February 11, 2015 — A lawsuit has been filed against Ethicon Inc. on behalf of a woman who died of cancer after a Gynecare Morcellex morcellator was used during her hysterectomy.
The woman, Cynthia Ostrander of Greenville, South Carolina, underwent a laparoscopic robotic hysterectomy for the treatment of fibroids and bleeding. Before this surgery, there was no evidence that she had cancer.
In fact, she had leiomyosarcoma, an aggressive form of cancer that was undiagnosed because it was encapsulated inside a fibroid.
During surgery in October 2012, the Morcellex was used to cut, shred, and remove three large fibroids from her body. After the surgery, doctors detected cancer in the tissue shredded by the morcellator.
According to the lawsuit (PDF), the cancer would have remained inside the fibroid if the Gynecare Morcellex had not been used in her surgery:
“The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in Ms. Ostrander’s abdominal cavity.”
The lawsuit claims that the use of a morcellator worsened her prognosis, upstaged the cancer, “profoundly and gravely injuring her.” Despite aggressive chemotherapy treatment, she died from cancer in September 2014.
Soon after her death, the FDA announced a “Black Box” warning for the Gynecare Morcellex, cautioning physicians against using it to remove fibroids in menopausal or post-menopausal women.
Ethicon is accused of negligence for failing to adequately warn surgeons about the risk of cancer associated with morcellators, despite knowing about the risk in 2006. They are also accused of failing to produce a safe, closed system for use with morcellators to prevent the dissemination of undiagnosed cancer.
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