Medical Device Safety and Surgical Dissemination of Unrecognized Uterine Malignancy: Morcellation in Minimally Invasive Gynecologic Surgery

Abstract

There is a risk of dissemination of uterine malignancies during minimally invasive hysterectomies when morcellation is used. Although the technique of uterine power morcellation allows timely removal of large benign tumors through small laparoscopic incisions, there are concerns about iatrogenic spread of cancers and reduced survival for women with preoperatively unrecognized malignancies. This review examines the literature on intraperitoneal spread and implantation of mechanically disrupted malignant tissue, discusses the current diagnostic tools for preoperative assessment of uterine tumors, and summarizes the current recommendations of the Society of Gynecologic Oncologists, the American College of Obstetricians and Gynecologists, and the American Association of Gynecologic Laparoscopists. Recommendations include informed consent of the risk of disseminating an otherwise contained malignancy, appropriate preoperative evaluation for malignancy, and development of alternatives to intracorporeal morcellation. Implications for Practice: Preoperative assessment of uterine masses or abnormal uterine bleeding must include understanding of the limitations of an endometrial biopsy and imaging studies to evaluate the possibility of a uterine malignancy. Minimally invasive surgery using morcellation of benign uterine growths is well established and safe; however, alternative surgical techniques to morcellation must be considered when the malignant potential of a uterine mass is uncertain. Morcellation carries the risk of widespread peritoneal seeding of an unrecognized uterine malignancy. Gynecologic surgeons must weigh the unlikely occurrence of disseminating an undiagnosed uterine sarcoma with the much more common surgical risks of abdominal surgery.

Late presentation of extrauterine adenomyomas after laparoscopic morcellation at hysterectomy: a case report

“…The American Congress of Obstetricians and Gynecologists (ACOG) presented a statement in aims of conveying the pressing matter around morcellation and their contribution towards tackling it. The American Association of Gynecologic Laparoscopists (AAGL) displayed their stance on morcellation through various actions all governed by striking a balance between acknowledging its advantages as a minimally invasive procedure whilst stating its risk for increased morbidity [ 9 ]. The European Society for Gynaecological Endoscopy (ESGE) acknowledges the concern raised regarding morcellation and recognizes the importance of patient education concerning its risks and benefits.…”

“…These changes were supported by AAGL as well. While some gynecologists became hesitant towards the use of morcellation for liability concerns after the release of FDA warnings; on the other hand, AAGL went forth to encourage improvements towards morcellation and not abandonment in one of their statements [ 9 ].…”

“…Furthermore, in December 2020, the FDA released an updated safety communication inclusive of the boxed warning and stated, “laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are or post-menopausal, or over 50 years of age, or are candidates for en bloc tissue removal” [ 12 ]. This encouraged further statements to be released by societies such as ACOG and AAGL exhibiting support towards the role of power morcellation in gynecologic surgery under the condition that strict patient criteria and consent were incorporated [ 9 ].…”

“…In the case of morcellation, some pertinent complications would be dissemination of malignancy and port-site metastasis, which can be recognized only after a widespread use and reporting of the product. However, there is an evident lack of centralized reporting of data regarding the usage of a morcellator and its outcomes, all of which has led to the Federal Bureau of Investigation posing queries concerning the transparency of delivering information between manufacturers and consumers [ 9 ].…”

Surgical treatment of fibroids for subfertility

“…In the late 1970s, laparoscopic myomectomy was first described for SS fibroids, which extended to IM fibroids by the early 1990s (Dubuisso 2000). Since 2015, the routine use of laparoscopic myomectomy has fallen, following case reports of iatrogenic spreading of non-benign leiomyomas within the peritoneum during morcellation (permitting fibroid extraction from the abdomen through small incisions) (Hall 2015). Consequently, alternative techniques are favoured.…”