Fibroid Surgery Morcellators Removed From Market Due to Cancer Risk
Johnson & Johnson’s Ethicon subsidiary has indicated that it will stop selling power morcellators used for uterine fibroid removal surgery, amid concerns that use of the devices during minimally invasive laparoscopic hysterectomy and myomectomy procedures may carry a risk of spreading cancer.
The company, which has sold uterine fibroid surgery morcellators since 1998, has halted sales and stopped promoting and distributing the devices following an April 17 FDA warning, which urged doctors to avoid use of the devices due to the risk of spreading sarcomas that may be contained within the uterus prior to the procedure.
Although many hospitals have announced that they will no longer be performing laparoscopic hysterectomy or fibroid removal surgery with morcellators, Johnson & Johnson has indicated that it is not recalling the devices at this time.
On the Ethicon website, in its section for healthcare professionals, the company announced that: “In light of an April 17 FDA public safety communication, Ethicon has suspended sales, distribution, and promotion of its morcellation devices while the role of morcellation with symptomatic fibroid disease is redefined by the FDA and the medical community.”
Johnson & Johnson says it is not yet issuing a power morcellator recall, but will no longer market or distribute the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-Tract. The company is the largest morcellator manufacturer, commanding nearly three quarters of the market in 2011.
The sales halt does not prevent doctors from using those already in hospital inventories. However, the FDA has indicated that use of the devices carries an unreasonable risk, since an estimated 1 out of every 350 women who undergo a laparoscopic hysterectomy or myomectomy may have unsuspected sarcoma, and there is no consistently reliable way of discovering the cancer prior to the fibroid surgery.
Power morcellators cut tissue into smaller pieces, which allow doctors to remove the uterus or fibroid tumors through a port incision during minimally invasive laparoscopic surgery, providing shorter recovery times and reduced risk of infections or other complications. However, for women with sarcomas contained within the uterus, morcellators may spread the aggressive cancer throughout the body, greatly reducing the chances for long-term survival.
Lawsuits Over Fibroid Surgery Morcellators
As women and families learn that cases of stage 4 leiomyosarcoma or other cancers diagnosed following a hysterectomy or myomectomy may have been caused by the use of morcellators, questions are being raised about why adequate warnings were not provided and whether Johnson & Johnson and other manufacturers failed to make the devices as safe as they could have been.
FDA officials say they plan to hold a hearing this summer to determine next steps and to hopefully answer some questions as to why the medical community was not better informed. While the manufacturers claim they provided warnings, a number of fibroid surgery morcellation lawsuits are likely to be filed in the coming months on behalf of individuals who had cancer spread by the devices.
The FDA has indicated that a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy 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.
Some critics have suggested that morcellators could have been sold together with surgical bags, which would allow doctors to collect uterine tissue and prevent the spread of potentially cancerous tissue. While some manufacturers have provided warnings that surgical bags should be used when a malignancy is suspected, critics have pointed out it is impossible for doctors to detect sarcoma or leiomyosarcoma until after the morcellation procedure.