As power morcellator lawsuit numbers climb, questions regarding FDA approval's and safety emerge.With over 30 power morcellator lawsuits filed against manufacturers such as Johnson & Johnson, Richard Wolf GmbH, Karl Storz GmbH and Gyrus ACMI, the medical community and the public have numerous questions about the device, as well as the litigation.
Why Is the Morcellator So Dangerous?The power morcellator is a surgical instrument which is used during laparoscopic surgeries. The tool is inserted into the body cavity through tiny incisions where it cuts unwanted tissue into smaller pieces. Those smaller pieces are then extracted through a hollow tube in the morcellator.
The morcellator is often used during laparoscopic hysterectomies and myomectomies. The majority of these gynecological surgeries are performed due to the presence of uterine fibroids. Unfortunately, when these fibroids encapsulate uterine cancer, the cancer is virtually undetectable. Researchers have found that if a morcellator is used to cut through a fibroid, it has the potential to disseminate cancer cells throughout the abdominal cavity.
Why Was The Morcellator Approved By The FDA?The morcellator has been used by surgeons for decades. The U.S. Food and Drug Administration first granted approval for the morcellator in 1991, and the surgical tool was introduced into the U.S. market in 1993.
The alleged risks associated with morcellation were not discovered by the FDA because the tool was approved under a 501(k). The 501(k) is an approval process which allows companies to forgo safety testing if they are able to show that their device is “substantially equivalent” to a device the FDA previously approved.
What Studies Have Been Performed?What makes researchers question the FDA’s approval of the morcellator via a 501(k), is that even in 1991 there were studies claiming the morcellator could potentially spread and upstage cancer. One company, Vance Products Incorporated, designed a surgical tissue bag for surgeons to use with the device.
In their submission for a patent, Vance Products indicated that the problem “associated with the debulking, removal or morcellation of large tissue volumes is the concern for malignant or pathogenic tissue. The morbidity of patients significantly increases when malignant cells of such large volume tissue are permitted to come in contact with surrounding healthy tissue.”
Numerous other studies have been performed, all of which report that the morcellator has the potential to spread malignant cancer cells.
What Should I Do If A Morcellator Was Used During My Surgery?If you’ve undergone a gynecological surgery for the treatment of uterine fibroids, and your surgeon did not warn you of the alleged risks associated with the use of a morcellator, you may be entitled to compensation.
For questions regarding the ongoing power morcellator litigation, contact Banville Law at (917) 688-2632.