The FDA Doesn't Care About Us

Women protesting at a Gynecological Convention in San Diego, California trying to gain awareness of doctors of the dangers of Essure

Birth control is something that many women contemplate throughout their lives. Usually women want to look for something nonpermanent, to prevent pregnancy to a later time. However, some women decide they want to permanently prevent pregnancy-- thats where Essure-- and IUD-type device developed and marketed by Bayer-- slithered its way into the fallopian tubes of unsuspecting women, sinking its venemous fangs into their lives, poisoning them forever.

Diagram of Essure device and fuction

FDA-approved in November of  2002, Essure was marketed as a simple, easy way to permanently prevent pregnancy-- it could be implanted right in the doctors office and functioned by creating scar tissue that closed the entryway to the fallopian tubes.

However, this tiny medical device has hurt, destroyed, and even ended the lives of thousands of women to date.

The FDA does not care about the real human patients who are using new, "innovative" medical devices. Some of them are not tested on actual human beings, and many on top of that are tested on only small groups of people that are only tracked for a year or two.

Essure device migration in a patient after implantation

On top of this, the FDA is actively trying to disprove women of their symptoms and doctors are unlikely to truly believe women of their symptoms. This device has caused women to need hysterectomies, chronic headaches from inflammatory response, deadly perforation of the fallopian tube, miscarriages and stillbirths from failed sterilization, and is almost impossible to fully remove-- with the manufacturing company Bayer constantly changing the protocol. If it is pulled out, it breaks apart, creating often irretrievable fragments in the uterus that can cause a sleuth of incredibly dangerous, painful, life-threatening health problems.

It is still being argued as a new, breakthrough medical device. So why was this ever on the market for doctors and their patients they are supposed to "do no harm" to?

Greed, corruption, and apathy for women's bodies.

There are so many examples of the ways that medicine has neglected women. From "hysteria" claims to stifle health concerns and the refusal of researchers to include women intersectionally in medical research,The FDA has said that "the benefits of Essure outweigh the risks". But thousands of health complications were reported to the FDA in 2017 alone.

In addition, there are some pretty serious loopholes in the FDA medical device approval process-- if a device is similar to a predecessor, it does not need to be tested as if it is a new device.

So essentially, devices can be approved based on the previous approval of a device it was developed from-- without ever being tested on a real life human being. You can imagine the chain of devices approved based on this from some original device that may have been recalled years ago.

How has the FDA allowing this to happen?

Scott Gottlieb at his Senate confirmation hearing

Last May, Trump appointed Dr. Scott Gottlieb as the new FDA commissioner, and headlines across the board reeled that the man was actually well-qualified for the job, and even praised as "against the stereotype".

However, Dr. Gottlieb does have background with New Enterprise Associates, which funded the development of Essure and other medical device startups, as well as financial ties to some pharmaceutical companies. Oh, and he also hired a new head attorney for the FDA whose previous job was defending Bayer against patient claims.

And whenever you have people saying "it could have been worse", in regards to Trump's FDA commissioner pick, does that really inspire much confidence? Is this our new standard?

All of these problems I've detailed existed far prior to Gottlieb being appointed to FDA commissioner, and he has since supposedly "cut off" his ties to these companies, so we can't blame all of these issues on his "alleged" corruption. And he is doing some good in the world of public health. But is he really taking us in the right direction in response to problems like Essure and other medical devices? Not really.

In 2018, Bayer announced that it would no longer be selling Essure on the American market. This was very close to after the Netflix documentary The Bleeding Edge was released-- which details much of what I've talked about here. The U.S. market was the last of their international markets that Essure was being sold to.

But think about that for a moment-- sold to. When will medical companies and the FDA stop treating our lives like a possible money grab?

They won't. At least not any time within the next few years. We know this will keep happening, the evidence is there. The FDA hasn't changed their protocol. So the only question is, who will be the next victim?


Related Literature/Media:

Dick, Kirby, (director) .The Bleeding Edge. Netflix Productions, 2018.

McGinley, Laurie. "Sales of Essure Birth Control Implant to Be Halted by Bayer; U.S. Last to Sell Controversial Device." The Washington Post. July 20, 2018. Accessed November 12, 2018. https://www.washingtonpost.com/news/to-your-health/wp/2018/07/20/sales-of-essure-birth-control-implant-halted-by-bayer-u-s-was-last-to-sell-controversial-device/?utm_term=.3fd13db20f83.

Takeshita, The Global Biopolitics of the IUD.