FDA Puts Major Restrictions on Power Morcellators Following Cancer Concerns

Posted 24 November 2014 | By Alexander GaffneyRAC

FDA Puts Major Restrictions on Power Morcellators Following Cancer Concerns

US regulators today announced major restrictions on laparoscopic power morcellator (LPM) devices following major concerns that the devices could be harming patients.

Background

The restrictions, announced on 24 November 2014 by the US Food and Drug Administration (FDA), follow months of major concern that the devices could be harming women more than they helped. Power morcellators were primarily used to remove non-cancerous uterine fibroids by morcellating the tissue (i.e. chopping it up into smaller pieces), allowing the fibroids to be removed through a small incision.

However, reports in the Wall Street Journal and other outlets found evidence the devices were actually contributing to the spread of undiagnosed cancerous cells in some cases, leading to fatal outcomes for some women. In April 2014, FDA warned the public of this link, and discouraged their use in most cases.

FDA said it estimated that approximately one in every 350 women undergoing an LPM procedure has an "unsuspected uterine sarcoma, a type of uterine cancer." The morcellator could spread this cancerous tissue, FDA noted.

While some advocates pushed for an outright ban on the devices, some healthcare providers pushed back, saying there is a small subset of women for whom other surgical options are either ineffective or more dangerous than LPM.

New Restrictions

FDA's latest restrictions, outlined in its guidance document, Product Labeling for Laparoscopic Power Morcellators, are meant to "promote the safe and effective use of LPMs when used for gynecologic surgeries," FDA wrote.

Effective immediately, LPMs will need to be labeled with both a prominent warning and two contraindications:

CONTRAINDICATION: Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.

CONTRAINDICATION: Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are:

  • peri- or post-menopausal, or
  • candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.

WARNING: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

The new warnings will preclude the "vast majority of women" from ever having the devices used on them, FDA said in a statement.

Still, FDA said it will be monitoring adverse event reports and other data to determine if "further action," including a ban on the devices, is necessary.

 

FDA Statement

Product Labeling for Laparoscopic Power Morcellators (FR)

FDA Safety Communication

Categories: Regulatory News

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