Scores of speakers expressed outrage before a panel of FDA experts gathered at a public meeting yesterday and today to discuss the future of laparoscopic power morcellators (LPMs), devices used to break up and extract tissue during minimally invasive gynecologic surgeries.
The devices have been the subject of controversy and lawsuits over concerns that they may cause the spread of undetected cancers by disseminating cancerous tissue when used to break up and remove what are thought to be benign growths in the uterus. This can cause the "upstaging" of a cancerous growth that could have been removed through an abdominal surgery to a fatal stage IV cancer.
The FDA convened the Obstetrics & Gynecology Devices Advisory Committee this week to discuss how best to address the emerging risks of LPM devices. The panel lost one of its members just days before the meeting when gynecologist Andrew Brill stepped down due to his financial ties to companies that make LPMs, the Wall Street Journal reported.
In addition to addressing the FDA’s docket of questions, the panel heard some passionate perspectives from physicians and patients affected by the device, some of whom called for an outright ban on LPMs. Earlier this year Johnson & Johnson (NYSE:JNJ) and its Ethicon subsidiary voluntarily opted to suspend sales of LPMs, but no official recalls have been initiated by regulators.
This week’s panel called for surgeons to take further precautions, including MRI, to ensure a fibroid is not cancerous prior to removal. They also called for enhanced warnings to surgeons and increased communication to ensure that patients know there is a small, but grave risk associated with the use of laparoscopic surgery and the use of LPMs and that other options, such as more invasive abdominal surgery, are available.
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