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.
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.
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.
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.
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.
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.
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.
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.
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!
J&J Brigade, April 24, 2014 Video( here)
MND, Transvaginal Mesh and $800,000 Conflicts of Interest, March 14, 2014 (here)
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)