FDA Approves New Morcellator Device Despite Cancer Concerns
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In 2014, the U.S. Food and Drug Administration (FDA) published a statement discouraging the use of power morcellators during procedures to remove uterine fibroids. As a result, many morcellator sellers ceased manufacturing the devices and their use has drastically declined. However, Olympus America Inc. recently launched a new bladeless morcellator that is meant to prevent the inadvertent spreading of cancerous cells. Despite these changes, the FDA required the company to include a warning on the device’s label explaining that the instrument has not been proven to reduce the risk of spreading cancer.
The Dangers of Morcellators
Morcellators are surgical devices used to break up and remove internal tissue. Basically, the instrument is made up of rotating blades that enter the abdomen through small incisions and then shred large masses of tissue for removal. These instruments allow for non-invasive procedures and so are primarily used for removing nonmalignant tumors, such as uterine fibroids or hysterectomies. Unfortunately, as doctors later discovered, when pieces of fibroids are inadvertently left behind they can migrate elsewhere in the body, which can cause serious and dangerous complications. For instance, fibroids can lead to the development of ectopic tissue implantation on abdominal organs. This, in turn, can cause obstructions, inflammation, and abnormal growths, some of which may require additional surgeries and procedures to remove.
Malignant fibroids also have the potential to spread cancer cells throughout the body when left behind in the abdominal cavity, which can be deadly for some patients. In fact, when the FDA announced the dangers of the morcellator in 2014, it stated that these devices could inadvertently spread cancer cells in as many as one out of 350 women.
Olympus America Inc. has stated that its new device will allow doctors to perform safe and minimally-invasive hysterectomies and fibroid removal. However, the evidence supporting these assertions is questionable, meaning that thousands of women may be in danger when undergoing future procedures.
How a Boston Defective Products Lawyer Can Help
Morcellators can have devastating consequences for patients and their families, so if you are a resident of Massachusetts and were recently diagnosed with cancer after undergoing a hysterectomy or standard fibroid removal procedure, please contact Thornton Law Firm, LLP by calling 888-341-1405 and a member of our dedicated legal team will help you set up an initial consultation with an experienced defective products attorney who can explain your legal options.