FREE Case Review (866) 588-0600

FDA Strengthens Warning Against Use of Power Morcellator for Fibroid Removal

The FDA has strengthened its warning about the cancer-spreading risk associated with laparoscopic power morcellators.

The U.S. Food & Drug Administration (FDA) has strengthened its warning about the cancer-spreading risk associated with laparoscopic power morcellators, saying the devices should not be used for most women during fibroid removal surgery. Morcellators, which use fast-spinning blades to cut up tissue for removal through tiny incisions, can spread undetected cancers called sarcomas to other parts of the body.

Free Morcellator Cancer Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the morcellator and we can help.

What’s the Problem?

The FDA first warned about the risks of power morcellators in April 2014, discouraging use of the devices based on data indicating that hidden sarcomas are much more common than previously realized. The agency confirmed that analysis in its updated warning on November 24, stating that approximately 1 in 350 women undergoing fibroid removal surgery have unsuspected cancerous cells found in later testing.

FDA Recommends Black Box Warning on Power Morcellators

FDA said it is recommending that companies who make morcellators immediately update their products’ labeling to include a “boxed warning,” and to detail specific cases where the devices should not be used.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”

The updated warnings will state that uterine tissue may contain previously undiagnosed cancers that power morcellators could spread to other parts of the body. The contraindications note that morcellators should not be used to remove uterine tissue in women who have gone through or are in the process of transitioning into menopause.

Additionally, the devices shouldn’t be used in women who could have their uterus removed through their vagina or in a “mini-laparotomy,” which is a larger incision than a morcellator requires but not considered open surgery. These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy surgeries, according to the FDA.

Insurers Call for Tighter Regulation Over Power Morcellator Use

April 15, 2015 – The trade group America’s Health Insurance Plans sent a letter this week to Senator Bob Casey (D-PA) regarding how problems with morcellators reveal weaknesses in how the devices are approved and monitored, according to the Wall Street Journal. Casey wrote the group in part to gauge the insurance industry’s response to last November’s FDA warning on power morcellators, and to determine whether health plans track adverse events related to the devices. Click here to learn more.

Do I Have a Morcellator Cancer Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in laparoscopic power morcellator lawsuits. We are handling individual litigation nationwide and currently accepting new morcellation cancer cases in all 50 states.

Free Morcellator Cancer Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellation Cancer Suit and we can help.

Free Confidential Case Evaluation

Verified 100% Secure SiteTo contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.
*
*
*

Awards & recognition