A Dangerous New FDA “Draft Guidance” on Use of Laparoscopic Power Morcellators in Women Under 50 Years of Age.
On February 25, 2020 FDA released a series of documents on the use of Laparoscopic Power Morcellators.
These documents were issued by the current director of the Center for Devices and Radiological Health (CDRH), Dr. Jeffrey Shuren.
You may find these HERE.
Director Shuren has released these documents under the rubric of “New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries”.
Specifically one of the documents is a “draft guidance for Industry and Food and Drug Administration Staff” for Labeling of Laparoscopic Power Morcellators. You may view this “draft” document HERE.
This new draft guidance has one critical, but deliberate, changed embedded in it, which distinguishes it from the guidances FDA released in 2014 and again in 2016, contraindicating the use of this device in the “vast majority of women”.
Now, the FDA is proposing to limit the use of this device to women under age 50 ONLY. This would mean that Laparoscopic Power Morcellators can be quite liberally used in ANY women under the age of 50 by Gynecologists.
If this language is formalized in an FDA guidance, it would represents a major win for gynecological industry associations and the many lucrative minimally invasive GYN practices that felt their profit and convenience margins dissipate when their deadly meat-grinders were no longer available to them.
The critical trouble with FDA using an age threshold for contraindicating the use of these Laparoscopic Power Morcellator devices is that selecting this metric is based in poor scientific reasoning — and it is ultimately dangerous to the lives of the women under age 50 in whom the device is sure to be used if the FDA relaxes its current restriction.
Today, for the public record, I entered a critique into the Regulations.gov public comments portal for this draft guidance. My comment reads as follows:
“This comment pertains to the new age cut-off introduced as the contra-indication threshold for contained Laparoscopic Power Morcellation in women undergoing gynecological surgery.
It is a point of dangerous inaccuracy for FDA to be introducing a new age cut-off for avoidance of LPM use in women. Specifically, the guidance states that AGE 50 ought to be used as the threshold, after which morcellation should not be performed using LPM devices. Whereas in 2014 and in 2016 the FDA had contraindicated the use of LPM devices in the “vast majority of women”, in this updated draft guidance FDA is opening the door to morcellation of MISSED uterine cancers in women under the age of 50.
This change to FDA’s position exposes all American women under 50 years old to the possibility of their MISSED (so-called occult) uterine cancer diagnoses being spread and upstaged by morcellation — and, critically, it is a totally arbitrary criterion with no positive predictive value in identifying the actual women with uterine cancers.
To be clear, though it is true that most types of cancer are more prevalent in older people, neither age nor any other non-histology based clinical parameters have been shown to have sufficient positive predictive value (or sensitivity) in identifying the specific women at highest risk of having uterine cancers. The FDA judgement error in arbitrarily choosing an age threshold is that the agency seems to be more focused on the almost linear increased prevalence of cancer with age, and not the FACT that age has no positive predictive value (or sensitivity) in identifying the women with cancer.
On a real and visible level, all involved CDRH leaders will recall that many of the actual women whose disastrous outcomes from LPM devices, and who originally made FDA aware of this public health hazard in 2013, were well under the age 50 when they were harmed by this gynecological device and practice — Dr. Amy Josephine Reed, Ms. Brenda Leuzzi, Ms. Elizabeth Jacobsen, Ms. Vivianna Ruschitto, Ms. Erin Harris, among countless other women under the age of 50 across the US and globally, whose names we will never know.
Therefore, by opening the door to the use of LPM devices in women under age 50, FDA is in fact NOT enhancing the safety of women with MISSED uterine cancer diagnoses, as it is proclaiming with this new release. Rather the agency is eroding the more robust (and scientifically correct) safety language in the prior guidances from 2014 and 2016. Again, the age of the affected woman has NO useful positive predictive value in identifying and protecting the mortality risk posed by the LPM device to the actual women with uterine cancers.
The FDA error in setting an age threshold for its contra-indication for use of LPM devices is such a fundamental point for any physician with a rudimentary understanding of epidemiology, not to mention public health experts at FDA, I find it quite shocking to have to even articulate it for the agency in the present comment.
Here, for the historic record, I am respectfully requesting that FDA, and specifically the CDRH Director Jeff Shuren, immediately remove ANY age threshold for contra-indication against use of the LPM device. This language is dangerous and is certain to cause harm and totally avoidable deaths in the unsuspecting American women at highest risk of having their MISSED cancer subjected to the oncological catastrophe caused by the LPM device.
This draft guidance has embedded in it a fundamental error in epidemiological reasoning — the new age threshold (50) for contraindication is an incorrect and dangerous metric to be using.”
The FDA claim that its 2/25/2020 document release on Laparoscopic Power Morcellators is introducing new steps towards safety is a disingenuous camouflage for the CDRH’s real intent: to appease gynecological industry stake-holders.
In endorsing an age threshold of 50 years old into the labeling contraindication for use of Laparoscopic Power Morcellators, the CDRH director, Jeffrey Shuren, and his colleagues are making a profound error in epidemiological reasoning — an error that is certain to cause harm to unsuspecting women and cost even more lives.
I am also certain that if Shuren’s own wife or daughter, perhaps his sister or mother, had been on the receiving end of the catastrophe caused by LPM devices, there is no way he’d accept the dangerous language he’s now endorsing on behalf of gynecological industry advocates— but I suppose I could be wrong about that, time and again this CDRH director has proven to me that his ethical compass is quite deranged.
In an ironic way, I take solace in the explanation that we are living in the era of “alternative facts” and American dys-reason….Shuren’s CDRH is making the point well.
