Lawsuits for Essure Problems
November 3, 2015 Last Updated on September 10, 2019
Important Information
Attorneys working with ClassAction.org are no longer investigating this matter. The information here is for reference only. A list of open investigations and lawsuits can be viewed here.
At A Glance
- This Alert Affects:
- Anyone who experienced side effects after being implanted with Essure.
- What's Going On?
- Attorneys looking to push the litigation involving Essure forward are now talking to women 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's the Catch?
- These lawsuits face significant legal hurdles, but attorneys suspect that, with the right strategy, Essure patients may have an opportunity to sue Bayer and seek compensation for their injuries. It doesn't cost anything to contact us or to talk to an attorney.
Attorneys working with ClassAction.org are no longer handling claims involving Essure. The information below is for reference only. If you have questions about your rights regarding Essure, please reach out to an attorney in your area.
Attorneys looking to push the litigation involving Essure forward need to speak with any woman who was implanted with the permanent birth control device and suffered serious complications.
They have reason to believe they can craft a lawsuit that gets around the loophole that has been barring women from seeking compensation for their injuries – but, before they can take action, they need to speak with women who believe they were injured by the device. Although these lawsuits face significant legal hurdles, the attorneys believe that if they can find the right plaintiff for their first lawsuit that they may be able to create momentum for the rest of the women who were implanted with the device.
Is There a Lawsuit Against Essure?
To date, there have only been a handful of lawsuits filed against Bayer over its permanent birth control device – and the cases face serious legal challenges. Specifically, the way the device was approved for sale protects Bayer against liability for any injuries the device causes. (You can read more about these challenges here.) Attorneys are now strategizing for the ideal way of getting around this issue – which is known as “federal preemption” – to help ensure other women have a chance at seeking compensation for their injuries.
What Do the Lawsuits Say Bayer Did Wrong?
One lawsuit accuses Bayer 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.”
Bayer Violated the Conditional Premarket Approval Order
In the suit, plaintiff Heather Walsh alleges 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, the lawsuit claims 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
- Manufacturing Essure for three years with a license to do so
Bayer Concealed Complications, Problems
The lawsuit claims that in mid-2013 the FDA found an internal document with more than 16,000 entries of complaints, which included device migration, that were never properly reported to the FDA. According to the suit, 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, the suit claims that Bayer even went as 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
The lawsuit also claims 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
Over-promoted Essure
The suit claims that Bayer required doctors to buy two Essure kits per month regardless of whether they actually used them. The suit calls this promotion “unreasonably dangerous” and that Bayer’s distribution plan “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
- Death
- Stillborn children
- 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. It is our belief that if this litigation moves forward, it will be on an individual basis and not as a class action. You can learn more about why lawsuits involving medical devices typically aren’t suited for class actions here.
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