What are Power Morcellators?
Minimally invasive (or laparoscopic) surgery has grown in popularity across general medicine. Power morcellators have become a commonly used medical device in laparoscopic procedures ranging from uterine, fibroid, liver, kidney, and spleen removal surgeries.
Frequently power morcellators are used in laparoscopic hysterectomies and myomectomies (removal of uterine fibroids). During the procedure, large masses of tissue are pulled into a spinning blade, which then cuts it into smaller pieces so that it can easily be removed through a laparoscopic incision site in the abdomen.
This not only makes the tissue easier to remove, it results in less invasive procedures, shorter surgical procedures, shorter patient recovery time, and less scarring on the patient’s abdomen.
What is the Issue with Power Morcellators?
The problem, however, is that an estimated one in 350 women that undergo this type of procedure has undetected uterine sarcoma, a form of cancer affecting the muscle and supporting tissue of the uterus.
In these cases, power morcellators cut up cancerous tissue, spreading cancerous cells to other parts of the body. This ultimately reduces the life expectancy of the patient; often turning what might have been a treatable cancer to a deadly one.
Unintended consequences of power morcellators include:
- Cancer growth including: metastatic leiomyosarcoma, uterine cancer, uterine sarcoma and endometrial stromal sarcoma
- Abnormal growth of tissue
- Direct harm to healthy tissue
FDA Alerts & Warnings
In 1991, the FDA approved the first laparoscopic power morcellator for Cook Urological Inc. who cited four devices as precedents to clear its device. Then in 1995, the FDA approved the first power morcellator gynecological surgery through its 510(k) process.
In April 2014, the FDA issued a safety alert discouraging the use of power morcellation in myomectomies and hysterectomies, citing that these devices could unintentionally spread undetected cancer cells to the pelvis and abdomen.
In November 2014, the FDA issued another safety communication asking manufacturers to include a “Black Box” warning because of the extreme risks the devices posed, including two contraindications and a boxed warning in their product labeling warning the medical community against using laparoscopic power morcellators in myomectomies and hysterectomies.
Johnson & Johnson’s Ethicon Division Voluntarily Withdraws Power Morcellators
The largest manufacturer of power morcellators, Johnson & Johnson’s Ethicon division, suspended sales and distribution worldwide after the April 2014 FDA alert, eventually withdrawing the power morcellators from the market.
In May 2015, the Wall Street Journal reported that the FBI had begun its own investigation to determine whether Johnson & Johnson knew about the risks before withdrawing the devices from the market
Lawsuits allege that Johnson & Johnson may have been aware of the risks as early as 2006.
Cancer Risk Leads to Power Morcellator Lawsuits
These devices can put women at an increased risk for a number of uterine cancers, including a rare and aggressive type called leiomyosarcoma. Since these uterine cancers can’t reliably be detected prior to surgery, in many cases, the cancer has been diagnosed at a late stage.
Leiomyosarcoma is an aggressive cancer of the smooth muscle cells of the uterus that often appears to be harmless fibroids. A leiomyosarcoma that is contained in the fibroid capsule is Stage I; however, once a power morcellator cuts into the capsule the sarcoma can quickly move to Stage IV. According to the American Cancer Society, survival rates for this type of cancer at Stage I is 60% but quickly falls to just 15% at Stage IV.
Women who have suffered due to power morcellators are beginning to sue Ethicon and other manufacturers. Power morcellator lawsuits allege:
- Failure to warn
- Consumer risk
- Failure to recall
In one case, that of Brenda Leuzzi, her complaint states that Ethicon failed to warn her about the risks, complications, and adverse events associated with the Morcelex morcellator.
In March 2014, a widowed husband filed a hysterectomy cancer lawsuit after his wife died from uterine cancer less than a year after having a hysterectomy that used power morcellation to treat uterine bleeding
News Update on Power Morcellator Lawsuits
MDL Established: Johnson & Johnson / Ethicon Power Morcellator Cancer Lawsuits
In an October 15, 2015 Order, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has decided to consolidate 15 federally filed power morcellator lawsuits for coordinated pretrial proceedings, transferring the cases to the District of Kansas under the Honorable Kathryn H. Vratil.
Receive a Free Evaluation
If you or a loved one has suffered from cancer spread by a power morcellator during surgery, make sure you know your options. You may be eligible to receive compensation for medical costs, wrongful death, pain and suffering and possibly punitive damages. Contact the lawyers at Nash & Franciskato for a free, no-obligation review of your situation.