Ethicon, a Johnson & Johnson company, has temporarily halted sales of its laparoscopic power morcellators for the treatment of uterine fibroids, following concerns that the devices could spread cancerous tissue in women with unsuspected uterine sarcoma.
The company is suspending global sales, distribution, and promotion of its three morcellation devices until the role of morcellation for patients with symptomatic fibroid disease is redefined by the Food and Drug Administration (FDA) and the medical communities.
The suspended products include the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-tract Tissue Morcellator.
"Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," the company said in a statement. "However, interpretation of the available epidemiological evidence is complex, and it is difficult to diagnose certain malignancies in advance of surgery."
On April 17, the FDA issued a safety communication to patients and physicians warning that if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure could spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s chances 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."
The FDA recommended that physicians not use laparoscopic uterine power morcellation in women with known or suspected uterine cancer and that they carefully consider all the available treatment options for women with symptomatic uterine fibroids.
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