Please note that we are no longer accepting Power Morcellator cases.
In April, 2014 (later updated November, 2014), the FDA released a Safety Communication for Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy to medical providers and the public warning of the risk of spread and/or upstaging of undetected cancerous tissue in women, thereby reducing chances of survival from the cancer.
If you or someone you love were diagnosed with cancer after a laparascopic hysterectomy or myomecyomy, you may be eligible for financial compensation from the drug manufacturer.
How the Device Works
The laparascopic power morcellator is a device used in treating and removing uterine fibroids in hysterectomies and myomectomies that works by breaking up the tumors into small pieces, allowing the surgeon to vacuum out the tissue. While the procedure is minimally invasive and reduces recovery times from many days to just a couple of days (when compared to hysterectomy and myomectomy procedures without use of the device), the FDA has now taken action based on scientific information suggesting that the device can cause the spread and upstaging of undetected uterine cancer. Spread and upstaging happens when cancerous tissue is spread beyond the uterus through the division of the tissue into fragments, or morcellation. Unfortunately, uterine sarcoma cannot be reliably predicted or screened for currently.
It is estimated that approximately 1 in 350 women have unsuspected uterine cancer who undergo a hysterectomy or myomectomy for the removal of fibroids.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.”
In most cases, uterine fibroids are noncancerous, asymptomatic growths that are actually common in women (called leiomyomas). For women experiencing symptoms, they can include such things as excessive menstrual bleeding, pain or pressure in the pelvic area, and/or frequent urination.
Because laparoscopic hysterectomy and myomectomy is associated with less risk of infection and shorter recovery times, many women choose this procedure over abdominal hysterectomy or myomectomy. The power morcellator is frequently used in the laparoscopic procedures.
The FDA has stated, “if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.” Further, they said, “while the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.”
In the safety communication, they specifically warn against the use of the device in most women undergoing either procedure.
The FDA’s recommendations for Health Care Providers
Be aware of the following new contraindications recommended by the FDA;
Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or are candidates for en bloc tissue removal, for example through the vagina or mini-laparotomy incision. (Note: These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
Be aware of the following new boxed warning recommended by the FDA:
The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
Carefully consider all the available treatment options for women with uterine fibroids.
Thoroughly discuss the benefits and risks of all treatments with patients. Be certain to inform the small group of patients for whom laparoscopic power morcellation may be an acceptable therapeutic option that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis. This population might include some younger women who want to maintain their fertility or women not yet peri-menopausal who wish to keep their uterus after being informed of the risks.
The FDA’s Recommendations for Women:
Ask your health care provider to discuss all the options available to treat your condition. There are risks and benefits associated with all medical devices and procedures and you should be aware of them.
If your doctor recommends laparoscopic hysterectomy or myomectomy, ask him/her if power morcellation will be performed during your procedure, and to explain why he or she believes it is an appropriate treatment option for you.
If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care provider.
A number of additional surgical treatment options are available for women with symptomatic uterine fibroids including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy and myomectomy without morcellation, and laparotomy using a smaller incision (minilaparotomy). All treatments carry risk, and you should discuss them thoroughly with your health care provider.
Lawsuits Mount Against Device Manufacturers
One lawsuit against the device manufacturers alleges that Eva Cohn Galambos’s hidden cancer spread in 2011 after a total laparoscopic hysterectomy procedure that eventually led to her death on April 19, 2015. Mrs. Galambos had not been diagnosed with of cancer, had shown no symptoms, and had elected to have the procedure without any warning of the risk of spread or upstaging.
In the case of Donna Burkhart, her husband filed suit after her death by metastic leiomyosarcoma less than a year after her morcellated hysterectomy procedure in March, 2012. She also showed no evidence of cancer and was not informed of any risk in spread or upstaging. The case was settled by device makers LiNA Medical APS, Kebomed AG and LiNA Medical U.S. for undisclosed terms.
Johnson & Johnson’s Ethicon unit has pulled the device off the market as cases continue to be filed against them alleging the spread of undetected tumors. About 70 cases have been settled so far, ranging from $100,000 to $1 million. It is anticipated that the company will spend millions more to settle pending cases.
About Sanders Phillips Grossman
Sanders Phillips Grossman has been holding pharmaceutical companies responsible for injuring individuals by their defective drugs and devices for over 30 years. Defective drugs are pharmaceuticals with side effects that potentially harm, injure, or kill the patient to the point that they outweigh the drug’s intended benefits. Defective devices, such as faulty prosthetics, implants, pacemakers or surgical instruments can harm patients when the product is defective in the manufacturing process, design or marketing strategy.
Pharmaceutical companies are some of the largest, wealthiest, and most influential corporate entities in the world. Sanders Phillips Grossman and its predecessors have recovered over one billion dollars for injured consumers. Our firm’s history in dealing with drug and medical device injury claims has allowed us to take leadership roles in many of the national defective drug and device litigations.
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