An Open Letter to FDA’s Director of the Center for Devices and Radiological Health, Dr. Jeff Shuren — On A Severe Medical Device Mortality Risk to Women, “Uncontained”.

Dr. Jeff Shuren, the director of FDA’s Center for Devices and Radiological Health (CDRH).

The following letter was sent to Dr. Jeff Shuren and his colleagues at FDA’s CDRH on the occasion of my wife’s 46th birthday on March 22.

Director Shuren, Commissioner Gottlieb and colleagues,

Today, March 22, 2019 is the 46th birthday of Dr. Amy Josephine Reed — my wife.

As you and your colleagues at CDRH well know, Amy’s life was cut short tragically and intolerably by a medical device known as a Laparoscopic Power Morcellator, cleared by FDA via the 510(k) pathway.

It is abundantly clear now that the “uncontained” Laparoscopic Power Morcellator’s 510(k) clearance by FDA was inappropriate and unsafe — because it never fully considered the severe oncological danger associated with shredding tumors and tissues with malignant potential inside a women’s body cavity.

Dr. Reed was harmed and died at the hands of negligent Gynecologists at the Brigham and Women’s Hospital in Boston, using an “uncontained” Power Morcellator developed, manufactured and marketed carelessly by STORZ and its American subsidiary KSEA.

Based on all available public data, it is not difficult to deduce that 510(k) clearances for the laparoscopic Power Morcellator devices were granted by FDA based on incomplete and, likely, illegal applications by at least some of the manufacturers. Of course, you and your agency have access to all the records necessary to determine whether STORZ, specifically, made any effort to warn the FDA of the deadly oncological risk posed by its Power Morcellator device. You should know that our civil court system in the state of MA is in the process of litigating the company to understand who at STORZ knew what, and when, about this deadly design defect and the catastrophic risk it poses to women.

For the record, I have no access to the proceedings of this civil litigation with regards to STORZ or BWH, because of a protective order barring me from access to confidential discovery documents. A few “good lawyers” are doing their jobs well to protect the interests of their negligent clients in civil court as far as they can, I assure you. In fact, the various manufacturers of “uncontained” Laparoscopic Power Morcellators, including STORZ, have literally achieved settlements, NDAs or Summary Judgements in hundreds of such cases of deadly harm. Not one of these cases has seen the light of day in civil court for the public to understand the gravity of corporate malfeasance and carelessness in the marketing and distribution of the “uncontained” Laparoscopic Power Morcellator!

Nonetheless, I am certain that the press and our federal and state public health agencies will have a keen interest in understanding whether these manufacturers illegally withheld critical information and knowledge relevant to women’s health from FDA in their 510(k) filings.

But more critically, now,CDRH has left “uncontained” laparoscopic Power Morcellators on the US marketplace, with their totally unmitigated design defect exposing unsuspecting women to deadly harm. As you well know, the engineered operation of these “uncontained” morcellators leads to the spread of uterine tissues inside women’s abdominal cavities in an indiscriminate fashion. You fully understand that in those women with missed cancer diagnoses, like Dr. Amy Josephine Reed, the result is catastrophic and deadly spread and upstaging of potentially curable or early stage cancers.

In fact, the “uncontained” Laparoscopic Power Morcellators’ main design defect is that it has NO specifically-engineered mitigation system to “contain” the shredded tissue, which thus spills into the patient’s abdominal cavity to cause serious morbidities and tragic mortalities from the spread/upstaging of cancer.

This astonishing continued availability of the “uncontained” Power Morcellator on the US marketplace is despite the fact that an “alternative design” allowing the dissemination of the shredded tissue to be contained/mitigated is demonstrably possible — as the FDA clearly understands.

Because FDA failed to rescind its 510(k) clearance or ban the use of these devices in uterine operations, “uncontained” Laparoscopic Power Morcellators remain on the US and global marketplace and continue to harm women. Women such as Ms. Erin Harris of NY whose cancer was spread and upstaged in 2018 using a LiNA Power Morcellator for which no specifcially adapted mitigation system has been cleared by FDA. Please refer to MAUDE complaint Access # MW5083832 filed with CDRH’s Office of Surveillance and Biometrics — and acknowledged on March 8, 2019 by that office’s director, Dr. Tom Gross.

American Gynecologists, many of whom fail to acknowledge the deadly peril of morcellating tumors with malignant potential, are continuing to place unsuspecting women in harm’s way using morcellation of uterine tissues. This assertion is a matter of certainty.

But even more importantly, following Dr. Amy Reed’s complication it is becoming vastly clear that nearly 1% of the hundreds of thousands of American women undergoing non-oncological uterine operations annually carry a missed cancer diagnosis (not just the one in 200–400 women with uLMS) . EVERY one of these women is potentially exposed to the iatrogenic risk of cancer spread and upstaging when a 510(k) cleared, “uncontained” Power Morcellator is used.

It is also a fact that FDA has now cleared a “contained” iteration of the Power Morcellator device known as the “PK Morcellator” along with its “Pneumoliner” mitigation component being distributed by Olympus.

Therefore, I am certain that as a physician and an attorney, you are able to see that FDA and its Medical Device section, the CDRH, are in terribly unsound legal territory by retaining the “uncontained” Laparoscopic Power Morcellator in the Gynecology marketplace, given: 1) FDA’s clear knowledge that “uncontained” Power Morcellators, by virtue of a specific design defect, pose a deadly oncological risk of cancer spread and upstaging in, potentially, up to 1% of women exposed and 2) the availability of a 510(k) cleared “contained” iteration of the device from Olympus, which includes a specifically engineered mitigation module.

THIS WEBLINK provides the CDRH director and FDA commissioner’s offices with a direct legal pathway to exercising their jurisdiction to immediately eliminate the severe mortality risk posed to unsuspecting American women by “uncontained” Laparoscopic Power Morcellators.

It is, of course, self-evident that the federal legal violations likely committed by manufacturers of “uncontained” Power Morcellator devices ought to be fully investigated by federal authorities — because this illegal behavior has caused the premature or unnecessary death of unsuspecting Americans and a serious loss to our federal and private health insurance invetsments. It is, in fact, highly probable that the executive and engineers at these companies had full and clear knowledge of the deadly oncological risk of “uncontained” Power Morcellators but failed to warn the FDA, or to include such information in their 510(k) applications, or to formally request a FDA label change to include the possibility of an oncological catastrophe. After all, as the GAO investigation demonstrated, FDA seems to have had no knowledge of this deadly oncological risk or the unmitigated design defect that caused it. Given the extremely high likelihood that the allegations described herein are true, I believe that investigation and public litigation of these companies and their executives is a legal duty of our federal public health and DoJ authorities.

Today, I write this message, in memory of Dr. Amy Josephine Reed (now 46), to again specifically request that FDA immediately rescind all 510(k) clearances of “uncontained” Laparoscopic Power Morcellators, or to ban the use of “uncontained” Laparoscpic Power Morcellators in Gynecological uterine operations — and to demand an immediate investigation of STORZ and KSEA executive for illegal and negligent behavior causing the death of American women and unjustifiable loss to our federal and private health insurance investments.

Dr. Shuren, it ought not fall to individual citizens and plaintiff’s lawyers to do the job of the CDRH well. Your agency’s incomplete action in leaving the defective “uncontained” iterations of the Laparoscopic Power Morcellator on the market, and not stimulating a detailed investigation into the extent to which companies like STORZ have violated federal law, will become an historic hallmark of your career as CDRH director. As a public health regulator, a physician, an attorney and an epidemiologist, you surely understand that hundreds, if not thousands, of unsuspecting American women have died because of the unmitigated mortality risk posed by the design defect intrinsic to “uncontained” Laparoscopic Power Morcellators.

Today, I write for the record — in memory of my wife and the others.

Sincerely,

Hooman Noorchashm MD, PhD.

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.