Morcellators

 

If you have developed cancer after undergoing minimally invasive hysterectomy or uterine fibroid removal, a tool used in your procedure may have spread previously undetected cancerous tissue throughout your abdomen and pelvis. This tool is called a power morcellator, and the U.S. Food and Drug Administration (FDA) now discourages the use of this medical device in hysterectomy and uterine fibroid removal.

Laparoscopic Power Morcellation

A morcellator is a small bladed device that cuts the uterus or fibroid tissues into very small pieces so the tissue can be removed through a laparoscopic tube that is small incision in the abdomen. This is considered a minimally invasive procedure. Minimally invasive procedures are generally preferred because they carry a lower risk of complications and an easier recovery for the patient.

The FDA approved the first power morcellation device for gynecological use in 1995. There are more than a dozen on the market today.

The Risk

If there is undetected cancer in the uterus, the morcellator can spread the cancer tissue throughout the abdomen, pelvis and other organs. This makes the chance of survival much worse.

The FDA issued a safety warning on April 17, 2014, discouraging the use of power morcellators in hysterectomies and myomectomies. Myomectomy is surgery to treat fibroids. In that safety warning the FDA said that “it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”

Sales Suspended

In response to the FDA warning Ethicon 360, a subsidiary of Johnson & Johnson and the leading supplier of this morcellators, suspended worldwide sales of the device on July 31, 2014.

In August, 2014, Senators Kirsten Gillibrand and Charles E. Schumer wrote to the FDA asking the agency to urge manufacturers to withdraw morcellators form the market until more can be learned about the risks and doctors can be taught how to use them more safely.

Were You Harmed?

You may have been harmed by power morcellation if you developed one of the following within one to two years after undergoing hysterectomy or fibroid removal with power morcellation:

  • Leiomyosarcomas
  • Cancer spread through the abdomen
  • Abnormal growth of fibroids or similar tissue throughout the abdomen

Your doctor may not have specifically used the term “morcellator” or “morcellation” when explaining your procedure. If your procedure was described as laparoscopic or minimally invasive, or if your uterus or fibroids were removed through your belly button, it is likely that morcellation was involved.

If you believe that you or someone you loved was harmed by morcellation, use our directory to find a lawyer near you.