During a recent advisory committee meeting, the FDA concluded that power morcellators – popular devices used in uterine surgeries – can spread undiagnosed uterine cancer. This finding followed a lengthy investigation, which was sparked by several medical journal articles that highlighted this potential risk.
Power morcellators are utilized in various uterine surgeries, including those to remove uterine fibroids. These devices are manufactured by several companies; however, the leader in market share is the Johnson & Johnson subsidiary, Ethicon. In response to the recent public scrutiny surrounding these devices, Ethicon recently announced that it would be voluntarily recalling all of its morcellator products.
Power morcellators have been shown to spread and thereby upstage undiagnosed uterine sarcoma, which is a rare and deadly form of uterine cancer. Upstaging of uterine cancer is a significant problem, given the significantly lower survival rates as cancer stages increase. As a result of this risk, the FDA has recommended that power morcellators no longer be used in uterine fibroid surgeries.
The FDA estimated that 1 in 350 women undergoing surgical procedures where power morcellators are used have undiagnosed uterine sarcoma. This obviously means that many women now face the prospect of premature death as a result of these products being used in surgical procedures performed on them. It is all the more tragic that the warning labels for these devices failed to notify physicians that the risk of spreading undiagnosed cancer even existed.
Brandon Bogle is an attorney with the Levin Papantonio law firm.
