In recent years, laparoscopic morcellation of tissue has become an established technique in surgery and gynaecology. This surgical procedure is frequently used in hysterectomy and myomectomy in particular. Intra-abdominal morcellation of the uterus is a technique that avoids a larger incision for containment. Compared to hysterectomy or myomectomy with abdominal incision, laparoscopic morcellation is gentler and carries a lower risk of infection, according to the FDA. Patients also benefit from a shorter post-operative recovery period.
"Warning Letter" from the Food and Drug Administration (FDA)
Despite these advantages of laparoscopic morcellation, the US Food and Drug Administration issued a warning letter in 2014 for the use of laparoscopic morcellation in hysterectomy and myomectomy. This is based on the potential risk of tumour cells spreading in hidden uterine sarcomas.
Statement by the Elevating Gynecologic Surgery Association (AAGL)
To assess the risk of morcellation, AAGL has used a decision analysis model that compares the mortality rates of abdominal hysterectomy and laparoscopic hysterectomy with morcellation. In a worst-case scenario, the median prevalence of leiomyosarcoma was conservatively estimated to be 1: 585 and the risk of tumour spread due to morcellation was reported to be between 15 and 35 %. Based on these data, mortality was 0.077 % for laparoscopic hysterectomy with morcellation and 0.085 % for open hysterectomy. In the opinion of AAGL, it would therefore not make sense to abandon the surgical procedure. The focus should rather be on optimising tissue morcellation.
The FDA recommends the use of an in-bag system for morcellation
In December 2020, the U.S. Food and Drug Administration (FDA) published a definitive recommendation on laparoscopic morcellation for gynaecological procedures. In the guidelines, the FDA warns of the risk of sarcoma morcellation and cell dispersion during hysterectomy and myomectomy. It also strongly recommends that uterine morcellation is only performed in an enclosed system (tissue containment system).
More safety in laparoscopic hysterectomy and myomectomy
In-bag morcellation with minimal cell dispersion optimises safety during laparoscopic hysterectomy and myomectomy. With a containment bag, the risk of tumour cell dispersion is reduced and the excised material is safely collected in the enclosed system. This enables controlled tissue morcellation.