On April 17, 2014, the U.S. Food and Drug Administration issued a warning to discourage the use of laparoscopic power morcellation for removal of uterus or uterine fibroids. The power morcellator may spread undetected cancerous tissue in women with unsuspected cancer cells. The FDA said that when the power morcellator is used for hysterectomy or myomectomy for women with uterine fibroids, laparoscopic power morcellators can sometimes disperse occult cancerous tissues beyond the uterus, causing the cancer cells to spread.

What Does The FDA Say?

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 likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”

Source: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm

Johnson & Johnson Suspends Morcellator Sales

Johnson & Johnson, the largest manufacturer of power morcellator devices, has suspended all sales of the devices after the FDA warning letter.

What You Should Do

If you have undergone a hysterectomy or myomectomy for fibroids, the tissues removed are usually tested for cancerous cells. If the results were normal and you are not experiencing any symptoms, routine follow-up with your physician is recommended. Patients with persistent issues should consult their health care professional immediately.

Contact Wilson Kehoe Winingham

If you underwent a myomectomy or hysterectomy and later developed uterine cancer, contact the Indiana product liability and defective medical device lawyers at Wilson Kehoe Winingham. Our attorneys provide a free case evaluation to discuss your specific injuries and complications. Email us at help@wkw.com or 317-920-6400.

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