Allegations against Use of the Power Morcellators. Power morcellators were designed to facilitate the removal of tissue during laparoscopic procedures. The morcellator works by breaking tissue into smaller chunks for easier removal. Power morcellation has been used as a replacement for traditional surgery as the smaller incision puts the patient at less risk of blood loss and infection and normally has a shorter recovery time. What at first seemed to be a positive device used in hysterectomies and other surgeries, has since had numerous lawsuits filed against it for allegedly doing more harm than good. The device has been linked to the spread of cancer throughout the abdomen.
Power morcellators are used in women suspected of having a uterine fibroid. Uterine fibroids are generally non-cancerous growths in the uterus that do not typically cause health problems but may cause pelvic pressure, pain, and prolonged menstrual bleeding. In some cases, women diagnosed with a benign fibroid actually have cancer that may be undiagnosed. When the morcellator breaks up the uterine tissue, it may also break up cancerous tissue and spread it throughout the woman’s abdomen.
Uterine cancer is relatively curable, as long as the cancerous cells remain within the uterus. However, when power morcellators grind up uterine tissue in routine hysterectomies, the possibility of undetected cancer cells spreading throughout the body can turn a manageable cancer into a deadly one. These women are unaware they have the sarcoma until after the surgery is complete. In some cases, patients claim their cancer progressed from stage one to stage four in a matter of months after having undergone surgery.
In 2014, the U.S. Food and Drug Administration (FDA) said in a formal warning, “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.”
According to the FDA, as many as one in 350 women who undergo treatment for uterine fibroids may be at risk of having an undiagnosed cancer.
A bill called the Medical Device Guardians Act of 2016 was introduced earlier this year. The act would require physicians and their offices to alert the FDA regarding adverse events associated with the use of medical devices.
Parker Waichman LLP has successfully represented individuals who have suffered from injuries allegedly associated with defective medical devices.
A recent study implies that the use of myomectomies (removal of fibroids from the wall of the uterus) has decreased by over 60 percent since the warning was issued by the FDA concerning the use of laparoscopic power morcellation. The study was presented at the American Society for Reproductive Medicine 2016 Scientific Congress and suggests that in the same time period, traditional myomectomies have also decreased.
Researchers discovered that the general rate of laparoscopic myomectomies decreased by over 70 percent, while the rate of traditional myomectomies decreased by just over 56 percent. Before the FDA issued its warning, the laparoscopic surgery was more common that traditional, while after the warning was issued, the traditional became more common that the laparoscopic, according to Medscape.
Legal Issues Regarding the Power Morcellators
There were allegations that manufacturers of the power morcellator, Ethicon’s division of Johnson & Johnson knew, or should have known, about the risk of a morcellation device spreading cancer in a patient’s body, but neglected to warn about that risk.
Morcellators were made available in the 1990s, and there was some evidence that the device could spread a rare but dangerous type of uterine cancer, Fortune magazine reports. The FDA did not get direct reports of actual cases until late 2013 but it was not until 2014, that a “black box warning” was added on the devices to increase awareness of the potential dangers.
In July 2014, Ethicon withdrew the power morcellator from the market, after suspending all sales of the device the previous April. As of August 2016, pending further examination, the FDA has decided that power morcellators can remain on the market, leaving it up to doctors and patients to decide whether to use invasive surgery or take the risk of spreading cancer using the power morcellator.