On the Road to Safer Morcellation
Laparoscopic morcellation was first reported more than 25 years ago.3 To assist with laparoscopic hysterectomies, Kurt Semm3 developed a manual, and later a power, laparoscopic morcellator, which consisted of a rotating tubular blade through which a tissue mass was drawn so that it was simultaneously cut into narrow strips and removed from the abdomen through a laparoscopic port. Large leiomyomas or the entire uterus could be removed efficiently through a laparoscopic port, thus avoiding large abdominal incisions and thereby decreasing surgical complication risk, pain, and recovery time.4 For decades, it was accepted that the risk of intraperitoneal tissue dissemination using this unenclosed technique was greatly outweighed by the advantages of minimally invasive surgery.
The acceptability of unenclosed intraperitoneal power morcellation greatly diminished over the past 4 years, at least in part in response to concerns raised by a patient whose leiomyomatous uterus was found to contain a leiomyosarcoma after being laparoscopically removed using unenclosed power morcellation.1 In 2014, the US. Food and Drug Administration (FDA) released a directive titled, “Uterine Power Morcellation in Hysterectomy and Myomectomy,” which stated that, “1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma”; therefore the use of laparoscopic power morcellators was contraindicated for removal of uterine tissue containing apparent leiomyomas when malignancy was known or suspected or in women who were perimenopausal or postmenopausal.5 Power morcellation was also contraindicated in women who were “candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision.” According to this directive, this latter group of women “represent the majority of women with fibroids who undergo hysterectomy and myomectomy.” Surprisingly, the FDA did not consider the ramifications of unenclosed compared with enclosed intraperitoneal morcellation but instead concluded that power morcellation was the root source of the danger.
A number of gynecologic surgeons had serious concerns about this directive, primarily because the FDA greatly overestimated the risk of encountering an undiagnosed leiomyosarcoma, and the obvious benefits to a patient of minimally invasive gynecologic surgery outweighed this extremely small risk.6 In addition, the FDA’s unsupported assertion, that uterine tissue and leiomyomas could be removed without morcellation through small incisions in the majority of these women, was inconsistent with common experience.
Despite the limitations of the FDA directive, the predictable result was that power morcellators were taken off the market and many hospitals and health care systems proscribed their use.7,8 As a result, the use of laparoscopic power morcellation for gynecologic surgery, either unenclosed or enclosed, has been almost completely eliminated.9
It was widely believed that the inability to use power morcellators would greatly reduce our ability to perform many minimally invasive procedures.6,9 However, according to the data presented in three articles in the current issue (see pages 996, 1007, and 1014), the effect has been much less than anticipated.9–11 Apparently, innovative gynecologic surgeons have been able to continue to provide minimally invasive options to their patients by developing techniques other than unenclosed power morcellation for removal of tissue through small incisions.