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FDA warns against procedure to remove uterine fibroids; says it could spread hidden cancer | FDA warns against procedure to remove uterine fibroids; says it could spread hidden cancer |
(about 2 hours later) | |
The Food and Drug Administration on Thursday took the rare step of warning against a surgical procedure commonly used to remove uterine growths, saying that the practice risks spreading hidden cancers within a woman’s body. | The Food and Drug Administration on Thursday took the rare step of warning against a surgical procedure commonly used to remove uterine growths, saying that the practice risks spreading hidden cancers within a woman’s body. |
Laparoscopic power morcellation involves inserting a device through a small incision in the abdomen to slice up uterine tissue, which is then removed through the incision. It is intended to be quicker and far less invasive than more traditional abdominal surgery. | Laparoscopic power morcellation involves inserting a device through a small incision in the abdomen to slice up uterine tissue, which is then removed through the incision. It is intended to be quicker and far less invasive than more traditional abdominal surgery. |
But the FDA on Thursday agreed with a growing number of researchers who have questioned the procedure, saying that it could slice up cancerous tissue that then could spread beyond the uterus. | |
During their lifetimes, many women develop uterine fibroids — growths that originate from the smooth muscle tissue in the wall of the uterus. While many cause no problems, others can cause issues such as frequent urination, prolonged menstrual bleeding and pelvic pain. | During their lifetimes, many women develop uterine fibroids — growths that originate from the smooth muscle tissue in the wall of the uterus. While many cause no problems, others can cause issues such as frequent urination, prolonged menstrual bleeding and pelvic pain. |
While most fibroids are non-cancerous, the FDA said current data shows that about 1 in 350 women who undergo a procedure, such as a hysterectomy, to remove uterine fibroids has an unsuspected type of cancer known as uterine sarcoma. If laparoscopic power morcellation is performed in those cases, the procedure has the potential to spread the cancer within the pelvis and abdomen, “significantly worsening the patient’s likelihood of long-term survival,” the agency said. | While most fibroids are non-cancerous, the FDA said current data shows that about 1 in 350 women who undergo a procedure, such as a hysterectomy, to remove uterine fibroids has an unsuspected type of cancer known as uterine sarcoma. If laparoscopic power morcellation is performed in those cases, the procedure has the potential to spread the cancer within the pelvis and abdomen, “significantly worsening the patient’s likelihood of long-term survival,” the agency said. |
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, said in a statement Thursday. | “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” William Maisel, chief scientist at FDA’s Center for Devices and Radiological Health, said in a statement Thursday. |
Therefore, the agency decided to discourage use of the practice altogether, noting that other treatment options exist. The agency also said it plans to hold a public meeting to discuss the practice in the future. | Therefore, the agency decided to discourage use of the practice altogether, noting that other treatment options exist. The agency also said it plans to hold a public meeting to discuss the practice in the future. |
The issue has gained increased attention recently, thanks in large part to the outspokenness of a Massachusetts couple, both doctors, who wrestled with the problem first-hand. | The issue has gained increased attention recently, thanks in large part to the outspokenness of a Massachusetts couple, both doctors, who wrestled with the problem first-hand. |
Amy Reed, a doctor and mother of six, was diagnosed with a rare form of uterine cancer after undergoing the morcellation procedure. Her husband, Hooman Noorchashm, a Harvard-affiliated cardiothoracic surgeon, has undertaken an aggressive campaign to ban the widely used procedure. He has sent countless e-mails to regulators and doctors throughout the medical field, and the couple has started a Change.org petition to bring an end to the practice. | Amy Reed, a doctor and mother of six, was diagnosed with a rare form of uterine cancer after undergoing the morcellation procedure. Her husband, Hooman Noorchashm, a Harvard-affiliated cardiothoracic surgeon, has undertaken an aggressive campaign to ban the widely used procedure. He has sent countless e-mails to regulators and doctors throughout the medical field, and the couple has started a Change.org petition to bring an end to the practice. |