Power Morcellator Lawsuit- Risk of Spreading Unsuspected Cancer
Power Morcellator FDA Warning
Recently, the FDA released a warning that there may be a risk of spreading unsuspected cancer after the use of laparoscopic power morcellators during myomectomy or hysterectomy procedures.
The FDA has issued a safety communication warning that scientific evidence suggests that the use of laparoscopic power morcellators may contribute to the spread and upstaging of unsuspected uterine cancer in women undergoing hysterectomy and myomectomy for fibroids.
What is a Laparoscopic Power Morcellator?
A morcellator is a medical device (tool) used during uterine procedures such as hysterectomies or myomectomies. The morcellator slices fibroids (uterine masses) and uteruses into small pieces or fragments in order for them to be removed through small incisions in the abdomen in minimally invasive surgery.
What are uterine fibroids and how are they treated?
Uterine fibroids are non-cancerious growths that develop from the muscular tissue of the uterus. Uterine fibroids, also known as leimtomas, are developed by most women during their lives, although most cause no symptoms. However, for those women that are experiencing symptoms such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, they may go through therapy.
Treatment for uterine fibroids could be traditional surgical hysterectomy or myomectomy. Many women choose the laparoscopic surgery (hysterectomy or myomectomy) because of the shorter post operative recovery time and reduced risk of infection.
The Risk from Laparoscopic Power Morcellation
On April 17, 2014, the U.S. Food and Drug Administration (FDA) announced to the public and physicians that they discourage the use of laparoscopic power morcellation when it involves the removal of the uterus or uterine fibroids. They stated, “based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.” This reduces the patient’s likelihood of long-term survival. It is further explained that there isn’t a reliable method for predicting whether a woman with fibroids may have a uterine sarcoma.
Approximately 1 in 350 women have unsuspected uterine cancer known as sarcoma, according to the FDA. The FDA has also estimated the tool has been used in 50,000 hysterectomies a year.
According to the Wall Street Journal (July 30, 2014), the largest manufacture of the power morcellator device, Johnson & Johnson (Ethicon division), has agreed to withdraw the medical device from the market (worldwide).
According to the FDA, for women that have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If the patient was informed that these tests were normal and they have no symptoms, routine follow up with their physician is all that’s recommended. If they do have persistent or recurrent symptoms or questions you should consult your healthcare provider.
How to contact a ZK Power Morcellator Lawyer
Nationally recognized, Zoll & Kranz, has over 50 years of combined legal experience. We focus our efforts on making clients our priority. Our attorneys represent victims of defective medical devices such as the power morcellator mentioned here. We continue our investigation on the Power Morcellator Lawsuit and we welcome your questions in regards to this defective device. Our attorneys and reliable staff working on the power morcellator lawsuit can be reached toll-free at 888-841-9623. Our initial consultation is complimentary, please fill out the form.