Growing Number of Lawsuits Filed over Cancer Risks Associated with Power MorcellatorsJan 7, 2016
New lawsuits continue to be filed against the manufacturers of the power morcellator, a surgical tool used in gynecological surgeries that is alleged to spread hidden cancers, significantly reducing a woman's long-term life expectancy.
The U.S. Judicial Panel on Multidistrict Litigation recently consolidated more than 20 such lawsuits into a federal multidistrict litigation (MDL). More than 30 cases were centralized for pretrial proceedings. The lawsuits have been filed primarily against Johnson & Johnson's Ethicon division. Plaintiffs allege that the morcellator caused serious complications, including the spread of cancerous tissue.
In one of the latest cases filed, the plaintiff alleges that the morcellator used in her surgery exposed and spread previously undetected cancer cells throughout her body, including beyond her uterine walls. She had the surgery to treat painful uterine fibroids; The morcellator procedure was chosen as a less invasive technique than open surgery. After the surgery, the woman was suddenly diagnosed with aggressive and widespread cancer.
The laparoscopic power morcellator is inserted through a woman's lower abdomen via a small incision. Rapidly spinning blades cut up tissue into tiny pieces that can be removed from the body. But if the uterine tissue contains any cancerous cells-which are virtually impossible to detect prior to surgery-the procedure can spread the cancer throughout the abdomen, where it becomes more aggressive and sharply reduces life expectancy.
Twelve members of Congress have asked the U.S. Government Accountability Office (GAO) to investigate why the morcellator was on the market for two decades before the Food and Drug Administration (FDA) issued a warning about the device's potential to spread uterine cancer. The GAO investigation increases scrutiny into how the FDA handled issues with power morcellators that date back to 1991, when the first morcellator received clearance for sale in the U.S. The FDA now says evidence indicates that the risk of hidden uterine sarcoma is much higher than many gynecologists believed.
The FDA has defended the regulatory process used to approve morcellators but said it is strengthening its surveillance of devices on the market. Johnson and Johnson, which had been the largest morcellator maker, voluntarily pulled its morcellators from the market last year, according to the Wall Street Journal.
In November 2014, the FDA amended an earlier morcellator advisory by calling for a black box warning for the device. The black box is the FDA's strongest warning. Despite calls for a ban, the power morcellator remains on the market, although many hospitals have restricted its use to carefully screened patients and a number of health insurers say they will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.