Morcellator

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A morcellator is a surgical instrument used for division and removal of large masses of tissues during laparoscopic surgery. [1] In laparoscopic hysterectomy the uterus is cut up in strips, or morcellated, into smaller pieces inside the patient'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 [1] or cutting jaws, [2] through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece. [1] [2]

Contents

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

Morcellation is associated with spreading of cellular material of the morcellated tissue. In gynecologic surgery for benign pathologies there is approximately a 0.1% risk of an unexpected leiomyosarcoma. [3] [4] [5] [6] 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. [3] [7]

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. [8] A second warning was followed in November of the same year. [9] Johnson & Johnson subsequently suspended sale of its morcellators until the role of morcellation "is redefined by the FDA and the medical community," [8] and later pulled its morcellators from the market. [10] Critics of this device have mounted a high-profile campaign to have the devices recalled. [11] At least one device maker has threatened legal action against what it calls "unfounded and unproven allegations." [12] 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. [9]

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 leading them to reopen the investigation, and they discovered a higher risk than was initially reported. [13] [ citation needed ] 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.[ citation needed ] 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. [5] [6]

See also

Related Research Articles

<span class="mw-page-title-main">Laparoscopy</span> Minimally invasive operation within the abdominal or pelvic cavities

Laparoscopy is an operation performed in the abdomen or pelvis using small incisions with the aid of a camera. The laparoscope aids diagnosis or therapeutic interventions with a few small cuts in the abdomen.

<span class="mw-page-title-main">Hysterectomy</span> Surgical removal of the uterus

Hysterectomy is the surgical removal of the uterus and cervix. Supracervical hysterectomy refers to removal of the uterus while the cervix is spared. These procedures may also involve removal of the ovaries (oophorectomy), fallopian tubes (salpingectomy), and other surrounding structures. The term “partial” or “total” hysterectomy are lay-terms that incorrectly describe the addition or omission of oophorectomy at the time of hysterectomy. These procedures are usually performed by a gynecologist. Removal of the uterus renders the patient unable to bear children and has surgical risks as well as long-term effects, so the surgery is normally recommended only when other treatment options are not available or have failed. It is the second most commonly performed gynecological surgical procedure, after cesarean section, in the United States. Nearly 68 percent were performed for conditions such as endometriosis, irregular bleeding, and uterine fibroids. It is expected that the frequency of hysterectomies for non-malignant indications will continue to fall given the development of alternative treatment options.

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Heavy menstrual bleeding (HMB), previously known as menorrhagia or hematomunia, is a menstrual period with excessively heavy flow. It is a type of abnormal uterine bleeding (AUB).

<span class="mw-page-title-main">Leiomyoma</span> Medical condition

A leiomyoma, also known as a fibroid, is a benign smooth muscle tumor that very rarely becomes cancer (0.1%). They can occur in any organ, but the most common forms occur in the uterus, small bowel, and the esophagus. Polycythemia may occur due to increased erythropoietin production as part of a paraneoplastic syndrome.

<span class="mw-page-title-main">Uterine fibroid</span> Medical condition with benign tumors of uterus

Uterine fibroids, also known as uterine leiomyomas or fibroids, are benign smooth muscle tumors of the uterus, part of the female reproductive system. Some women with fibroids have no symptoms while others may have painful or heavy periods. If large enough, they may push on the bladder, causing a frequent need to urinate. They may also cause pain during penetrative sex or lower back pain. A woman can have one uterine fibroid or many. It is uncommon but possible that fibroids may make it difficult to become pregnant.

<span class="mw-page-title-main">Uterine myomectomy</span> Surgical removal of uterine fibroid

Myomectomy, sometimes also called fibroidectomy, refers to the surgical removal of uterine leiomyomas, also known as fibroids. In contrast to a hysterectomy, the uterus remains preserved and the woman retains her reproductive potential. It still may impact hormonal regulation and the menstrual cycle.

<span class="mw-page-title-main">Leiomyosarcoma</span> Medical condition

A leiomyosarcoma, also known as LMS, is a rare malignant (cancerous) smooth muscle tumor. The origin of the word is from leio- + myo- + sarcoma which means malignant smooth muscle tumor. The stomach, bladder, uterus, blood vessels, and intestines are examples of hollow organs made up of smooth muscles where LMS can be located; however, the uterus or abdomen are the most common sites.

<span class="mw-page-title-main">Uterine artery embolization</span>

Uterine artery embolization is a procedure in which an interventional radiologist uses a catheter to deliver small particles that block the blood supply to the uterine body. The procedure is primarily done for the treatment of uterine fibroids and adenomyosis. Since uterine fibroids are the most common indication, it is also often referred to as uterine fibroid embolization. Compared to surgical treatment for fibroids such as a hysterectomy, in which a woman's uterus is removed, uterine artery embolization may be beneficial in women who wish to retain their uterus. Other reasons for uterine artery embolization are postpartum hemorrhage and uterine arteriovenous malformations.

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Genital leiomyomas are leiomyomas that originate in the dartos muscles, or smooth muscles, of the genitalia, areola, and nipple. They are a subtype of cutaneous leiomyomas that affect smooth muscle found in the scrotum, labia, or nipple. They are benign tumors, but may cause pain and discomfort to patients. Genital leiomyoma can be symptomatic or asymptomatic and is dependent on the type of leiomyoma. In most cases, pain in the affected area or region is most common. For vaginal leiomyoma, vaginal bleeding and pain may occur. Uterine leiomyoma may exhibit pain in the area as well as painful bowel movement and/or sexual intercourse. Nipple pain, enlargement, and tenderness can be a symptom of nipple-areolar leiomyomas. Genital leiomyomas can be caused by multiple factors, one can be genetic mutations that affect hormones such as estrogen and progesterone. Moreover, risk factors to the development of genital leiomyomas include age, race, and gender. Ultrasound and imaging procedures are used to diagnose genital leiomyomas, while surgically removing the tumor is the most common treatment of these diseases. Case studies for nipple areolar, scrotal, and uterine leiomyoma were used, since there were not enough secondary resources to provide more evidence.

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<span class="mw-page-title-main">Victor Bonney</span>

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References

  1. 1 2 3 Disposable laparoscopic morcellator, GM Savage, JJ Christian, DC Dillow - US Patent 6,039,748, 2000
  2. 1 2 Morcellator, Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent 5562694. Issue date: Oct 8, 1996.
  3. 1 2 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. Bibcode:2012PLoSO...750058S. doi: 10.1371/journal.pone.0050058 . PMC   3506532 . PMID   23189178.
  4. ↑ 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 (3): 270–1. doi:10.1016/j.ijgo.2014.12.004. PMID   25790796. S2CID   42355712.
  5. 1 2 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. 23 (4): 1287–1293. doi:10.1245/s10434-015-4976-3. PMID   26577118. S2CID   19615919.
  6. 1 2 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". Gynecologic Oncology. 151 (1): 91–95. doi:10.1016/j.ygyno.2018.08.026. PMID   30146112. S2CID   52092926.
  7. ↑ 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 . hdl: 10447/77912 . PMID   21719004.
  8. 1 2 Robert Lowes (April 30, 2014). "J&J Suspends Power Morcellator Sales Over Cancer Risk". Medscape . Retrieved April 30, 2014.
  9. 1 2 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
  10. ↑ Jon Kamp; Jennifer Levitz (July 30, 2014). "Johnson & Johnson to Call for Return of Hysterectomy Device". Wall Street Journal . Retrieved July 20, 2014.
  11. ↑ Levitz, Jennifer (26 February 2014). "Doctor's War on a Common Surgery". The Wall Street Journal. Retrieved 30 June 2024.
  12. ↑ Lowes, Robert (5 September 2014). "Morcellation Critic Dares Device Maker on Lawsuit Threat". Medscape. Retrieved 30 June 2024.
  13. ↑ Kamp, Jon (2014-07-08). "Women's Cancer Risk Raises Doubts About FDA Oversight". The Wall Street Journal. Retrieved 17 February 2015.
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