Holly Kelly Ennis
Essure: The End is Here, But We're Not Going Anywhere!
After a long and hard fought battle, thousands of women are getting ready to celebrate the end of Essure. As the new year rings in, Essure will be forever gone. On December 31, 2018, Bayer stopped selling and distributing the Essure device in the United States. However, shockingly health care providers were allowed to implant Essure up to one year from the date the device was purchased, but no later than December 31, 2019. Health care providers and facilities which have purchased Essure units from Bayer in the past should have already been contacted by the manufacturer about how to return Essure units and in just 11 short days, Essure will no longer be permitted to be implanted.
The FDA claims it will continue to monitor the performance of Essure in women through a revised FDA-approved postmarket ("522") study protocol that extends Bayer's mandatory follow up of women through five years. However as of 9/1/19 there were only 67 clinical trials sites enrolled. The study criteria originally required 2800 participants: 1400 women to be implanted with Essure and the other 1400 women to undergo laparoscopic tubal ligation. As of 9/1/19, only 1002 patients had been enrolled in the clinical trial: 673 women seeking tubal ligation and only 329 implanted with Essure. It will be difficult, if not impossible, now that Essure can no longer be implanted, how the study will progress and what modifications the FDA intends to allow Bayer to make.
Despite the positive news that Essure will no longer be implanted for the next generation of women seeking sterilization, the daily realities of thousands of women who suffer from Essure's devastating injuries, remain unchanged. As such, the Essure Problems ladies are committed to continuing their fight against Bayer until justice is served. Angie Firmalino, founder of the Essure Problems Facebook Page and President of ASHES described the feelings of thousands of women harmed by Essure: "December 31, 2019 is a day that I, and thousands of E-sisters, have been fighting for since 2011. It is the last day that any woman in the world can be implanted with Essure. Even when we brought to the attention of Bayer and the FDA, the devastating harm women were suffering, they still continued to sell and implant this device into unsuspecting women. Although this means that our fight to get it off the market is over, it does not mean that our fight for justice is finished. Tens of thousands of women worldwide were harmed by this device and we won't stop until justice is served."
Ladies across the country have echoed similar sentiments. Angela Desa from California also felt relief the product was off the market, but notes the fight is not over. "I am ecstatic that Essure can no longer be implanted outside of the trials. But the damage it has done is unacceptible. It has changed our health, broken families and claimed lives. This might be the end of this phase but marks the begining of the next....justice for all who were damaged and prevention from this ever taking place again." As an important victory celebration, many of the E-sisters planned to rally outside Bayer's Headquaters in Whippany, New Jersey. This celebration was to occur at the exact site where the infamous E-sister protest was held on July 17, 2018 showing the Netflix documentary, The Bleeding Edge. (3 days later, Bayer announced it would no longer sell the Essure device after 12/31/18.) When the E-sisters contacted the Hanover Township Police Department to obtain the necessary permitting, they were informed that the rally would not be allowed as Bayer had recently purchased the exact property from Hanover Township for the whopping sum of $10.00. (Such lengths Bayer went through to prevent being embarrassed again by the Essure Problems Group.)
Bayer continues to vigorously defend the thousands of cases pending against it in various courts across the country. The first Essure case is set for trial on February 18, 2020 in Alameda County with two more Essure cases set for trial at the conclusion of the first case. Other trial dates are being set in the various litigations across the country. The collective eyes of thousands of Essure advocates around the country will be watching closely. If history is an indicator, these ladies won't stop until justice is truly served.