The Problem with the FDA’s New Physician Requirements for Prescribing Essure

posted on July 7, 2018 by Dr. John Littell Dr. John Littell

In a recent issue of the Journal of the American Medical Association (JAMA), one can find among news from the FDA a piece entitled “New Physician Requirements to Use Permanent Birth Control Device.”

Natural Womanhood NFP Natural Family Planning Fertility Awareness Based Methods FABM Contraception Hormonal Birth Control Risks Essure FDA Physician Requirements

Within the 7-paragraph article is the following statement about the permanent sterilization device known as Essure that has been on the market for 16 years and used by over 750,000 women worldwide.

“Physicians are now required to give patients a 22-page educational brochure and discuss with them the device’s risks and benefits before the device is implanted. Physicians also must inform patients of alternative contraceptive methods, answer any other questions they have about the device, and sign the brochure to document that the discussions have taken place.

The FDA’s actions are in response to ongoing reports of serious adverse effects and the agency’s concerns that women don’t receive enough information before they decide whether to have the device implanted.”

Ya think?

Essure, a flexible metallic coil inserted through the vagina into the Fallopian tubes, has led to chronic pelvic pain in over 21,000 women (often to the point of requiring a hysterectomy), headaches in over 7,000 women, and at least 10 deaths due to perforation of the Fallopian tube or the uterus by the device, according to the JAMA article.

Why has it taken so long for the FDA to sound this alarm? As I detailed in my book, The Hidden Truth: Deception in Women’s Health Care, I have encountered numerous patients in my practice who have made choices which, given more information, and more time to consider the available information, they say they may not have chosen. Being fully informed is key to making choices, but for far too long with regard to hormonal contraception, many doctors don’t give patients all the information about health risks and side effects out of concern it will inhibit a woman from choosing it.

How many women have had a physician, nurse practitioner, or other health care provider when prescribing ANY method of birth control—oral contraceptives, IUDs, implants, injections, or sterilization—initiate a discussion about the side effects and health risks? The adverse impact of each of these methods has been outlined in previous articles here at Natural Womanhood as well as in my book.

Physicians and others in clinical practice are deluged by journal articles espousing the many supposed “health benefits” of hormonal contraception and the various artificial and invasive methods of birth control and sterilization. There was a time in the early years of my medical practice that I believed I was providing a great service to young women by prescribing the “best” oral contraceptive for them. But the patient’s “choice” wasn’t the focus, as I learned it. Rather, the ethos we absorbed in medical school was that we the physicians had been granted by society a unique role as being the one who always knows what is best for the health of the patient. When it comes to doctors mass-prescribing hormonal birth control, this is very dangerous. When prescribing these drugs in today’s health system, healthcare providers are often following the dictates of the government, the insurance companies, and the pharmaceutical companies rather than the principles of the Hippocratic Oath.

Many doctors today struggle to avoid being penalized when we select a course of action that is not on the “approved list” sent to us by those who pay for health care. Sadly, it is no longer the patient’s choice in most cases! Should we providers stray from that list, we need to provide explanations as to why we have deviated from the expected course of action and hope that we can get approval from the almighty third party to allow the patient to receive a given prescription—or not.

This may well explain why patients have long been denied true “informed consent” before embarking on the road to contraception or sterilization. There are other agendas at work.

How else to explain why the FDA took 16 years to requires physicians to explain the risks of Essure to its potential victims? Or why our FDA has ignored the recent studies of over 1,000,000 users of birth control pill in Denmark, revealing a four-fold increase in the use of antidepressants, 60% increase in the incidence of breast cancer, and significant increases in the incidence of myocardial infarction and stroke?

Are the new physician requirements on Essure a sign of things improving regarding informed consent on contraceptives? I don’t think so. First, despite this victory that the risks of Essure have been acknowledged in JAMA, it is dwarfed by the number of journal articles physicians read supporting mass-prescribed birth control to anyone with symptoms as wide-ranging as acne to PMS. I’m afraid that, practically speaking, this journal article isn’t going to change physician behavior much, if at all. The 22-page document doctors are being told to go over with their patients is unlikely to be read by anyone. The real problem is that Essure is on the market and that women will continue to be prescribed something that harms a great number of them.

Contrary to seeing improvements, I think issues of informed consent on contraceptives are going to continue to worsen: we’re losing independent physicians as more of them choose to become employees of the hospital and other large healthcare systems that have protocols on birth-control prescriptions. Many physicians in recent decades have been trained into becoming agents for social good—putting “population health” (with the need for population control) over the best interests of the individual patient before them. A significant percentage of medical journal articles are written by physicians employed by drug companies.

It is my hope that all women will attempt to do their own research before making medical choices for any given health care issue. Seek physicians who recognize alternatives to hormonal birth control that come with such dangerous health risks.

References

Voelker, R. “New Physician Requirements to Use Permanent Birth Control Device.JAMA. 2018;319(19):1974. doi:10.1001/jama.2018.5587

Lidegaard, Ø. “Thrombotic Stroke and Myocardial Infarction with Hormonal Contraception.” New England Journal of Medicine. 2012; 366:2257-2266 DOI: 10.1056/NEJMoa1111840

Mørch, L. “Contemporary Hormonal Contraception and the Risk of Breast Cancer.” December 7, 2017: New England Journal of Medicine. 2017; 377:2228-2239 DOI: 10.1056/NEJMoa1700732

The opinions, representations, and statements made within this guest article are those of the author and do not necessarily reflect those of Natural Womanhood.

Posted by Dr. John Littell Dr. John Littell
Dr. John Littell is a board-certified family physician and author of The Hidden Truth: Deception in Women's Health Care: A Physician's Advice to Women and All Who Care for Them.

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