Morcellation Device Recalled

 Posted on June 03, 2014 in Defective Medical Devices

Morcellation devices are used to remove uterine fibroid growths that are common in women. They are non-cancerous growths that appear in the smooth muscle tissue in the uterus. If these fibroid growths are not removed, they can cause serious health issues for the affected women.

Uterine tissue is divided into smaller segments so it can be removed through an incision in the abdominal area of the body. A morcellation device is small enough to go into the body to perform this work. This medical device has recently been recalled by the FDA because it has been linked to the spread of undiagnosed cancer throughout the body.

FDA Warning

The FDA found that one in 350 women who receive myomectomy procedures for uterine fibroids also have an undetected cancer of the uterus known as uterine sarcoma. The FDA warned against the use of the morcellation device due to the increased risk of cancer spreading throughout the body.

The reason for this is that neither the doctor nor the patient know of the cancer in the body. Because of this, the risk is higher for cancer cells to become dislodged and then metastasize throughout the body.

Suspension of Sales

The manufacturer of the morcellation device, Johnson & Johnson, has suspended the sales of these devices following the warning from the FDA.

The statement from the company said the following:

“This decision was not made lightly … However, interpretation of the available epidemiological evidence is complex and it is difficult to diagnose certain malignancies in advance of surgery. Therefore, we believe that suspending the commercialization of these products until their role is better understood and redefined by the medical community is the appropriate course of action at this time.”

If you or a loved one had a uterine fibroid removed by a morcellation device, contact an Illinois medical device attorney today to discuss your case.