The Food and Drug Administration (FDA) is warning doctors and women who are considering surgery to remove fibroids, the uterus, ovaries or fallopian tubes to avoid laparoscopic power morcellators—especially in women with suspected or known uterine cancer. The federal agency is concerned that laparoscopic power morcellation used during hysterectomy, myomectomy, oophorectomy, and salpingectomy procedures may cause the spread of aggressive cancer in women.
If your cancer has spread following the use of a power morcellator and you believe it was the cause, share the details of your case with our experienced surgical product lawsuit attorneys. You may be entitled to significant compensation for your suffering—money that can help with your medical costs and the financial burdens caused by a dangerous medical device.
The unintended side effects of using a power morcellator during your surgical procedure may have resulted in:
- Cancer growth, particularly metastatic leiomyosarcoma
- Abnormal tissue growth or tumors
- Direct harm to healthy tissues
What is a Fibroid and Why Should You Care?
Uterine fibroids are noncancerous lumps that develop from the muscular tissue of the uterus and located on the wall of the uterus. Not all fibroids cause symptoms in and of themselves, and you may have them without knowing it.
However, the fibrous lumps can cause complications, among them pain. When fibroids do cause problems and pain, in those cases, a majority of women are recommended a hysterectomy or myomectomy procedure as treatment. Many of these surgeries have been done laparoscopically using a power morcellator.
Many of these surgeries have been done laparoscopically using a power morcellator. In layman’s terms, a device goes in and chops up the lumpy tissue.
What problems would push women to consider these procedures?
Uterine fibroids can cause the following problems in women:
- Difficult to get pregnant, can cause premature labor, and miscarriages
- Abnormal menstrual bleeding (between periods, periods can have much heavier blood flow and painful)
- Pelvic pain and feelings pressure (pain in the pelvis or low back, might be a cause of cramping and painful sex)
- Affects the urinary system (frequent urination, incontinence leakage, etc).
Laparoscopic procedures have a number of benefits over a surgical treatment. The benefits including a shorter post-operative recovery time and a small risk of infection compared with an abdominal hysterectomy and myomectomy surgical treatments.
Dangerous Medical Device?
Laparoscopic power morcellation is a minimally invasive surgical technique that is used to perform a variety of procedures, including removal of the uterus or removing uterine fibroids. For these procedures, morcellation involves the use of an electric tissue-cutting device called a morcellator that allows a doctor to remove tissue through a small incision.
Many women choose laparoscopic surgery for hysterectomy or myomectomy because the procedures are associated with shorter recovery time and a reduced risk of infection compared with abdominal surgeries.
The Food and Drug Administration (FDA) issued a safety warning to Doctors in April 2004 regarding the use of power morcellators and the potential for harmful side effects.
However, according to a recent FDA safety analysis “approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”
Since the safety alert, Johnson & Johnson has issued a recall of the device, despite the product not officially having been banned by the FDA at this time. For the victims whose cancer may have been spread further due to its use than would otherwise have occurred, it is already too late.
Because 1 in 350 women undergoing hysterectomy or myomectomy for treatment of fibroids are found to have uterine sarcoma, and there is currently no reliable way to determine which women may have unsuspected sarcomas, the agency has warned doctors to stop using power morcellation during hysterectomy or myomectomy for uterine fibroids.
Even before the FDA’s warning, many complained that women and medical professionals were not being informed about the power morcellator cancer risk. Further, some experts are concerned that the laparoscopic power morcellators were not adequately studied or tested before they were used for surgical procedures.
Originally used to remove fibroids and noncancerous growths during a hysterectomy or myomectomy, the power morcellator device was commonly used during surgical treatments.
Following a study correlating a significant link between use of the devices and cancer growth, Johnson & Johnson has recalled three of their products—the Gynecare Morcellex, Gynecare X-Tract, and Morcellex Sigma.
Get Help Today With Your Morcellation Side Effects
The unintended consequences of a laparoscopic power morcellator being used during your procedure may entitle you to significant compensation for the harm you suffered. While our attorneys cannot turn back the clock, we will fight to get you whatever compensation the law allows.
Compensation can help ensure you get the medical treatment you deserve, and the peace of mind in knowing your needs will not be ignored. If a power morcellator was used in your procedure, share the details of your case today, or call us today at (800) 610-2001 to learn what we can accomplish for you.
The road to recovery can be a long and hard fight, taking a large toll on the sufferer as well as family and friends. Our attorneys will fight your morcellation cancer lawsuit on your behalf to get the justice you deserve, and the compensation you may be entitled to, giving you the freedom to focus on recovery. Contact us to schedule a free consultation and learn how we can help your claim.