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Morcellator in Myomectomies
Myomectomy is a surgery by which uterine fibroids are removed and the uterus itself remains intact. Myomectomy can be performed either through a traditional “open” surgery through an incision along the lower abdomen – the preferred method when large fibroids are present – or by more minimally invasive methods known as laparoscopy or hysteroscopy.
What Are Fibroids and How Do They Develop
Uterine fibroids (also called leiomyomas) are an abnormal tissue growth that occurs within the muscular layer of the uterus. It is not known what causes this abnormal growth, but theories include a spectrum from genetic abnormalities to tissue damage.
Uterine fibroids are the most common benign tumor to form in women, with 50-75% of women developing them at some point in their lifetime. They most commonly occur during childbearing years, and often are present without causing any symptoms or complications.
The Risks of Fibroid Morcellation
In 2014 the FDA released a warning discouraging the use of power morcellators for the removal of uterine fibroids. According to evidence reported in their press release, one in 350 women undergoing surgical removal of uterine fibroids have unsuspected uterine cancer. The use of power fibroid morcellation in those with cancerous lesions may spread that tissue to other areas and decrease the likelihood of survival.
What Is A Hysterectomy and Why Are They Necessary
A hysterectomy is a surgery by which all or part of the uterus is removed. In what is called a total hysterectomy the cervix is removed as well, and in some cases the fallopian tubes and ovaries may additionally be removed. Because hysterectomy makes it impossible for a woman to become pregnant, it is generally only performed in cases of medical necessity.
Other Surgical Options Besides Morcellation
Use of a power morcellator is not a requirement in the performance of a hysterectomy. Abdominal hysterectomy, the most common procedure, is performed without the use of a morcellator and does not commonly have complications. Vaginal hysterectomy and some types of laparoscopic hysterectomy are also performed without the use of a morcellator. If your surgeon recommends a surgery involving the use of a power morcellator and you are not comfortable with that option, it is well within your right to seek out a surgeon who employs other methods.
As an alternative to morcellation, the FDA recommends one of the following treatments:
- Open hysterectomy/myomectomy by either the vaginal or abdominal route
- Laparoscopic hysterectomy/myomectomy without morcellation
- Uterine artery embolization (deliberate blocking of the artery supplying the fibroid)
- High-intensity focused ultrasound
- Drug therapy
The Risks Of Morcellation And Cancer
- One in 352 women undergoing hysterectomy or myomectomy for presumed fibroids have an unsuspected uterine sarcoma.
- One in 498 women undergoing the same surgeries have an unsuspected uterine leiomyosarcoma.
- In 25-64% of cases where morcellation is performed in the presence of an unsuspected sarcoma, cancer spreads or advances in its staging.
- Approximately one in 368 women who underwent hysterectomy using morcellation between 2006 and 2012 developed uterine cancer.
- Cancer risk in patients undergoing hysterectomy or myomectomy increases with increasing age.
Power Morcellation Lawsuits
Numerous patients have fallen victim to the increased cancer risks associated with the use of power morcellators. As a result, lawsuits have been filed based in part on the following complaints:
- Failure to warn of risks and complications associated with morcellation
- Production and distribution of a product that is unsafe and unfit for its intended use
- Lack of proper safety testing prior to releasing the product to market
- Failure to remove the product from the market once health risks were known