“Many health professionals have either joined our page or reached out to us, asking about our removal experiences, and what seems to have worked. In fact, one gynecologist who reached out was part of the development team that brought Essure to market! He has completely switched his practice around and is now an infertility expert.
After their third child, Amanda and her husband decided their family was complete so Amanda discussed with her gynecologist permanent birth control options. “I was considering the traditional tubal ligation, but she suggested the Essure device, telling me there were no side effects, no down time, it was easy. It sounded amazing and I trusted her, she delivered my son,” says Amanda. “Needless to say, she is no longer my doctor.”
”One gynecologist who reached out was part of the development team that brought Essure to market!”
That was several years ago. At the follow-up exam three months after having Essure implanted, Amanda discovered that she had gained 25 lbs, and she wasn’t feeling her usual self. “I had migraines and dizziness and constant exhaustion, which were totally new to me,” she says. “I was an active, busy mom with hardly any time to eat! I played softball all my life, I was fit and healthy.”
At first, Amanda attributed the weight gain to just getting older. But she was only in her mid-30s. As well, her periods were becoming irregular and full of clots and painful to the point of emergency room painful. “I questioned whether I could be pregnant, and I had taken several home pregnancy tests, but my doctor assured me that was not possible,” Amanda says.
But Amanda wasn’t convinced. She did some research and found online a support group of women who had become pregnant after Essure had been implanted. They compared experiences and four women had also suffered similar side effects such as migraines, bloating, fatigue and joint pain. Amanda knew she had to get this defective device removed, but at that time it was uncommon, there was no “removal protocol”.
“Due to lack of knowledge and experience, a total hysterectomy was the only solution,” Amanda explains. “I also had to know everything about this device to figure out why we were experiencing these Essure side effects, so I went on a research escapade.” She discovered that Essure is a Class III (the highest-risk medical devices, subject to the highest level of regulatory control) medical device approved by the FDA through the pre-market approval process; that many Essure lawsuits had been dismissed or narrowed on pre-emption grounds; and that women had little recourse. Amanda talked to women who didn’t have insurance and couldn’t afford to have the device removed.
Because Amanda no longer trusted her gynecologist, she shopped around for someone who would remove the Essure device. “They told me that Essure couldn’t possibly be causing these problems,” says Amanda. “One doctor wanted to implant the Mirena IUD along with Essure to regulate my hormones! Another suggested a hysterectomy because that was the only procedure my insurance would cover, given the pain and bleeding Essure was causing.”
Amanda went ahead with the hysterectomy and right away most of her symptoms were gone. But to this day she is still dealing with lingering side effects such as severe bloating, scar tissue and other abdominal issues.
READ MORE ESSURE SIDE EFFECTS LEGAL NEWS
So, what does this support group hope to achieve? Obviously, the FDA must have it withdrawn. Amanda believes that the only thing keeping Essure on the US market is profitability because the government has a contract with the manufacturer. It has been withdrawn from every other market in the world.
She has also filed a lawsuit against Bayer. “It is in the discovery phase right now and it has been slow-moving because Bayer has been so difficult with proceedings,” Amanda explains. “Bayer wants to reject everything we request and they don’t want to give away any information, maybe thinking that we will go away. But that won’t happen, I am never giving up. I am determined to see this device withdrawn from the market.”