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FDA: No Reported Adverse Events Involving Morcellation Cancer Upstaging for 8 Years

Posted By Anapol Weiss on this February 15, 2016 at 11:00 am

Federal law requires the reporting of adverse events, but for eight years the U.S. Food and Drug Administration (FDA) did not receive reports of cases involving power morcellation and the spread of cancer.

Between December 2013 and November 2014, however, the FDA received about two dozen reports discussing cancer and upstaging or dissemination – but all of them pertained to morcellation procedures women had undergone prior to December 2013.

Power morcellators use spinning blades to break up tissue and fibroids for laparoscopic removal. The devices have been touted as a less invasive surgical option in gynecological procedures such as hysterectomies and myomectomies. Unfortunately, one in 350 women undergoing a hysterectomy or myomectomy for fibroid treatment is found to have undetected uterine sarcoma – a type of uterine cancer that includes leiomyosarcoma. There is currently no reliable test to determine whether a woman with fibroids has a uterine sarcoma, so women could unknowingly have cancer blasted throughout their bodies during one of these routine procedures.

Ethicon withdrew its power morcellators from the market after the FDA warned about the potential to spread undetected cancerous and infected uterine tissue in women’s bodies. In 2014, the FDA cautioned against using laparoscopic power morcellators in the majority of women undergoing hysterectomies or myomectomies for uterine fibroids.

All power morcellator cases against Johnson & Johnson’s Ethicon subsidiary were consolidated and transferred to the U.S. District of Kansas in October 2015. The litigation was renamed In Re: Ethicon, Inc. Power Morcellator Products Liability Litigation (MDL Case No. 2652). Anapol Weiss is proud to have a leadership role in the litigation and will work tirelessly to protect the rights of people who have filed morcellator lawsuits.

Contact Anapol Weiss if you underwent a minimally invasive hysterectomy or myomectomy and suspect recurring health problems may be related to the use of a power morcellator.

Topics Unsafe Medical Devices