FDA Issues Safety Communication Regarding Power Morcellators

JNJ LOGOJohnson & Johnson has voluntarily recalled three laparoscopic power morcellators from hospitals worldwide as evidence points to the spread of cancer as a result of morcellation procedures.

Power morcellators are medical devices used during certain types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.

Johnson & Johnson released a statement, stating that the “worldwide voluntary market withdrawal” is the next step following the company’s April 2014 suspension of device sales and distribution. That same month, the U.S. Food and Drug Administration (FDA) recommended that doctors stop using the device as it could result in the spread of cancerous tissue. In a letter sent to hospitals, the company asked that its three devices be returned: the Gynecare Morcellex, the Morcellex Sigma and the Gynecare X-Tract.

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 long-term survival.

Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids. Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spreading unsuspected cancer and the recommendation that doctors share this information directly with their patients are part of FDA guidance to manufacturers of morcellators. The guidance strongly urges these manufacturers to include this new information in their product labels.

If you believe you or a loved one has contracted a uterine sarcoma after a surgery involving a power morcellator, or had fibroids removed from other organs after such a surgery, contact Pope McGlamry for your free legal consultation online or at 877-265-7656.