Johnson & Johnson, the largest maker of the laparoscopic morcellator device, has announced a worldwide voluntary recall of the product. This comes three months after the company decided to suspend sales of the device in April, when the U.S. Food & Drug Administration issued a warning that it may unknowingly spread cancer tissue.
Laparoscopic morcellators are used to remove uterine fibroids (myomectomy) or uteruses (hysterectomy). The device uses small blades to slice up the tissue, which allows it to be removed from the small laparoscopic incision rather than have the patient subjected to general surgery. The FDA estimates the device has been used in 50,000 hysterectomies a year in recent years.
The Wall Street Journal reported that Johnson & Johnson’s subsidiary Ethicon plans to announce the recall to customers this week. It told the Wall Street Journal that it initiated the action because it is no longer clear that the device’s benefits outweigh the risks:
“Because of this 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.”
Voluntary recall comes before any FDA action
Johnson & Johnson says this move is not an “official recall” because the action isn’t related to how the device performs. Rather, the problem that became widely publicized this spring is that the device can unknowingly spread cancerous tissue, causing leiomyosarcoma, the type of cancer commonly reported as a result of the use of morcellators, into other parts of the body, and worsen a patient’s prognosis for recovery.
The problem is that most fibroids are benign, and doctors cannot detect before the procedure which of the one in 350 women undergoing the procedure will have fibroids that turn out to be cancerous. The morcellator’s fast-spinning rotary blade is now believed to cast that cancerous tissue into other parts of the patient’s body and decrease their chances of long-term survival.
The FDA issued a safety communication in April, telling doctors “the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids” because the procedure “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.” The FDA did not recall the device, but only suggested that, “Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids.”
J&J said in April that instructions for its morcellator devices had always included precautions about the possible spread of malignant tissue. However, new data is showing the risk of spreading cancer is higher than previously reported and additional cancers might have been spread.
Johnson & Johnson was the largest manufacturer of the laparoscopic morcellator, with 72% of the market share. The Wall Street Journal reports that the company doesn’t disclose revenue from morcellator sales, but the Journal estimates those sales are only a small part of the conglomerate’s overall revenue.