Uterine issues leading to the use of power morcellators

Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue wall of the uterus. Most women will develop uterine fibroids at some point in their lives. Most uterine fibroids do not cause problems, however, in some cases, they do cause heavy or prolonged menstrual bleeding, pelvic pain or pressure, and frequent urination. These symptoms sometimes require surgery.

What is uterine sarcoma?
The U.S. Food and Drug Administration (FDA) estimates that in women who undergo hysterectomy or myomectomy for fibroids, approximately 1 in 350 have an unsuspected type of uterine cancer called uterine sarcoma. Uterine sarcoma is a rare type of cancer that forms in muscles or other tissues of the uterus. It usually occurs after menopause. The two main types of uterine sarcoma are leiomyosarcoma, which begins in smooth muscle cells, and endometrial stromal sarcoma, which begins in connective tissue cells.

What action has the FDA taken?
A peer-reviewed study published online in Plos One in November 2012, Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms, Michael A. Seidman, et al., reviewed 1091 cases of uterine morecellation performed from 2005 to 2010 at Brigham & Women’s Hospital in Boston, and concluded that “uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated increases in mortality much higher than appreciated currently.” Despite such concerns, the FDA provided its first warning about morcellation cancer risk on April 17, 2014. In its April FDA News Release and FDA Safety Communication, the FDA unequivocally discouraged the use of laparoscopic power morcellation for the treatment of women with uterine fibroids. The intended audience for the FDA Safety Communication was all healthcare providers, all healthcare facilities, all medical professional associations, all cancer advocacy groups, all women with symptomatic uterine fibroids, and all manufacturers of power morcellators.

Who are the manufacturers of power morcellators?

Ethicon, a division of Johnson & Johnson, was by far the largest seller of laparoscopic power morcellators. In response to the April FDA Safety Communication, Ethicon suspended worldwide sales, promotion, and distribution of its power morcellators. It did not recall already sold morcellators. Companies manufacturing power morcellators include:

• Ethicon – Morcellex Sigma, Gynecare – X-Tract, and Morcellex Tissue Morcellator
• Fem Rx – Diva Morcellator
• Hologic – MyoSure
• Lumenis Inc. – VersaCut Morcellator
• Interlace Medical – Hysteroscopic Morcellator
• Smith & Nephew – Trueclear Hysteroscopic Morcellator
• Oympus – PlasmaSORD and Gyrus PKS PlasmaSORD
• Nouvag – Morcellator TCM3000BL
• LiNA Medical – Xcise Cordless Laparoscopic Morcellators
• Karl Storz – Rotocut G1, G2 Steiner, and Sawalhell Supercut Morcellator
• Richard Wolf – Morce-Power 2306 Electronic Morcellator

Related:

• Laparoscopic Power Morcellators Used to Treat Uterine Fibroids Could Spread Cancer
• Patients Should Know: Power Morcellation to Treat Uterine Fibroids May Spread Cancer