FDA strengthens existing warning on Morcellators
Today, the FDA strengthened an existing warning about the dangers posed by power morcellators. These devices, which have come under heavy scrutiny in recent months, had previously been a common surgical tool used in hysterectomies and in the removal of uterine fibroids. Unfortunately, these devices pose an immense threat as they have the ability to spread undetected uterine cancer to other parts of the body.
Because of these dangers, the FDA issued a warning in April 2014 discussing the potential risk associated with these devices. However, this warning was updated and strengthened today, as the FDA noted that for the removal of fibroids and in hysterectomies, these devices should not be used in “the vast majority of women.” To help protect patients, the FDA has recommended that a boxed warning be added to detail the dangers of the devices. The agency has also mentioned two specific situations in which these devices should never be used; however, these two instances cover the vast majority of situations in which the use of a power morcellator may have been appropriate.
When the FDA issued their initial warning earlier this year, medical device manufacturer Johnson & Johnson recalled three of their popular power morcellators, and advised medical professionals to stop utilizing these devices in procedures.
Today’s FDA announcement can be read in full by clicking here.