, the fear of legal consequences or medical malpractice for unknown ULM power morcellation, should be targeted to analyze, in terms of cost/benefit ratio, the surgical priority. It should focus on the prevention of the risk of having a rare and statistically limited ULM or on the surgical-related complications, often linked to a slowdown minimally invasive surgery, or on the use of the authorized in-bag morcellations.

Banning the use of intracorporeal morcellation.

132 Background: In response to the FDA safety communication we banned the use of intracorporeal morcellation effective April 22nd 2014. Clinicians expressed frustration and a concern that an increase in the abdominal hysterectomy rate or percentage, wound complications, and length of stay would occur. Our PDCA (plan, do, check, and act) safety process reviewed these quality and safety metrics one year later. Methods: This is a retrospective evaluation of a prospective institutional decision. Data evaluated in a patient anonymous fashion using Crimson and Optum quality reporting software. Results: In 2013 the power morcellator was used in 157 cases. In the twelve months following the ban, the wound complication rate, SSI's, and LOS all decreased, and vaginal hysterectomy rate increased. Conclusions: An institutional ban of intracorporeal and power morcellation resulted in a decrease in the overall number of hysterectomies, including abdominal hysterectomy. Laparoscopic supracervical hysterectomy was replaced by vaginal hysterectomy and an associated decrease in complications and length of stay. [Table: see text]