FDA advisors weigh the risks of uterine fibroid removal procedures

Latest Women’s Health News

Dennis Thompson
Health Day Reporter

Saturday, July 12, 2014 (HealthDay News)-There is no way to guarantee that the surgical procedure was used for grinding. Uterine growth Removing them through a small incision does not increase the risk of spreading cancer On other parts of the woman’s body, a US health adviser said Friday.

The Food and Drug Administration’s advisory board also said that women undergoing a procedure called laparoscopic power shredding must sign a written consent to show that they understand the potential risks. Associated Press report.

The panel’s advisory opinion follows the April 17 warning from the FDA that this procedure could inadvertently spread cancerous tissue beyond the woman’s uterus to other parts of her body. ..

The FDA has not set a decision date for the use of power shredding equipment. AP Said. The agency is not obliged to follow the advice and recommendations of the advisory board, but it usually does.

Surgeons often use it when performing laparoscopic power shredding. Hysterectomy Or delete Uterine fibroid, Non-cancerous growth of smooth muscle tissue of the uterine wall.

In minimally invasive surgery, a power tool is used to chop the tissue of the uterine fibroid. Hysterectomy, The uterus itself. According to background information from the FDA, these pieces of tissue are removed through a small incision.

Authorities say about 1 in 350 women undergoing a hysterectomy or Uterine fibroid There are unexpected types of removal cancer It is called uterine sarcoma.

When a surgeon performs scorch on these women, the procedure risks spreading cancerous tissue into the patient’s abdomen and pelvis.

Approximately 60,000 of these procedures are performed annually, estimates Dr. William Maisel, Deputy Director and Chief Scientist of the FDA’s Center for Devices and Radiation Health.

The FDA stopped banning power shredding equipment from the market in April, but requires doctors and patients to weigh the risks before using them.

“Women need to ask their healthcare providers if they want to use power shreds during surgery and explain why it’s the best option,” Mrs. Maisel said at a press conference on April 17. Said.

Women who have already undergone power shredding Cancer screening, Said Mr. Maisel, because some of the tissue removed during the procedure was sent for pathological cancer They would have been informed if they had been detected, he added.

“I think most women who receive these treatments need routine care,” he said. “If you have no ongoing or recurrent symptoms, you should be fine.”

Most women develop Uterine fibroid At some point in their lives, according to the National Institutes of Health. These fibroids can cause symptoms such as severe or long-term menstrual bleeding. Pelvic pain Or Frequent urination..

Women who need a hysterectomy or Uterine fibroid According to Mrs. Maisel, the removal can undergo conventional surgery or laparoscopic surgery without the use of a power chopstick.

The agency has instructed the power shredder manufacturer to check the current product label for accurate risk information for patients and healthcare professionals.

The FDA approved the first power shredder for use in 1995, Maisel said. The non-powered version of the shredder was FDA approved in 1991.

The medical community cancer “The risk seems to be higher than that accepted by the clinical community,” said Mr. Maisel, who has spread during power segmentation since the device came on the market.

Copyright © 2014 Health Day. all rights reserved.

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Source: News briefing from the US Food and Drug Administration on April 17, 2014. William Maisel, MD, MPH, Deputy Director of Science, Chief Scientist, Center for Devices and Radiological Health; Associated Press

FDA advisors weigh the risks of uterine fibroid removal procedures

Source link FDA advisors weigh the risks of uterine fibroid removal procedures

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