A power morcellator is a surgical instrument used in laparoscopic surgery to divide and remove large masses of tissues. It is most often a hollow cylinder that is inserted into the abdominal wall. A grasping instrument is inserted into the cylinder to cut out a piece of the mass and pull it back out of the morcellator.
When first introduced to the medical community, the morcellator had a handle a surgeon or a surgical assistant could squeeze to grasp the pieces of the tissue mass. In 1993, a power morcellator was introduced in the United States and is commonly used to remove the uterus and/or fibroid tumors in a hysterectomy or myomectomy surgical procedure. This surgical instrument has also been used in other organ surgeries.
There are approximately 24 devices approved by the Federal Drug Administration for laparoscopic power morcellation, with Ethicon, a subsidiary of Johnson & Johnson, as the largest maker of the devices. Other makers include Blue Endo, Karl Storz and Olympus.
According to a warning issued on April 17, 2014 by the FDA, when a power morcellation is used on women with uterine fibroids during a hysterectomy or myomectomy, there is a risk of occult cancerous tissues spreading beyond the uterus.
Uterine fibroids are non-cancerous growths that begin at the wall of the uterus. The National Institute of Health reports that most women will develop fibroids in their uterus at some point. Most do not cause problems, but sometimes, surgery is required to remove fibroids because of symptoms such as prolonged or heavy menstrual bleed, pelvic pain or pressure and frequent urination.
The FDA analyzed the most current data available and determined that about 1 in 350 women who have a myomectomy or hysterectomy for fibroids have a type of uterine cancer called uterine sarcoma. In these women, laparoscopic power morcellation can spread this cancerous tissue around the pelvis and abdomen. Other types of cancer spread by power morcellation include leiomyosarcoma and myelosarcoma. The spreading of cancerous tissues increases the women’s chances of experiencing life-threatening complications, including premature death. There is no way to tell, according to the FDA, if a uterine fibroid is cancerous before it is removed.
According to an article in March 5, 2014 edition of the Journal of the American Medical Association, unexpected uterine sarcomas were reported in 13 women after 5,666 patients underwent uterine surgery from 1983 through 2010. There were 1,192 women who underwent morcellation, and two were diagnosed with sarcoma that had spread to the abdomen.
Specialists at Boston’s Brigham & Women’s Hospital reported that the rate of unexpected uterine sarcoma is nine times higher than what surgeons are telling their patients. The researchers looked at the records of 1,000 women who underwent surgery for fibroids and morcellation was used. According to one peer-review scientific journal, PLOS One, the researchers wrote that, “These data suggest uterine morcellation carries a risk of disseminating unexpected malignancy with apparent increase in mortality much higher than appreciated currently.”
At least a half-dozen lawsuits have been filed against the manufacturers of power morcellators, other entities and individuals. The women allege they were never warned about the possibility of cancer spreading if the device was used in fibroid surgery or a hysterectomy.
One woman has filed a lawsuit against Ethicon Endo Surgery, Inc. She is currently undergoing chemotherapy for uterine cancer after she underwent surgery where a morcellator was used. A federal lawsuit has been filed by the estate of a woman who died of cancer after she underwent a hysterectomy where a Lina Xcise power morcellator was used.How Can an Attorney Help?
On April 30, 2014, Johnson & Johnson’s Ethicon division stopped all promotion and sales of their power morcellators because of the increased risk that these popular surgical devices could spread cancer. The FDA announced on June 9, 2014 that an advisory panel to the federal agency will meet next month to discuss the regulatory status and safety of power morcellators.
If you have been diagnosed with cancer after undergoing a medical procedure involving a power morcellator, you may have a right to compensation. You should contact an attorney experienced in medical litigation. This will ensure that you receive a proper evaluation by a medical expert. You may be eligible to receive a monetary award for economic and non-economic losses resulting from the use of this dangerous medical device.
If you have lost a loved one to cancer because of the use of a power morcellation, an attorney can provide valuable advice as to your legal options. While financial compensation will not bring back your loved one, it could hold the manufacturers and other entities accountable for your loss.
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FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids