Editor's Note: While the US Food and Drug Administration (FDA) considers restrictions on the use of laparoscopic power morcellators in uterine fibroid surgery, one physician says the controversy is an example of why the approval process for medical devices needs to be revamped.
David Challoner, MD, once chaired an Institute of Medicine (IOM) committee that was asked by the FDA and Congress to review the 510(k) approval process. The committee concluded in a report published in 2011 that the process doesn't ensure that devices entering the marketplace are safe.
It was through the 510(k) process that the first power morcellators were cleared for sale in the 1990s. In October 2013, however, the safety of the devices started to come into question when Boston-based cardiothoracic surgeon Hooman Noorchashm, MD, PhD, launched a campaign calling for a ban on morcellation. Dr. Noorchashm became involved in the issue after his wife learned that she had an unsuspected uterine leiomyosarcoma morcellated during what was supposed to be a routine hysterectomy.
This month, the FDA's Obstetrics and Gynecology Devices Advisory Committee met to review data on the potential for morcellators to spread occult cancers. A majority of the panel members recommended that a black box warning be placed on the devices. In a letter to the advisory committee , Dr. Challoner recommended that the agency reconsider the recommendations made in the 2011 IOM report.
Dr. Challoner recently spoke with Medscape about his recommendations for what the FDA should do now.
Medscape: Why did you decide to submit a statement for the FDA advisory panel meeting on morcellation?
Dr. Challoner: The 510(k) clearance process is not an approval process. It is a clearance process established by legislation passed in 1975. Clearly, it was a player in what has turned out to be the current morcellation tragedy, so we need -- from a public policy point of view -- to think about it once again. It was a series of similar device public health disasters in 2007, 2008, and 2009, involving the use of pelvic mesh and breaking cardiac leads, that led to Congress and the FDA's request to the IOM that we study the 510(k) process and recommend what changes might be made.
Medscape Ob/Gyn © 2014
Cite this: Morcellation Controversy Could Have Been Avoided With Surveillance, Former IOM Chair Says - Medscape - Jul 23, 2014.