Power Morcellators

History of Power Morcellators

• It is believed that tissue removal devices were developed as early as 1973.
• The first electric morcellator was approved for use in 1993 by the FDA through its 510(k) approval process. The device name was Cook Tissue Morcellator and it was manufactured and developed by Cook Urological, Inc.
• After the Cook Tissue Morcellator came on the market, Gynecare Innovation, which would later be purchased by Ethicon, a subsidiary of Johnson & Johnson, developed a Femrx Operastar System Morcellator predicated on previous morcellator devices. The device was approved on March 14, 1996.
• The device name was later changed to Gynecare X-tract. Ethicon received approval for its second device, the Gynecare Laparoscopic Morcellator on February 7, 2000. As the 510(k) application states, “no clinical data was deemed necessary to support this premarket notification.”
• On July 14, 2006, the FDA approved Ethicon’s Gynecare Morcellex Tissue Morcellator, which is predicated on the original Gynecare X-Tract Tissue Morcellator from 1996.
• In 2010 and 2013, Ethicon developed two other morcellator devices. Notably, the device approved in 2013, Morcellex Sigma Generator, was predicated on the Gynecare X-Tract device from 1996. The mere fact that a device developed in 2013 is predicated on a device that was approved almost 20 years previously should cast significant concerns regarding the 510(k) approval process.

Power Morcellator Injuries

Of greater concern is the fact that a review of the Manufacturer and User Facility Device Experience (MAUDE) database of the U.S. Food and Drug Administration found 55 complications from 1993 through 2013 including 6 deaths and injuries caused by the morcellator blade.

These injuries do not include reports of uterine sarcoma, including leiomyosarcoma (“LMS”), a serious form of cancer that is often fatal. While the incidence of uterine sarcoma attributed to this device is unclear, the FDA estimates that 1 in 350 women undergoing hysterecotomy or myomectomy for treatment of fibroids is found to have an unsuspected uterine sarcoma. This is in contrast to a recent statement by the Society of Gynecologic Oncology, which estimated that fewer than 1 woman in 1000 who undergoes a hysterectomy will develop a leiomyomata. One of the primary concerns regarding uterine sarcoma is that there are no good methods to screen for it.

While the litigation is just commencing, there have been reports that a pathologist warned Johnson & Johnson in 2006 that the morcellators carried significant risks. Additionally, an article published on November 26, 2012, examined 1091 instances of uterine morcellation from 2005 to 2010 and revealed a high rate of unexpected sarcoma after morcellation. The article found that there was a 9-fold higher rate of unexpected sarcoma than what had been advised to patients prior to the procedure.