September 15, 2015 — Olympus Corp. has been sued by a woman from Mississippi who blames a morcellator for spreading undiagnosed uterine cancer.
In July 2011, plaintiff Marlene Kay Waltman had a hysterectomy to treat what she thought were benign (non-cancerous) fibroids and post-menopausal bleeding.
Her surgeon used the Olympus PKS™ PlasmaSORD™ Bipolar Morcellator to cut her fibroids into tiny pieces that could be removed through “keyhole” incisions in her abdomen.
Waltman claims she was not adequately warned that the morcellator could upstage, disseminate, or “seed” malignant cancer cells throughout her abdomen and greatly worsen her chances of survival.
She was subsequently diagnosed with endometrial cancer caused by morcellated tissue, which her oncologist called “a port site metastasis in the setting of a morcellated specimen,” according to the complaint.
According to the FDA, one in 350 women who get a hysterectomy to treat symptomatic fibroids will eventually be diagnosed with uterine sarcoma. The threat of morcellators spreading cancer has led the FDA to require a “Black Box” warning on all power morcellators.
In the past, hand-operated morcellators were almost always used with surgical bags that could contain morcellated tissues. After electric-powered morcellators were introduced in the 1990s, surgical bags were rarely used.
Hundreds of lawsuits have been filed by women who accuse device-makers of failing to adequately design their products or warn about the risk of cancer. The largest manufacturer, Johnson & Johnson, has stopped selling the devices. However, smaller manufacturers like Olympus remain in the market.
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