A Boston couple behind a campaign to stop doctors from performing a controversial surgical procedure is applauding a new U.S. Food and Drug Administration warning against doctors performing the procedure called laparoscopic power morcellation.
The FDA want doctors to stop using laparoscopic power morcellation during the removal of the uterus or uterine fibroids since it poses a risk of spreading unsuspected cancerous tissue beyond the uterus.
The procedure involves a small metal device that shreds tissue, in this case fibroids or the uterus, which is then removed through a small incision in the abdomen. The surgical technique came under scrutiny last December after two cases came to light where the women undergoing the procedure had undetected cancer cells spread through their body during the surgery.
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One of those cases involved Dr. Amy Reed, 41, an anesthesiologist at Beth-Israel Hospital in Boston. Reed underwent a laparoscopic hysterectomy morcellation last fall. During the procedure undetected cancer cells were spread through her abdomen. A few days after her surgery she was diagnosed with a stage IV cancer called leiomyosarcoma.
According to the FDA statement, approximately 1 in 350 women who are having a hysterectomy or myomectomy (to remove uterine fibroids) have an undetected type of cancer called uterine sarcoma. The morcellation of this tissue could lead it to spread throughout the abdomen.
Since her diagnosis, Reed and her husband Hoorman Noorchashm, a surgeon at Brigham and Women's Hospital in Boston, have launched a campaign to get doctors and hospitals to stop using the procedure including a Change.org petition with nearly 8,000 signatures and meeting with politicians and writing to different gynecological and surgical organizations in the medical community.
Noorchashm said he has been disappointed with some initial reactions from hospitals and medical staff but 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. "What helped here was the sheer magnitude of the truth here…I just didn't stop. I've been generating somewhere between three to ten emails a day since November."
Since Reed's diagnosis, two medical articles have been published in the Journal of American Medical Association questioning the safety of 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."
In a statement, the FDA confirmed that Noorchashm brought the issue to their attention last December.
"After further discussion, we involved staff from across the agency to look into the issue further," The FDA told ABC News in a statement.
At least two Boston hospitals have changed their approach to the technique in the last few months, although they still would allow some morcellation in rare cases and they were investigating the use of encasing tissue in a plastic bag before morcellation.
The FDA will hold a committee meeting to see if encasing tissue in a bag before morcellation can be a safe alternative. Noorchashm points out the bag can easily break if it comes into contact with the morcellation device.
Noorchashm, who is a cardio-thoracic surgeon, said he has been in touch with many other families who have had similar experiences and wants more regulation on medical devices in general to protect patients. Although he said he was gratified by the FDA's decision, he said more still needs to be done to protect patients including more oversight and medical transparency.
Since Reed's disease has stabilized, Noorchashm said she plans to return to work as an anesthesiologist in June in Philadelphia where they can be closer to extended family. While Noorchashm plans to continue with his work drawing attention to the danger of morcellation, he says he hopes to get back to normal life soon.
"It's a diagnosis where it hangs over your head. Failure is not an option, we have six kids with bright futures," said Noorchashm. "I'm going back to normal and I'm going back to work."
Source : http://abcnews.go.com/Health/couple-campaign-stop-surgical-procedure-applauds-fda-decision/story?id%3D23369823
