FDA orders black box warning placed on power morcellators used in hysterectomy, myomectomy procedure

posted on:
November 25, 2014

author:
Jennifer Walker-Journey

The Food and Drug Administration (FDA) is warning that laparoscopic power morcellators should not be used to remove uteruses (hysterectomies) or fibroids (myomectomies) in the vast majority of women. And, in an Immediately in Effect (IIE) guidance, the agency is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling a boxed warning and two contraindications that use of the devices may spread previously undetected cancer and decrease the long-term survival of patients.

Black box warnings are the most serious type of warning the FDA can give and are reserved for products in which there is a reasonable probability that use of the product will cause serious health consequences or death.

The Safety Advisory comes in the wake of lawsuits and petitions to the FDA from women who say that undergoing gynecological procedures with the power morcellator caused their cancer to spread. In April, the FDA issued its first alert discouraging the use of the surgical tools for hysterectomies or myomectomies.

The tools are designed to grind the uterus or fibroids into bits within the body and then remove them through small incisions in the abdomen. The tools were introduced in the 1990s and quickly fell into favor because they were less invasive than traditional surgical methods, resulted in less scarring and required less recovery time than traditional surgery. About 50,0000 procedures using power morcellators are done each year.

Uterine fibroids are benign, but in rare instances a type of uterine cancer known as uterine sarcoma is present. The process of morcellation can send bits of cancerous tissue throughout the abdomen and seed new cancerous growths, making treatment more difficult. Since there is no reliable method for predicting whether a woman with fibroids has uterine sarcoma, the FDA discourages use of laparoscopic power morcellation for hysterectomies or myomectomies.

The black box warning informs health care providers and patients that:

  • Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

The two contraindications advise of the following:

  • Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
  • Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

The FDA also recommended that doctors follow up with patients who have undergone power morcellation procedures even if their lab results came back normal and they are not showing any symptoms of uterine cancer. Women who have undergone power morcellation and have persistent or recurrent symptoms should see their doctors for further testing.

Symptoms of uterine cancer include abnormal bleeding, abnormal vaginal discharge, pelvic pain or lumps/masses in the pelvic region.

Several lawsuits have been filed against manufacturers of power morcellators claiming the companies should have warned users of the serious risks associated with the surgical tools.

Source: FDA

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