Pending a review by the U.S. Food and Drug Administration, Johnson & Johnson plans to ask doctors to return its laparoscopic power morcellators, surgical tools that may inadvertently spread cancer in women being treating for fibroid tumors. The company’s Ethicon unit suspended sales and distribution of the devices in April 2014.
Morcellators are used in hysterectomies, and also to cut up uterine masses in the uterus so that they can be more easily removed through non-invasive procedures. The problem is that uterine cancers commonly known as sarcomas sometimes appear to be benign fibroids and can’t be reliably detected before surgery. When the blade of the morcellators spins, it potentially spreads the cancer and worsens patient outcomes.
Johnson & Johnson is the world’s largest manufacturer of laparoscopic morcellators, holding an estimated 72 percent of the market in 2011, according to iData Research Inc. Smaller manufacturers, including the German companies Karl Storz GmbH and Rich Wolf GmbH, and Danish company LiNA Medical, haven’t responded to requests for comment regarding the morcellator controversy and their market plans.
The risks of cutting up cancer inside a human body have been known for some time, but the risk that a woman with presumed fibroids actually had cancer was always believed to be extremely small, 1 in 10,000, and most gynecologists did not consider it worth mentioning to patients. But in April 2014, the FDA stated that women undergoing surgery for fibroids actually have a 1 in 350 risk that the growths are cancerous, much greater than originally thought. A new study by Columbia University found that 1 in 368 women undergoing hysterectomies actually have hidden uterine cancer that is capable of being spread by a morcellator.
According to the FDA, the tool was being used in approximately 50,000 hysterectomies per year, and very commonly used to remove uterine fibroids as well.
Other Morcellator News
A recent study links the FDA’s morcellation warning to increased invasive surgeries for uterine fibroids, raising concerns about reduced access to minimally invasive treatment options for women.
Olympus America is redesigning its power morcellator with a containment system, but the FDA remains concerned about cancer risks. Legal and safety questions persist amid ongoing clinical trials and lawsuits.
The GAO report finds the FDA underestimated cancer risks from power morcellators, highlighting gaps in postmarket device monitoring and raising concerns for patients undergoing fibroid surgeries.
Johnson & Johnson has settled nearly 70 lawsuits over its laparoscopic power morcellator, with cases citing risks of spreading undetected cancer. Additional claims remain pending in multidistrict and state court litigation.
Federal courts have consolidated morcellator cancer lawsuits against Johnson & Johnson and Ethicon, streamlining pretrial proceedings for women alleging the device spread undetected cancer during surgery.
The U.S. Government Accountability Office will investigate whether FDA approval and oversight failures allowed dangerous power morcellators to remain on the market despite their potential to spread hidden cancers.
