July 31, 2014 – Healthcare giant Johnson & Johnson is urging surgeons not to use a device that has recently been found to spread certain types of uterine cancer in women. Sales of J&J’s laparoscopic power morcellators were halted earlier this year after the FDA issued a warning statement regarding the devices. The agency warned that when used for hysterectomy and fibroid removal surgeries, morcellators could spread sarcoma in some patients, lowering the chances for survival.
Free Morcellation Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the morcellator and we can help.
What’s the Problem?
A pair of new studies — from the U.S. Food & Drug Administration (FDA) and researchers at Columbia University — determined that approximately 1 in 350 women has undiagnosed cancer when undergoing fibroid surgery; for women requiring hysterectomy operations, the risk is about 1 in 368.
As a result of these findings, J&J is now expanding the pullback on its power morcellators, urging those who have purchased one to discontinue use of the device and return it immediately. According to an article published in the Wall Street Journal, Johnson & Johnson originally stood by its morcellators, but now says the risk of spreading cancer outweighs any potential benefits. Though sales of the device only represent a tiny fraction of J&J’s business, the company represents nearly 75% of the U.S. marketshare for laparoscopic power morcellators.
What is Power Morcellation?
Laparoscopic power morcellation is a type of fibroid treatment that uses a special device to divide uterine tissue into smaller pieces so it can be removed through a tiny incision in the abdomen, such as during a laparoscopic procedure. Before these devices became available, morcellation was performed using a machine that required the surgeon to manually ‘squeeze’ the handle, or use a scalpel to create small specimens that could be removed from the abdominal cavity. The first electronic power morcellator was introduced to the U.S. market in 1993.
FDA Warning on Laparoscopic Morcellation
In April 2014, the FDA issued a warning which recommended that surgeons avoid using morcellators during hysterectomy or myomectomy operations due to the risk that the devices may spread cancerous uterine tissue to other parts of the body.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”
Do I Have a Morcellation Cancer Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in laparoscopic power morcellator lawsuits. We are handling individual litigation nationwide and currently accepting new morcellation cancer cases in all 50 states.
Free Morcellation Cancer Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellation Cancer Suit and we can help.