FDA Discourages Use of Laparoscopic Power Morcellation When Removing the Uterus or Uterine Fibroids
According to the U.S. Food and Drug Administration, the use of laparoscopic power morcellation poses a risk of causing the spread of uterine sarcomas if used during uterus removal (hysterectomy) or removal of uterine fibroids (myomectomy). As a result, the FDA has discouraged the use of the treatment and requested physicians to use alternative treatments instead.
During the laparoscopic power morcellation procedure, a medical device is used to break up uterine tissues in order to make them easier for removal through a small abdomen incision. Because uterine fibroids may have an unsuspected type of uterine cancer, the concern is that breaking up the tissue would result in the cancerous tissue to spread to other parts of the body, such as the pelvis or abdomen.
The National Institutes of Health states that, at one point or another during their lifetime, most women will develop uterine fibroids. Furthermore, using recent studies, the FDA determined that one in every 350 women would develop uterine sarcoma after hysterectomy or myomectomy. This is a cause for concern when discussing laparoscopic power morcellation procedures.
Women who need hysterectomy or myomectomy have numerous treatment options that do not involve morcellation. The FDA has requested that power morcellator manufacturers place warnings on product labels regarding the risks involved in use during hysterectomy and myomectomy.
The FDA has made the following recommendations:
- Physicians should use safer, alternative options.
- Patients should be informed of the risks should laparoscopic power morcellation be determine the best option.
- Discuss all options for treatment.
- Be sure to conduct routine follow-ups if the procedure was performed.
The FDA released their new findings on April 17, 2014. If you or someone you love has undergone a laparoscopic power morcellation procedure and developed uterine sarcoma or other complications occurred, reach out to our national trial lawyers at Fleming | Nolen | Jez, L.L.P. We work with our clients in order to find the strongest legal strategy and seek the most favorable outcomes possible.