While cancer warriors attested to the tool's role in promoting the spread of cancer throughout their bodies, the Food and Drug Association reportedly found only inconsequential evidence absolving the grinding and grasping morcellation tool from the accusations raised against the surgical instrument when the association's advisory panel convened for a two-day inquiry into the matter.
Primarily used to perform hysterectomies or to remove uterine fibroids, the FDA has officially disproved use of the laparoscopic power morcellation tool. Women should be presented with a waiver that ensures they understand the risks of the power morcellation tool, before undergoing a procedure in which the instrument will be employed, the FDA reportedly recommended months before it convened for a hearing on the issue.
An outspoken advocate for initiating a ban on morcellation tools, Walter Reed medical center's Craig Shriver stated before the FDA's advisory panel that there wasn't presently any safe way to use morcellation in gynecological surgery. He said containment devices and other safety measures couldn't effectively mitigate the risk associated with the use of the tool.
Though the FDA has continued to investigate the controversial tool, its first and foremost concern has remained the well-being of patients, stated William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health.
"There is no reliable way to determine if a uterine fibroid is cancerous prior to removal," stated Maisel. "Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals."
Before the July 11 review, held by the FDA's advisory panel, the administration announced on April 17 its official stance against the use of morcellation tools and cited evidence it reviewed in when looking into the matter. The FDA said it concluded that roughly 1 in every 350 women who undergo a procedure for the removal of a uterus or uterine fibroids have uterine sarcoma, a form of cancer, and risk awakening it when undergoing a procedure in which morcellation is used.
"If laparoscopic power morcellation is performed in these women, 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," stated the FDA on April 17.
Debra Valverde, of Arvada, Colo., said she was treated with a morcellation tool. She said the procedure made her cancer worse and brings her to tears every day since, as she contemplates the lives of children and 82-year-old father without her.
"I am waiting to die. I am counting the days. I beg you, please stop morcellation," said Valverde.
