JNJ Halts Sales of Uterine Fibroid Treatment Device the FDA Says Could Increase Risk of Cancer

Johnson & Johnson is globally suspending the sale of its morcellation devices because the technology may pay a role in spreading a rare, but deadly uterine cancer.  The devices are distributed through JNJ’s Ethicon division. The company has said they’re not pulling the technology from the market, but halting sales until it better understands the details of the situation.

Morcellators typically use long, tube-shaped blades to cut and remove tissue through tiny incisions, helping patients avoid open abdominal surgery associated with longer scars and recovery.

On April 17, the U.S. Food and Drug Administration (FDA) issued an advisory discouraging physicians from using laparoscopic power morcellators to remove uterine fibroids because of a risk of making uterine sarcomas worse.  JNJ is the largest maker of such devices. The FDA estimates that morcellators are used about 50,000 times yearly to perform fibroid-removal procedures. Overall, fibroids account for about 40 percent of the roughly 500,000 hysterectomies performed annually in the U.S., according to some estimates. The FDA had advised that, in cases where power morcellation is still considered the best option, doctors should inform patients about the cancer risk.

According to the FDA, if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the agency is “discouraging” the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

JNJ’s Ethicon became a major player in the field after its 1998 purchase of FemRx, a market pioneer with a morcellator called Diva. According to the most recent data provided by iData Research Inc., a market-research firm, JNJ had an estimated 72 percent of the laparoscopic morcellator market in 2011.

The suspension will affect all of JNJ’s morcellator products, which go by the names Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract.

The suspension won’t keep doctors from using devices already in inventory, and JNJ hasn’t recalled those devices from the market. Several hospitals, including the Cleveland Clinic, have suspended morcellator procedures following the FDA’s advisory.

The FDA plans a meeting of its Obstetrics and Gynecological Medical Device Advisory Committee this summer to examine the clinical role of laparoscopic power morcellation in the treatment of uterine fibroids; whether surgical techniques and/or use of accessories, such as morcellation/specimen bags, can enhance the safe and effective use of these devices; and whether a “boxed warning” related to the risk of cancer spread should be required for laparoscopic power morcellators.

The agency will continue to review adverse event reports, peer-reviewed scientific literature, and information from patients, healthcare providers, gynecologic and surgical professional societies, and medical device manufacturers.

In a letter to customers cited by the Wall Street Journal, JNJ officials said they’re waiting for the FDA and the medical community to further clarify the role of morcellation in fibroid treatment. JNJ has said the instructions have always cautioned doctors about the potential spread of malignant or suspicious tissue. But the company also acknowledged it is difficult to diagnose some cancer ahead of surgery.

“We believe that suspending the commercialization of these products until their role is better understood and redefined by the medical community is the appropriate course of action at this time,” JNJ officials told customers.

In addition to open surgery, there are other less-invasive options for fibroid treatment, including vaginal hysterectomies. There are also nonsurgical options such as ultrasound and drug therapy, according to the FDA.

“This decision was not made lightly because we are well aware of the significant benefits that these products can offer many women,” J&J said in its customer letter. “Since 1998, Ethicon’s morcellation devices have enabled thousands of patients to have minimally-invasive surgical hysterectomy and myomectomy procedures, instead of more-invasive surgical procedures.”

Other morcellator manufacturers include Karl Storz GmbH, Olympus Corp. and Richard Wolf GmbH.