In a notice issued last year, the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.
Many women are now filing claims against Ethicon Inc., a division of Johnson & Johnson, and the manufacturer of the Power Morcellator. The Morcellator has the potential of leaving cancerous fragments behind and making the spread of the cancer cells to other parts of the body possible.The FDA estimates that 1 in 350 women who undergo a procedure with a Power Morcellator may have undiagnosed uterine cancer. The FDA issued a safety warning in April 2014 against using this device in uterine and fibroid removal surgeries.
Morcellation devices are used during several medical procedures. While the morcellator device provides a less-invasive surgery and quicker recovery time, the following have been listed as potential side effects:
- Spread of malignant tissue
- Advanced-stage cancerous growths
- Metastatic leiomyosarcoma, an aggressive uterine cancer
Women who believe that their cancer diagnosis was made worse as a result of their choice to undergo a less invasive fibroid surgery or hysterectomy are currently filing lawsuits.
If you or a loved one has been diagnosed with cancer and you previously had a fibroid removal or hysterectomy, you should consult with one of our knowledgeable attorneys. There is no charge for a consultation.
Shaw Cowart LLP will continue to update you with news of the ongoing litigation and the status of these devices in the market.