The Food and Drug Administration has issued a warning about a common type of hysterectomy procedure following a Boston couple’s campaign to spread awareness about the surgery’s cancer-causing effects.
The FDA has advised doctors to stop using laparoscopic power morcellation to remove the uterus or uterine fibroids, ABC reports. The procedure, which involves shredding tissue with a small metal device that is then removed from an incision in the abdomen, has repeatedly spread cancerous tissue beyond the uterus.
Two cases of women who were diagnosed with cancer almost immediately following the procedure came to light last December.
41-year-old Dr. Amy Reed, 41, an anesthesiologist at Beth-Israel Hospital in Boston, underwent the procedure last fall. Just a few days later, she was diagnosed with stage IV leiomyosarcoma, a type of cancer. Undetected cancer cells had spread through her abdomen, a direct consequence of the hysterectomy.
The FDA said in its statement that 1 in 350 women who have a hysterectomy or myomectomy, a procedure to remove uterine fibroids, have an undetected type of cancer called uterine sarcoma which can be spread through the procedure.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said Dr. William Maisel deputy director for science and 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.”
Reed and her husband, surgeon Hoorman Noorchashm, launched a campaign to stop the procedure, meeting with politicians and contacting gynecological and surgical organizations. A Change.org petition gained nearly 8,000 signatures.
Noorchashm called the FDA decision a “major step forward.”
“The major accomplishment is going to be 10 years from now when Amy is cancer-free,” said Noorchashm, who has six children with his wife. “What helped here was the sheer magnitude of the truth here…I just didn’t stop.”
While the response was initially poor, there have since been two medical articles have been published in the Journal of American Medical Association raising questions about the procedure’s safety.
Diana Zuckerman, president of the nonprofit National Research Center for Women & Families, anticipates a major impact form the FDA's warning.
"What surgeon is going to take the chance of using this device if the FDA has made such a strong warning?" Zuckerman told the Wall Street Journal. The statement, she said, "is going to save a lot of lives."