The FDA’s Obstetrics and Gynecology Devices Panel has scheduled a hearing in July to discuss whether to ban power morcellators. According to the FDA, the agency has only banned a medical device once before.
Morcellation is sometimes used in minimally invasive laparoscopic hysterectomy operations to remove the uterus and/or fibroids that can cause pain, bleeding and ...
continue reading...The FDA previously advised doctors to stop all use of power morcellators while the devices’ propensity to spread cancer was reviewed. Now J&J is pursuing a global, voluntary return of its power morcellator devices. An article in Reuters reports that this move comes as a result of concerns that the surgical device potentially spreads cancerous uterine growths in women.
Uterine growths, called fibroids, ...
continue reading...A Pennsylvania man is suing the manufacturer of a device used to remove large masses of tissue during minimally invasive surgeries. The man is alleging that the device caused the spread of cancerous tissue during his wife’s hysterectomy, ultimately resulting in her death. The device at issue is known as a morcellator, which operates by breaking up tissue into smaller fragments, allowing a surgeon to remove the tissue through a smaller incision than would be required in standard laparoscopic surgery.
On ...
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