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Last update: October 8th, 2018.
In July 2018, Essure manufacturer Bayer announced it was going to completely discontinue its Essure device in the US before the year ends. In a press release, Bayer blamed poor sales and a decrease in usage of the device.
Interestingly enough, the announcement came a week before the airing of the Netflix documentary ‘The Bleeding Edge’. The movie discusses problems caused by medical devices. The makers of The Bleeding Edge already responded to the announcement: “This is exactly why we do this work: This film has already changed policies and changed history.”
The idea of permanent birth control appeals to many women, because it presents them with a solution of avoiding pregnancy without needing to constantly take birth control pills.
And Essure claims to offer a permanent birth control solution that is 99 percent effective at preventing pregnancy. Essure is reportedly non-hormonal too.
Unfortunately, the safety claims do not seem to match up with the experiences of women who went through the procedure of having the device inserted into their bodies.
Essure is a device that provides a permanent birth control solution for women who no longer wish to have children. The procedure to implant the device involves placing a soft and flexible insert into each of the fallopian tubes.
What results is a barrier around the inserts in the fallopian tubes, which ensures that sperm cannot reach the eggs – and that means pregnancy is no longer a possibility.
It does take three months for the procedure to work, which means women must continue to use birth control during those months. When the three months are up, they can stop taking their usual method of birth control because the procedure will have fully closed their fallopian tubes.
Since the FDA approved Essure in 2002, it is estimated that more than 750,000 women have gone through the procedure around the world.
The Essure procedure is extremely straightforward, despite the scary sounding impact it can have on a woman’s body. There is no cutting, which means scar tissue is not an issue.
Women can remain conscious during the procedure, because a local anesthesia is the only pain relief they will need while the doctor is working.
Most procedures are performed at doctors’ offices, and around 75 percent of patients could resume their regular activity within one or two days.
It reportedly takes 45 minutes for the procedure to reach completion, with around 96 percent of patients having the inserts placed into their fallopian tubes at the first time.
For many women, it appears the positive aspects of Essure disappear the moment they leave the doctor’s office. For all the advantages of the procedure, and how easy it is to perform, tens of thousands of women have paid a big price for going through with Essure.
Some of the more common side effects from the procedure include:
– chronic pelvic pain
– abdominal bleeding
– migraine-style headaches
– debilitating fatigue
Several studies were performed to assess the long-term impact of Essure, and the results were not promising. One study concluded that after five years, roughly one in eight women stated their menstruation was abnormally painful compared to how it would feel before the procedure.
Around three percent of women had an issue where the implant perforated the fallopian tube, and in some cases the surgeons were not even able to remove the device from the abdominal cavity.
Other women reported issues related to abdominal pain, back pain and pain during sexual intercourse. An alarming percentage of women also experience abnormally heavy menstrual periods.
When comparing Essure to sterilization, Essure caused women complications a lot more often. Studies show that women who underwent the Essure procedure were ten times more likely to require another operation to resolve issues from the first procedure, as compared to women who went through with sterilization surgery.
Finally, Essure is linked to four deaths, fifteen fetal deaths, and more than 600 pregnancies. So, not only is the procedure painful and problematic for women, but in rare cases it can have fatal consequences.
The major blowback against Essure began around 2009, even though its maker, Bayer HealthCare, was still touting its excellent success rate.
Patients were beginning to come forward and reveal their issues, such as fallopian tube perforation, persistent pain and bleeding, unwanted pregnancies and other complications.
Concerns began to grow because it appeared Essure was not thoroughly tested with regards to its long-term consequences. The case against the manufacturer is predicated on the fact that patients were not properly informed about the side effects.
Lawsuits against Essure are currently underway in California and several other states. The FDA held a full hearing on the matter in 2015 and is conducting investigations, and Bayer is now fielding complaints about the procedure through toll-free numbers.
If you went through the Essure procedure over the past few years, and you have been experiencing some or all the side effects mentioned in this article, you may have a case.
The best thing you can do is speak with an attorney, who can guide you with regards to your legal options for compensation.
While the FDA has not made a full recall of Essure, some changes are being made. They have instructed all sellers to include a black box information warning regarding the side effects of the procedure.They were also looking to hear more clinical and scientific opinions before they come to a final decision on the matter.
In July 2018, after more than three years of controversies, Bayer finally announced that it would stop selling the dangerous birth control device Essure after December 31, 2018. The decision comes after the U.S. Food and Drug Administration (FDA) threatened the corporation with criminal and civil penalties if it didn’t warn the patients about the dangers associated with the use of the device. Bayer keeps standing behind’s the contraceptive’s efficacy and safety, and claims it is simply pulling it from the market because the sales declined too much after all the negative advertisement. FDA’s latest threats helped to push the pharmaceutical company’s back to the wall, giving a chance to the countless women who have been harmed to seek the compensation they deserve.