The Fight Against Power Morcellators
Power morcellators are surgical devices that grind uterine fibroids into fragments for removal through small incisions in the abdomen. Unfortunately, there are no reliable methods to determine, prior to surgery, whether a fibroid contains hidden uterine cancer. The inability to rule out cancer prior to using the morcellator makes the laparoscopic supracervical hysterectomy using a power morcellator a high risk procedure. If a fibroid contains cancer cells, including a deadly type known as leiomyosarcoma, cutting the fibroid or uterus with the morcellator could cause the cancer to upstage by spreading cancerous cells throughout a woman’s abdomen and pelvic area.
The risk posed by power morcellators may be higher than initially suggested. In 2014, the U.S. Food and Drug Administration (FDA) updated a warning regarding power morcellators and the risk for spreading previously undetected cancer. The update stated the following:
- Power morcellators should not be used in the removal of the uterus or uterine fibroids in the vast majority of women.
- The FDA recommends that power morcellator devices contain boxed warnings on labels stating that the device may spread undetected cancer during fibroid surgery.
- In rare cases when a power morcellator is recommended by a physician for removal of uterine fibroids, the FDA recommends that physicians must fully advise patients of the risks involved.
Previous studies maintained that the occurrence and risk of undetected cancer in hysterectomy and myomectomy patients was extremely low. However, more recent research indicates that there may be a much higher risk than previously believed. In 2015, researchers from the Boston Medical Center published data which revealed that nearly 1 in 352 women had unsuspected cancer at the time of hysterectomy or myomectomy for a disease that was thought to be benign, and that nearly half of the women diagnosed with uterine cancer following an operation did not undergo testing prior to surgery. An FDA communication suggested, based on additional research, that one in 498 women who underwent morcellation developed leiomyosarcoma.
In January of 2016, United States Representative Congressman Mike Fitzpatrick petitioned the FDA to launch a criminal investigation regarding power morcellator-related deaths in three prominent hospitals, and into power morcellator manufacturer, Ethicon—a Johnson & Johnson subsidiary. The Congressman specifically questioned the reporting of adverse effects and deaths related to the device, maintaining that the hospitals in question may have failed to report the deaths of multiple patients. Congressman Fitzpatrick stated, “For the over 2 decades since the power morcellator was 1st cleared for use on patients, the FDA’s Medical Device Reporting regulations failed to catch the severe dangers posed to women’s health by morcellation.”
If you, a family member or a friend has been diagnosed with cancer or other serious medical complications after a power morcellator procedure for removal of uterine fibroids, you should contact Peter Angelos Law for additional information and a no-charge consultation with one of our experienced attorneys.