A hospital chain in the United States and Great Britain operates 280, a device used in hysterectomies banned after FDA said it can spread cancer.
The device, a network morcellator, not hospitals HCA Holdings Inc., Jeff Prescott, a spokesman for the company based in Nashville, said Monday.
The decision was the same day warned the FDA, the device could spread the hidden cancer.
"We believe it is, the process is not carried out in the vast majority of women," said William Maisel, deputy director for science and scientific director at the FDA's Center for Devices and Radiological Health, said the Wall Street Journal.
The unit must be removed for minimally invasive method for growth of fibroids and perform hysterectomies. The FDA said that since often difficult to distinguish cancerous fibroids uterine sarcoma, surgeons could inadvertently spread the cancer cells during the procedure.
The device uses a rapidly rotating knife to cut the uterine tissue before they are removed, a process that malignant cells could spread.
350 from fibroid process led to the discovery of cancer cells.
The FDA warned before the first use of the current morcellator in April, but this week, the warning used stronger language.
"I think the wording is such that no sound practitioner would use it," said Dr. Amy Reed, a mother of six children of 41 years, compounding their cancer after hysterectomy with the device said, "But there are still people who do not know who will thank you to their physicians."
Hospital chain bans hysterectomy device after FDA warning
4/
5
Oleh
Unknown