An Open Letter to US Representative Michael C. Burgess: A Plea for a Non-Partisan Congressional Inquiry to Protect Women from Cancer
Honorable Congressman Burgess,
I write this letter to you as a non-partisan plea to use your voice as a United States congressman and a Gynecologist, in defense of American women in harm’s way.
As you recall, my wife Dr. Amy Josephine Reed succumbed to an iatrogenic abdominal sarcomatosis in May 2017 — following dissemination of her “missed” Uterine Leiomyosarcoma using a Laparoscopic Power Morcellator (LPM) manufactured and distributed by the German company STORZ.
Her complication and public heath campaign, ultimately led to the Food and Drug Administration (FDA) placing significant limits on the use of LPM devices in uterine surgery across the US in 2014. In 2018, FDA reiterated its black-box warning — this time indicating that the incidence of “missed” Uterine Sarcomas can be as high as One in 225 women, based on several reputable analyses by independent groups.
As you know, Dr. Reed and I worked closely with your colleague from Pennsylvania, US Rep. Fitzpatrick, to address the safety gaps in the medical device 510(k) clearance process at FDA, which allowed the LPM hazard onto the US marketplace unchecked for well over 2 decades. This effort culminated in introduction of the so-called “Medical Device Guardians Act” by Rep. Fitzpatrick, as well as his focused attempt to introduce amendments to the “21st Century Cures Act”, of which you are well aware.
Of course, given the complexity of changing FDA policy, especially where the medical device industry wields disproportionate influence over CDRH and in Congress, the Fitzpatrick amendments and bill gained little traction in the House. As you know, it is my opinion that this was a terrible failure on the part of congress, because Fitzpatrick’s amendments represented an opportunity to eliminate a real and present safety gap in the medical device space in a bipartisan fashion.
Irrespective, Rep. Fitzpatrick’s serious efforts were fruitful in shedding light and stimulating discourse not only on gaps in Medical Device safety deficits on the regulatory front, but also on a deadly problem in gynecological practice.
Specifically, as it pertains to your own comments from the House Rules Committee.
Indeed, your words on July 8, 2015 from the House Rules Committee have stayed with me — as they did with Dr. Reed and have with the many other women and families harmed across the United States.
I am writing here now to inform you that despite my serious disagreement with your handling of Rep. Fitzpatrick’s amendments in 2015, your words regarding the serious oncological danger of uterine morcellation in Gynecology were incisively accurate in describing what is an ongoing iatrogenic catastrophe in women’s health.
Given your clear understanding of what is a clear and present danger to the lives of American women, I now ask for your friendship and support — from the United States House of Representatives.
Since your brief involvement with this issue in 2015, it has become clear that incidence of “missed” uterine cancer diagnoses, including sarcomas, can be as high as 10% in certain subsets. Certainly, the one in 200–400 incidence of “missed” uterine sarcomas is now well-established.
As you stated in your comments from the House Rules Committee on July 8, 2015, when these “missed” uterine cancers are morcellated an oncological disaster is created for the affected women. You are 100% correct on this point. And specifically as it pertains to “missed” uterine sarcomas, when these are morcellated by gynecologists, most of the affected women succumb to horrific premature or unnecessary deaths from abdominal sarcomatosis.
Dr. Burgess, I know you will recognize that in the case of the uterine tumors known as “fibroids”, the One in 200–400 incidence of malignancy are fundamentally “missed” diagnoses — because the current gynecological standards for pre-operative cancer risk stratification of women with symptomatic uterine fibroids are dangerously deficient and inadequate. So, when morcellated, these missed soft tissue malignancies become irreversibly catastrophic to women like Dr. Amy J. Reed and families like mine across the United States.
ACOG Committee Opinion 770 delineates the most current guidelines recommended for use by Gynecologists prior to morcellating women’s uterine tissues. That the current guidelines have little to no predictive value in identifying the women with cancer is a clear and present danger to the lives of the affected women.
Furthermore, it should concern all regulators and public health experts that ACOG and AAGL continue to endorse morcellation of uterine tissues, despite guidelines they know to be diagnostically ineffective — and using only the rubric of “shared decision-making” or “informed consent”. As I know you will agree, neither “shared decision making” nor “patient consent” will protect a woman from a specific and totally avoidable mortality risk, when her “missed” cancer diagnosis is spread and upstaged by Gynecological morcellation.
I ask that you read THIS analysis with care — in order that you might appreciate the magnitude of the safety failure in Gynecology, as it pertains to the practice of uterine morcellation.
The current practice in Gynecology remains indiscriminate morcellation of the enlarged uterus, which is performed either manually or using a Laparoscopic Power Morcellator device. And, as you publicly acknowledged in 2015, a “missed and morcellated” uterine cancer can have dire consequences to the affected woman.
I have repeatedly attempted to warn and engage ACOG, AAGL and CDC about the current dangerous standards used in uterine morcellation, which are very literally causing the premature or unnecessary deaths of unsuspecting American women across our nation — but to no avail. CDC remains silent despite high level officials at the agency having clear information regarding the hazard — and ACOG and AAGL have maintained a protectionist posture, unable to see the harm their practitioners are causing.
Congressman Burgess, we may have reached the limit of FDA’s capacity to regulate an unsafe medical device (i.e., the LPM), but the fundamental issue you raised has been left untouched.
Unfortunately, when professional organizations responsible for setting standards of practice in the US (e.g., ACOG and AAGL) fail to identify and appropriately correct public safety deficits with the urgency they deserve, very few barriers exist to protect the public.
Certainly, the civil court system is highly inefficient and, in most cases, powerless as it pertains to “professional standards”. Moreover, Federal agencies such as FDA and CDC are either plagued by political or policy limitations. So, when adequate self-governance falters and compromises lives, I believe that this leaves the United States congress as the only viable body capable of asking the cogent question necessary to steer professional bodies in the correct direction to protect the public in harm’s way.
Dr. Burgess, as 2020 approaches, very literally hundreds of thousands of American women are continuing to undergo uterine morcellation operations, where one in hundreds of them carry an undiagnosed cancer. Given the inadequacy of the current pre-operative risk stratification guidelines, as a physician, you know that this is a clear and present, but totally avoidable, cancer death risk to American women — you stated so explicitly yourself in the video caption here.
Therefore, is it not reasonable for Congress to gather leading Gynecologist representatives of ACOG and AAGL, along with other surgical and cancer experts, to help understand and shed light on this profession’s reasoning for exposing women to a cancer risk no other surgical specialty exposes its patients to?
Dr. Burgess, I believe in the principles of professional autonomy and limited government interference in specialized commerce — however, when an entire guild of American professionals verifiably compromises unsuspecting lives because of inadequate/incorrect safety standards, it becomes incumbent on Congress to raise an eyebrow and query with urgency.
I ask that you consider my comparison of the LPM disaster in women’s health to the recent airline industry disasters with the Boeing 737MAX aircraft HERE.
Rep. Burgess, I sincerely hope that you are able to understand the critical importance of the issue I’ve raised in this open letter to you. Notwithstanding my prior disturbance over the part you played in the Rules Committee’s handling of Rep. Fitzpatrick’s amendments, I know fully well that as a physician, gynecologist and congressman you understand the issue I am raising here with clarity.
You do not mince any word in the above video caption!
What a hero you could become to women across the US and to the specialty of Gynecology, if you steer the House to ask the right questions of ACOG, AAGL and a multi-disciplinary group of surgeons, bioethicists and legal experts!
Congressman Burgess, I ask that you please help us solve this problem — not only in memory of women like Dr. Amy Josephine Reed, but in the name of all women, including those you love yourself. Let neither ego, nor a perception of political animus, drive you in the wrong direction on this issue. Because it is yours to solve as a Physician-turned-Congressman — and a Gynecologist at that!
I ask that you remember that “the only thing necessary for the triumph of evil is for good men to do nothing.” And I assure you that deaths like that experienced by Dr. Amy J. Reed are nothing short of unjust and, yes, “evil”!
This problem I’ve now publicly brought to you is real and the American lives being lost in Gynecology are not hypothetical. But, will you remain silent — despite the words and what you know to be true?
With hope and faith that you, Dr. Burgess, will remember and be true to the words you spoke that day in 2015.
Sincerely,
Hooman Noorchashm MD, PhD (For Amy and the others).
