FDA Urges Healthcare Professionals To Consider Alternatives to Power Morcellation

The scrutiny that has arisen within the healthcare community over hysterectomies performed by laparoscopic power morcellation has the Food and Drug Administration (“FDA”) thinking twice about the safety of the procedure.

A news release issued by the agency includes a list of recommendations for medical professionals who conduct such surgeries, among them, a nudge to “consider all the available treatment options for women with symptomatic uterine fibroids.” The release also indicates further meetings of the Obstetrics and Gynecological Medical Devices Panel will take place to gather more information about the risks.

“Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” said Dr. William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health.

Here is a diagram of the different types of fibroids that can develop around the uterus. Here is a diagram of the different types of fibroids that can develop around the uterus.

Uterine fibroids develop on the smooth wall of muscle encasing the uterus as benign growths. Most do not cause problems, and women can live with them and not know they exist. Other uterine fibroids cause women to experience unusually heavy periods, frequent urination and pain in the pelvis – symptoms for which a hysterectomy (removal of the uterus) is to be considered.

Laparoscopic power morcellation, in which the uterus is broken into small pieces of tissue that are removed though a port, can go afoul when those small pieces of tissue drift away and flow into the body. In some instances, that tissue could contain undetected cancer cells.

Instead of laparoscopic power morcellation, an FDA safety communication offers the following options for treatment: a myomectomy (removal of uterine fibroids); a myomectomy and laparoscopic hysterectomy without laparoscopic power morcellation; and a traditional hysterectomy performed abdominally or vaginally.

If laparoscopic power morcellation is deemed the preferred remedy, doctors need to inform their patients of the consequences in the event a cancer spread occurs. Here’s what the FDA recommends:

  • Avoid laparoscopic power morcellation when the patient is suspected to have uterine cancer.
  • Inform patients that some medical institutions’ protocols are for a specimen bag to be used, if laparoscopic power morcellation is performed, in an effort to contain any malignant tissue.

In addition to waving the red flag in front of doctors about the cancer risks associated with laparoscopic power morcellation, the FDA has put manufacturers of the device on notice.

“We anticipate the discussion will include whether 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 healthcare professionals are adequately informed of the risks,” Maisel said.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Searcy Denney Scarola Barnhart & Shipley | Attorney Advertising

Written by:

more+
less-

Searcy Denney Scarola Barnhart & Shipley on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×
Loading...
×
×