J&J Voluntarily Recalls Power Morcellators Over Concerns of Spreading Cancerous Cells


September 15, 2014

Johnson & Johnson (J&J) announced a worldwide voluntary recall of its morcellator medical devices due to concerns of spreading cancerous cells. Removal of the device from the market follows J&J's Ethicon Inc. subsidiary's decision to suspend global distribution of the surgical tool three months ago. Ethicon is one of the biggest manufacturers of the device.

Morcellators are designed to be used in minimally invasive surgeries to remove uterine fibroids and to perform hysterectomies. The devices are used in a significant number of procedures because hysterectomies constitute the most common surgical procedure involving women. The surgical tool is used in approximately 100,000 procedures annually. The medical device uses tiny blade to mince uterine tissue for efficient removal in minimally invasive procedures. The devices are supposed to limit blood loss, accelerate healing and minimize the risk of infection in patients who undergo this type of surgical procedure.

However, the medical devise has been withdrawn from the market because of uncertainty regarding the risk-benefit assessment according to a spokesman for the manufacturer. The decision to voluntarily recall the device is based on concerns that it might spread undetected uterine cancer cells that have not been identified prior to the surgical procedure.

The medical device has been the subject of multiple lawsuits from women who were diagnosed with cancer following the surgeries after undergoing morcellator procedures. One such case involves Bonnie Davis who underwent a hysterectomy in 2012 which involved used of the surgical device. The operation was performed through a keyhole incision in her abdomen. The morcellator was inserted, and the small blades minced the tissue.

The lawsuit alleges that a cancerous tumor that no one knew existed was diced up by the blades and spread to other tissues in her abdomen. The story is especially tragic because the hysterectomy was an entirely elective procedure. The lawsuit indicates that Davis would never have undergone the risk of this unnecessary medical procedure had the risks been disclosed. The failure to provide her with this information deprived her of the opportunity to exercise informed consent before undergoing the surgical procedure according to the lawsuit.

Dr. Amy Reed also provides another compelling story regarding the risk involved in use of the morcellator surgical device. The procedure allegedly seeds undetected cancer throughout a patient's abdomen. Further, the cancer cannot always be detected prior to using the morcellator. According to Dr. Amy Reed, "It spreads everywhere." Reed, an anesthesiologist and surgical intensivist, had a biopsy, ultrasound and MRI to confirm she was cancer free before receiving a hysterectomy with the device. "They spilled it inside. You can't keep track of all the pieces. It's criminal what they're doing to people", said Dr. Reed.

The U.S. Food and Drug Administration previously issued an alert regarding the use of electric power morcellators. On April 17, 2014, the FDA issued an alert discouraging the use of power morcellators in hysterectomies and myomectomies. This recommendation was based on FDA data that indicated 1 in 350 women who undergo surgeries using this medical device are at-risk for having cancer cells spread through the procedure.

The Associated Press reports that the FDA is considering further regulatory action regarding the risk of spreading cancer through procedures involving morcellators. If you have received a laparoscopic hysterectomy or other surgical procedure involving the uterus, you may have a legal claim for financial compensation if a power morcellator was used during the surgery. The manufacturer of a defective medical device can be liable under product liability law, so you should speak to an Atlanta product liability attorney for an evaluation of your rights and remedies.

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Sources:

http://www.bizjournals.com/pittsburgh/print-edition/2014/06/20/a-life-shattered-by-surgery.html?page=2

http://www.bizjournals.com/pittsburgh/blog/the-pulse/2014/04/j-j-suspends-marketing-of-controversial-surgical.html
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393689.htm

http://www.nytimes.com/2014/08/01/business/johnson-johnson-wins-praise-for-pulling-uterine-surgery-devices.html?partner=rss&emc=rss&smid=tw-nytimes&_r=1

Category: Personal Injury

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