FDA Further Investigation Into the Dangers of Power Morcellation

Sep 05, 2014
Paul M. da Costa

As we have previously blogged about, the FDA has recently begun investigating the use of a medical device called a power morcellator.  Power morcellators have been used in women undergoing hysterectomies or myomectomies, or the removal of the uterus or uterine tumors.  The device makes it easier to break tissue into smaller pieces, which can then be removed from the body through a small incision.  The dangers involved in using this device have recently come to light and show that there is much greater risk of the device spreading undetected cancer throughout the abdomen of the woman undergoing the procedure. 

In April, the FDA issued a warning to doctors against further use of power morcellators.  Manufacturers of the device, including Johnson & Johnson, recalled all power morcellators shortly thereafter.  Now, as reported by Democrat & Chronicle, the FDA wants consumers to make reports of any “adverse events” that they experienced after undergoing surgery where a power morcellator was used. 

The FDA has asked that all reports be made to its MedWatch program.  For most consumers, this can be done using a simple form.  The form gives the consumer directions as to what information to include and when use of the form is appropriate.  Hopefully, consumer reports will help the FDA assess the full extent of the damage caused by power morcellators.

If you or a loved one has undergone surgery using a power morcellator and suffered injury as a result, you may have a legal claim to compensation for your injuries.  The experienced attorneys at Sarno da Costa D’Aniello Maceri LLC can help you with your case.  Call us today at 973-274-5200.