Power morcellators are medical devices widely used by gynecologic surgeons and other surgical specialists for the removal of noncancerous growths in the abdomen. Morcellators are most commonly associated with the treatment of uterine fibroids, either by removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy.) They have also been used to remove other organs, such as the kidney or spleen. Recently, the FDA has issued warnings against use of the devices after they have been linked with an increased risk for the spread of certain types of cancer.
Morcellation is a type of laparoscopic procedure that involves fragmenting tissue into smaller pieces so that they can be easily removed through small incisions. Laparoscopic procedures have been the preferred method of surgeons because they offer quicker recovery, less post-operative pain, and fewer wound complications than traditional open and invasive procedures.
Uterine fibroids, also called leiomyomas, are noncancerous growths that develop from the muscular tissue of the uterus. Nearly 80 percent of women will develop uterine fibroids before the age of 50, and most cause no symptoms. Some women, however, suffer symptoms like heavy or prolonged menstrual bleeding, pelvic pain or pressure, and frequent urination. When this is the case, medical intervention in the form of hysterectomy or myomectomy is indicated.
Using minimally invasive techniques to perform hysterectomies and myomectomies shorten recovery time and reduce the risk of complications. In order to remove large tissues from an incision no more than 2 cm, the tissue must be morcellated, or broken into tiny pieces. Originally performed by use of a surgeon’s laparoscopic scalpel, newer methods include the use of a power morcellator that uses tiny rotating blades to shred the lesion so that it can be vacuumed through a small port incision.
Morcellators are particularly well-suited to remove non-cancerous tissues, but are not recommended for use in tumors known to be cancerous. This is because the velocity with which the blades break apart the tissues may cause microscopic tumor fragments to be dispersed throughout the abdominal cavity where they can begin to grow again.
According to the most recent information by the FDA, as many as one in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of cancer that includes the rare and highly aggressive leiomyosarcoma. These cancers can be difficult to diagnose prior to surgery, as they can mimic the appearance of benign uterine fibroids in medical imaging.
The use of power morcellators has also been linked to the spread of other cancers, including ovarian, renal, and endometrial carcinomas. Moreover, morcellators can lead to significantly lower long-term survival rates and poorer quality of life.
In addition to the risk of spreading cancer, morcellators have also been found to cause other complications. A review of the Manufacturer and User Facility Device Experience (MAUDE) found at least 55 complications, including six deaths, attributed to the devices. Injuries caused by the morcellator blade involved almost every organ in the abdominal cavity, including the small and large intestines, bladder, kidney, vena cava and aorta. Most of these injuries were attributed to surgeon inexperience.
The U.S. Food and Drug Administration (FDA) issued warnings to the medical community in April 2014 discouraging the use of morcellators in uterine procedures. In response, Johnson & Johnson suspended worldwide sales of its laparoscopic power morcellators and later pulled them from the market all together.
In November 2014, the FDA issued a safety communication that included a Black Box Warning to the extreme dangers posed by power morcellators. The warning stated that the devices should not be used in the majority of cases in women with uterine fibroids, as the risk does not outweigh any potential benefits. Doctors are instructed to inform their patients of these risks and discuss with them the possibility of alternative treatment.
If you or a loved one has suffered injury or been diagnosed with cancer following a procedure performed with an electric morcellator, a personal injury lawsuit may help you get the justice you deserve. New Jersey personal injury lawyers at Eichen Crutchlow Zaslow & McElroy, LLP have obtained hundreds of millions of dollars in settlements and verdicts on behalf of clients harmed by the negligence on the part of another person or due to medically defective product.
For your free case review and to discuss your options with one of our knowledgeable and highly skilled medical malpractice lawyers in New Jersey, call today at 732-777-0100 or contact us online. We have offices in Edison, Red Bank, and Toms River, allowing us to serve clients throughout New Jersey.