After Morcellators Shown to Spread Cancer, Manufacturer Will Recall the Device

Johnson & Johnson said on Wednesday, July 30th, that it will issue a recall for its power morcellators, after studies show that both fibroid removal and hysterectomy procedures can spread uterine cancer in patients.

In April, J&J’s subsidiary Ethicon suspended sales and production of the morcellators while the US Food and Drug Administration investigated the potential for the laparoscopic devices to spread previously-undetected cancer when used in fibroid treatment. A more recent study has shown that the devices can also spread uterine cancer to other parts of the body when the device is used to remove the uterus as part of a hysterectomy procedure.

Now, Ethicon and J&J have announced that they will take a further step to protect patients by asking doctors and surgeons to return the morcellators in what the company refers to as “a worldwide market withdrawal,” which is not exactly a product recall, but should have a similar effect.

“Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” the company said in an e-mailed statement.

Laparoscopic morcellators allow for tiny incisions in the abdomen, rather than more open surgery, reducing recovery time in the hospital. According to FDA estimates, as many as 1 in 350 women have undetected uterine cancer that can look like fibroids, and the cancerous tissue can be ruptured with morcellation surgery. The previous rate was estimated at 1 in every 7,000 women. The latest study, conducted by Columbia University doctors, found that 1 in 368 women who undergo a morcellator hysterectomy have undetected uterine cancer and are at risk of having that cancer spread to other organ systems.

The first LPM was cleared for use by the FDA in 1991. Current estimates suggest that 20,000 women undergo elective fibroid surgery or partial or full hysterectomy surgery with a morcellator or surgical robot each year. Fibroid surgery is often used to treat painful menstrual periods, which can also be a sign of uterine cancer. If the fibroids are tumors rather than benign cysts, then the morcellator can slice the tumors open and spread uterine cancer. In the hysterectomy procedure, the uterus is cut up and removed through small incisions in the abdomen, but slicing up cancerous tissue, similarly with fibroid removal, can lead to the spread of uterine cancer to other organ systems.

On July 11th, the Food and Drug Administration stated that they would create a panel to investigate the potential safety, and danger, of laparoscopic power morcellators (LPM’s), which have been called dangerous devices by patients who believe their fibroid surgery contributed to uterine cancer.

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