J&J Pulls Hysterectomy Tool Due to Cancer Risk

Posted in Drug & Medical Devices on August 1, 2014

Johnson & Johnson has asked all hospitals to return a surgical device that can spread cancer in women being treated for uterine growths called fibroids. The company has instituted a voluntary “worldwide market withdrawal” of the surgical tool known as a laparoscopic power morcellator.

During laparoscopic hysterectomies and myomectomies, surgeons use a power morcellator to cut fibroids and uterine tissue into smaller pieces. The procedure has long been preferred over open abdominal surgery, which has an increased risk of infection, requires a longer hospital stay, as well as more time before the patient can return to normal activity.

However, in April 2014, the FDA announced that the device could spread undetected cancer cells throughout the abdominal cavity. Shortly thereafter, Johnson & Johnson suspended sales of new devices.

In a letter sent to healthcare providers on July 30, 2014, Johnson & Johnson’s Ethicon unit states:

We believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.

So, how risky is the procedure? A recent study published in the Journal of the American Medical Association (JAMA) estimates that one in 370 women who undergo a laparoscopic hysterectomy using a power morcellator has undiagnosed uterine cancer.

Colleen Daley, who lost her sister to rare and aggressive uterine cancer called leiomyosarcoma after a power morcellator procedure, asked the FDA advisory committee,

“Would you permit your wife or sister to undergo a procedure that has a one in 351 chance of spreading cancer throughout the body?”

Several manufacturers of power morcellators are now facing lawsuits from women who allege they were never warned the devices can spread cancer if they are used in a hysterectomy or fibroid surgery.

Source:

“Johnson & Johnson Pulls Hysterectomy Device From Hospitals” by Jon Kamp and Jennier Levitz, The Wall Street Journal, July 30, 2014.