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Power Morcellator Recall by J&J’s Ethicon Unit

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Medical devices known as power morcellators are a set of spinning blades used during laparoscopic surgeries to cut tissues.  Morcellation refers to the division of tissue into small fragments, which allows the surgeon to remove the tissue through small incission sites.  Power morcellation has been in vogue for treatment of uterine fibroids during  surgeries involving hysterectomy (removal of the uterus) and myomectomy (removal of the uterine fibroids).

In April 2014, the Food and Drug Administration (FDA) estimated that 1 in 350 women undergoing hysterectomy or myomectomy have unsuspected uterine sarcoma, which is a type of cancer.  The FDA warned surgeons against the the use of power morcellation for uterine fibroids due to the risk that the spinning morcellator blades will spray cancerous material throughout the abdomen and pelvis.  The result may be that a relatively dormant uterine sarcoma is cut up and dispersed throughout the abdomen, resulting in a deadly form of cancer known as leiomyosarcoma.

Johnson and Johnson (J&J), the world’s largest seller of health care products, announced recently a worldwide recall of the power morcellation devices manufactured by its Ethicon unit.   Following the April FDA warning, J&J decided to suspend sale of the devices, but took no steps to withdraw devices that had already been sold.  The power morcellator recall completes the loop.

J&J’s Ethicon unit, the largest maker of the devices, is withdrawing them from the market because the risks and benefits for women undergoing hysterectomies or surgery to remove fibroids remain uncertain, Matthew Johnson, a company spokesman, said yesterday in an e-mail. The decision was reinforced by an FDA meeting earlier this month that highlighted the difficulty in diagnosingcancer before a procedure is performed and the risk of disseminating tumors, he said.

“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,” he said.

New technologies that may make safer the power morcellation technique include intra-operative use of a bag to enclose the tissue that is being chopped up.  As reported earlier on this site, the technique is called enclosed morcellation and has already been used at Brigham and Women’s Hospital in Boston. There are many benefits to minimally invasive surgery, including a much shorter recovery time.  Hopefully, new technology and better cancer screening procedures will render safe this procedure.  Until such time, the FDA and Ethicon have concluded that power morcellation simply poses too great a risk to women.  It will be interesting to see if the American Congress of Obstetricians follows suit.

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  1. a.murphy says:
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    this is not a true recall as the device works properly. Its a market suspension(take back) due to risk involved using it on unknown or known cancers