Complications With Essure Procedures Continue To Mount After Recall, Settlements

Nearly two years after Bayer removed the Essure birth control implant from the market in the U.S., and one year after the company announced a $1.6 billion settlement to resolve thousands of Essure lawsuits, the manufacturer continues to report a growing number of complications suffered by women after undergoing the procedure.

On May 17, the FDA released the latest Essure variance quarterly analysis report, which outlines adverse event data collected by Bayer.

According to the manufacturer’s data, it has received at least 33,097 reportable events involving complications with Essure procedures, including 19 deaths. Although federal regulators warn that some of these incidents may be duplicates, the data provides concerning signals about the long-term risks associated with the sterilization implant.

Essure procedures were marketed by Bayer for years as a safe and effective form of permanent birth control, involving flexible coils inserted into the Fallopian tubes during an outpatient procedure which caused scar tissue to develop blocking the tubes and prevents insemination. However, the device was removed from the market amid thousands of reports involving painful and debilitating Essure injuries.

According to the FDA, the most commonly reported problems identified in the data submitted by Bayer were pain, perforation of organs, parts of the Essure breaking off and being left behind in the body, pregnancies (including ectopic pregnancies which put the mother’s life at risk), and heavier periods.

The agency cautions that the reports do not necessarily involve unique cases, as Bayer gathers events identified in multiple locations, including comment threads from social media posts, which may include recurring reports by the same individual.

Previous reports have linked Essure complications to nine patient deaths, but in the latest report, that number jumps to 19 deaths. In addition, Bayer indicates it has received a total of 32,667 reports of serious injuries and 411 malfunctions. However, these numbers should not be seen as authoritative, as many could be duplicates reported repeatedly on social media or may be duplicate reports submitted to the FDA’s medical device reporting database by multiple sources.

Tracking of Essure Injuries Following Recall

Although Essure was recalled from the market in most countries in 2017, Bayer continued to sell the device in the United States until the end of 2018. In the face of mounting pressure and publicity about the injuries women were experiencing from Essure, the company announced in July 2018 that it was removing Essure from the US. market on December 31, 2018.

Following the decision, the FDA confirmed Bayer would be required to extend a post-market surveillance study and take other measures to ensure long-term Essure oversight well after production and sales have ceased. The new data released by Bayer is part of those requirements.

In August, Bayer officials announced they would pay $1.6 billion to settle about 90% of all Essure lawsuits filed by women who claimed they were left with devastating injuries. However, the settlement does not address future claims brought by women who are likely to continue to experience problems from the birth control implant.

The deal was reached as the company faced a number of approaching trial dates in the litigation, and as a series of reports were released that highlighted the problems with Essure, including interim results from a post-marketing study the FDA released in September, which found that more than 20% of women implanted with the device faced hypersensitivity reactions, chronic abdominal pain, and abnormal bleeding, and many had much higher rates of additional gynecological procedures.

Approximately 750,000 women worldwide implanted with the device, and about 70% of those procedures occurring in the United States. As Essure injury lawyers continue to review and file claims in the coming months and years, it is expected that Bayer will have to fund additional settlements or face future rounds of jury trials.

Image Credit: Image via Lukassek / Shutterstock.com

10 Comments

  • Rebecca HJune 28, 2022 at 7:17 pm

    I need to speak to an attorney as soon as possible on 2008 I had these Essure put in me but for many years I’ve been having lots of pelvic pain and my ovaries are always swollen and constant headache always feeling tired do the fact that there is lotta side affects on these Essure. Please help.

  • JeanneDecember 21, 2021 at 11:25 pm

    I had Essure since02/28/2018 implanted and suffered many side effects since then. Then 01/25/2021 had him choice and had laparoscopic hysterectomy. I would like to be a part of the class action law suit.

  • SandyDecember 21, 2021 at 10:11 pm

    These were actually put in me against my will!!! In 2005 I went for a tubal ligation (at a teaching hospital), the doctor offered me 3 options, cut, tie and cauterize, a silicone clip described like a "bread clip" or these brand new coils. I did my homework and decided on the cut & tie method. The doctor argued with me the day I went in, he wanted me to choose the coils. I refused and he agre[Show More]These were actually put in me against my will!!! In 2005 I went for a tubal ligation (at a teaching hospital), the doctor offered me 3 options, cut, tie and cauterize, a silicone clip described like a "bread clip" or these brand new coils. I did my homework and decided on the cut & tie method. The doctor argued with me the day I went in, he wanted me to choose the coils. I refused and he agreed to do the procedure as I asked. About 3 months later I began to have strange symptoms, but every doctor blew me off. About a 1-2 years later, I had hip X-rays done by a chiropractor, and I was aghast when I saw symmetrical foreign objects exactly where my Fallopian tubes were! I immediately knew exactly what had happened. By then I was already disabled. Every time I tried to get help, I was referred to psychiatric care. No one believed me. The hospital that did the procedure claimed that Hurricane Katrina destroyed all the records, and much of my own records have been lost - I cannot even recall the name of the monster, I mean doctor that did this to me. My entire life was destroyed. I suffer from auto immune disorder(s), chronic pain, a litany of health issues, the loss of social connections, career and family. I have been gaslighted by the doctors I go to for help. I FINALLY found a doctor that believes me, December2021, and we are trying to find a way for Medicare to cover the costs of removing these things safely. The cost of out of pocket removal is out of my reach, as this has destroyed me to the point of utter poverty. At every level, the arrogance of these manufacturers and doctors is criminal, this was an actual crime, but I have/had no way to fight back, few women do, which is why things like this happens so often, and they do happen often. I have no evidence except the coils in my body and the lack of any medical records that the procedure ever happened. I doubt I can even be helped at this point, legally. I feel so much compassion for all those that have been harmed by reckless medical manufacturers and providers.

  • LaurenNovember 29, 2021 at 8:05 am

    I had the essure placed in 2012, since then I have done nothing but suffered and it gets worst as years go by. I’ve developed an autoimmune disease, have extreme back pain, stomach cramps( I can push down on my belly and my uterus feels tender), weight gain that I can’t lose, random rashes in weird places at spontaneous times, random migraines, etc. I tell my doc these issues and he says I need to[Show More]I had the essure placed in 2012, since then I have done nothing but suffered and it gets worst as years go by. I’ve developed an autoimmune disease, have extreme back pain, stomach cramps( I can push down on my belly and my uterus feels tender), weight gain that I can’t lose, random rashes in weird places at spontaneous times, random migraines, etc. I tell my doc these issues and he says I need to have it removed, my gynecologist and I are working on scheduling a surgery date for removal. I really need to be apart of this class action because I have been suffering for 9yrs.

  • StephanieNovember 16, 2021 at 1:27 pm

    My body have been the same after receiving Essure. I hurt all the time and the device was removed in 2014

  • IvanaSeptember 21, 2021 at 12:56 am

    I got essure implanted in August 2016 and I had many complications since then. I experienced pain and heavy breeding. Headaches. Same as Kimble, I had fatigue , loss of energy and cant get lose weight. Gynecologists seems they dont care. I want to join the lawsuit.

  • PriscillaSeptember 16, 2021 at 4:38 pm

    Hi, I was implanted with the Essure contraceptive back in 2015 and have had many complications since then not knowing it was the Essure causing it. Years later, I underwent surgery to have them removed, which was recently. Now that I had them removed, I feel the difference and realize that those devices were the cause of all my suffering. I want to participate in the lawsuit against the Essure dev[Show More]Hi, I was implanted with the Essure contraceptive back in 2015 and have had many complications since then not knowing it was the Essure causing it. Years later, I underwent surgery to have them removed, which was recently. Now that I had them removed, I feel the difference and realize that those devices were the cause of all my suffering. I want to participate in the lawsuit against the Essure devices.

  • VenusSeptember 6, 2021 at 3:52 pm

    I received the implants in March of 2006 and suffered for 12 years with excruciating pain and heavy bleeding and my abdomen has distended. I also would have random cases of angioedema! I went to several doctors complaining about my condition and no one believed me until September of 2018! I finally received a hysterectomy and it was found that the implants were touching my uterus causing mild endo[Show More]I received the implants in March of 2006 and suffered for 12 years with excruciating pain and heavy bleeding and my abdomen has distended. I also would have random cases of angioedema! I went to several doctors complaining about my condition and no one believed me until September of 2018! I finally received a hysterectomy and it was found that the implants were touching my uterus causing mild endometriosis!

  • KimbleSeptember 5, 2021 at 11:25 pm

    I have also suffered greatly from the Essure implant. Since having them implanted I have since developed psoriatic arthritis, osteoarthritis, severe back pain, degenerative disc disease, spondylitis, and many other diagnosis. I am fatigued always and can not seem to lose weight my hair falls out by the handful. I am just tired of it all and want them out. But I can not find a doctor that will list[Show More]I have also suffered greatly from the Essure implant. Since having them implanted I have since developed psoriatic arthritis, osteoarthritis, severe back pain, degenerative disc disease, spondylitis, and many other diagnosis. I am fatigued always and can not seem to lose weight my hair falls out by the handful. I am just tired of it all and want them out. But I can not find a doctor that will listen. I have gone to 3 different gynocologist and they have all dismissed me and my pain. I need help.

  • VickiMay 31, 2021 at 9:54 pm

    In 2008 I received the Essure device. By 2010 I had to have a partial hysterectomy. My health health has never been the same.

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