The apparent risk of spreading undetected cancerous tissue has put surgeons considering the use of laparoscopic power morcellation, an electronic method of removing the uterus or uterine fibroids, in a quandary.
In the November issue of The Oncologist, which is a medical journal, Harvard Medical School researchers wrote about this risk-balancing act that doctors considering using power morcellation must perform.
They explain from the outset of their article, "There is a risk of dissemination of uterine malignancies during minimally invasive hysterectomies when morcellation is used. Although the technique of uterine power morcellation allows timely removal of large benign tumors through small laparoscopic incisions, there are concerns about iatrogenic spread of cancers and reduced survival for women with preoperatively unrecognized malignancies."
So what do the surgeons do? Well, if something in there could be cancerous, think carefully whether power morcellation is worth the risk, many physicians reason.
"Preoperative assessment of uterine masses or abnormal uterine bleeding must include understanding of the limitations of an endometrial biopsy and imaging studies to evaluate the possibility of a uterine malignancy," the authors conclude. "Minimally invasive surgery using morcellation of benign uterine growths is well established and safe; however, alternative surgical techniques to morcellation must be considered when the malignant potential of a uterine mass is uncertain. Morcellation carries the risk of widespread peritoneal seeding of an unrecognized uterine malignancy."
Laparoscopic power morcellators, according to the U.S. Food and Drug Administration, are medical devices used during different types of laparoscopic (minimally invasive) surgeries such as hysterectomy and myomectomy in which tissue is divided into smaller pieces or fragments to facilitate their removal through small incision sites.
Tuesday, the 24th, will mark the first anniversary of the FDA's warning against the use of power morcellators for these procedures.
"Based on an FDA analysis of currently available data," the agency announced Nov. 24, 2014, "we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma. If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood."
Injured patients in the U.S. have attempted to recover medical expenses and other losses by filing power morcellator lawsuits. Johnson & Johnson's Ethicon division is one of the defendants. Indeed, the U.S. Judicial Panel on Multidistrict Litigation, which is a panel of judges, centralized the Ethicon power morcellator lawsuits before a single judge in Kansas for ideally more efficient and coordinated pretrial proceedings.
"These actions," the panel wrote, "involve common factual questions surrounding the design, testing, manufacture, and marketing of Ethicon's power morcellators, including the warnings accompanying those devices and whether they should have included a bag to contain tissue. Most actions also involve common factual questions regarding the risk that women undergoing hysterectomies and myomectomies had occult cancer, and what Ethicon knew about that risk and when."
A case filed in April in a Georgia federal court illustrated what many of these power morcellator victims have undergone; Ethicon was one of the defendants.
The patient underwent a power morcellator hysterectomy in January 2011. Her pre-surgical evaluation "showed no evidence of disseminated or metastatic cancer," according to court documents. The patient wasn't warned about the cancer risk.
A biopsy during surgery showed a form of "endometrial" cancer. She was treated for that, and she thought that she was cancer-free until April 2013. That was when the patient underwent an exploratory procedure showing that the cancer was back - and much worse. "She was diagnosed with a recurrence of metastatic endometrial sarcoma, involving the pelvis and left anterior abdominal wall through the peritoneum."
Any woman who has undergone a uterine power morcellator procedure and who since was diagnosed with cancer should know what her legal options are. All she has to do is call the power morcellator attorneys at Reich & Binstock for a free consultation at 1-866-LAW-2400.