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FDA issues Black Box Warning for Laparoscopic Power Morcellation

by | Dec 7, 2014 | Class Action Lawsuits, Defective Medical Devices, Medical Device Recalls

Two widowers say they are disappointed in the Food and Drug Administration’s (FDA) decision not to ban a surgical tool blamed for worsening their wives’ uterine cancer. After months of deliberation, the agency opted instead to add a black box warning on laparoscopic power morcellation for the removal of uteruses or uterine fibroids, and to strongly discourage surgeons from using the devices for these procedures.

“It’s weak,” said Frank Interlichia, whose wife Linda died two weeks ago. “It still leaves a lot of room for more women to be hurt. I don’t know what they’re waiting for. I wish they could have been more courageous.”

“It’s very, very sad,” added Jim Leary, whose wife Barbara died last fall. Both men blame the device for spreading undetected cancer and lessening their wives’ odds of survival, and shared their disappointment with the Democrat & Chronicle. “I would have thought the FDA had the courage to stand up and help women. Now more women will suffer tragic death as a result of a government agency that has failed to do the job they are employed to do,” Leary said.

Laparoscopic power morcellators are surgical tools that are fitted with a blade that grinds uterine fibroids or entire uteruses inside the body and removes them through an incision in the abdomen. About 50,000 power morcellation procedures are performed each year in the United States. They were often preferred by doctors to open surgery because they are less invasive, offer shorter recovery time, and leave less scarring.

In rare cases, cancer may be present in the uterus, known as uterine sarcoma, and morcellation can send bits of cancerous tissue throughout the abdomen where it can seed additional tumors, making the cancer more difficult to treat. The problem is that there is no reliable method for detecting uterine sarcoma before the fibroids or uterus is removed. Thus, the chances of the device spreading cancer in any women is a gamble.

Both Interlichia and Leary’s wives had petitioned the FDA to ban the devices, but both lost their fight before action was taken. In April, the FDA issued a warning of the risk of cancer spread and this week followed up by reiterating it discouraged the use in hysterectomies and myomectomies (uterine fibroid removal) and added the black box warning, which is the most serious type of warning the FDA can give and is reserved for products in which there is a reasonable probability that use will cause serious health complications or death.