“I am someone whose wife is affected by this. That fueled my fire for sure, but as a physician and as a citizen, how can you live with the understanding that mothers, daughters and sisters are laying on operating tables and this procedure is causing their cancer to spread,” says Dr. Noorchashm. “For me this is an unwelcome fight I did not go looking for. It became a responsibility to public health. I started to hear more and more stories.”
In October of 2013, Dr. Reed was suffering some abdominal pain and bleeding due to fibroids in her uterus. There was no reason to believe she might have cancer. Fibroids in the uterus are a common gynecological problem that can be remediated by removing the tumors.
Removing the fibroids through open surgery, which is costly, involves a long recovery time and carries the risk of wound infection, and gynecological surgeons have for the last two decades routinely opted for laparoscopic (minimally invasive) uterine surgery via power morcellator to do hysterectomies and myomectomies (uterine fibroid removal). A small incision is made into the uterus and the device literally morcellates (grinds up) the tissue and extracts it.
The problem is that sometimes there is undetected cancer lurking in one or more of those fibroids. The power morcellator literally upstages the cancer, literally spraying the cancer cells into the abdominal cavity and pelvic area.
“If you had a stage-one-contained leiomysosarcoma (LMS) contained in the uterus and you take it out in one piece, intact with good margins, there is a very good chance you can cure that patient,” says Dr. Noorchashm, who is a trained and certified cardiac surgeon. “These folks have been violating that principle and causing premature deaths for over two decades. This is a systemic medical error and continuing this is a systemic ethical error.”
As a result of Dr. Noorchashm’s campaign against power morcellation and as a result of recent scientific studies, the FDA has warned that the use of power morcellators “may contribute to the spread and upstaging of unsuspected uterine cancer in women undergoing hysterectomy and myomectomy for fibroids.” (FDA Nov. 24, 2014.)
An FDA review of published and unpublished literature estimates that the “prevalence of unsuspected uterine leiomysosarcoma is 1 in 352.” The FDA went on to write that this number was higher than previously understood.
A JAMA (Journal of the American Medical Association) study published July 22, 2014 by Jason Wright, MD, chief of the division of gynecologic oncology and associate professor at Columbia University College of Physicians and Surgeons, looked at the insurance records of more than 250,000 women, including 36,470 women whose surgery involved morcellation. The study found 99 cases of uterine cancer, particularly in older women.
“This is a global problem, this is not just in the United States. This has gone on all over the world. It has been going on in Europe, in Australia, in Canada, in South America,” says Noorchashm.
“This is a global health hazard.”
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Dr. Noorchashm is also critical of the FDA process for approving medical devices. “There is no safety testing of medical devices and there is no surveillance of outcomes,” notes Noorchashm.”The legislation governing these devices does not in any way ensure the safety of patients.
“My wife is doing okay,” says Dr. Noorchashm. “She’s had a big damage control operation and she is in remission, but the battle still rages on.”
Dr. Noorchashm and Dr. Reed have six children. The youngest is two years old.