A morcellator is a surgical instrument used for division and removal of large masses of tissues during laparoscopic surgery. In laparoscopic hysterectomy the uterus is minced up, or morcellated, into smaller pieces inside the woman's abdominal cavity in order to extract from the abdomen. It can consist of a hollow cylinder that penetrates the abdominal wall, ending with sharp edges or cutting jaws, through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece.
Morcellation devices in surgery
Laparoscopic morcellation is commonly used at surgery to remove bulky specimens from the abdomen using minimally invasive techniques. Historically, morcellation was performed using a device that required the surgeon or assistant to manually 'squeeze' the handle. Other reports describe using a scalpel directly through the abdomen to create small specimens that can be drawn out of the abdominal cavity. In 1993, the first electric morcellator was introduced in the US market. It was initially used for uterine extraction, but later applied to other organs. The use of morcellators at surgery has now become commonplace, with at least 5 devices currently on the US market. Despite decades of experience, there remains limited understanding of the short-term and long-term sequelae of morcellation. Concerns have been raised about injury to surrounding organs including bowel, bladder, ureters, pancreas, spleen and major vascular structures. Long-term issues may include parasitic growth of retained tissue with the potential to cause adhesions, cause bowel dysfunction and potentially disseminate unrecognized cancer.
Safety concerns of morcellation devices in gynecologic surgery
Morcellation is associated with spreading of cellular material of the morcellated tissue. In gynecologic surgery for benign pathologies there is approximately a 0.09~0.1% risk of an unexpected leiomyosarcoma. After morcellation 64% of such cases may develop disseminated disease which is of particular concern because of the considerable mortality of leiomyosarcoma. Morcellation of the more frequent benign leiomyoma variants may also cause disseminated disease, which while not associated with increased mortality is frequently inoperable and therefore much more difficult to manage than the original disease.
Since April 2014 the Food and Drug Administration (FDA) has discouraged its use for uterine procedures, issuing a warning that morcellators may spread occult cancer in the course of fibroid removal. A second warning was followed in November of the same year. Johnson & Johnson subsequently suspended sale of its morcellators until the role of morcellation "is redefined by the FDA and the medical community," and later pulled its morcellators from the market. Critics of this device have mounted a high-profile campaign to have the devices recalled. At least one device maker has threatened legal action against what it calls "unfounded and unproven allegations." In the same statement the FDA discouraged the use of power morcellators in patients seeking hysterectomy (removal of uterus through lower abdomen) and myomectomy (surgery to remove uterine fibroids – also called leiomyomas) procedures, estimating that approximately 1 in 350 such patients is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.
The FDA says that it has known for some time that the morcellators could spread uterine cancer, but the recent[vague] attention given to the subject because of the death of Barbara Leary led them to reopen the investigation, and they discovered a higher risk than was initially reported. Magdy Milad, chief of gynecology and gynecologic surgery at Northwestern Memorial Hospital reported that “there were times connections were made but not reported."[original research?]
The problem of secondary leiomyosarcoma and parasitic leiomyoma after gynaecological surgeries is not new and such problems have been reported independently of the methods of surgery. The surgery may not be the only or main culprit: the disseminated disease may also be the result of predisposition, reduced paracrine feedback, or metastasis independent of surgery. According to some studies, there was no difference in the overall survival of women with unsuspected uterine malignancy with or without endometrial cancer between laparotomic myomectomy group and laparoscopic myomectomy group.
In 2017 Karl Storz GmbH was the subject of several lawsuits concerning deaths following use of morcellators that it sold; Ethicon, the market leader in morcellators, had withdrawn their devices in 2014, Karl Storz had not.
- Disposable laparoscopic morcellator, GM Savage, JJ Christian, DC Dillow - US Patent 6,039,748, 2000
- Morcellator, Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent 5562694. Issue date: Oct 8, 1996.
- Seidman, M. A.; Oduyebo, T.; Muto, M. G.; Crum, C. P.; Nucci, M. R.; Quade, B. J. (2012). Sullivan, David J (ed.). "Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms". PLoS ONE. 7 (11): e50058. doi:10.1371/journal.pone.0050058. PMC 3506532. PMID 23189178.
- Yuk, J. S.; Ji, H. Y.; Lee, S. H.; Park, Y. S.; Lee, J. H. (2015). "Unexpected uterine malignancy in women who have undergone myomectomy". International Journal of Gynecology & Obstetrics. 129: 270–1. doi:10.1016/j.ijgo.2014.12.004. PMID 25790796.
- Yuk, J. S.; Ji, H. Y.; Shin, J.Y.; Kim, L.Y.; Kim, S.Y.; Lee, J. H. (2015). "Comparison of Survival Outcomes in Women with Unsuspected Uterine Malignancy Diagnosed After Laparotomic Versus Laparoscopic Myomectomy: A National, Population-Based Study". Annals of Surgical Oncology. doi:10.1245/s10434-015-4976-3. PMID 26577118.
- Yuk, J. S.; Lee, J.H. (2018). "Six-year survival of patients with unsuspected uterine malignancy after laparoscopic versus laparotomic myomectomy: An 11-year national retrospective cohort study". Gynecol Oncology. doi:10.1016/j.ygyno.2018.08.026. PMID 30146112.
- Cucinella, G.; Granese, R.; Calagna, G.; Somigliana, E.; Perino, A. (2011). "Parasitic myomas after laparoscopic surgery: An emerging complication in the use of morcellator? Description of four cases". Fertility and Sterility. 96 (2): e90–e96. doi:10.1016/j.fertnstert.2011.05.095. PMID 21719004.
- Robert Lowes (April 30, 2014). "J&J Suspends Power Morcellator Sales Over Cancer Risk". Medscape. Retrieved April 30, 2014.
- Linda a. Johnson (November 24, 2014). "FDA strengthens warning on device linked to cancer". AP Business Writer. Retrieved November 24, 2014.
FDA strengthens warning on gynecologic surgical device linked to spreading cancer inside women
- Jon Kamp; Jennifer Levitz (July 30, 2014). "Johnson & Johnson to Call for Return of Hysterectomy Device". Wall Street Journal. Retrieved July 20, 2014.
- High profile campaign against device
- Legal action threatened against critics
- Kamp, Jon. "Women's Cancer Risk Raises Doubts About FDA Oversight". The Wall Street Journal. Retrieved 17 February 2015.
- Ong, Matthew Bin Han (21 July 2017). "Anti-morcellation advocate files "wrongful death" suit against Karl Storz and Brigham & Women's Hospital – The Cancer Letter Publications". The Cancer Letter.