Karl Storz Morcellator Lawsuit Filed in MichiganFebruary 3, 2015 — A lawsuit has been filed against Karl Storz, Inc. by a woman who was diagnosed with stage-4 bone and breast cancer after a morcellator was used during her hysterectomy.

The lawsuit was filed last week by Denise Whitfield in federal court in Michigan.

She underwent a minimally-invasive hysterectomy for the treatment of fibroids in June 2011. During the operation, a Storz Rotocut G1 power morcellator was used to cut up tissues in her uterus. This allegedly spread undiagnosed cancer, resulting in the development of cancer outside the uterus.

Whitfield was diagnosed with stage-4, metastasized bone and breast cancer in July 2014, when she was hospitalized for spinal surgery.

She now must undergo extensive medical treatments for cancer, including medications and radiation therapy. She continues to suffer from fatigue, body pain, joint pain, stiffness, inflammation, swelling, insomnia, and gastrointestinal problems.

The Rotocut G1 was approved with a 510(k) clearance in July 2006. Karl Storz marketed it as safe and effective, but like all medical devices approved with a 510(k) application, it was approved because it was similar to another device and not because it was proven to be safe through rigorous clinical trials.

The lawsuit accuses Karl Storz of negligence for failing to warn that the use of morcellators in uterine surgery could potentially spread cancer. Long before the Rotocut G1 was marketed, non-power morcellators were used with surgical tissue bags designed to prevent the spread of cancer.

According to the complaint:

“Defendants knew or should have known that use of the tissue bag could prevent the spread of malignant cells to healthy tissue in the body cavity, yet failed to require concomitant use of the bag, or warn that failure to use the tissue bag can lead to subsequent development of cancer outside the uterus.”

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