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Laparoscopic power morcellation can spread undetected cancer with disastrous results. Laparoscopic power morcellators are used during surgery to remove uterine fibroids or to preform a hysterectomy. Uterine fibroids are usually non-cancerous (benign) tumors that grow within the wall of the uterus. Unfortunately, some uterine fibroids are cancerous.

Laparoscopic power morcellators are medical devices that, until last year, were often used to remove uterine fibroids during hysterecomy or myomectomy. Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.[2]

Spread of Cancer Due to Power Morcellation

The most significant complication is the risk of disseminating, seeding, and upstaging an undiagnosed uterine cancer, significantly worsening the patient’s likelihood of long-term survival. Leiomyosarcoma is an aggressive cancer of the smooth muscle cells of the uterus that often presents as harmless fibroids. A leiomyosarcoma that is contained in the fibroid capsule is Stage I. Once the fibroid capsule is breached by the morcellator, the sarcoma may be upstaged quickly to Stage IV.[3] According to the National Cancer Institute, the five-year relative survival rates for leiomyosarcoma are:

  • Stage I – 63%
  • Stages II and III – 36%
  • Stage IV – 14%[4]

Federal Safety Alerts Regarding Power Morcellation and Market Withdrawal

On April 17, 2014, the FDA issued a warning discouraging the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids:

Importantly, based on an FDA analysis of currently available data, it is 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.

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.[5]

On July 10, 2014, the FDA Obstetrics and Gynecology Devices Panel met to evaluate the risks and benefits of the use of laparoscopic power morcellators during minimally invasive hysterectomy for symptomatic uterine fibroids and myomectomy. Based on its risk-benefit analysis, the FDA concluded that market withdrawal was warranted.[6]

On July 30, 2014, Johnson & Johnson, the largest manufacturer of power morcellators, issued a worldwide medical device market withdrawal of its Ethicon morcellation devices.

On November 24, 2014, the FDA asked manufacturers to include two contraindications and a boxed warning in their product labeling, which warns the medical community against using Laparoscopic Power Morcellators in the majority of women undergoing myomectomy or hysterectomy and recommended doctors share this information with their patients.[7]

While Ethicon issued a voluntary recall, other companies such as Karl Storz, have not recalled their power morcellators and continue to promote their products.

FBI Launches Investigation of Power Morcellator Manufacturer

The FBI is investigating whether Johnson & Johnson knew about the hazards of power morcellation before pulling its devices off the market last year.

Dr. Hooman Noorchashm, a cardio-thoracic surgeon whose wife, Dr. Amy Reed, was diagnosed with Stage IV uterine cancer after undergoing a morcellation procedure, contacted the FBI after suspecting that doctors and hospitals using power morcellation devices violated federal law requiring adverse events to be reported to the FDA. Drs. Reed and Noorchashm have launched a nationwide campaign to ban morcellation.

Dr. Robert Lamparter, a retired pathologist, has also spoken with the FBI. In 2006, he corresponded with Ethicon (Johnson & Johnson), warning of the potential for  morcellators to spread undetected cancer.

Power Morcellator Lawsuits Consolidated

On October 15, 2015, the U.S. Panel on Multidistrict Litigation ordered most of the federal lawsuits against power morcellator manufacturers consolidated in the District of Kansas under Judge Kathryn Vratil. In its decision, the Panel appeared persuaded that there could be more cases, noting that 650,000 women undergo surgery for uterine fibroid removal yearly and, until 2014, were likely to have had surgery using laparoscopic power morcellation.

If you or a loved one has been diagnosed with gynecologic cancer following laparoscopic removal of uterine fibroids, please contact Andrews Thornton Higgins Razmara for a free case evaluation at 1-800-664-1734 or www.andrewsthornton.com.

 

[1] http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=50

[2] http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm

[3] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM404148.pdf

[4] http://www.cancer.org/cancer/uterinesarcoma/detailedguide/uterine-sarcoma-survival-rates

[5] http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm

[6] http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM404148.pdf

[7] http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm

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