Power Morcellators and the Risk of Uterine Cancer
The FDA has recently issued a Safety Communication alerting doctors and consumers that Power morcellators can spread undiagnosed cancer cells throughout the abdomen when used for surgical hysterectomies and myomectomies. Power morcellation is used in about 55,000 to 75,000 laparascopic surgeries annually in the United States.
What are Power Morcellators?
Power morcellators are surgical devices commonly used in minimally invasive hysterectomies and fibroid removals. The morcellators are inserted through a small incision in the abdomen where it grinds and shreds the uterine tissue into small pieces that are then removed through a tube or laparascope. The controversial issue is that some of the morcellated tissue from the uterine mass may have undiscovered cancerous cells that disperse or spill and are left behind in the uterus.
When the entire uterus is removed via a total abdominal hysterectomy there is not a risk of these cancerous cells spreading. Many surgeons were aware of the possibility that morcellation devices could spread cancerous cells, but they continued to use the devices because some felt that the benefits (shorter recovery time, smaller incisions, lower rates of infection) outweighed the risks. Often patients were not being educated about the dangers of power morcellators prior to the removal of their uterus or uterine fibroids. When the FDA made the warning announcement about the power morcellators, many gynecologists and doctors groups suspended their use of the power morcellation procedure.
What is the Research on Power Morcellators?
There is no proven method for diagnosing uterine sarcoma prior to a hysterectomy or myoectomy. These cancerous cells may spread and grow in the abdominal and pelvic cavity and develop into aggressive cancers such as uterine leiomyosarcoma, myelosarcoma and uterine sarcoma. The incidence of uterine cancer is roughly 1 in 350 women that undergo power morcellator-assisted surgery. The Journal of American Medicine (JAMA) published a study indicating that the risks of these uterine cancers is significantly higher (36%) for women over the age of 65 who have a hysterectomy using a power morcellator.
In February of 2015 a new study was published in the journal Obstetrics & Gynecology, which cited research from the University of Michigan that echoed the findings of the JAMA study. The study showed that one in 368 women who had hysterectomies for fibroids had an undetected uterine sarcoma.
What Power Morcellator Device Manufacturers are Involved?
Medical device manufacturers and have the responsibility to manufacture, label and market products that are safe for the public. Lawsuits are beginning to arise alleging that the manufacturers of power morcellators should have known the risks of these devices spreading cancerous cells. Johnson and Johnson’s Ethican division halted sales of their power morcellator after the 2014 FDA warning pending further review; however, The Pittsburgh Times reported that Johnson and Johnson was alerted to the risks of power morcellators in communications with Dr. Robert Lamparter in 2006.
The following companies are also manufacturers of power morcellators:
- Blue Endo
- Karl Storz
- Smith and Nephew
- Richard Wolf Gmbh
- KSE American
- LiNa Medical
- Lumenis Ltd
- Cook Urological
If you are a patient facing a hysterectomy using a power morcellator, it is prudent to ask your surgeon about the potential dangers of the surgery. Doctors should make you aware of the risks associated with the use of any medical device. If you have had a power morcellator-assisted surgery in Kentucky and believe you have suffered serious injury as the result of its use, you will want to contact an attorney familiar with medical malpractice and product liability law.
Please contact Brett H. Oppenheimer, PLLC for a free consultation on your case today. You may also call Brett at (502) 242-8877.