FDA reviewers assess uterine surgical method tied to rare cancer
July 8 (Reuters) - A uterine surgical technique that has been linked with the spread of a rare type of cancer poses a serious concern to regulators that will be addressed this week by an advisory committee to the U.S. Food and Drug Administration.
In preparatory documents posted on the agency's website on Tuesday, FDA reviewers said laparoscopic power morcellator devices, which are used to treat uterine fibroids, allow for less invasive surgeries, shorter recovery time and fewer wound site infections.
Risks, however, include injury to local tissues and organs and, most importantly, the spread of unsuspected malignant uterine tissue to places outside the uterus. The advisory panel will meet July 10-11 to discuss potential ways to mitigate these risks and potential changes to the design of the devices and to the label and directions for use.
Power morcellators are used to slice fibroid and uterine tissue into small pieces that can be removed through a small opening during surgery. The procedure is used in an estimated 50,000 U.S. uterine surgeries each year.
In April the FDA issued an alert discouraging use of the devices to remove fibroids due to cancer concerns. Fibroids are often benign but can cause pelvic pain and bleeding. Sometimes a hysterectomy is needed to remove them.
The FDA estimates 1 in 350 women who have fibroid surgery have an unsuspected uterine cancer. Following the agency's advisory some hospitals have suspended or restricted the procedure pending the outcome of the advisory committee meeting.
Johnson & Johnson's Ethicon unit, the biggest maker of morcellator devices, suspended sales, distribution and promotion of the products following the FDA advisory.
Matthew Johnson, a J&J spokesman, said the suspension will be in effect "until their role is better understood and redefined by the medical community." (Reporting by Toni Clarke in Washington; Editing by Paul Simao)