FDA Warns of Uterine Cancer Risk from Fibroid Removal Tool
“Morcellation” is a technique used in surgery to shred and remove large masses of tissue, wherein a small instrument with a blade or “cutting jaws”—i.e., the morcellator—is used to tear up body tissues so that smaller pieces can be removed with a laparoscopic tube.
In April 2014, the United States Food & Drug Administration (FDA) warned against using morcellation in fibroid removal surgery due to the risk of spreading cancer. While most fibroids are simple, non-cancerous growths on the uterus, the FDA cautioned that a deadly form of uterine cancer known as leiomyosarcoma is often mistaken for fibroids.
If morcellation is used to perform a hysterectomy in a woman with undiagnosed leiomyosarcoma, there is a serious risk that the procedure will spread the cancerous tissue throughout the abdomen and pelvis, significantly worsening the patient’s odds of survival.
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The FDA estimated that 1 in 350 women undergoing fibroid removal has undiagnosed uterine sarcoma. Studies suggest the rate may be as high as 1 in 100 when other types of potentially malignant tissue are included. The FDA warned that “there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma” before surgery, making it too late to guard against morcellation cancer risks.
The FDA’s findings have prompted many patients to investigate why they were not properly warned of the risks of morcellator fibroid surgery. In their communications with doctors and patients, some manufacturers relayed cancer risks that were up to nine times lower than those confirmed by the FDA earlier this year.
While the FDA urged physicians consider alternate treatments, manufacturers promoted these devices in disregard of other treatments without the same risks, including:
- Laparoscopic surgery without morcellation
- Catheter treatment for uterine arteries
- Traditional surgery
- Focused ultrasound
- Hormone therapy
Many patients who have undergone morcellator surgery have begun to file suit. A review of court records reveals that there are cases pending in at least three federal courts. In the meantime, the leading manufacturer of morcellators, Johnson & Johnson, completely withdrew its morcellation products from the market just eight days after the FDA warning. A subsidiary of Johnson & Johnson named Ethicon had previously held an estimated 70% of the market for morcellator devices. The company has resisted calls for stronger measures, such as the full product recall requested by some physicians.
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