Our team of medical mistake attorneys recently reported that doctors throughout the country were calling for a ban on one popular gynecological procedure, known as morcellation. In the wake of public outcry, at least three of the nation’s top hospitals have banned the procedure. Importantly, the FDA has also released a statement discouraging surgeons from using morcellation procedures.
Morcellation was generally used during hysterectomy or myomectomy procedures to treat uterine fibroids in women. The practice involved using a laparoscopic power morcellator (a medical device) to divide the uterine tissue into smaller pieces or fragments.
Now, it has become clear that about one in every 350 women who undergo this type of procedure will be diagnosed with uterine sarcoma, which is a type of uterine cancer. This is possible because uterine sarcoma hides in the fibroids that morcellation procedures are designed to break up. If such cancer cells are already present in fibroids when a morcellator divides them, the cancer cells spread into the abdomen and pelvis, significantly worsening the patient’s likelihood of survival.
What makes this issue particularly frightening is that there is no reliable method for predicting whether a woman’s fibroids contain cancerous cells. Because of this, the FDA is now discouraging the use of morcellators during hysterectomies and myomectomies for uterine fibroids.
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This issue was brought to the forefront of public and medical attention when a prominent doctor at Beth Israel Daconess Medical Center was diagnosed with uterine sarcoma after undergoing the procedure. Her husband is a Harvard-affiliated surgeon who went public with the dire news, calling on hospitals and doctors to stop practicing morcellation.
This couple has become the driving force behind the call to ban the procedure. Two hospitals affiliated with Harvard Medical School – Brigham and Women’s Hospital and Massachusetts General Hospital – were the first to cease using morcellation procedures. Two more of the nation’s most esteemed hospitals, the Cleveland Clinic and the University of Pennsylvania Health System, are the latest to suspend the use of morcellators. Temple University Hospital has also sharply limited power morcellator.
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Officials at these four hospitals have gone on record saying that the public called on them to act immediately, so they did. A chairman at the Cleveland Clinic stated that the hospital will decide whether or not it will permanently ban the procedure in the upcoming months.
The FDA also plans to hold a hearing on morcellators in the coming months, which hospitals throughout the country will surely look to for guidance. Over the past ten years power morcellators have become extremely popular because they are used in less-invasive forms of hysterectomies and myomectomies. Known as laparoscopic procedures, these operations use only tiny incisions to break up fibroids instead of previous practices that left large scars and longer recoveries.
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Women undergoing hysterectomies or myomectomies need to be completely aware of the risks of the procedure. Once the patient has been counselled on how the surgery will be performed, she reserves the right to request a different method or choose a different surgeon altogether. This is known as an informed-consent process.
It is important to note that there are still other ways to perform surgery on uterine fibroids using minimally-invasive techniques. Among these include vaginal hysterectomies and mini-laparotomy procedures, which do not require abdominal incisions. Temple University Hospital already designates the mini-laparotomy as its preferred uterine fibroid technique.
In addition to its recent warning, the FDA may also require morcellator manufacturers to put Black Box Warnings on the devices. This is the most severe type of labeling the FDA can require medical devices or pharmaceuticals to include.
If you or someone you love underwent a morcellation procedure and was consequently diagnosed with uterine sarcoma, conduct our team of all-female gynecological malpractice attorneys immediately. We provide free case reviews to patients injured by medical mistakes in all 50 states.