Following a warning by the U.S. Food and Drug Administration (FDA) that Laparoscopic Power Morcellation could further the spread of cancerous cells outside of the uterus, a unit of Johnson & Johnson (J&J) has been hit with the first of what could amount to a wave of lawsuits regarding the device.
Morcellation has become the preferred treatment for uterine fibroids, common in middle-aged women, involving the appearance and buildup of fibrous tissue in the uterus. Such tissue is benign in most cases. However, in some cases cancerous tissue can become intermingled with non-cancerous fibroids and go undetected.
Morcellation is one way to remove fibroids through a minimally invasive laparoscopic surgery. The morcellation device breaks the fibrous uterine tissue into many small fragments, which are then removed through a very small incision in the stomach.
The advantage of the laparoscopic power morcellation device is that patients heal faster, experience less bleeding and scarring, and hospital beds are freed up for other patients.
As we posted on our blog recently, there have been cases when morcellation has succeeding in spreading undetected cancerous tissue beyond the uterus, making it more difficult to treat. The J&J unit responsible for the Morcelex device suspended all sales of its morcellator following the issuance of a safety warning by the FDA. Ethicon Endo-Surgery Inc. has stated it will re-introduce the device, according to reports, once it receives further direction from the federal drug and medical device regulator.
According to court records, Brenda and George Leuzzi recently filed an action in federal court in New York alleging a diagnosis of cancer following a laparoscopic power morcellation hysterectomy in 2012. This procedure was robot-assisted.
“Defendants warranted that said product or products, including the Morcelex morcellator, were safe for use, which had the natural tendency to induce physicians and hospitals to use the same for patients and for patients to want to be treated with the same,” the Leuzzis said in their suit.
In response, a spokesperson for the manufacturer pointed out that, “Ethicon morcellation devices have always included cautions in their instructions for use,” said Sheri Woodruff, “about the potential spread of malignant, or suspected malignant tissue.”
Some hospitals have announced protocol changes regarding the use of morcellation in hysterectomy, fibroid removal or laparoscopic power morcellation myomectomy. Now, power morcellation will not occur unless the surgical team uses a bag in which to contain all fibroids and uterine tissue in order to prevent the spread of potentially cancerous tissue. Other hospitals have stopped using power morcellation altogether.
Power morcellation is still not banned, and the Ethicon Morcelex has not been formally recalled. However, Ethicon has suspended new sales of the device temporarily. Hospitals with power morcellators are free to continue using the device, or not, as they choose. Doctors should warn patients of the potential risks prior to undergoing laparoscopic power morcellation.
If you or a loved one have been adversely affected after undergoing laparoscopic power morcellation, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).