Attorneys Tracey & Fox Report: Woman Says Gyrus Morcellator Caused Cancer’s Spread To Abdomen

June 17, 2015 – – On October 9, 2014, a husband and wife living in Grass Valley, California filed one of the first lawsuits to claim that the use of a power morcellator spread previously undiagnosed uterine cancer. Along with her husband Kurt Nielsen, Lisa Nielsen brought her claim against Gyrus ACMI in the US District Court for the Eastern District of California. Registered under case number 2:14-cv-02375-GEB-DAD, a copy of the couple’s complaint can be found at Tracey & Fox. The firm’s attorneys, who are currently investigating potential power morcellator lawsuits, say that the Nielsen’s have joined a quickly growing litigation. At least twelve claims against morcellator manufacturers have been filed so far, they report, with more expected to follow.

In court documents, Nielsen says that she underwent a hysterectomy for the removal of uterine fibroids. While fibroids are assumed to be benign, there is “no reliable method of […] testing whether a woman with fibroids may have a uterine sarcoma,” according to the US Food & Drug Administration. Nielsen writes that prior to her procedure, she was unaware that she had any form of cancer, including the aggressive soft tissue cancer known as sarcoma. But over a year after her hysterectomy, Nielsen learned that she did: doctors informed her that they had found seven cancerous tumors in her abdomen. She was forced to undergo multiple surgeries, as well as chemotherapy. Currently, Nielsen says that she is being “actively monitored for new tumors.”

Nielsen claims that the morcellator employed during her hysterectomy spread undetected uterine cancer, harbored in what were believed to be benign fibroids, to other locations in her body. But she says that she was never even warned of the possibility that her “fibroids” could be cancerous, let alone that morcellation could spread the undetected disease. Plaintiff claims that she only learned of morcellation’s risks, now accepted as fact within the medical community, in 2012.

Nielsen accuses Gyrus ACMI of failing to warn patients and healthcare professionals of the risks presented by its medical device. She says that Gyrus owed patients, including herself, a duty to design and manufacture the power morcellator “in such a way as to avoid harm,” and claims that the company failed to honor this duty.

The Nielsens’ complaint comes in the wake of several strongly-worded warnings from the Food & Drug Administration. In fact, the FDA now “warn[s] against the use of laparoscopic power morcellators in the majority of women” undergoing fibroid removal procedures. The risk of a woman harboring an undetected uterine sarcoma “is higher than previously understood,” the federal agency stated in its November 24, 2014 Safety Communication. And while studies have suggested the morcellator’s risks for more than two decades, plaintiffs in recent lawsuits claim that manufacturers actively “downplayed […] serious and dangerous side effects […] to encourage sales of the product.” Nielsen herself writes that Gyrus “conceal[ed] from the FDA, National Institutes of Health, the general medical community and / or physicians […] their full knowledge and experience regarding the potential that products used for uterine morcellation are harmful to humans.”

This is at least the third morcellator complaint to be filed against Gyrus ACMI, a subsidiary of Japan’s Olympus Corporation and manufacturer of the PKS™ PlasmaSORD™ Bipolar Morcellator. Unlike many other morcellators, which utilize spinning blades to grind uterine or fibroid tissue, Gyrus’ product uses electrical current to sear through tissues and break them into smaller pieces. And while Gyrus says that its “completely bladeless” morcellator “creates fewer tissue fragments to clean up,” the FDA has announced that there is no morcellator that does not present the risk of spreading undetected uterine cancer cells.

Tracey & Fox’s power morcellator attorneys report that as many as 60,000 morcellator procedures are performed for the removal of uterine or fibroid tissue every year. While recent industry pressures may have reduced this number substantially, the lawyers believe that many women are now battling cancers that may have been worsened by the use of a power morcellator. In response, Tracey & Fox’s experienced dangerous medical device attorneys are providing free consultations to patients who were diagnosed with uterine cancer after undergoing a hysterectomy or myomectomy procedure. For more information, and a case eligibility evaluation, call 713-495-2333.

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Contact Tracey & Fox:

Sean Tracey
888-427-0543
440 Louisiana Street , Suite 1901
Houston, TX 77002

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