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Drugs & Medical Devices

FDA Failed Women and Left Deadly Essure on Market

— March 3, 2016

Those of us who advocate for the removal of Bayer’s “permanent” birth control device, Essure, from the market, as well as the tens of thousands of innocent victims whose lives this product has destroyed have waited since September 2015 for the FDA to take action to protect innocent women. All the waiting was for naught, sadly. The FDA failed women and left deadly Essure on market.

Those of us who advocate for the removal of Bayer’s “permanent” birth control device, Essure, from the market, as well as the tens of thousands of innocent victims whose lives this product has destroyed have waited since September 2015 for the FDA to take action to protect innocent women. All the waiting was for naught, sadly. The FDA failed women and left deadly Essure on market.

The agency, which promised some form of action by the end of February this year, announced on March 1 that Bayer AG, Essure’s owner, must begin new safety studies of the Essure device. It took tens of thousands of injured women, several legislators and grassroots activists pressuring the FDA to get even that much from the agency, whose mandate is to protect innocent patients from harmful drugs and medical devices. One of the other “victories” for those of us opposed to Essure is that the FDA will require a “black box” label that warns about Essure’s “potentially serious” (how about deadly?) side effects. The last is that the agency will create a checklist that doctor will use to discuss Essure risks with their patients.

According to William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, “The agency has carefully reviewed all the available evidence … While there are risks associated with the use of Essure, there are also benefits. We believe informed women should have this as an option available to them.”

One could almost buy that last statement if there were assurances that patients would truly be informed of all possible risks. One is far from convinced that such is the case.

Apparently, one is not alone in one’s skepticism. Lawmakers from both sides of the aisle let fly their criticism of the agency’s spineless decision. The women of Essure Problems, a 27K+ member grassroots Facebook community also had some things to say. If you haven’t been following the story, these are the victims, the innocent women who suffer without ceasing from stomach swelling, dizziness, pelvic pain, cramps, fatigue, bleeding and a whole host of other side effects that look like something out of a horror movie.

Rep. Mike Fitzpatrick (R-PA), the author of the “E-Free Act,” legislation that if passed would force Essure off the market and strip Bayer of the pre-market approval (PMA), which is basically lawsuit-proof armor had this to say:

“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market.”

Another member of Congress, Rep. Rosa DeLauro (D-CT) added that the FDA needs to ensure that Bayer actually does the follow-up studies but that “Essure should be off the market until the requested studies are completed.”

Essure Problems issued a statement expressing its members’ “outrage” at the FDA’s toothless determination.

The group’s statement read, “These studies could take several years, and leaving the device on the market will only put more women’s lives at risk. We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device.” The group is, understandably so, outraged that the agency is allowing Bayer to conduct the studies, instead of an independent third party.

The group also said, “We are outraged that it appears as if the FDA is going to leave Essure on the market. Take the device OFF the market and revoke PMA [premarket approval]. Do not continue to allow more women to be harmed.”

Madris Tomes, a former FDA contractor and head of Device Events, runs data analysis of public FDA data. She said, “I feel as if the FDA truly failed these women. My hope was that they would recommend a recall. How can we trust the FDA to make good decisions regarding safe and effective devices?”

Tomes assisted Rep. Fitzpatrick on a press call in February. The pair gave the FDA raw data showing 303 fetal deaths among Essure patients, while the FDA said on Monday that it was 294. Although it’s previously released number of fetal deaths was “only five.”

In explanation of the difference, Tomes said she employed a different analysis method than the FDA. “Most of the story of what happened and all the side effects, those are going to be in the narrative. So we searched for keywords in that narrative that women and their doctors would use, such as fetal death, miscarriage, still birth, stillborn and ectopic pregnancies. I actually think the 303 number is conservative because some of these women have had multiple miscarriages, they’ve had multiple pregnancies, after confirmation, but I only counted them once.”

For its part, Bayer’s party line has never changed. It contends that Essure, approved by the FDA in 2002 when developed and owned by Conceptus, is a safe product that gives women an option for permanent birth control other than surgical sterilization. Sure. Just like taking a kitchen knife to the testicles is a viable alternative to vasectomy.

Dario Mirski, senior VP and head of Medical Affairs Americas for Bayer, issued the following statement:

“Patient safety and appropriate use of Essure are our greatest priorities. A woman’s decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure.”

That’s why the company successfully lobbied to have the label changed, removing all mention of possible nickel reactions and why doctors are no longer instructed to test women for nickel allergies prior to implantation of  Essure. Patient safety, indeed. I’m sure it was patient safety that drove Essure’s designers to include PET (polyethylene terephthalate) fibers in the device. The manufacturer of the fibers warns in its material safety data sheet (MSDS) that PET is not for use in medical applications involving permanent implantation in the human body.

Photo courtesy of
Photo courtesy of

Dr. Edio Zampaglione, Bayer’s VP of Medical Affairs for Women’s Health (and resident fox in charge of the hen house) said, “Clearly, the data for Essure shows the benefits outweigh the risks. There’s nothing [we’ve seen] with the product itself that says we’ve got a defective product or something that needs to be taken off the market.”

Apparently, 27K+ women and their families are invisible to Dr. Zampaglione. Or, perhaps in scientific parlance, such a number isn’t statistically valid proof that there is a problem with Essure.

The FDA has pretty much bent over, grabbed its ankles and allowed Bayer free rein to do whatever it pleases regarding Essure. Despite making Bayer update Essure’s labeling based on patient reports, information from clinical trials and other medical literature, the agency still holds the opinion that “Essure remains an appropriate option for the majority of women seeking a permanent form of birth control.”

At least the FDA could (sort of) see the tens of thousands of women whose lives, careers, health and in some cases, families and marriages were destroyed by Essure complications because it wants the black box warning to acknowledge serious risks for “some women.” Oh, let’s not forget the “patient decision checklist,” meant to help doctors and patients decide if Essure is the best option.

One would love to get one’s hands on that checklist when it’s ready. One cannot help but wonder if it will include such pertinent information as the fact that Bayer provides doctors who purchase a minimum quantity of Essure kits per month expensive hysteroscopic equipment at no charge. The equipment, typically priced at nearly $20K, surely isn’t motivation for doctors to recommend Essure.

Will the checklist mention that Bayer lied about Essure’s efficacy? While the company insists Essure is almost 100% effective at preventing pregnancy, independent data shows that traditional tubal ligation sterilization is much more effective, as Essure’s failure rate is pushing 10%.

Bayer bought Essure from Conceptus in 2013. The FDA’s Monday announcement will require Bayer to start a new study meant to “provide important information about the risks of the device in a real-world environment.” The study must follow implanted patients, monitoring them for problems such as pelvic pain, unwanted pregnancy and other issues, as well as assessing how Essure complications affect the participants’ quality of life. The study must follow at least 2,000 women for at least three years.

The FDA wants to see a study protocol from Bayer within 30 days and Bayer is legally required to start the study within 15 months, according to Dr. Maisel. Should Bayer fail to comply, the FDA can declare Essure misbranded which would remove it from the market. Additionally, Bayer must submit interim reports from the study that include data and analysis. The first such report is expected to be available to the FDA within a few months of the study’s beginning.

The new recommendations are open for public comment for 60 days beginning March 1. I strongly urge readers concerned about women’s health issues to leave comments via the instructions here.

In my opinion, the FDA, the Food and Drug Administration, may as well be renamed the Fools and Dolts Alliance. This organization, whose mission statement reads, in part…:

“FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices…”

…has utterly and completely failed to perform its most basic responsibilities toward a huge population of those it was created to protect, namely women. In today’s FDA, the paradigm is “Profits over Patients,” the same as it is for Big Pharma. The collusion between the pharmaceutical industry and the FDA is destructive to women’s health.

And, with the confirmation of Dr. Robert Califf as the new head of the FDA, that collusion and destructiveness is only going to worsen. The new head honcho at the agency has more ties to Big Pharma than the largest shareholders of the largest pharmaceutical firms. He has spent years suckling at the teat of the industry he is now sworn to regulate. And, in the blink of an eye and the change of a title, we the people are to believe that all of those past ties will magically disappear and the Fools and Dolts Alliance will kick Big Pharma out of its heart-shaped bed and become, once again the Food and Drug Administration that will stand for the safety of the public.

As a science fiction fan, one is capable of great feats of suspension of disbelief. However, one simply does not have the ability to make such a great leap of faith.

Short of the passage of the E-Free Act, a ruling in favor of the plaintiffs in a federal case revolving around whether Bayer violated the terms of the impenetrable PMA thus losing its protection, or some as yet-to-be discovered miracle, Essure isn’t going away soon and that means tens of thousands more women are going to suffer.

Frankly, if this doesn’t piss you off, you are not paying attention.


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FDA mandates new warnings, new data for Essure contraceptive device


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