Ethicon, Inc. (“Ethicon”), a Johnson & Johnson company, announced on July 30, 2014 that it was voluntarily withdrawing from the market all remaining Ethicon Morcellation Devices, following its April 2014 worldwide commercial suspension of selling the devices.
The withdrawal of the morcellation devices followed the July 10 – 11, 2014 meeting of the FDA’s Obstetrics and Gynecology Panel of the Medical Devices Advisory Committee (“Panel”) that met to discuss the safety of laparoscopic power morcellator devices and their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy.
The Panel discussed the risks and benefits of the use of laparoscopic morcellators during minimally invasive hysterectomy for symptomatic uterine fibroids and myomectomy, and the difficulty for medical professionals to preoperatively diagnose some malignancies; the risk of disseminating unsuspected malignant tissue while using power morcellation devices; and, methods to mitigate the risk.
What Is A Morcellator?
According to the FDA, laparoscopic power morcellators are medical devices used during different types of laparoscopic surgeries that can be used to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellators divide tissue into smaller pieces or fragments to facilitate the removal of tissue through small incision sites.
In its April 17, 2014 FDA Safety Communication, the FDA warned that laparoscopic power morcellation used for hysterectomy or myomectomy in women with uterine fibroids poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. The FDA estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.
The FDA warned: 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.
The risk of the spread of cancer when using laparoscopic power morcellation does not appear to be an academic question: a MAUDE report filed by a physician on December 31, 2013 stated, “Pt underwent a morcellation procedure on a fibroid that turned out to have leiomyosarcoma. Now has metastatic disease. Reason for use: fibroid removal.”
A May 23, 2014 MAUDE report stated, “It was reported through an article that a patient underwent a gynecological surgical procedure involving morcellation on unknown date. Following the procedure, the patient died from sarcoma. Additional information has been requested.”
The FDA’s website states that the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
If you or a family member had surgery during which a morcellator was used and you were subsequently diagnosed with cancer, you should promptly seek the legal advice of a medical device attorney in your U.S. state who may investigate your dangerous medical device claim for you and represent you in a defective medical device lawsuit, if appropriate.
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