Johnson & Johnson Recalls Surgical Tool Over Concerns of Spreading Cancer

Johnson & Johnson, the largest maker of a tool used to perform hysterectomies and remove uterine growths, is urging surgeons not to use the device over concerns that it could spread cancer in women.

J&J’s Ethicon division makes the devices, which are known as laparoscopic power morcellators. Sales of new morcellators were halted in April after a warning was issued by the Food and Drug Administration (FDA).

At that time, the FDA discouraged doctors from using the tool because it could spread a form of uterine cancer called sarcoma. Now, in a letter sent to doctors, J&J is telling medical providers to return the Gynecare Morcellex, the Morcellex Sigma and the Gynecare X-Tract, the New York Times reports.

Studies Find Morcellators Can Spread Sarcoma Tissue

Used to remove noncancerous growths on the uterus known as fibroids as well as the uterus itself, morcellators slice uterine tissue into smaller fragments so that they can be removed by a minimally invasive procedure, according to HealthDay News.

Recent studies from the FDA and Columbia University found that approximately 1 in 350 women being treated for fibroids has undetected uterine sarcoma, while around 1 in 368 women undergoing hysterectomies have the cancer.

Using a morcellator can spread the cancerous tissue to other parts of the body. Around 60,000 women undergo a morcellator procedure each year.

Previously it was believed that the risk of a woman with presumed fibroids having sarcoma was 1 in 10,000, the Wall Street Journal reports. A high-profile case involving a Boston anesthesiologist, however, prompted closer scrutiny of the cancer risk.

‘Sarcoma Risk Is Much Higher’

Steven McCarus, a paid Ethicon consultant and chief of gynecological surgery at Florida Hospital Celebration Health, where surgeons are trained to use morcellators, told the Wall Street Journal, “The bottom line is that it looks like the sarcoma risk is much higher than we originally thought.”

McCarus was part of a committee formed by Ethicon to review research on the ability of morcellators to spread cancer. He advised the company that the risk was too high.

In its letter to doctors, J&J said, “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 FDA has yet to weigh in further on the issue.

Dr. William Maisel of the FDA’s Center for Devices and Radiological Health said women who have undergone power morcellation don’t need a cancer screening because pathologic analysis of removed tissue is standard procedure, and that they would have been informed if cancer was detected.

Morrow Kidman Tinker Macey-Cushman, PLLC represents patients who have been harmed by medical negligence in Seattle and throughout Washington State. If you developed cancer following a morcellator device procedure, contact us to explore your legal options.