An Open Letter to FDA Commissioner, Dr. Scott Gottlieb: On Persistence of A Deadly Women’s Health Hazard Within FDA’s Reach.
Honorable Commissioner Gottlieb,
I write this open letter to you after a nearly 5-year long and personally taxing public health campaign to protect women from a hazardous gynecological practice known as “morcellation”.
I am certain that you are well aware that my wife, Dr. Amy Josephine Reed, became the “index case” that brought the deadly oncological danger of morcellation to FDA’s attention in 2013.
Since the beginning of Dr. Reed’s public health campaign, many in the minimally invasive gynecological community tried to cast doubt on the validity of her campaign to eliminate Laparoscopic Power Morcellators from gynecology.
They quibbled about the exact incidence of occult uterine sarcomas in symptomatic women. They argued that iatrogenic spread and upstaging of contained uterine Sarcomas does not worsen outcomes. They argued that Dr. Reed and I were disgruntled and personally affected patients who lacked objectivity.
But, after a public hearing and an extensive analysis, in November 2014 FDA sharply curtailed the use of Laparoscopic Power Morcellators in Gynecology, issuing an Immediately In Effect (IIE) warning. You may review this warning HERE.
Almost immediately after the FDA hearing, which ultimately led to this November 2014 warning, the American corporation, Johnson & Johnson, the largest global manufacturer and distributor of Laparoscopic Power Morcellators voluntarily withdrew its product from the market. You may review news of this 2014 market withdrawal for safety reasons, HERE.
It is a striking fact for medical history to ponder that despite the highly appropriate public health decision made by J&J leaders, the foreign manufacturers of identical Laparoscopic Power Morcellators rigidly refused to withdraw their product from the US marketplace. Even more astonishing was that the FDA commissioner, at the time, did not seem to view this disparate behavior as anomalous or problematic. Notable among the corporate manufacturers of Laparoscopic Power Morcellators is the German company KARL STORZ, whose Laparoscopic Power Morcellator caused Dr. Amy Reed’s premature or unnecessary death.
Needless to say, the 2014 FDA warning and J&J’s market withdrawal caused an astonishing backlash from minimally invasive gynecologists and their advocacy organizations. The main thrust of their argument was that FDA’s estimate of one in 350 for occult uterine Sarcomas was “overblown” — and that the deadly iatrogenic oncological risk posed by morcellation ought to be subjected to a trade-off analysis with other surgical morbidities. The true incidence of uterine Sarcoma, they claimed, based on data “crunched” by Drs. Elizabeth Pritts, William Parker, David Olive and Jubilee Brown, was close to one in several thousand — as though a magically concocted threshold level of incidence could somehow justify the cancer mortality risk imposed by systematized iatrogenic upstaging of deadly cancers.
The fire FDA drew from these professional advocates and their organizations was strong, and it ultimately forced your agency to re-review the incidence of occult uterine sarcomas based on new available data.
It is my understanding that your office was personally involved in this process, which ultimately led to FDA reaffirming the incidence of one in 350 women for uterine sarcoma — and reiterating its warning about the danger of Laparoscopic Power Morcellation in women. You may review this latter FDA press release from December 2017, HERE.
Needless to say, several prominent studies using varied methodologies to analyze primary data from insurance databases and medical records, subsequently demonstrated the FDA estimate to be very accurate. The most recent one of these studies came from a large patient population in China and demonstrated the incidence of occult Sarcoma in women undergoing “uncontained” Laparoscopic Power Morcellation to be on the order of one in 200. You may view this most recent study HERE.
Now, based on overwhelming epidemiological evidence, it is fair to say that incidence of uterine Sarcoma in symptomatic women is in the range of one in 200–400 — I suspect that FDA’s public health experts would agree with this.
Then, in spring 2018, gynecologists at Yale University published a bombshell epidemiological analysis. They demonstrated that in women undergoing general gynecological operations of the uterus and ovaries in the range of 2–10% harbor occult or missed cancers —and not just Sarcomas. You may review this paper, HERE.
Commissioner Gottlieb, the Yale study implies that somewhere in the range of 2–10 out of 100 American women, depending on their age group, who undergo general gynecological operations on their uterus and ovaries are susceptible to their cancers being upstaged by morcellation. This is simply a seismic public health risk.
I’ve had the good fortune and privilege of being able to directly communicate these concerns to CDC director, Dr. Redfield, and his colleague, Dr. Peter Briss. It is my understanding that CDC experts have been carefully eyeing this hazard for the past several months.
Perhaps as was to be expected following FDA’s 2014 warning and black box label on Laparoscopic Power Morcellators, the minimally invasive gynecological industry placed a concerted effort on creating a version of the device with a specifically adapted mitigation system for morcellated tissue containment. This industry effort at correcting a deadly product defect, though somewhat misguided, was undertaken by industry advocates based on their recognition that “UNCONTAINED” Laparoscopic Power Morcellators pose an unacceptably high probability of spreading and upstaging occult or missed cancers — leading to the premature or unnecessary deaths of the at risk women, like Dr. Amy J. Reed.
In April 2016, FDA used its 510(k) clearance mechanism and opened the US markets to this presumably safer iteration of the Laparoscopic Power Morcellator device, which included a more robust mitigation system. You may review the FDA press release about this “contained” Power Morcellator device HERE.
A critical disclaimer regarding this new “CONTAINED” Laparoscopic Power Morcellator is its unknown efficacy at protecting women with occult or missed uterine cancers from iatrogenic upstaging by morcellation — a fact that FDA’s Dr. Jeff Shuren readily admitted in the FDA press release on this medical device. Nonetheless, the Pneumoliner and its associated PK Morcellator are now cleared by FDA’s 510(k) mechanism for distribution in the US marketplace by Olympus.
It will become known as an historic professional blunder by gynecologists, that despite Dr. Reed’s vocal public awareness campaign, FDA action, appropriate market action by J&J, large and various primary data sets confirming the high incidence of occult/missed cancers subjected to Power Morcellation, as well as, wide-ranging professional discourse, a large number of American gynecologists currently continue to perform “UNCONTAINED” morcellation on unsuspecting women. With definitive certainty, this fact is placing more American women in deadly harm’s way from an iatrogenic and totally avoidable cancer mortality risk.
Therefore with this public letter, I am requesting that your office carefully and immediately review the following facts — in order that your agency recognizes the need for an immediate FDA ban on the use of “UNCONTAINED” Laparoscopic Power Morcellators from companys such as KARL STORZ in American women.
1) The unequivocal evidence from Yale University is now demonstrating the rates of occult/missed uterine cancers to be in the range of 2–10% in symptomatic women, with an incidence approaching 10% in women over 50 years old. This is an astonishingly high incidence of occult/missed cancer of the gynecological tract.
2) “UNCONTAINED” laparoscopic Morcellation of occult or missed cancers leads to spread and upstaging of potentially curable cancers of the gynecological tract — with the result that the affected women across the United States die premature or unnecessary deaths.
3) The FDA has recently cleared a “CONTAINED” Laparoscopic Power Morcellator system, available in the marketplace from Olympus (i.e., Pneumoliner and its associated PK Morcellator).
The above three facts leave NO rational or, likely, legal justifications for FDA to retain the “UNCONTAINED” iterations of Laparoscopic Power Morcellators in the US marketplace. It is a verifiable fact that none of these traditional Power Morcellator devices have an adequately adapted and robust mitigation system for tissue containment. As such, their continued routine use by many gynecologists in the United States (and abroad) is posing a threat to the lives of unsuspecting American women with symptomatic uterine disease — of whom an astonishing 2–10% harbor occult or preoperatively missed cancers.
On 10/9/2018, I filed a Citizen Petition with your office (Docket #: FDA-2018-P-3843), formally requesting your office to institute a ban on the use of
“UNCONTAINED” laparoscopic power morcellators in gynecological operations.
It is my sincere hope that you will take this petition seriously. Specifically, because it is now clear that not only are “UNCONTAINED” Laparoscopic Power Morcellators in continued use by many gynecologists, but the risk of occult/missed cancer is seismically higher in women undergoing gynecological operations than anyone had previously considered.
Finally, it is my sincere hope that you will communicate with Drs. Redfield, Briss and Jones at CDC — in order that your two agencies could definitively and cogently eliminate the deadly public threat that is continuing to be posed by “UNCONTAINED” Laparoscopic Power Morcellators in gynecology.
Commissioner Gottlieb, you now have ripe epidemiological data and sound regulatory rationale to act to more definitively protect American women from harm — while preserving the gynecology specialty’s autonomy by inducing the field to become intrinsically more stringent and careful in preventing iatrogenic cancer upstaging in women.
It is well within your legal jurisdiction as FDA commissioner to eliminate the now well established iatrogenic cancer risk posed by “UNCONTAINED” Laparoscopic Power Morcellators from American Healthcare — in order that you might protect any more mothers, wives, daughters and sisters from falling to disaster as did my wife, Dr. Amy Josephine Reed.
I look forward to hearing from your office in the near future.
Hooman Noorchashm MD, PhD.