In, April 2014, The FDA issued a safety communication discouraging doctors from using power morcellator devices to remove uterine fibroids because of risk of spreading undiagnosed cancer throughout the abdominal cavity. A recent from The Cancer Letter, an online source on development of cancer therapies, cancer research funding and health care finance, legislation and policy published an article titled: “As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study” discussing what options the Federal Drug Administration (FDA) can take in regulating the power morcellator devices.
Read the full in depth article here: http://www.cancerletter.com/articles/20141121_1
Morcellators are medical devices produced by Johnson & Johnson’s Ethicon division. They are used to remove noncancerous growth from the uterus and performing hysterectomies, as well as on some kidney and spleen surgeries. Doctors insert these devices through small incisions and remove cutting tissue after cutting and shredding it. Currently, the power morcellator is categorized as a Class II moderate-risk device.
The Cancer Letter highlights four key options in their article that the FDA will need to consider:
• Ban, recall, or issue a warning on the risks of using the power morcellators for hysterectomies and myomectomies;
• Order device manufacturers to resubmit the power morcellator through the Class III high-risk device approval protocol;
• Put a black box label on the devices—FDA’s sternest warning for significant risk of serious or life-threatening adverse effects;
• Request more data via post-market surveillance studies, which can include registries and controlled trials.
Products and devices can be eligible to obtain FDA approval without clinical trials as long as the product is “substantially equivalent” to a product already on the market. However, given the problems associated with power morcellators, this expedited approval process has been called into question. According to the article, the FDA has no deadline to act.
If you or someone you love has suffered from complications connected to procedures where morcellators were used, then you could be eligible for a morcellator lawsuit. Contact a Babbitt & Johnson, P.A. medical device attorney for a free consultation. Our medical device injury lawyers represent morcellator victims throughout Florida and across the United States.
1. JAMA report: Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation http://jama.jamanetwork.com/article.aspx?articleid=1890400
2. The Cancer Letter article: “As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study” http://www.cancerletter.com/articles/20141121_1
3. Wikipedia-Morcellator: http://en.wikipedia.org/wiki/Morcellator