Can I Sue if My Cancer Spread after a Hysterectomy or Myomectomy Using a Morcellator?
If our lawyers can prove a connection between the use of a morcellator and the cancer (generally, uterine sarcoma) spreading, you have the legal right to sue the manufacturer of the morcellator for money damages. Your spouse and other members of your family may also have claims.
The key to these cases is proving “causation”–that the removing the uterous (hysterectomy) and/or fibroids (myomectomy) by morcellation spread cancerous cells you didn’t even know you had, which lead to the uterine sarcoma spreading to the abdomen and/or pelvis.
This product is injuring women needlessly. There are other alternatives for these surgeries that do not pose a risk. The FDA issued a warning discouraging the use of morcellators for hysterectomy and myomectomy, but not one manufacturer has recalled these products.
What is Laparoscopic Morcellation?
Laparoscopic power morcellation is one of several available treatments for fibroids. It is a procedure that uses a medical device to divide the uterine tissue into smaller pieces or fragments so it can be removed through a small incision in the abdomen, such as during laparoscopy.
FDA Says Morcellation for Removal of Uterus or Uterine Fibroids Can Spread Cancerous Tissue
The U.S. Food and Drug Administration (FDA) issued a warning discouraging the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) because it poses a risk of spreading cancerous tissue, notably uterine sarcomas, beyond the uterus.
The FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. According to the FDA:
If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.
The FDA’s Obstetrics and Gynecological Medical Devices Panel is holding meetings to discuss laparoscopic power morcellation. The agency is not taking steps to force a recall of these products, nor will it. The action the FDA is seeking is a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks.
We are concerned that the FDA does not force the recall of dangerous products when there are safe alternatives. We have seen this time and time again with medical products. We urge readers to contact their U.S. senators regarding this issue. Perhaps with enough voices calling for change, the FDA will put consumer safety above the financial gain of corporations.
Johnson & Johnson Suspends Sale of Laparoscopic Power Morcellators — No Recall
Prompted by the FDA warning discussed above, Johnson & Johnson (J&J) suspended worldwide sales of its laparoscopic power morcellators, all sold by Ethicon, a subsidiary corporation of J&J. The J&J products include the following:
- Gynecare Morcellex Tissue Morcellator;
- Morcellex Sigma Tissue Morcellator System;
- Gynecare X-Tract Tissue Morcellator.