SACRAMENTO (CN) - A power tool used in a hysterectomy spread cancer into a woman's abdomen, giving her seven more tumors, she claims in court.
Lisa Nielsen sued Gyrus ACMI on Oct. 9. in Federal Court.
The doctor who performed Nielsen's hysterectomy used a Gyrus Power morcellator, which minces up tissue so it can be extracted.
Nielsen says she did not know she had cancer when she had the surgery.
More than a year after the hysterectomy, she was diagnosed with seven cancerous tumors in her abdomen. She had to undergo more surgeries and chemotherapy, and continues to be monitored for new tumors, the complaint states.
She claims she "learned that the tumors in her abdominal existed because the Gyrus Power Morcellator had been used during her hysterectomy. That surgery disseminated the cancer cells that were in her uterine fibroids."
She never was warned that her fibroids could be cancerous or that using the power morcellator could spread that cancer, the complaint states.
Nielsen claims that Gyrus ACMI did not adequately test the power morcellator to determine possible side effects and dangers before putting it on the market, and failed to warn physicians of the potential for metastases from using the product.
The U.S. Food and Drug Administration in April issued a safety warning that using power morcellators for a hysterectomy in women with uterine fibroids could be dangerous.
"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. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids," the FDA said in a statement.
Nielsen seeks damages for negligence, product liability, breach of warranty and fraudulent misrepresentation.
She is represented by Robert Clarkson with Clarkson/Riley.
Gyrus did not immediately respond to a request for comment.