How Women Got Essure Off the Market

//How Women Got Essure Off the Market

How Women Got Essure Off the Market

Essure women on Capital Hill

Mesh Medical Device News Desk, July 30, 2018 ~ Essure Problems was the Facebook group that became the driving force behind the removal of the Essure birth control device from the market, first overseas, then in the U.S.

The announcement was made last week by manufacturer Bayer that the company would phase out Essure use in the States by the end of the year.

Angie Firmalino of Essure Problems talked to Mesh News Desk about the Essure campaign, its success and the similarities and differences with another problematic medical device, surgical mesh.

Bayer says the removal from the market of its controversial birth control device, Essure is for business reasons.  Last September, Bayer began removing Essure from the market outside of the U.S. but this country was the last holdout.

Angie Firmalino, Essure Problems

Essure Problems, became a problem for Bayer.

Over the last seven years, a Facebook group, Essure Problems has gained momentum as thousands of women gathered online to complain of serious health problems associated with their Essure implant, including pain, and perforations of the uterus and fallopian tubes.

Angie Firmalino, 46, of Tannersville, N.Y. had the device inserted in 2009, a couple of years later she developed pain and bleeding. The coils had traveled to her uterus. She had to have a hysterectomy.

 

MOMENTUM OF ESSURE PROBLEMS 

Firmalino tells MND the Facebook support group, Essure Problems, blossomed, especially as women found out they were not alone. There is no way to know how many women have been implanted but Bayer says its sold 750,000 Essure kits.

We thought we were alone, and we found each other, how to talk to your doctors, the removal process and how to educate physicians on how to remove properly.”

Then a member came across the 2002 transcript of the FDA meeting where they approved this device.

“We started reading it and we were just blown away at this approval process. There were such a small number of women in the clinical trials, they were followed for a short period of time.  All of the FDA panel members had significant questions that Bayer couldn’t answer because they had no long-term data, yet they approved this device.”

At the end of that panel meeting transcript, there was a number for the company that videotaped the expert panel meeting.  They raised the money and bought those DVD.

They were mind blowing. I sat there for 4 hours and I couldn’t believe what I was watching.”

Taking excerpts of the panel meeting, the group then put the videos on YouTube after they bought the rights to the video. There are now four YouTube videos on the approval meeting.

Everybody got angry, and the more we dug and the more we found, the angrier we got.”

The group dug further – into the materials and methods of implantation, doctors and the FDA approval process. Essure was approved under the FDA’s PMA, premarket approval process, with supporting documentation in the form of clinical trials submitted to the FDA to assure safety.  A class III device, its manufacturer enjoys federal preemption. A U.S. Supreme Court case established that manufacturers could not be sued if their device was approved by the FDA.

Surgical mesh was class II, meaning there were no clinical trials, just an FDA requirement to name a “predicate device” already marketed which is similar.

Erin Brockovich on The Doctors 2014

Before activist, Erin Brockovich got involved, Firmalino says media interest was “very minimal” but then Brockovich set up a web page where women could submit their stories.

Mainstream media took notice.

 

THE FDA

They are in bed with the manufacturers, they’re putting profits before patients. The documentary, newly released on Netflix, The Bleeding Edge explores the relationships where a previous FDA commissioner will then gain a job with the very industries he regulated. Then later, that person revolves back into a job within the FDA.

 

 

THEIR OWN DOCTORS RESISTANT TO PATIENT COMPLAINTS 

Scene from The Bleeding Edge

Did you find doctors were resistant to your message, MND asked Firmalino?

“100 percent of the time.  100 percent of the time!  Not to mention they are getting paid ten times more to do Essure than a tubal ligation.  They’re doing 1500 in ten minute versus 3 hour tubal ligation. “You be the judge what do you think they want to do?”

Then there is the woman bias. “God forbid it was a penis, it doesn’t work that way for women.   Go on an antidepressant, they are told. I can’t believe some of the things women are told comes out of their doctors’ mouths.”

Firmalino describes one encounter she experienced.

“You look fine to me” said her doctor.  “I can look at someone and in 30 seconds tell if they are sick, you look fine to me.”  I was like goodbye, said Firmalino, I haven’t even told you my story.

 

Slater and Lucente, from Netherlands doc.

CONFLICTS OF INTEREST

Like mesh, Essure was heralded by gynecologists, some of whom had conflicting financial arrangements with device maker, Bayer.

CNN reports Bayer paid $2.5 million to 11,850 doctors, some earning more than $100,000. These payments are legal and often lead to more device sales and implants than other doctors. In the case profiled in CNN, Dr. Cindy Basinski was paid $168,000 during a four year period. She implanted the woman profiled in the story (here).

Major mesh makers, Ethicon, C.R. Bard, Boston Scientific and American Medical Systems also relied on the reward system for doctors, who in many cases became the highest implanters.  Doctors such as Vince Lucente, also head the AUGS (American Urogynecology Society) medical society, which issues policy to 1,900 member urogynecologists.

 

ORGANIZING FOR CHANGE NOW 

Bleeding Edge premier at Tribeca, including Tammy Jackson and family

With the launch of The Bleeding Edge, Firmalino and others believe now is the time to tackle surgical mesh, still used every day to treat incontinence and for hernia repair.

Firmalino believes Congress needs to get involved.

“We have some faulty approval processes in place. We are starting with the Medical Device Safety Act, which is a small change to the Food Drug and Cosmetic Act which would remove the preemption that class three medical devices have. But if you look at the 510(k), that is a nightmare too.  Things are approved based on a predicate that has been found to be defective. ”

“This is a technologically advanced world now and we are relying on things from the 1970’s and 80’s and we need to bring things up to date, and we need to stop this conflict between industry and the FDA. There needs to be a third party doing clinical trials and not just industry bringing their biased information to the FDA. They are going to tell them what they want the results to be.”~ Angie Firmalino

Essure Problems is working with a nonprofit Peace Is Loud and last Friday launched the website, MedicalDeviceProblems.com (also dot org and dot net).  The goal is one think tank where people harmed by medical devices can talk to each other and work collectively to enact change.

“It seems as though the mesh world is very divided, that’s what we are trying to figure it out. There are many groups and a lot of animosity between them. It’s hard to know who to work with; we are trying to navigate that right now. Who is willing to put their drama aside and get things done?  We need help to bring those groups together. If you want to be heard you have to unify and stop fighting amongst yourself.”

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Post Script- Firmalino was under the assumption that all mesh was off the market! Your MND editor informed her that POP mesh is largely off the market, but incontinence mesh is still on the market and is called the Gold Standard by one medical society, AUGS. It continues to be used every day. See Mesh News Desk on meshes still on the market here!

LEARN MORE:

J&J Brigade, April 24, 2014 Video( here) 

MND, Transvaginal Mesh and $800,000 Conflicts of Interest, March 14, 2014 (here)

MedicalDeviceProblems.com

Medical Device Safety Act (here)

Mesh News Desk website (here) 

Mesh News Desk, Facebook Group (here

Mesh News Desk, Facebook Page (here)

Mesh Awareness Movement Facebook Group (here)

FDA News Archive, on Mesh News Desk (here)

MND, Doctor Sunshine – What You May Want to Know About Your Doctors’ Conflicts of Interest,  July 2016 (here

By | 2018-08-06T15:46:45+00:00 July 30th, 2018|News|9 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

9 Comments

  1. Still Standing July 31, 2018 at 9:42 pm - Reply

    I congratulate the Essure women who persevered to get their product off the market. It was a remarkable accomplishment. However, as I read the comments made about the animosity among the mesh community, I was deeply troubled by the comments about “putting the drama aside” and that the Essure group trying to figure out which mesh group to work with. In one fell swoop, mesh women were globally minimalized by a group who has not lived the injuries we experience. Let me tell you why I believe that.

    First, there are similarities experienced by Essure women and tranvaginal mesh women include some of the following, a faulty FDA clearance process, pain, device migration, uterine organ perforation, painful intercourse and Im sure there are others I cant speak to because I have not experienced the complications of Essure.

    Here is a summary of what I feel are great differences in our injuries.

    1. Transvaginal mesh required a surgical placement. Essure did not. With the incisions and the placement of the arms mesh women were placed at a higher risk of surgical infection and the development of adhesions, which are a painful outcome of surgery. Abdominal adhesions grow to and fuse together major organs, seriously impacting just the ability to move without pain. Bowel movements are even painful.

    2. Most mesh women were older. Essure women were young. Older women bring a host of problems brought on by the aging process. Tissues are less elastic. Women who had mesh had already gone through pain and discomfort and humiliation from pelvic organ prolapse or urinary incontinence and more than likely brought pelvic floor dysfunction to the mix. Many had already undergone abdominal hysterectomy or even another kind of repair. This raised the severity of potential complications. Older women also have higher damage from of other disease processes such a high blood pressure, high cholesterol, cancer, smoking, etc. some had worked many years in blue collar work and were unable to continue that work and too old to try to retrain and seek a different career, leaving them forced to survive on social secutity or social security disability. This limits their access to good medical care, including non traditional medicine such as yoga, massage. If you arent aware of this, many many primary care and specialists are not seeing new Medicare patients, another seemingly overwhelmig roadblock.

    3. Doctors have some idea where to search for the essure device and fragments left behind.can be viewed on xray. Mesh does not have an imaging imprint except in 3D ultrasound,which is not available at all hospitals. Because of the blind placement of the mesh arms, mesh can show up in unbelievable places. Mine were initially cut ( all eight of them) because they were placed to tight and then shrunk, making ;me feel that I was being pulled apart by chains. One arm ended up migrating to my thigh, where it had to be filleted out liike filleting a fish. Now, one arm is rolled up in a ball and pushing into my rectum, threatening to rupture it. recently, another suprise piece of mesh ( yes, I had multiple mesh removals) has punched through my vagina ( not the first one ) and I feel that there are little people in my vagina cutting me with little razors day and night. I had mine mesh placed 10 years ago. Because o the insidious development of scar tissue, my doctor now has to use the smallest pediatric speculum for an exam. i am 67. Doc finally said the s-word today (surgery) but that will have to wait until my three week trip to Mayo in a couple. Of weeks taking care of all of the bowel problems caused by mesh inflammation and adhesions. Losing my colon is a high possibility. I describe these injuries not because I want sympathy, but to try to bring about an understanding of how far a reach mesh makes into our lives. It s totally unpredictible where and what will happen next. I thought I was in a good place, had made the necessary mental and physical adjustments that allowed me to move forward with purpose,then more mesh showed up without warning. This is the twisted story of mesh complications. They cant be put into categories. That is why the mesh awareness movement has a has a hard time getting a cohesive story out because there are so many unique stories.

    • Jane Akre July 31, 2018 at 10:22 pm - Reply

      This comments seems to accurately sum up the differences between the injuries, but your first sentence is the most important. The FDA, and its least burdensome” approval process for manufacturers of medical devices, NOT least burdensome on the patient, must change. The public doesn’t know until it happens to them and the burden apparently falls on the injured to make sure it doesn’t happen to anyone else. The FDA clearance process is an excellent start and whether you’ve been implanted with faulty hips, Essure or plastic mesh, the collective voice needs to be heard. Thank You!

  2. Cathy August 1, 2018 at 10:43 am - Reply

    Thank you Still Standing and Jane for all your wisdom and knowledge! My husband and I watched The Bleeding Edge and immediately afterwards, he asked why the mesh women weren’t as organized as the Essure women. I explained to him that the Essure women were younger and mesh women were older. Also, the Essure women are “in better standing” with society whereas the mesh women being older are ignored by society/medical community and every complaint is chalked up to “the aging process”. I believe the mesh women have suffered at the hands of discrimination. Yes, there has been “drama” and “conflict” among the mesh women, but I believe when it comes to protecting the younger women coming up behind us, we are UNITED in stopping future harm.

    • Jane Akre August 1, 2018 at 11:10 am - Reply

      I think you are right. Older women seem to be dispensable and age discrimination against men and women is very apparent. United- Absolutely!!!!!

  3. Hopeful August 1, 2018 at 12:20 pm - Reply

    I agree with all the comments and would like to add that Essure has a core and common target, FDA, Bayer and Essure. All the women could get behind the message that this one product is horrible and defective and destructive with commonalities in symptoms!

    Pelvic mesh is such a broad landscape, there are multiple companies, many different lines of mesh products and it’s difficult finding a message everyone can get behind. Even with the large pelvic organ prolapse mesh, just consider the Prolift by Johnson & Johnson, there is an anterior, a posterior and a total vaginal vault kit each with different symptoms and their own set of complications but it has been found defective in numerous trials There is a wealth of information available to have it recalled.

    However (this is really important) the petition to the FDA was to recall ALL mesh for Pelvic Organ Prolapse, this was denied, they won’t issues a broad POP ban…BUT, the FDA left it open in their denial letter that they would consider a recall on SPECIFIC DEVICES!

    This is an area we could all support, petitioning the FDA one device at a time! We do need to get organized because even though the Prolift is no longer sold, complications can occur 10 years later, every woman implanted with a Prolift deserves to be notified of what symptoms to be aware of, what complications can occur and what her treatment options are! There has to be a common commitment we can all get behind and pushing for FDA recall of each device from each manufacturer starting with the oldest would be a great activity we could all support because it wouldn’t leave anyone out!

    We also would benefit from identifying a specific message everyone can relate to! The transvaginal insertion of mesh, the ease with which it was marketed, the simplicity of the procedure, minimally invasive, we all fell for the hook they set! That does not apply to more invasive procedures to include open abdominal surgeries! So we need to limit the scope of the successful campaign to TVM mesh, then once we are successful in that campaign then we move to supporting hernia mesh victims or rectopexy mesh victims. i think that’s why the Essure movement was so successful they were able to keep it simple, let’s utilize their strategies for our success starting with TVM procedures for POP, one device at a time!

    Save a life, recall every TVM device! This specific procedure needs to stop!

    • Jane Akre August 1, 2018 at 4:53 pm - Reply

      Would you include the denial letter here? Thank you. One simple message- anything permanently implanted should be Class III, high risk. What would be required are clinical trials and higher bar to prove safety. Remember Essure is Class III but obviously that didn’t work and then you have the problem with federal preemption….. so I’m interested in hearing more from you….. thank you.

    • Still Standing August 2, 2018 at 11:26 pm - Reply

      I have a couple of questions. What POP transvaginal mesh products are still on the market? I am not aware that there are any being marketed for transvaginal POP repair. There is also not a central mesh registry so a mandated recall would be difficult. Many women, especially those who have not had complications, have no idea what company made their device. Im just wondering how a campaign to recall mesh products that are off the market already wouod look. Would it get traction?

      Jane’s suggestion about reclassification of permanent implantable devices to Class III is a good one. Are transvaginal bladder slings the logical next step? If so, which one, which company, where do you start? And, if those are off the market, what do women with SUI do? What SUI mesh has the highest complication rates? There are women who are not good candidates for harvesting grafts from their own tissue. Age can impact the success of this type because tissue becomes less elastic. What options are in place for that these women? Abdominal placement of mesh has its own risks. Im just thinking through the process and trying to visualize it.

      • Jane Akre August 2, 2018 at 11:35 pm - Reply

        I just did this story to answer that question.
        https://www.meshmedicaldevicenewsdesk.com/mesh-101-basics/
        Gynemesh for POP sold in sheets and Gynecare Prosima Pelvic Fl Repair, also Artisyn for sacrocolpopexy. also Uphold Lite and Upsylon Y mesh by Boston Sci. They are supposed to now be reclassified so how are they still sold by the company as they are on the brochures?
        I was told by the FDA that some of the post-approval monitoring done for the 522 studies might suffice, but that means you, the public, substituted for a clinical trial….
        Implantable medical devices should be high risk, obviously and the 510(k needs to be revamped, but the Institute of Medicine suggested that in 2011. With lobbyists having the ear of Congress and congress funding the FDA, you can see it is a circular mess…With no mesh return to fascia slings, or reserve mesh as a last resort. It will not come off the market because so many do well with it, at least in the short run…… but one thing is obvious,,, the FDA is broken and needs to be fixed! To rely on the integrity of medical device makers is a very bad joke. Just my opinion here..

  4. Dawn August 2, 2018 at 2:52 am - Reply

    I would totally go and contact the senators as they did.. I want a strong group of women that know their shit !! Lol.? I will be the cheerleader 🙏🏻😘 this might be the opening we are looking for …
    How do we get these meetings???
    To go into a surgery because you pee a lil.. and a few years later you are wheelchaired for life😢😢😢😡 that’s not a risk anybody should have to take

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