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FDA Meeting Planned to Discuss Risks & Benefits of Morcellation

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The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will come together on July 10th and 11th of 2014 to discuss the risks and benefits of power morcellation.

One of those risks includes the potential for the power morcellator to spread cancerous tissues to other parts of the body during uterine surgery.

The FDA discouraged the use of power morcellation for uterine surgery on April 17, 2014.  The agency recommended that healthcare providers consider other treatment options for uterine fibroids due to the associated risk with morcellation.  It found that one in 350 women who have uterine fibroids or their uterus removed have an undetected form of uterine cancer called a uterine sarcoma.  Unfortunately, there is no way to determine whether or not a woman has a uterine sarcoma before performing surgery.

What is Morcellation?

Morcellation is an option for women who have problems with uterine fibroids or need uterine surgery.  It is minimally invasive and leads to a shorter recovery period.  A power morcellator is used to slice the tissue into smaller pieces and remove them through a tiny incision.

Uterine fibroids are very common among women.  Data shows that as many as 3 out of 4 women will develop one in their lifetime.  Some women might not have any symptoms, while others will need to seek medical treatment.  Here are some common signs that you might have uterine fibroids:

• Urinating often
• Leg pain, backaches
• Constipation
• Pelvic pressure, pain
• Seven or more days of menstrual bleeding
• Heavy menstrual bleeding
• Urinating frequently
• Trouble emptying your bladder

A doctor will be able to determine whether or not you have a uterine fibroid through a physical examination and by using an ultrasound.

Doctors are unsure exactly what causes uterine fibroids to develop.  They point to genetics, hormones and certain medications as possible triggers.

Improving the Safety of Power Morcellation

In a statement released in 2013, the Society of Gynecologic Oncology (SGO) suggested doctors use a “laparoscopic bag,” during power morcellation which would collect all of the tissue, including any unsuspected uterine sarcomas.

Hopefully the FDA meeting on July 10th and July 11th will help the medical community come up with a viable solution to help stop the spread of unsuspected cancerous tissue when using power morcellation.