Safety issues with laparoscopic uterine/fibroid procedure
Posted by on April 17, 2014 - 11:38am

Today, FDA issued a safety communication discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women.  This type of procedure poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, a type of uterine cancer.

Laparoscopic power morcellation is one of several available treatments for fibroids.  It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces so it can be removed through a small incision in the abdomen.  Prior to treatment, there is no reliable method for identifying whether a woman may have an unsuspected uterine sarcoma instead of, or in addition to, fibroids.  Published studies suggest that morcellation of an unsuspected uterine sarcoma increases the risk of cancer spread.

Most women will develop uterine fibroids at some point in their lives, and, while most uterine fibroids do not cause problems for women who have them, they can cause symptoms such as heavy or prolonged menstrual bleeding and pain, requiring medical or surgical therapy.

The FDA’s primary concern as it considers the continued use of these devices is the safety and well-being of patients, and will continue looking into this issue by convening a panel of outside experts at a public meeting to discuss the clinical role of laparoscopic power morcellation in these treatments, surgical techniques, and labeling related to these devices. Information on this meeting will be posted as soon as it becomes available.

In today’s safety communication, the FDA made specific recommendations on this topic for health care providers and women.

If you have questions about this communication, please contact the Center for Devices and Radiological Health’s Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

Estrogen may protect against stroke in younger women
Posted by on October 17, 2011 - 1:03pm

Contrary to popular belief that estrogen is a risk factor for stroke at all ages, researchers found that the sex hormone actually may prevent strokes in premature or early menopausal women. For the research, published in the journal Menopause, Mayo Clinic scientists analyzed seven other studies to determine how premature or early menopause is associated with stroke.

They found that women who had their ovaries removed before age 50 were more likely to suffer a stroke than women who did not have a bilateral oophorectomy before age 50. But hormone therapy seemed to lower the increased stroke risk for the first group of women, suggesting that a lack of estrogen is linked to the greater risk.

In addition, the age of menopause onset was more important to stroke risk than whether menopause was natural or induced, with earlier onset menopause connected to higher stroke risk.

Study author Walter Rocca said scientists must correct the idea that estrogen is always a problem in the brain. While estrogen can be an issue in older women, the hormone may protect younger women from stroke, he said. Women who experience premature (before age 40) or early menopause (before age 45), whether from natural causes or from ovary removal, should consider taking estrogen up to about age 50 to prevent stroke, Rocca said.

Stroke is the third leading cause of death and the top cause of long-term disability in the U.S. In 2006, more than half of deaths due to stroke were in women, according to the CDC.

Click here to read the Mayo Clinic study.