On September 24, 2015 the Food and Drug Administration is planning to convene another hearing of the OB/Gyn Device Panel. Again, a harmful medical device in question is a gynecological one – a permanent female sterilization device, known as Essure. You can view the announcement here.
Essure is a system manufactured by Bayer Healthcare - originally approved by FDA in 2002. It consists of a delivery system and nickel-containing permanent coil implants. The coils are placed into each fallopian tube without a skin incision, through the vagina. The nickel in Essure elicits an inflammatory response and tissue in-growth, in theory, over time, causing tubal occlusion leading to sterilization of the woman. Here is Bayer's advertisement for Essure.
Unlike the gynecological power morcellator, Essure was FDA approved through the Pre-Market Approval (PMA) mechanism. This approval mechanism for medical devices supposedly tests the device for safety and efficacy, prior to FDA approval for marketing. And because the device has supposedly undergone stringent safety testing and FDA review, federal law provides strong legal protections to the manufacturer against liability. In other words, any patients claiming harm by Essure can't even take their claim to court.
Bayer markets Essure as one the most effective, affordable and convenient means of birth control – ideal for the busy 21st century woman and mother. Of course, the American College of Obstetrics and Gynecology (ACOG) and a large majority of gynecological surgeons appear to do very little to inform patients of the shallowness of this marketing message.
The trouble with Essure is that since obtaining FDA approval in 2002 it has become clear that beneath the nicely packaged and marketed gloss and convenience, severe hazards lurk.
There are literally thousands of American women harmed by complications following placement of the Essure sterilization coils. You can read about the fight being waged by the Essure women here.
The side-effects of Essure sterilization include severe joint pain, recurrent debilitating headaches, weight gain, chronic fatigue, hair loss, heavy, painful and irregular menstrual bleeding – to name only a few. And these complications are floridly debilitating to the mothers, wives, daughter and sisters who prior to Essure sterilization were healthy young women.
In some cases the women with Essure coils in place have felt so catastrophically debilitated, they have been offered minimally invasive hysterectomies in hopes of removing the coils. Many of these women underwent morcellation as part of their hysterectomy operation. And when the Essure coil is morcellated, bits of nickel are spread all over the abdominal and pelvic cavity – like bits of shrapnel from a grenade.
One would think that with thousands of sterilized women catastrophically debilitated, the ACOG would present a more complete view of this potentially dangerous procedure to young and otherwise healthy women. But quite to the contrary, the ACOG presents this procedure as an efficient and safe means of permanent sterilization. You can read the ACOG's Frequently Asked Questions involving "tubal sterilization" here.
Here again, we have another example of gynecological surgeons and their major society committing maleficence against women.
In many ways, endorsement of this practice by leading gynecologists is being defended and justified using the same arguments these surgeons used to defend the practice of power morcellation. We deconstructed this language previously here.
Specifically, American gynecologists in the year 2015 seem to believe that any procedure with foreseeable harm is justifiable to perform on otherwise healthy women so long as: 1) the "majority benefits" and 2) "women's right to choose" is preserved - no matter what the consequences to a minority subset of unsuspecting women might be.
This line of reasoning by a group of American physicians is a fully egregious violation of a bedrock medical ethical principle, known as "non-maleficence". You can study the definition of non-maleficence here.
Of course, gynecological leaders do not appear to see it this way. Many believe and have stated that tubal sterilization using Essure is safe. Here is an example of gynecological marketing of Essure.
But, again we find ourselves asking why the specialty, charged with the health of women, in particular, is capable of accepting catastrophic collateral damage to a minority, unsuspecting and otherwise healthy subset of women.
What is most striking is that the dangers of the Essure female sterilization device are being shielded by the rubric of "women's reproductive choice". But this abuse of a hard-won American social value by medical device manufacturers and captains of the gynecological industry in America is a blatant marketing crime.
Of course, it is not difficult to see that the ethical corruption in the gynecological industry's operation has effectively hijacked the progressive notion of "women's reproductive health" in America for its business and corporate goals.
So it is, again, that FDA's Center for Devices and Radiological Health (CDRH) will find itself incapable of making the correct ethical decision to protect the minority subsets of unsuspecting women in harms way – as was the case with the power morcellator. The "fox guarding the hen house" is an apt analogy when it comes to that agency.
So it is, again, that ACOG, and many leading gynecologists, will accept and defend severe harm to minority subsets of unsuspecting women, using the rhetoric of "benefit of the majority" and "patient choice".
So it is, again, that our federal representatives in congress mistake false-marketing and unethical medical practice by the gynecological industry as being indication of our society's respect and valuation of "women's choice".
We are now confident that a common, and corrupted, denominator underlies the "power morcellator disaster" and the severe harm done thousands of Essure sterilized women: An FDA more committed to industry and streamlined marketing than patient safety and a gynecological industry more committed to its corporate revenue stream than to women's health.
Why and how can our society tolerate such systemic maleficence committed against women?
The only logical answer is that in the year 2015 the defense and propagation of corporate and industry interests, not the protection of American lives, dominates the practice of medicine, as well as our federal government and her agencies. And this simple fact has and will continue to compromise the health and wealth of our nation.
But, very likely, it is too late for America's spirit to save herself from corporate tyranny now.
Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.
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