Power Morcellator Linked To Spread Of Uterine Cancer

$5.7 Million Verdict For Patient In Tansvaginal Mesh Trial
April 22, 2016
Deadly New Bacteria Linked To Medical Devices
April 22, 2016
Show all

Power Morcellator Linked To Spread Of Uterine Cancer

Power Morcellator Linked To Spread Of Uterine Cancer

Power Morcellator Linked To Spread Of Uterine Cancer

If you or a loved one has undergone laparoscopic gynecologic surgery such as a hysterectomy or myomectomy, and were then diagnosed with uterine cancer, you may have a claim.

The FDA has recently issued warnings against the use of laparoscopic power morcellators in the majority of women for removal of fibroids (myomectomy) or removal of the uterus (hysterectomy).  Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

“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 boxed warning informs health care providers and patients that:

Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

The two contraindications advise of the following:

Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)

Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

Since this information was previously unknown to the public, even if you or a loved one had surgery years ago with a power morcellator and were later diagnosed with uterine cancer, you may have a claim.

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm424435.htm

Leave a Reply

Your email address will not be published.