A power morcellator is a surgical instrument that dates back to 1993 and is used for breaking up and removing large amounts of tissues during laparoscopic surgery, or surgery aided by a laparoscopic camera in which fewer incisions are made than in a traditional surgery. Power morcellators are often used in hysterectomies and used to mince, or morcellate, the uterus into smaller pieces for the purpose of more easily removing it from the patient. The device is made by Johnson & Johnson’s subsidiary, Ethicon, as well as other manufacturers.
One of the most dangerous risks associated with the use of power morcellators is the potential for the medical device to spread undetected malignant uterine tissue, which can lead to serious health risks such as cancer. The most at risk patients are women who have uterine fibroids, a fairly common and harmless condition. However, some of these fibroids may contain a uterine sarcoma, or a condition that can cause cancer. This uterine sarcoma can mostly remain in the fibroid with no danger to the women, but when destroyed by a power morcellator can release the sarcoma and cause a cancer.
Even if this tissue is benign, once spread by a power morcellator, it can lead to the development of ectopic tissue implantation on abdominal organs, which can lead to obstructions, inflammation, and other abnormal growths that would require the patient undergo further surgical procedures.
In 2014, the FDA released a statement discouraging power morcellators as used in laparoscopic gynecological surgeries. Soon after, the maker suspended sales and production of the medical device across the globe. Neither the company nor the FDA issued a recall and thousands of these power morcellators remain in use to perform surgeries throughout the nation.
“It looks like the sarcoma risk is much higher than we originally thought,” said maker Ethicon. “Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.”
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.