Johnson & Johnson is suspending sales of its uterine surgery tool following concerns that the device can cause the spread of deadly cancer. Johnson & Johnson’s subsidiary Ethicon is the largest maker of power morcellators, which are devices commonly used to remove uterine growths, or fibroids. The announcement comes two weeks after the Food and Drug Administration (FDA) warned doctors that 1 in 350 women develop a type of cancer known as uterine sarcoma after undergoing procedures with the device, which can also lessen their odds of long-term survival.
Morcellators are typically used with a tube-shaped blade that grinds up and removes uterine fibroids or, in some cases, the entire uterus. They were introduced in the 1990s and have been used in about 50,000 procedures a year since that time. Morcellator procedures have been favored over traditional open surgery because they are less invasive and are less scarring.
Ethicon began selling morcellators in 1998. The company claims the instructions caution doctors about the potential spread of malignant tissue. It is difficult to determine whether uterine growths are cancerous before they are surgically removed.
Johnson & Johnson said it was suspending the sale of all its morcellator products, which includes the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-tract, but was not pulling them from the market. Since the FDA’s warning, several hospitals have suspended morcellator procedures until more information is available. The FDA said it will convene a public advisory committee to discuss the safety of the devices.
Johnson & Johnson’s Ethicon is currently facing hundreds of lawsuits regarding another female medical device – transvaginal mesh. The mesh is used to treat pelvic organ prolapse and stress urinary incontinence, however it has been linked to serious complications including erosion into tissue and protrusion into other organs causing symptoms such as chronic pain, bleeding, and infections. Many women have had to undergo multiple surgeries to remove the device and some have been left with lifelong health problems.