FDA Warns Against Power Morcellators For Uterine Fibroid Surgery
This article was originally published in The Gray Sheet
FDA is discouraging use of laparoscopic power morcellation as a therapy for uterine fibroids due to risk of spreading cancer tissue. The agency has instructed manufacturers to ensure that device labeling accurately displays risks; it is planning an advisory panel meeting on the topic for the summer.
You may also be interested in...
The company was sued by a Georgia woman who said the surgical tool allowed uterine cancer to spread throughout her abdomen. Terms of the settlement were not disclosed.
Anesthesiologist Amy Reed, who with her cardiologist husband Hooman Noorchasm turned her battle against uterine cancer into a crusade to abolish unsafe uses of power morcellators, died May 24 at her home in Yardley, Pa., at the age of 44.
As arguments rage over whether the UK regulator has rushed its assessment of the Pfizer/BioNTech vaccine, the European Medicines Agency explains why its conditional marketing authorization approach is taking a little longer.