Uterine fibroids or leiomyoma are benign growths of muscle in the uterus and are very common. When they become symptomatic, they require treatment, often surgical removal. About 200,000 women in the United States each year have a hysterectomy (removal of uterus) for fibroids. Another 34,000 have surgery to remove the fibroid without removing the uterus (myomectomy).
These operations can be performed either with an abdominal or vaginal open incision or laparoscopically. The use of a laparoscope requires smaller incisions and usually a shorter hospital stay and quicker recovery. For this reason, the use of laparoscopy to treat uterine fibroids has been increasing.
In 1995, the FDA approved a device called a power morcellator for use in laparoscopic surgery including hysterectomy and myomectomy for uterine fibroids. These devices cut the uterus or fibroid tissue into small pieces to allow ease of removal through the laparoscopy tube. At present, there are about two dozen morcellators approved for this use.
Power morcellators, in cutting the tissue into small pieces, leave small fragments behind. The FDA has estimated that “…unsuspected uterine sarcoma [is found] in 1 in 352 women and an unsuspected LMS (leiomyosarcoma) [is found] in 1 in 498 women undergoing hysterectomy or myomectomy….” Both of these are cancerous tumors.
These two facts together led to an April 17, 2014 FDA warning:
“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 likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication
FDA’s Deputy Director for science, Dr. William Maisel, stated that, “[T]here is no reliable way to determine if a uterine fibroid is cancerous prior to removal.” FDA NEWS RELEASE
Before the FDA’s warning, some surgeons and hospitals had used a specimen bag in combination with the power morcellator in an attempt to contain fragments. Dr. Maisel commented on this as well:
“It’s important for people to understand that the use of the specimen bag is not a panacea. It will not completely remove the risk because the tissue can spread before placed in the specimen bag, the specimen bags can occasionally tear or perforate. And so it is not a complete removal of the risk. And in addition there are some who aren’t trained in the use of specimen bags, the specimen bags can obstruct the view of the operative field. There are occasional rare reports of organ damage that can occur during a use of a specimen bag.”
FDA Media Call on a Safety Communication on the Issue of Laparoscopic Power Morcellation for Removal of the Uterus or Uterine Fibroids
What prompted the FDA action was growing concern in the medical community leading to articles published in the Journal of the American Medical Association in March, 2014. These articles followed the well-publicized case of Amy Reed, the Beth Israel Deaconess anesthesiologist, whose uterine cancer is thought to have been spread by the morcellation procedure. (USA TODAY)
Power morcellators were approved by the FDA for use with uterine fibroids through its 501k process. This meant that they did not go through pre-market approval testing but were approved as based on “substantially equivalent” devices already in use. As a consequence, the manufacturers of power morcellators are not protected by the federal preemption doctrine and can be sued for defects in the devices or their accompanying warnings and instructions. SUGARMAN attorneys are investigating possible claims relating to morcellators. If you or a member of your family has developed advanced cancer after being treated for uterine fibroids with a power morcellator, please fill out a Contact Form, call us at 617-542-1000 or e-mail info@sugarman.com.