In April 2014, the FDA advised against the use of power morcellators in laparoscopic myomectomies for the majority of prospective myomectomy patients, after reviewing research that indicated a significant risk of spreading undiagnosed uterine cancer via morcellation.
A myomectomy is the surgical removal of uterine fibroids while leaving the uterus intact or reconstructing it.
The operation is one common treatment for adverse symptoms related to uterine fibroids, usually chosen over a hysterectomy (total or partial removal of the uterus) when a patient seeks to preserve her fertility.
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Uterine fibroids, which are also termed leiomyomas or myomas, are growths in the uterine muscle wall that are a very common occurrence, appearing in as many as 1 in 5 women of child-bearing age and older, as estimated by the U.S. National Library of Medicine.
These growths vary greatly in size and growth behavior—they can grow and shrink at various rates, remain the same size for many years, or even eventually disappear (a common occurrence after pregnancy).
Though they are benign, uterine fibroids can cause problems such as pain/discomfort and heavy or irregular bleeding and can contribute to infertility, according to the U.S. Office on Women’ Health.
Alleviation of undesirable uterine fibroid symptoms is the most common reason for undergoing a hysterectomy, and myomectomies are an alternative treatment for women who want to keep the uterus.
However, even women who wish to keep the uterus intact may be advised to consider undergoing hysterectomy for several reasons.
For example, hysterectomies have a reputation for being safer and involving less post-operative bleeding/discomfort. Also, sometimes women may experience recurrence of uterine fibroids after myomectomy, which of course cannot happen after a hysterectomy.
Another possible reason for choosing a hysterectomy would be suspected leiomyosarcoma (a type of uterine cancer that begins in uterine muscle) tumors, which can look similar to and cause the same symptoms as uterine fibroids, in which case removing the uterus may prevent the spread of cancer.
This is the most common type of myomectomy because it offers the greatest ease of access and because it is a type of surgery that all surgeons receive training for (whereas some of the newer techniques may require special training).
The operation is performed through a 3 to 6 inch incision that is either made vertically in the center of the abdomen or horizontally, just beneath the pubic bone, and utilizes traditional surgical techniques and instruments.
Recovery time lasts about 4 to 6 weeks.
This operation type makes use of an instrument called a hysteroscope, which is inserted through the vagina and provides vision and illumination of the uterus.
Hysteroscopic myomectomies can only be used for the removal of uterine fibroids smaller than 5 cm, but it offers benefits such as a much shorter recovery time (as it can often be performed as an outpatient procedure) of about 2 days.
However, it also is known for potential risks. For example, the uterus may be accidentally punctured by the long, thin hysteroscope.
This type of myomectomy is performed using laparoscopic instruments for vision and for the main operation procedures.
To make sufficient space for the operation, the abdomen is expanded via pumping with carbon dioxide gas. Instruments are inserted through very small incisions (from ¼ to ½ an inch long) made near the navel and lower abdomen.
Power morcellators, operated either through a handheld device or through a robotic system, are commonly used as the method of cutting/shredding the uterine fibroids.
Typical recovery times for these types of operations last 2-3 weeks. More information on laparoscipic myomectomies can be found on About Health.
The popularity of laparascopic myomectomies has grown in recent years because of the considerable benefits of reduced recovery time and less patient pain/trauma post-surgery.
But the risks of spreading undiagnosed uterine cancer via morcellation, highlighted in a series of 2014 FDA announcements, has led to a great deal of public backlash, including a ban on power morcellators in some Boston hospitals, recalls of several morcellator devices by leading manufacturer Johnson & Johnson, and personal injury lawsuits being being filed.
A wave of at least 22 lawsuits has been filed by patients and spouses of patients who underwent laparoscopic surgeries with morcellation and were later diagnosed with advanced leiomyosarcoma.
These plaintiffs allege that they were not sufficiently warned about the risks of power morcellators prior to surgery and seek to hold device manufacturers liable for pain, suffering, and loss endured.
The New York law firm, Banville Law, understands the pain and suffering these diagnoses can cause a patient and their family. If you or someone you love may have been harmed by power morcellation, contact us today to start exploring your legal options with a cost-free case evaluation.
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