Move Involving Power Morcellators Comes Amid Concerns Over Cancer Risk

Johnson & Johnson, the largest maker of devices used in a popular uterine surgery, said Tuesday it has suspended sales of the tools amid concerns about their potential to spread a rare but deadly cancer.

The health-care giant said it was halting world-wide sales, distribution and promotion of the tools called power morcellators but not permanently pulling them from the market.

The action follows a Food and Drug Administration advisory on April 17 discouraging doctors from using the devices to remove fibroids—common but often painful uterine growths—because of a risk of worsening an often-hidden cancer.

The FDA has said it plans an advisory committee meeting this summer to examine the tools’ use more deeply. J&J wrote in a letter to customers that it is waiting for the FDA and the medical community to further clarify the role of morcellation in fibroid treatment. The letter was reviewed by The Wall Street Journal.

J&J, which began selling the devices in 1998 through its Ethicon division, 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,” J&J told customers.

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. The FDA has estimated morcellators are used about 50,000 times yearly to perform fibroid-removal procedures. Overall, fibroids account for about 40% of the roughly 500,000 hysterectomies performed annually in the U.S., by some estimates.

Fibroids are most often benign. But the FDA cited a 1 in 350 risk that women undergoing surgery to remove these growths have an undetected cancer known as a uterine sarcoma. The risk of spreading this cancer with morcellators – highlighted in a series of Wall Street Journal articles—erupted into a heated gynecological debate late last year after a Boston-area couple began raising an alarm.

Amy Reed, a 41-year-old mother of six and anesthesiologist at Boston’s Beth Israel Deaconess Medical Center, developed advanced uterine cancer shortly after a hysterectomy in October. The hospital that performed the procedure, nearby Brigham and Women’s Hospital, acknowledged that use of morcellation worsened her cancer.

J&J said the suspension will affect all of its morcellator products, which go by the names “Gynecare Morcellex,” “Morcellex Sigma” and “Gynecare X-Tract.”

The sales halt doesn’t prevent doctors from using devices already in inventory, and J&J hasn’t recalled those devices from the market. But several hospitals, including Cleveland Clinic and Brigham and Women’s, have suspended morcellator procedures following the FDA’s advisory.

Other smaller morcellator manufacturers include Karl Storz GmbH, Olympus Corp. and Richard Wolf GmbH. Storz and Wolf didn’t respond to a request for comment about whether they have made any changes following the FDA advisory. An Olympus spokesman declined to comment.

The FDA also advised that, in cases where power morcellation is still considered the best option, doctors should inform patients about the hidden-cancer risk.

Medical societies have been reviewing the procedure as well. The American College of Obstetricians and Gynecologists has said its ongoing review includes the rate of undiagnosed uterine sarcomas. The AAGL—a trade group formerly known as the American Association of Gynecologic Laparoscopists—indicated in a message to members last week that it opposes any restrictions on power morcellation and would issue guidance soon.

J&J, a huge purveyor of drugs, medical devices and consumer products, doesn’t publicly disclose morcellator sales. The company became a major player in the field after its 1998 purchase of FemRx, a market pioneer with a morcellator called “Diva.” J&J had an estimated 72% of the laparoscopic morcellator market in 2011, according to the most recent data provided by iData Research Inc., a market-research firm.

J&J said it remains confident in its morcellators’ safety and effectiveness. 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.”

Myomectomies are procedures to just remove fibroids

Written by John Kamp and published by the Wall Street Journal, April 29, 2014.

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