A woman named Donna Burkhart underwent a routine robotic hysterectomy in March 2012. Before her surgery, she was healthy and there was no evidence whatsoever of cancer. Within ten days of her surgery, she was diagnosed with uterine cancer, and she died less than a year later. Her husband claims her death was due to the use of a power morcellator during her surgery.
What Is a Power Morcellator?
Unforeseen complications can be introduced along with technological advances in medical devices. When surgeons perform laparoscopic surgeries like hysterectomies and/or removal of uterine fibroid tumors, they often use a surgical instrument called a power morcellator.
These devices are used to cut the uterus and uterine fibroids into smaller pieces that are then extracted through a small incision in the abdomen. Annually, there are an estimated 55,000 to 75,000 procedures performed. The major manufacturer of power morcellators is Ethicon (a subsidiary of Johnson & Johnson), but there are also some smaller companies that manufacture them as well.
Morcellators Spread and Upstage Cancer
There have been approximately two dozen product liability cases filed against the manufacturers to date. Plaintiffs claim the devices can spread a dangerous hidden cancer from the uterus to other parts of the body. They allege that manufacturers knew or should have known about the risk of spreading cancer but failed to issue adequate warnings.
According to the FDA, 1 in 350 women undergoing fibroid removal or a hysterectomy may have a uterine sarcoma that resides undetected in the uterus. When doctors perform surgery using a power morcellator, small pieces of tissue are left behind, and they tend to spread throughout the patient’s body.
These pieces can contain cancerous cells that grow aggressively in the body, causing life-threatening health complications, and “upstaging” the cancer from stage 1 to stage 4.
FDA and Medical Community Divided The FDA issued a safety advisory in April requesting the manufacturers to review their current labels for accurate risk information and warnings.
The agency is discouraging doctors from using the devices until they are further evaluated and will later decide whether a “black box” warning should be placed on the devices in regards to the risk of spreading cancer. Many members of the medical community are defending the use of power morcellators, however, and are divided on the issue.
Johnson & Johnson has suspended their sales of the device. The FDA advisory is nonbinding, though, and those doctors and hospitals that agree with the defenders of the device may still be using it.
Doctors Often Uninformed of Risks
Doctors are often given shiny new medical devices that can enhance surgical procedures. But often times, they are not warned about the harmful adverse effects these devices may pose.
Trial lawyers allege that the manufacturers knew about the risk of spreading cancer through use of morcellators for years. Proving causation in these cases could be rather challenging. Defective medical device attorney Kay Van Wey is currently investigating claims on behalf of the victims who have experienced the spread and upstage of cancer due to the use of certain power morcellator devices.
If you or a loved one has been injured or killed due to the use of this device, contact Van Wey Law as soon as possible at (800) 489-5082. Time is limited in these cases.