You may be aware of the problems relating to the use of the laparoscopic surgical devices known as power morcellators. These are innovative tools that can be used in robotic surgical procedures as well as manual, laparoscopic ones. Essentially, they are a piece of gear that handles a great deal of the cutting of tissue, and they will segment tissue to allow the surgical tools to then suction it away.
The morcellator is a tool of choice for many gynecologists who are removing fibroid tumors and/or performing partial hysterectomies. It is also a tool used by surgeons doing other abdominal procedures relating to the spleen and the liver. The problem with these devices is that, though they do allow for a lot of precision, their very nature allows too many cells and bits of tissue to enter the bloodstream. Though this poses no immediate threat to the health of the patient, if the tissue being removed (and subsequently released) is from tissue with undiagnosed cancer, it can lead to a catastrophic outcome.
There are currently several lawsuits against the makers of power morcellator devices because of the incidence of aggressive cancer spreading throughout the bodies of patients who had procedures done using the equipment.
What is Happening
To explain the problem, let us consider a recent case out of Boston. A physician with six children was suddenly experiencing pain and bleeding from what her doctors diagnosed as severe fibroid tumors in her uterus. She consulted with her peers and they agreed to use a morcellator and laparoscopic procedure to remove the fibroids. Using this approach would allow much faster healing and much less pain from the surgery. However, though some cancer tests were run, they failed to detect the Leiomyosarcoma that the patient actually had at the time of the procedure.
This cancer is very aggressive, and spreads via the blood stream rather than lymphatic system. The use of the morcellator allowed the cells of the deadly cancer to be spread throughout her abdomen, and now the patient is facing a deadly threat to her life because of the use of the tool.
The FDA recently warned that cancer can be spread through the use of power morcellators, and particularly in open morcellation procedures. In this approach, a surgeon inserts the tool into the abdomen, and the device then gets to work shredding and removing tissue.
Makers & Models of Morcellators
The open nature of the procedure can allow the tissue to reach any part of the abdominal cavity, and almost all of the current morcellators on the market would be capable of creating such a scenario. The current makers and models are listed below:
- Blue Endo – MOREsolution
- Cook Urological, Inc. – Cook Tissue Morcellator
- Ethicon, Inc. – Gynecare Morcellex; Morcellex Sigma; Gynecare X Tract (Johnson & Johnson division that recalled all of its devices)
- Ethicon of FemRx – Diva
- LiNA Medical – Xcise
- Lumenis, Ltd. – VersaCut+ Tissue Morcellator
- KSE America – KSE Steiner Electromechanic Morcellator
- Karl Storz GmbH & Co. – ROTOCUT G1, G2; Swalhe II SuperCut Morcellator
- Olympus – PKS PlasmaSORD; VarioCarve Morcellator
- Richard Wolf GmbH – Morce Power Plus
At this time there are several lawsuits pending against the makers of the morcellator devices. The cases include negligence claims as well as failure on the part of the makers to warn or test gear, provide notices of consumer risk, or to have misrepresented the products as safe. Because of the severity of the issue, and the FDA warning against them, the global giant Johnson & Johnson willingly recalled all of its morcellators in July of 2014.
RecallCenter.com. ALERT (7/31/2014): JOHNSON AND JOHNSON WITHDRAWS POWER MORCELLATORS FROM WORLDWIDE MARKETS. 2014. http://www.recallcenter.com/power-morcellator/