Unfortunately, fibroid tumors among women are not uncommon. Often times to correct the problem, surgery may become necessary. This procedure is normally done laparoscopically, but can at times require a partial or full hysterectomy. In the last 20 years there have been incredible advances in surgery methods and treatment for women in need of medical assistance.
A power morcellator is a device that assists surgeons in removing fibroid tumors from a woman’s uterus. It is basically small rotary blade and a vacuum. This tool enables doctors to reach the tumor and dissect it into small pieces, so it can be easily removed through a small incision. It is also used to efficiently sever muscles during a hysterectomy.
Fibroids are benign smooth muscle growths that are found in the uterus, known as leiomyomas. It is estimated that 50 to 80% of women will deal with fibroids during their lifetime. They are often asymptomatic, but can occasionally cause pain and bleeding, making surgical removal necessary.
The advantage of using this device is that its use requires smaller incisions that allow for quicker healing by the patient. Unfortunately, it is becoming evidence that there are serious side effects from using this device. It appears that the device also can aid in the spread of cancer.
The data regarding their use states that 1 in 350 women having a myomectomy or hysterectomy for fibroid removal experience an unanticipated uterine sarcoma (cancer). If a morcellator is used, there is an increased risk that the procedure will disseminate the tissue to nearby organs. . There is that there is no way to detect the presence of cancer before the surgery takes place. If the tumor is benign, the tissue can cause more fibroids, adenomyosis and endometriosis. If the tumor is cancerous, the use of the morcellator can cause leiomyosarcoma, carcinomasarcona, endometrial adenocarcinoma and endometrial stomal carcinoma.
The Center for Disease Control states that there are approximately 600,000 hysterectomies performed annually. Ethicon (a subsidiary of Johnson and Johnson) is a lead manufacturer in the morcellator. Johnson and Johnson has announced an official recall of the device, which comes on the heels of the Federal Food and Drug Administration discouraging the use of this tool. This includes all Johnson and Johnson morcellator products including Gynecare Morcellex, MorCellex Signma, and Gynacare X-Tract. Some hospitals have suspended their use, and one insurance carrier will not cover procedures using this device. They report that there is a link between the use of the morcellator in myomectomies and hysterectomies and the spread of undetected cancer.
Last June, a study was released in the Journal of the American Medical Association stating that “uterine pathology in women undergoing minimally invasive hysterectomies using morcellation prompted the company to do a recall of the device.”
The FDA called for a meeting after issuing a safety alert regarding the device. The FDA sought feedback and recommendations from their panel as to whether a black box warning was appropriate. They also discussed changing the categorization of this device from a “class 2” to a “class 3” device (class 3 represents the highest degree of risk).
Lawsuits are currently being filed against the manufacturers of the morcellator. Missouri personal injury lawyers claim that women were diagnosed with cancer after surgery where a morcellator was used. In one instance, a man claims his wife had a surgery in 2012. He claims that she did not have cancer prior, but was diagnosed with leiomyosarcoma 10 days later. Sadly, she died in February 2013.
Many other lawsuits have followed, claiming that the manufacturer knew, or should have known of the risk that using a power morcellator involves.
If you or a loved one has undergone surgery using a morcellator and have subsequently been diagnosed with cancer, contact The Bradley Law Firm for evaluation and legal guidance.