FDA Expands Its Power Morcellator Warnings
Last April, the FDA issued a warning against the use of power morcellators, claiming that in the case of undetected uterine cancer the device inadvertently spread malignant cells through the uterus and abdomen. Now the agency has updated its warning, issued some startling statistics, and demanded measures from manufacturers to alert the medical community of the risks associated with the device.
On November 24, 2014, the FDA posted a safety communication update on its stance of power morcellators. It included the following info:
- They warn against the use of device on a “vast majority of women”
- They estimate 1 in 350 women are vulnerable to the device’s negative effects
- They recommend manufacturers label their products with the risks the device poses
The FDA’s actions here don’t constitute and outright ban of power morcellators, but it’s the strongest warning they give before seeking that option. That makes their stance crystal clear: power morcellators are dangerous and should be considered with extreme caution before deciding on its use. In recent years, the device has become popular in fibroid removal and hysterectomies as an invasive option of loosening benign tissue in the uterus.
This new spotlight on power morcellators started only a short time ago in Boston, when a doctor, Amy Reed, had her cancer worsen after a power morcellator procedure. She and her husband petitioned FDA and compelled hospitals to delay their use of the device.
If you or a loved one has been diagnosed with cancer after a power morcellator procedure, we urge to contact an aggressive Raleigh defective products lawyer today. Our litigation specialists are standing by.