Johnson & Johnson Recalls Morcellator Surgical Tool Due to Safety Concerns
Johnson & Johnson has voluntarily recalled the morcellator surgical tool used for removing uterine masses in women because of concern that the device can spread cancer throughout the body, The Wall Street Journal reported.
FDA action
The company’s recall follows the U.S. Food and Drug Administration’s safety notice in April and panel in July. The safety notice warned health care providers that the morcellators, which tear tissue into small easily removable fragments, may spread unknown cancer cells through a woman’s abdomen. Because of this risk, the FDA urged health care providers not to use the device to remove uterine fibroids. There is no reliable way to determine if the uterine tumors contain sarcoma, therefore the administration believes the benefits of the surgical tool are outweighed by the risk of cancer.
In July, the FDA convened a panel of experts to discuss the risk of cancer related to the use of a morcellator and whether the tool’s label should be changed, according to Fierce Medical Devices. The panelists determined the package label for the tool is not effective in informing patients because it is only seen by the physician and that an additional warning is needed. Some panelists believe physicians should get a signed informed consent form before using the tool.
The panel also discussed the use of surgical bags, which placed around the surgical site could help contain the spread of tissue. The experts find that these may be helpful, but there was no proof the surgical bags lowered the risk of cancer, Fierce Medical Devices reported.
Major manufacturer takes product off the market
As the concern over patient safety grew, Johnson & Johnson, the manufacturer of the morcellator, decided to issue a voluntary recall, according to The Wall Street Journal. This recall ends the debate over whether the FDA should further regulate the surgical tool or ban it.
Prior to the recall, Johnson & Johnson stopped selling morcellators in April. Since then, the company has determined the risk of cancer related to uterine fibroids is higher than originally thought. The company stated in a letter to physicians that it believes taking its morcellator off the market is the appropriate thing to do until the FDA or medical community has established new guidelines or technologies, according to The Wall Street Journal.
Johnson & Johnson is not the only manufacturer of morcellators, but it is one of the largest distributors in the U.S. The recall of the product along with the FDA’s warnings may reduce the use of the device, but it will still be available to physicians through other manufacturers.
Burg Simpson is evaluating claims of women who have undergone a procedure using a morcellator.
