To the U.S. Food and Drug Administration, the risk that a uterine fibroid surgical treatment poses is worthy of a warning. But cardiothoracic surgeon Dr. Hooman Noorchashm has made banning the procedure, which is known as laparoscopic power morcellation, a crusade.
Noorchashm's wife, Dr. Amy Reed, who is also a physician, believes laparoscopic power morcellation spread her hitherto undetected cancer when she underwent a hysterectomy in 2013.
Noorchashm sent a letter to President Barack Obama, to FDA Commissioner Dr. Margaret A. Hamburg, to representatives of the medical device industry, and to physicians' organizations. It stated simply, "Place an immediate moratorium on intracorporeal uterine morcellation during minimally invasive hysterectomy, on all gynecological tissue morcellation devices and any devices used to morcellate the uterus intracorporeally in the United States and Abroad. It is your high duty to first, do no harm."
In his call for petition signatories urging a power morcellation ban, Noorchashm wrote, "This problem has been recognized for more than two decades. A review of the literature, by the Food and Drug Administration, revealed that 1 in 350 women who go for fibroid surgery actually have sarcoma. This means that every day 2-5 women in the U.S. - and more around the world [-] are susceptible to having a deadly cancer spread because of morcellation. This catastrophic problem has happened in my family and we are fighting to stop this dangerous activity called morcellation..."
Laparoscopic power morcellation is an operation in which a surgical device divides fibroid tissue into smaller pieces so that they may be removed through small incisions.
Stopping short of a ban, the FDA explained in April 2014, following a literature review, "When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus."
In November 2014, again pumping the brakes instead of banning the procedure, the FDA strengthened its advisory, stating, "In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women."
The agency slapped a "boxed warning" on the procedure to this effect: "Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices." The FDA further advised restrictions on who should receive the procedure.
There's more data to crunch on this type of surgery.
For instance, the international journal Gynecologic Oncology released in November 2014 a literature review that researchers in Italy conducted. The highlights of their report on the risk of recurring cancer are as follows:
"Intra-abdominal morcellation of unexpected leiomyosarcoma is related to a 4-fold increase in intra-abdominal recurrence rate."
"Owing to the limited evidence about the effects of morcellation on patients with undiagnosed leiomyosarcoma, further studies are warranted."
A woman who suspects that her cancer diagnosis may be related to undergoing a laparoscopic power morcellator procedure may be entitled to compensation. For a free consultation on what legal options may be available, turn to the experienced product liability attorneys at Reich & Binstock. The law firm operates in all 50 states.
Contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through the form located on this web page.