Uterine Fibroid Removal Cancer Risk is “Substantially Higher” Than Originally Presumed
A Boston doctor whose wife is battling leiomyosarcoma cancer spread by a power morcellator, is sharply criticizing recent media reports that suggest the incidence of cancer among women undergoing uterine fibroid removal is “low”.
A Bloomberg News article picked up by several media outlets over the past week features the headline “Cancer Risk Low in Women With Fibroids Removed Using Morcellators.” However, Dr. Hooman Noorchashm has described the headline as “extremely misleading” and dangerous to public health.
The reports outline the findings of a study published last month in the medical journal JAMA Oncology, which examined the incidence of unsuspected cancer among women who underwent uterine fibroid removal surgery, with or without the use of power morcellators.
The controversial devices have been widely used during laparoscopic uterine fibroid removal, to provide a minimally invasive surgery. However, over the past few years, concerns have emerged about the risk that power morcellators may spread undiagnosed cancers throughout the body, rapidly upstaging aggressive uterine cancers like leiomyosarcoma or endometrial stromal sarcoma.
In a comment posted on a version of the Bloomberg News report published by the Daily Herald, Dr. Noorchashm indicates that “[t]his article has done a grave disservice to many women by its undeniable mischaracterization, using the word “low” risk in referring to morcellation.”
Noorchashm points out that until late 2013, the gynecological community widely assumed that only about 1 in 10,000 women with symptomatic uterine fibroids may have unsuspected sarcoma, leading to the assumption that fibroids are benign. However, this has lead to deadly consequences for many women, and Noorchashm indicates that the actual risks are “astronomically higher (up to 60 times higher) than previously assumed.”
The underlying study published in JAMA Oncology found that uterine cancer was present in 1 out of 528 women who underwent myomectomy procedures without the use of power morcellators, and in 1 out of 1,073 who did undergo uterine fibroid removal with morcellation. They found that the rate of any pathologic finding, such as cancer, endometrial hyperplasia or questionable tumors, in women who did not get morcellation was 1 in 150 and 1 in 230 for women who did get morcellation.
The researchers also concluded that the prevalence of cancer in women who undergo uterine fibroid removal appears to increase with age, leading to the recommendation that power morcellators should be used with caution.
Noorchashm began fighting against the use of power morcellators after his wife, Dr. Amy Reed, was diagnosed with leiomyosarcoma following uterine fibroid removal with morcellation. The couple has launched a petition calling for morcellator recalls to be issued, which has garnered tens of thousands of signatures.
Uterine Fibroid Morcellation Cancer Risk
Concerns about the risk of morcellators spreading cancer following a laparoscopic hysterectomy or uterine fibroid removal gained widespread attention within the medical community in April 2014, when the FDA announced that it was investigating the risk and warned doctors to avoid uterine fibroid morcellation after estimating that 1 out of every 350 women may have unsuspected sarcoma.
An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
In recent months, a growing number of women and families nationwide have been filing uterine fibroid removal cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have been provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.