FDA Revises Cancer Warning and Use Indications for Morcellators
This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.
The FDA has now weighed in on the use of morcellators for the removal of fibroid in women. Simply put, the warning are frightening.
The “vast majority” of women getting fibroids removed should not be treated using devices called morcellators, which grind up a woman’s uterus so it can be easily removed, the Food and Drug Administration said yesterday.
The FDA issued a revised warning saying the chopping process can spread undetected cancer in women and should only be used in very specific cases. As many as one in every 350 women having the procedure to remove uterine fibroids have tumors in the uterus that haven’t been diagnosed, the FDA says. Using the morcellators can break up and spread the tumors inside the woman’s body.
“We believe that in the vast majority of women, the procedure should not be performed,” said Dr. William Maisel of FDA’s Center for Devices and Radiological Health.
“We believe that in the vast majority of women, the procedure should not be performed.”
However, there is not complete consensus about the warnings.
The main US group representing gynecologists says the FDA’s guidance is confusing and doesn’t take into account all the variables and uncertainties. Morcellators are commonly used to remove fibroids but they can also be used in other procedures, such as removing a prolapsed uterus, and those procedures pose a much lower risk.
The risks have been known for months and one manufacturer even asked doctors to return its device, but they are still being used too commonly, the FDA says. It says the devices need to be more clearly labeled so doctors won’t use them in the women at risk of having undetected cancer.
“Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids,” the agency said in a statement.
“Uterine tissue may contain unsuspected cancer.”
“Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients,” FDA added.
There’s only a small group of women who might safely be treated using. For example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may be candidates for this procedure.
An estimated 600,000 U.S women get hysterectomies every year. Maisel said about 40 percent of hysterectomies are done because of fibroids and about 50,000 of these use laparascopic or “keyhole” surgery, which can include morcellators.
If you or a loved one has had fibroid removal procedure involving use of a morcellator, please contact The Michael Brady Lynch Firm for a free, no-obligation evaluation of your case.
About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Xarelto bleeding injuries, Mirena IUD, Actos Bladder Cancer, Testosterone heart attack and stroke injuries and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.