It may seem only logical that reporting information on surgical device malfunctions should be immediate and complete. Even so, a recent report indicates that the Food and Drug Administration (FDA) is in the process of extending the amount of time to report such occurrences.
The FDA recently proposed changes to the adverse event reporting requirement for industry from monthly reports to quarterly reports for “device malfunctions.” This is according to the most recent draft of the 2017 Medical Device User Fee Amendments. This proposal is now awaiting Senate approval.
It is important to note that device malfunctions often lead to injury or fatality, and this proposed delay will only slow down an already-slow method of recognizing malfunction problems, which will, in turn, lead to an increase in avoidable injuries and fatalities.
The controversy over power morcellation is an excellent case in point. A morcellator is a surgical device used for division and removal of large masses of tissues during laparoscopic surgery. In a laparoscopic hysterectomy, the uterus is morcellated into smaller pieces in the woman’s belly cavity so it can be extracted through the abdomen. The cancer that is most commonly spread by a power morcellator is uterine sarcoma.
At Eichen Crutchlow Zaslow & McElroy, we believe that anyone in the medical community – as well as patients – should have an easy way to report adverse events, and that the FDA should be reviewing that information on a monthly basis, at the least.
If you or someone you know has experienced an adverse event because of a surgical device, or has developed cancer from power morcellators, please call the New Jersey power morcellator lawyers at Eichen Crutchlow Zaslow & McElroy, LLP at 732-777-0100, or contact us online for a free consultation. Our offices are centrally located in Red Bank, Toms River, and Edison, and we serve clients throughout New Jersey.