Ethicon, a unit of Johnson & Johnson, is reportedly planning to ask doctors on Thursday to return the company’s morcellators (the tools used during a surgical procedure known as morcellation), effectively issuing a worldwide recall on its Morcelex device.
The problem with this procedure is that surgeons may mistake cancerous tumors for benign fibroids and use morcellation to remove them, which may cause cancer cells to spread.
Morcellation has been hotly debated in 2014 after reports that the procedure may spread unsuspected cancer cells throughout the body and upstage patients’ cancer diagnoses. During morcellation, tissue and/or uterine fibroids are broken down into smaller pieces so they can be removed through a small incision in the stomach. The problem with this procedure, however, is that surgeons may mistake cancerous tumors for benign fibroids and use morcellation to remove them, which may cause cancer cells to spread.
This issue spurred an investigation from the FDA, and in April 2014 the agency published a safety communication stating that it was discouraging use of the procedure during certain surgeries because more women than previously believed had undetected cancerous tumors (known as sarcomas) in their uterine tissue.
Shortly after that safety communication, Ethicon announced that it was suspending worldwide sales of its morcellators “until the role of morcellation for patients with symptomatic fibroid disease is redefined by the FDA and the medical community.” While the FDA has yet to redefine the role of morcellation in these procedures, the agency did hold a public meeting with its panel on obstetrics and gynecological medical devices earlier this month, which reportedly convinced Ethicon that the risk of morcellation may outweigh the benefits.
On Wednesday, Ethicon sent doctors a letter that said the FDA’s meeting on the devices “demonstrated the complexity of the issue,” according to the Wall Street Journal. Later in the letter, the company concluded 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.”
Ethicon plans to inform customers about the recall in a letter on Thursday, according to reports.