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FDA calls for black box warning for surgical tool used in hysterectomies

Laparoscopic power morcellators can spread undetected cancer in women

morcellator-black-box-lawsuitWomen having fibroids removed should not be treated using a surgical tool known as a laparoscopic power morcellator in the vast majority of cases, the Food and Drug Administration stated recently. The nation’s top health regulator warned that the gynecologic device has spread cancer in at least two-dozen women, escalating a health issue to from treatable to life-threatening.

On Nov. 24, 2014, the FDA put a “black box” warning on labels for power morcellators, informing doctors that the gynecologic device should not be used in the “vast majority” of fibroid-removal procedures. Earlier this year, the FDA warned that power morcellators have the potential to spread cancer, but declined to issue a “black box” warning, which is the strongest warning a medication may carry and remain on the market. Consumers nationwide have filed power morcellator lawsuits against companies that make and market the device, including Johnson & Johnson subsidiary Ethicon, Lina Medical, and Blue Endo.

The now-required “black box” warning states that laparoscopic power morcellators may spread cancer during fibroid surgery in women who have unsuspected uterine sarcoma, a type of uterine cancer. Currently, there is no reliable method for predicting whether a woman with fibroids has uterine sarcoma. The FDA estimates 1 in 350 women having fibroid removal surgery has uterine sarcoma.

Other companies that make laparoscopic power morcellators used for gynecological procedures such as fibroid removal and hysterectomies include:

  • Ethicon / Johnson& Johnson
    • Gynecare Morcellex
    • Gynecare X Tract
    • Morcellex Sigma
    • Diva by FemRx
  • Karl Storz GmbH
    • KSE Steiner Electromechanic Morcellator
  • Lumenis Ltd.
    • VersaCut+Tissue Morcellator
  • Olympus
    • PKS PlasmaSORD
    • VarioCarve Morcellator
  • Richard Wolf GmbH
    • Morce Power Plus
  • LiNA Medical
    • Xcise
  • Cook Urological Inc.
    • Cook Tissue Morcellator
  • Smith & Nephew
    • TRUCLEAR Morcellation System
  • Blue Endo
    • MOREsolution

The FDA also recommended that power morcellators should not be used on peri- or post-menipausal women or those having tissue removed in one piece. Additionally, the surgical tool should not be used if tissue is cancerous or suspected to be cancerous.

The Cochran Firm, D.C. is actively monitoring claims arising from power morcellators. If you or someone you love developed cancer or whose cancer spread after undergoing a procedure using a power morcellator, please contact The Cochran Firm, D.C. for a free, prompt, and confidential consultation. Because strict time deadlines apply to filing a claim, we recommend contacting us at your earliest convenience.

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