Dear Dr. Zampaglione,
Dr. Amy Reed and I are in receipt of your email letter of December 15, 2015 - attached.
We want to thank you for taking the time to write back.
Your personal involvement and letter clearly demonstrate the careful attention Bayer is placing on its defense of the Essure permanent female sterilization device.
We have no question that women's right to exercise safe and effective contraception must be defended and preserved in our society.
However, any and all treatments designed to preserve this right must be stringently subjected to safety testing and immediately excluded when severe safety problems arise - for one simple and undeniable reason: the vast majority of women exercising their right to contraception are otherwise young and healthy- many are working mothers, wives and bread-winners.
Dr. Zampaglione, I know that as an OB/Gyn you agree that contraceptive drugs and devices are not designed to cure an incurable disease. So for any such products to cause irreversible harm (or deaths) is unacceptable from a medical ethical perspective - even if "informed consent" has been obtained and even if this harm is to just a minority subset of women. The principle of patient autonomy will never justify bad medicine or our obligation to practice non-maleficence, beneficence and justice.
Furthermore, it is now a well-established fact that "mandated disclosure" (i.e., informed consent) does not protect consumers or corporations from harm or damage to their persons or reputations - simply because neither the provider, nor the consumer engaged in the transaction assume that they will be the unlucky ones - but if they are the "informed consent" process does nothing to protect either party from damage or liability.
We have communicated your concerns and your letter (attached below) to the women of the "Essure Problems" group, to the press, to the United States congress, to the FDA and to legal experts.
In order to allow the individual CC'd here to be briefed, here are a sereis of links summarizing our position on Essure:
We are sure you agree, as a physician and corporate leader, that the best strategy to ensuring the health of our society and corporations in the United States is full transparency and empathic discourse - particularly when it comes to products and services that are demonstrated to have caused Avoidable harm to subsets of unsuspecting people.
We are also sure you agree that, in the United States, government or corporate protectionism and secrecy when people's lives and rights are at stake, remain unconstitutional in the year 2015 - so when such concerns are raised by citizens, particularly from a professional and ethical perspective, they must be taken very seriously and corrected by all parties involved.
We are committed to helping your company take all the steps necessary to protect your customers and good corporate name - and women's health, in particular. I assure you that we are both users and supporters of good Bayer products - unfortunately, Essure is not one of those.
I do ask that heed our warning and act with responsible empathy to those harmed and to the advocates for patient safety and women's health - and in partnership with advocates in government and in the press.
Based on your detailed response to my email of October 15, I do feel compelled to respond specifically, and in turn.
We will start by saying we would be delighted to accept your offer of a meeting in person - but we ask that you bring several relevant parties to the table along with us. First, the leaders of the Essure Problems group are the ones harmed and with the most relevant platform you must address - they are the most important voice you must contend with. Second, Congressman Mike Fitzpatrick, who is the author and sponsor of the E-Free act in the United States House of Representatives. Third, the leaders of Planned Parenthood, as one of the highest volume corporate end users of Essure. And fourth, select members of the press to document this transparent conversation - sponsored by Bayer Health. I assure you that it will be an historic act of corporate "good-faith".
We also assure you that the intent of such a meeting would be to create understanding, friendship and solutions to quite a troubling problem posed by your company's product - and which will likely cost substantial tangible and intangible expenses to Bayer's revenue stream and corporate reputation in the coming future. Please let us know if such a meeting is something you and your colleagues might envision sponsoring.
The reality you must accept as physicians and corporate leaders is that Essure is not used to cure an incurable disease - and the fact that it has demonstrably caused avoidable but permanent harm to a subset of women, post-implantation, makes it a potentially dangerous device to all women.
But, perhaps worst of all, the PMA status of this device excludes the possibility of any real degree of free-market regulation. If the product and the doctors using it are both legally protected from litigation, in a setting where most insurance carriers easily pay for this well-marketed product, how can "the market" regulate this product? It, very certainly, cannot!
As a physician and corporate leader, we ask that you fully consider that your product is not operating within a free-market framework. We ask you to consider that when patients are harmed by this device or any other faulty device, their lives are damaged or strained. They go home and go bankrupt - some die.
No doubt, Essure is well marketed and legally protected with a PMA approval label from FDA, and it is practiced as a standard of care by licensed physician members of ACOG. So when consumers are harmed they have no legal recourse whatsoever - given the device's PMA status and given the "Standard of Care". Is that the free market operating? Is this not a violation of the harmed women's constitutional rights? Do you think accepting such a thing for otherwise young and healthy women is good doctoring or responsible corporate stewardship? I think not Dr. Zampaglione.
Your defense of the Nickel content of Essure is troubling - as you will find based on the transcript of the FDA hearing of September, 2015 we are not the only party to express surprise and concern at the lack of adequate focus on the widespread use of this Nickel based permanent medical device in an immunologically active and sensitive anatomic location.
There is no doubt in my mind that Essure's Nickel content is well wrapped in legal frosting, as you have alluded to well in your letter - after all the product bears the powerful PMA status from FDA.
There is also no doubt that FDA approved this product, despite its Nickel content, and accepted the data and arguments provided by the manufacturer - but as has been repeatedly demonstrated, the FDA process for evaluating the safety of medical devices is critically flawed and subject to unacceptable conflicts of interest. I assure you that entities within the United States congress are keenly looking at this FDA mission corruption - perhaps Bayer will have the foresight to extricate itself from FDA's scrambled regulatory paradigm.
In fact, as a corporate leader we would urge you to call on the United States congress to overhaul the CDRH leadership process at FDA immediately. Because, in the end, that federal agency's mission corruption and laxity in safety standards stands to harm the reputation and financial solvency of many corporate entities.
With regard to your defense of Essure's Nickel content, I took the liberty of performing a PubMed Search using the key-words "Essure", "Nickel", "Allergy", and "Hypersensitivity". A total of only 8 publications emerge - one of which is the paper by Zurawin et al., to which you allude. Without a question, this is an inadequate body of work by any scientific standard. On the other hand, reports and studies of allergic and hypersensitivity to nickel, and the basic science of this process number in the thousands. The fact that Nickel is a strong allergen is, indeed, well established.
Essure's Nickel content is a problem for Bayer, and it is a problem not to be solved by your risk managers and lawyers making statistical claims, but by ethical doctors, surgeons, scientists, allergists, rheumatologists and dermatologists, who understand that unlike a watch or a belt buckle that can be removed readily, Essure cannot be easily extricated from the body.
There is a paucity of well controlled, peer-reviewed and published studies on the Nickel content of Essure. The notion that Essure "leaches" less Nickel than some other devices, or that there is "less than that that ingested from food and water" is suspect and weak - particularly when it comes to placing a permanent nickel containing object in the highly immunologically reactive mucosal surface of the fallopian tube.
Nonetheless, even assuming your own stated estimate of a 0.1% Nickel hypersensitivity response, with hundreds of thousands of Essure coils being deployed in women annually, Hundreds of these unsuspecting women are exposed to the possibility of developing life-altering (sometimes life-threatening) hypersensitivity reactions. We hope you can see the simplicity of the math.
With respect to the issue of fraud in the conduct of the Essure trials, we ought to leave that up to the FDA, the OIG and the DoJ to investigate. Certainly the evidence presented by some advocates at the FDA in September 2015 was concerning for a product that is so well subsidized by our federal health insurance investments.
With respect to your analysis of the comparison we've drawn between Essure and power morcellators, we agree that these devices have entirely different purposes - your stating this, is simply stating the obvious.
What we are drawing attention to, however, is the commonalities in the approval and adoption of these potentially dangerous devices in the care of women. The issue at the heart of the matter, and the common denominator between Essure and the morcellator, is that many corporate entities today appear to comfortably accept the notion that avoidable collateral damage to, or sacrifice of, a minority subset of American lives is justifiable, and to be defended - so long as the "majority benefit" or if "choice" and "convenience" are maintained.
Of course, this approach is utilitarianism at its most despotic - because it hijacks the hard earned tenets of democracy and choice to justify the suppression of the lives and rights of a minority subset of the unsuspecting - for the sake of money and liability.
Fundamentally, you must ask yourself is that the kind of corporate framework you wish to lead? Is that the kind of company Bayer is? Is that the kind of doctor you wish to be? Is that the type of society and corporations you want leading the world of our children? And how would you respond if one of the harmed was yourself, or a daughter, your sister or your mother?
Ethical medicine and correct corporate medical reasoning, Dr. Zampaglione, cannot operate on utilitarian philosophies, but must rather be centered on the individual patient. And it must operate fully on the principles of non-maleficence, beneficence and justice for every patient - remember, Essure is not intended to cure an incurable disease.
So, our respectful suggestion to you and your colleagues in corporate leadership at Bayer is to partner with the harmed patients gathered in the group "Essure Problems" and with their advocates - not with FDA, not with corporate risk managers, not with ACOG or Planned Parenthood - and demonstrate what good stewardship in corporate medicine could look like in America.
The women of "Essure Problems" are real. Engage them in friendship. The vast majority of them were previously young and healthy - the vast majority of them have real stories of harm caused by Essure. And, now, Essure's PMA status is violating their legal and constitutional rights as Americans.
We assure you that this is not a matter to be trifled with and if Bayer's executive leadership does not exercise the foresight to contain this damage, it may very likely find itself on the receiving end of a constitutional violation sometime in the future. With all sincerity, we ask you to take the long term view and consider that you do not want your company to be the one to fall to the inadequacies introduced by the supreme court decision of Riegel vs. Medtronic.
A while back, following a severe complication our family experienced in a gynecological operating room, we took the KARL STORZ company executives to task regarding the oncological hazard posed their power morcellators. Instead of quickly acting to contain the harm to women, they established a defensive posture towards us and they continued to retain their product on the market - In fact, they responded to us with the threat of a law suit. You can read about this here:
And they kept their device on the market...So others continued to get severely harmed and died. You can read about this awful corporate mistake here:
The KARL STORZ corporate decision was not only unethical, it was utterly stupid - and we assure you that when you search through the legal archives, you will see that KARL STORZ is poised to incur massive liability and loss in court rooms around the world.
So, we thank you for the careful and empathic approach to the objection we've raised to Essure.
We do believe that your company has the ability and opportunity to think outside the box to resolve this problem. A defensive posture when it comes to devastated and harmed lives, especially in women's health, will not work well - particularly, in the United States.
Our strong recommendation is that you and Bayer's corporate leadership is to suspend the distribution of Essure coils in women, move towards compensating the Essure harmed women for their damages and begin the process of further developing safe and reversible contraceptive alternatives in the drug and device realm - Essure will only damage your good corporate reputation. And there are equally effective, reversible or surgical options available to women - access will not be denied on the basis of your decision to remove Essure.
My prediction is that if you elect to voluntarily remove this single, potentially dangerous, Bayer product from the market based on the very real safety concerns raised by the "Essure Problems" group, you will make up for any losses in droves from the investor and consumer confidence you will earn in exchange. It will simply be a revolutionary corporate move on the part of your company's leadership - one, which will benefit you immeasurably in the archives of corporate history.
The principle of pre-emption is operational in cutting corporate losses and in doing the right thing to preserve lives. We invite you to pre-empt by establishing a warm friendship with the "Essure Problems" women, by halting the sales of Essure...We invite you to make Bayer a different kind of corporation in America.
We wish you a happy and healthy holiday season.
Hooman Noorchashm MD, PhD. and Amy J. Reed MD, PhD.