According to court filings, there are many personal injury, wrongful death and defective product liability lawsuits being filed against the manufacturers of power morcellator medical devices. The injured women and their grieving families claim that the patients and doctors should have been warned about the risks associated with use of the popular medical devices during minimally invasive, laparoscopic hysterectomies.
Power morcellators are popular medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. The device has blades that allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive laparoscopic surgery, and reduces operative recovery time, scarring and speeds up recovery.
Unfortunately, the rotating blade of the power morcellator scatters undiagnosed aggressive cancer tissue fragments around a women’s abdomen and pelvic area, accelerating the disease’s progression.
Approximately 600,000 unsuspecting women annually are undergoing this minimally invasive procedure throughout the United States.
According to research, about 40 percent are done to remove presumably benign or noncancerous fibroids that are causing heavy bleeding, pelvic pressure or pain, or other symptoms. The actual number of morcellations is not tracked, leading experts to call for a nationwide registry of gynecological surgeries that would include information on the devices used.
FDA Black Box Warning November 2014
On November 24, 2014, the FDA issued a Safety Communication, in which they attached a “Black Box” warning to power morcellators because of the extreme risks they pose to users. A BLACK BOX warning is the strongest warning that the FDA can issue, short of nationwide recall. Unfortunately the FDA did not issue a nationwide recall.
The FDA stated that the risks posed by morcellators outweigh any potential benefits that, in almost all circumstances, the use of these devices should not be used. The FDA noted that the use of these devices puts too many women at risk.
Morcellators Approved Under the 510(k) Program
The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.
Johnson & Johnson Ethicon Morcellator Recall
All Ethicon power morcellators were recalled by the manufacturer, earlier last year. J&J, acknowledged that the devices pose an unreasonable risk of disseminating uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.
Power Morcellators Under FirePower morcellators have been under under fire since the well-publicized case of anesthesiologist Amy Reed, who underwent a hysterectomy, for fibroid removal in October 2013. Dr Reed, then discovered that power morcellation had spread an undiagnosed uterine leiomyosarcoma.
The hospital chain HCA Holdings prohibited their use at its facilities for removing uterine fibroids. Highmark, a health insurer in the eastern United States, stopped paying for laparoscopic power morcellation in gynecologic procedures.
In February 2015, United Healthcare announced that, it would require preauthorization for all hysterectomies other than vaginal procedures performed on an outpatient basis.
Most recently, health insurer Aetna announced that it will no longer cover most hysterectomies and myomectomies that utilize power morcellators to remove uterine fibroid tumors “because the safety and efficacy of this approach has not been demonstrated.”
Power Morcellator Cancer Litigation
Many complaints have been filed in the federal court system nationwide. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.
All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.