A Food and Drug Administration warning about the use of laparoscopic power morcellation to treat uterine fibroids led to widespread change about how the devices are used, where they are used and whether insurance will pay for a procedure using them.
According to the FDA, power morcellation could potentially spread undetected uterine sarcomas during myomectomies and hysterectomies.
Power morcellation was approved in 1991 to grind up and remove uterine fibroids, or benign tumors within the uterus. Power morcellators use extremely small incisions, which helps patients to recover more quickly and easily.
In the process of removing a structure such as fibroids, a power morcellator can cut up tissue fragments that, unknown to the doctor, are cancerous. These tissue fragments, once cut, are left behind as the fibroid or other structure is removed, and can spread from there to other parts of the body.
In its warning, the FDA estimated that approximately 1 in 352 women who undergo either a hysterectomy or myomectomy for uterine fibroid removal has an unsuspected uterine cancer.
The FDA also estimated that 1 in 498 women undergoing such surgeries has unsuspected leiomyosarcoma. Power morcellation could potentially distribute miniscule pieces of fibroids, which in some cases could be cancerous, throughout the body.
The FDA’s guidance advised companies that manufacture laparoscopic power morcellators to include a warning about the potential risks of cancerous uterine tissue, which could be disseminated throughout pelvic and abdominal cavities during morcellation.
Shortly after the FDA gave its warning, pharmaceutical and medical device manufacturing giant Johnson & Johnson removed its products from the market. Johnson & Johnson was a leading manufacturer of power morcellators.
Some large institutions stopped performing laparoscopic power morcellation altogether. Some health insurance companies no longer cover the cost of hysterectomies that include power morcellation.
While the FDA did recommend a black box warning about power morcellation’s risks and association with potential morcellation cancer, the federal agency did not ban the procedure entirely.
This has resulted in many companies investigating alternative methods of performing power morcellation. The goal for these companies is to maintain the minimally invasive surgery of the power morcellator without the increased cancer and mortality risk.
Medical experts are calling for informed consent from patients about the risks of power morcellation, or alternative procedures going forward.
Many patients have reacted to the warnings from the FDA as well, and have chosen to file power morcellation cancer lawsuits. These lawsuits claim that, had the plaintiffs involved known of the potential risk of cancer, they would not have consented to a power morcellation tool being used on them during surgery.
If you have undergone a surgery involving a power morcellator and have since been diagnosed with cancer, you may be able to file a power morcellation cancer lawsuit.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The morcellation cancer attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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