“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.”