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The Defense of Morcellation: An “Expert” Letter to FDA

Recently, a group of 48 gynecological surgeons, headed by William Parker of UCLA, and a few women's health advocates, including Carla Dionne of the National Uterine Fibroid Foundation (, published a letter in the journal Obstetrics and Gynecology.

You can read about this here and here.

This letter was directed to the Food and Drug Administration (FDA) and was written in defense of morcellation, used routinely by gynecologists when performing hysterectomies or myomectomies in women. It involves mincing up, and nearly emulsifying, the enlarged and diseased uterus inside a woman's abdominal cavity in order to avoid a larger incision.

You can read about morcellation here.

The trouble is that if the minced up tissue contains cancer, it will spread. This is called "upstaging" of a cancer and it could be deadly.

Ironically, in the same issue of Obstetrics and Gynecology another group of gynecologists wrote that the number of unsuspecting women having surgery who are at risk of cancer upstaging from morcellation is one in 276.

In medicine, this is considered a very high risk when it comes to an avoidable mortality hazard.

But, until December 2013, most gynecologists, including Dr. Parker of UCLA, were assuming this risk was far lower -- one in 10,000 women.

Over the past two years, the much higher incidence of hidden cancers has been confirmed by several other studies - including this recent study from Boston Medical Center (BMC).

As a result of this high risk, and because many women put in harm's way went public, in November 2014 FDA significantly restricted use of the power morcellator).

But Dr. Parker argues that the FDA analysis "was flawed, inadequate, and misleading" and that "their recommendations were not based on science, but rather on emotional and anecdotal information".

We believe that Parker's statements intend to divert the conversation into a discussion of statistical uncertainty, instead of admitting that when it comes to an incorrect and avoidable surgical practice, it is not acceptable to put women at risk, whether they number one in 156 or one in 10,000.

Parker compares the unavoidable risks of all surgery--wound infections, blood clots, or perioperative heart attacks - with the avoidable risk of spreading a cancer using morcellation.  This position is at best, incorrect, and at worst, unethical.

In addition, for nearly 20 years many women were having their cancer spread by morcellation.  But, not a single gynecologist, hospital or morcellator manufacturer bothered to comply with a specific federal law requiring them to "self-report" such hazards to the FDA.

FDA has confirmed that the first time it heard about adverse outcomes using power morcellators was in December 2013 - and it wasn't from the gynecologists or the manufacturers.

Recently, US Congressman Tim Murphy of PA, chairman of the House of Representatives' subcommittee on Oversight and Investigations, questioned the FDA's medical device center's chief about this, and the interchange is available on this video.

The FBI and the GAO also are investigating.

It appears that the U.S. Congress, federal law enforcement and the civil court system are poised to hold many accountable for their failure to protect precious lives across the United States. Still,  the recent expert letter to FDA is a disservice to the specialty of gynecology – and to all future women at risk - by not admitting how damaging and deadly this practice has been.

Read more from the Check Up blog »