Hysterectomy, Fibroids and Morcellators
Several hysterectomy cancer lawsuits have been recently filed against the manufacturers of power morcellators. These medical devices are used during laparoscopic procedures to cut the uterus into tiny pieces that can be removed through minimally invasive surgery.
Unfortunately power morcellators can cause devastating injuries, if there is an undiagnosed sarcoma in the uterus, the device could cause the cancer to be spread throughout the abdomen, pelvis and other organs including the liver, lungs and brain.
Plaintiff Allegations: Leiomyosarcoma Metastatic Cancer
According to Salem-Robinson, a Wolf Power Morcellator was used during her hysterectomy in 2012. Her doctors did not know that her uterus contained leiomyosarcoma (LMS), which was spread through her abdominal cavity by the use of the morcellator.
After the hysterectomy, Salem-Robinson was diagnosed with metastatic LMS cancer, and she is suing Wolf for negligence, strict products liability, breach of warranty, and fraud.
FDA: Morcellation Hysterectomy Cancer Risks
Laparoscopy-assisted hysterectomy (LASH) is a gynecological procedure for removal of uterine fibroids. The minimallly invasive procedures require use of power morcellators to cut the uterus and fibroids into very small pieces.
In April, the FDA issued a public safety communication that urged doctors to avoid using power morcellators for fibroid removal. This warning came after reports of patients diagnosed with leiomyosarcoma and other uterine cancers during laparoscopic hysterectomy procedures.
The FDA reported that one out of every 350 women who undergo laparoscopic hysterectomy or uterine fibroid removal has undiagnosed cancerous sarcoma cells. The agency warned that use of power morcellators carries an unreasonable risk of spreading the cancer and reducing the long-term survival.
Morcellator Manufacturers Knew or Should Have Known of Cancer Risks
The women affected with advanced uterine cancers claim that adequate warnings were not provided and Wolf and other manufacturers including Johnson and Johnson Ethicon failed to make the devices safe.
Salem-Robinson alleges that Wolf Corporation failed to conduct adequate testing on the risk of power morcellators spreading uterine cancer, claiming that information was concealed from the FDA, National Institutes of Health and the doctors.
Following the FDA warnings last month, Johnson & Johnson’s Ethicon subsidiary announced that it has halted sales of morcellators until it can determine if there is a safe way to use them for uterine fibroid removal.