On April 17, 2014, the Food & Drug Administration issued a Safety Communication warning consumers about the serious dangers posed by the use of power morcellators in certain surgeries. The FDA has discouraged the use of these devices during hysterectomies and myomectomies, as the devices may create a risk of spreading unsuspected cancerous tissue throughout the patient’s body. The pharmaceutical and medical device lawyers at Ashcraft & Gerel are now investigating injury claims arising from the use of power morcellators.
Power morcellators are surgical devices that cut uterine tissue during laparoscopic surgery. The devices are designed to cut uterine fibroids into small pieces, which the surgeon can then extract through a small incision. Doctors estimate that between 55,000 and 75,000 women undergo morcellator-aided hysterectomy and uterine fibroid removal procedures each year. Power morcellators are manufactured by Ethicon (a subsidiary of Johnson & Johnson), as well as a number of smaller companies such as Olympus, Karl Storz, and Blue Endo.
Morcellator Risks and Side Effects
The problem with power morcellators is that they occasionally detach and leave behind small pieces of tissue during surgery. These pieces of tissue can then spread throughout the patient’s body. On occasion, the detached tissue may contain cancerous cells, unbeknownst to the patient or surgeon. In such cases, the power morcellators may cause the cancerous tissue to spread and grow aggressively in the body of the patient, resulting in life-threatening health complications. The types of cancer spread by power morcellators may include leiomyosarcoma, myelosarcoma, and uterine sarcoma.
The FDA has announced that it will be conducting an investigation of the safety risks associated with power morcellator devices. Meanwhile, Johnson & Johnson, the largest manufacturer of these devices, has halted the sale and distribution of its power morcellators. Further, the dangers and risks of power morcellators are now recognized throughout the medical community. A number of notable medical centers and physicians around the country have recently stopped using the devices in hysterectomy and fibroid removal procedures.
Ongoing Morcellator Lawsuits
One lawsuit has already been filed regarding the dangers of power morcellators. In the official court filing, the plaintiff has listed over 20 charges of alleged negligence. Included in this list are:
- Failing to properly warn doctors, health care workers, and patients of the potential dangers of using power morcellators
- Marketing and selling the morcellators without properly testing for side effects
- Not informing the FDA, NIH, and the medical community knowledge of the potential for dangerous, even life threatening side effects in a timely manner
Another case has been filed in the U.S. District Court for the District of New York by a woman who was diagnosed with cancer after having robot-assisted hysterectomy that used power morcellation.
Protect Your Rights
If you or a loved one were diagnosed with cancer after undergoing a surgery involving the use of a morcellator, you may have a case. The experienced and skilled pharmaceutical and medical devices lawyers at Ashcraft & Gerel will conduct a free and confidential evaluation of your claim.
Please contact us online or call us at 800-829-7037 to discuss how we may assist you.