Lawsuits for Essure Problems
November 3, 2015 Last Updated on May 18, 2022
At A Glance
- This Alert Affects:
- Anyone who experienced side effects after being implanted with Essure.
- What's Going On?
- Attorneys working with ClassAction.org are talking to Essure patients about their legal options and what recourse is available. They want to speak with any woman who was implanted with the device and experienced serious side effects, including perforations and ectopic pregnancies.
- What You Can Do
- If you’ve experienced side effects from Essure, it may not be too late to take action. Fill out the form on this page to learn more. After you get in touch, one of the attorneys we work with may reach out to you directly.
- What's the Catch?
- There is none. It doesn't cost anything to contact us or to talk to an attorney. Plus, you’re not obligated to take legal action if you later decide you don’t want to.
Attorneys working with ClassAction.org are offering to speak with any woman who was implanted with the permanent birth control device Essure and suffered serious complications.
While a large percentage of cases have already been settled, it may not be too late for those who haven’t taken action yet.
If you’ve been injured by Essure, fill out the form on this page to learn more about your rights. After you get in touch, one of the attorneys we work with may reach out to you directly.
What Do the Lawsuits Say Bayer Did Wrong?
One of the first lawsuits filed against Bayer accused the company of selling and marketing a device that “migrates from the [fallopian] tubes, perforates organs, breaks into pieces, and/or corrodes, wreaking havoc on the female body.” The sections below detail additional allegations made against Bayer.
Bayer Violated the Conditional Premarket Approval Order
It has further been alleged that the conditional premarket approval (CPMA) received from the FDA is invalid because Bayer failed to follow the agency’s requirements for such an approval.
Specifically, lawsuits claim that Bayer was cited by the FDA and the Department of Health for:
- Actively concealing and failing to report a number of perforations in Essure patients
- Using a non-conforming material in the device
- Failing to use sterile cages
- Manufacturing Essure at an unlicensed facility
Bayer Concealed Complications, Problems
Allegedly, the FDA found an internal document in mid-2013 with more than 16,000 entries of complaints, which included device migration, that were never properly reported to the FDA.
According to filed lawsuits, Bayer claimed that the side effects were never reported because the patients were not “at last contact” experiencing pain and that the complications were “mere trivial damage” that did not “rise to the level of a serious injury.” Furthermore, it has been alleged that Bayer even went so far as to manipulate the medical records of its trial participants to reflect favorable data – specifically that patients were in less pain than they actually were.
Bayer Was Negligent in Marketing the Product
Lawsuits also claim that Bayer was negligent because it:
Failed to follow FDA guidelines when training doctors on how to implant the device
Entrusted doctors to use equipment that they were not qualified to use
Overpromoted Essure
The suits claim that Bayer required doctors to buy two Essure kits per month regardless of whether they actually used them. The suits call this promotion “unreasonably dangerous” and allege that Bayer’s distribution plan was “aimed solely at capturing the market with reckless disregard for the safety of the public.”
What Side Effects Have Been Linked to the Birth Control?
Thousands of women have come forward and reported problems including:
- Adhesions
- Scarring
- Chronic pelvic pain
- Serious infection requiring hospitalization
- Intestinal perforations and obstruction
- Uterine punctures and tears
- Ectopic pregnancy
- Excessive and abnormal bleeding
- Migration or “disappearance” of the device
- Pain during sex
- Migraines
- Hair loss
- Coil eruption
- Abscesses
- The need for a hysterectomy
Is This a Class Action?
No. Attorneys investigating lawsuits against Bayer are looking to file cases on an individual basis. This means that each woman who wishes to sue Bayer for her injuries must file her own lawsuit and hire her own attorney. You can learn more about why lawsuits involving medical devices typically aren’t suited for class actions here.
What Happened with the Settlement?
In August 2020, Bayer announced that it would pay $1.6 billion to end nearly all lawsuits filed over its Essure birth control device. According to the company, the settlement resolves 90% of the nearly 39,000 claims filed by women who alleged the device caused serious health issues, including miscarriages and organ perforation.
If you were implanted with Essure and have not yet taken action, it may not be too late.
Learn more about your legal rights by filling out the form on this page. An attorney may then reach out to you directly to learn more about the harm you suffered and answer any questions or concerns you may have about filing a lawsuit.
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