Johnson & Johnson is withdrawing from the global market a device used during hysterectomies and other uterine procedures after reports that it may spread and accelerate the growth of undetected cancer inside women.
The move is not a recall, said Ethicon spokesman Matthew Johnson, according to Reuters. The device is not inherently defective; it functions as designed.
"Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk," the company said in an e-mailed statement.
When this device was launched by the company, it was expected that this would prove to be a good non-invasive technique for the treatment of fibroid, uterine growth in women. The surgical tool is used in minimally invasive, laparoscopic surgery, allowing the surgeon to mince uterine tissue and vacuum it out through a small tube. In the process, however, some tissue can splatter throughout the abdominal cavity and avoid removal.
The FDA found that 1 in 350 women who undergo surgery with the devices may have a type of cancer that the procedure can spread beyond the uterus. The seeding of malignant cells in the abdomen and pelvis can significantly worsen a woman's chance of survival, the agency said.
It has been announced by FDA that doctors would not use the device until it got a review from it and gives further direction for using it.
