Laparoscopic Power Morcellators®
Laparoscopic Power Morcellators
Following a warning released by the US Food and Drug Administration (FDA) last April, one of the medical industry’s most prominent manufacturers (Johnson & Johnson) has recently suspended the sale of power morcellators across the globe. The devices under scrutiny had been sold under the J&J Ethicon label. The FDA’s warning was issued in order to address the serious health risks associated with the use of laparoscopic power morcellators during certain surgical procedures.
Laparoscopic Morcellators Legal Action
If you or a family member has been diagnosed with cancer following hysterectomy and/or the laparoscopic removal of fibroids with a power morcellator, contact the lawyers at the Richard Harris Personal Injury Law Firm at (702) 444-4444 or use our Free Consultation Form.
Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a surgical device to break up the uterine tissue into smaller fragments so they can then be extracted through a small incision in the abdomen (laporoscopy). In women with undiagnosed cancer, the use of a power morcellator during hysterectomy or to remove fibroids includes the risk of spreading the undiagnosed cancer throughout the abdominal cavity and therefore to other parts of the body as well. This is a serious health concern as it can catapult a previously non-cancer patient into advanced stages of cancer in a relatively short amount of time.
There are reports indicating the manufacturers were aware of the risks well before the FDA issued their news release on April 17, 2014. One such report that has come to light during the current FDA investigation shows that in 2006 Johnson & Johnson received a letter from a respected Pennsylvania pathologist imploring them to “reconsider the risk to the patient” as these devices “may lead to dissemination of malignant tissue” during the removal of the uterus or uterine fibroids, as prescreening for cancer before the procedure is not always effective.
Pre-hysterectomy screening for cancer is not 100% accurate and many women who test negative for uterine cancer prior to surgery may indeed have undiagnosed sarcoma. For that reason, the FDA is urging both physicians as well as manufactures to look at alternative methods and procedures for hysterectomy and the removal of fibroids.
This law firm is not associated with, sponsored by, or affiliated with Johnson & Johnson, Ethicon Inc, or the U.S. Food and Drug Administration
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