Power morcellators are medical devices commonly used to remove fibroids and other noncancerous growths in the abdomen. Used primarily for hysterectomies and myomectomies (removal of fibroids), they have also been used to remove other organs such as the kidney or spleen. While the use of this device, with its small point of entry, results in a quicker post-operative recovery in many patients, the U.S. Food and Drug Administration (FDA) has since warned against the use of power morcellators in the treatment of uterine fibroids. According to a “Safety Communication” from the FDA, power morcellators may increase the risk for spreading undetected cancer cells throughout the body.
Uterine fibroids are very common among women under the age of 50. While they are not life threatening, they can cause heavy bleeding, severe pain and have a significant impact on a woman’s quality of life. For many women, a hysterectomy or myomectomy is the medical option recommended by their physician. The power morcellator uses tiny, rotating blades to excise the tissue into smaller pieces, which are then suctioned out of the body via a small port incision.
Power morcellators are very effective at removing non-cancerous tissue like fibroids. However, there is a disturbing link between the use of morcellators and the spread of undetected cancerous cells. During the surgical procedure, the blades of the device break apart the tissue. If cancerous cells are present, it can send microscopic tumor fragments into the abdominal cavity where the cancer cells can grow at a rapid rate.
According to the FDA, approximately one in 350 women who are diagnosed with fibroids have undiagnosed cancer, including the rare and highly aggressive leiomyosarcoma. Unfortunately, these cancers often mimic benign uterine fibroids and can be difficult to diagnose with medical imaging. In addition to leiomyosarcoma, morcellators can spread ovarian, renal and endometrial cancer at a rate that can significantly lower a patient’s quality of life and long term survival rate.
In 2014, the FDA issued a document stating the use of gynecologic power morcellators should not be used in uterine procedures. As a result, device manufacturers must include warnings on all packaging, clearly stating that morcellators can spread tissue containing undetected cancer cells. The packaging must also clarify that the medical device should not be used in peri or post-menopausal women, or those who are candidates of alternative methods of hysterectomies or myomectomies. Finally, the packaging must also clearly state that power morcellators should not be used in tissues that are “known or suspected to be cancerous.”
According to a report published by The Wall Street Journal, research shows that power morcellators may cause the spread of more types of cancer than previously thought. Dr. Jason D. Wright, Director of Gynecologic Oncology at the Columbia University College of Physicians and Surgeons, and one of the key authors of the study, said physicians test patients prior to surgery to rule out endometrial cancer, which originates in the uterine lining. Unfortunately, there are few symptoms and it is not always detectable with current testing methods. He continued by saying that, at the time of morcellation, the risk of sarcomas, endometrial cancer and other gynecologic cancers is a very real concern.
For the many women who suffer from fibroids, there are other treatment options available that are potentially safer, less invasive and do not run the risk of spreading undetected cancer cells. Traditional hysterectomy and myomectomy procedures, laparoscopic hysterectomy without morcellation, vaginal hysterectomy, drug therapy and high-intensity focused ultrasounds are all safe, viable options for women suffering from fibroids, according to the FDA.
If you or someone you love has been seriously injured or diagnosed with cancer following a routine gynecologic procedure using a power morcellator, you are urged to contact our Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler. We have a proven track record of obtaining the maximum financial compensation for our clients. We will not stop fighting until the negligent party is held responsible and justice has been served.