Essure Lawsuit Alleges Women Were Harmed with No Warning of Risks
Another woman has filed an Essure lawsuit against Bayer, alleging the permanent sterilization device caused her to suffer severe injuries that she was not warned about and which forced her to undergo numerous surgical procedures to correct.
Plaintiff M. Luster is seeking over $75,000 in compensation for the “significant sums of money” she has spent – and will spend – to treat her Essure problems, as well as for punitive damages, pain and suffering, and more.
The Essure lawsuit joins more than 3,700 cases filed against the Bayer Group in the U.S., alleging Essure caused significant harm.
Essure Lawsuit Details Serious Injuries that Required Surgery to Correct
Essure is marketed as a non-surgical procedure for sterilization that is simpler than traditional sterilization methods such as tubal ligation or hysterectomy.
According to the Essure lawsuit, Luster received an Essure in each of her fallopian tubes in July 2010, and was told that it was a “good device and a good way to avoid surgery.”
The purpose of the Essure device is to cause bilateral occlusion (blockage) of the fallopian tubes using micro inserts that anchor into the tissue and cause tissue growth, theoretically causing the blockage. However, the device is alleged to be dangerous and defective because it migrates from the tubes, breaks into pieces, corrodes and perforates organs, “wreaking havoc on the female body,” the Essure lawsuit states.
This can cause significant ramifications and pain for any patient who is coping with Essure problems.
Luster suffered Essure side effects such as dizziness, excessive menses, vaginal bleeding, vaginal pain, light-headedness, and more, the Essure lawsuit says. As a result, she was forced to undergo a hysterectomy in 2017 even though she had attempted to use Essure as a way to avoid surgery.
As with any implant, a patient and the doctor carrying out the treatment should be aware of all the risks before they make the decision to use it. When patients are not told of the potential problems and only find out post-implantation, serious injuries can occur. Patients should know they might have grounds to file a legal claim against the manufacturers of defective medical devices.
Essure Problems Hid from FDA
The Essure lawsuit alleges that Bayer misbranded the device because they failed to report known hazards to the FDA and did not meet regular reporting requirements.
In 2013 the FDA discovered an internal spreadsheet with more than 16,000 Essure complaints that were never reported to the FDA.
The Essure lawsuit details numerous instances in which Bayer was cited by the FDA and the Department of Health for failing to comply with federal regulations and the Conditional Premarket Approval Essure received by the FDA, including:
- Failing to report complaints that Essure migrated.
- Failing to report incidents of Essure bowel perforation, Essure coils breaking into pieces and migrating out of the fallopian tubes.
- Only disclosing 22 Essure perforations while having knowledge of 144 perforations.
“Had Defendants disclosed such information as was required by CPMA and Federal law to Plaintiff or [her] Implanting Physician, Plaintiff would never had Essure implanted in her and would have avoided her injuries,” the Essure lawsuit states.
“As a result of Defendants’ negligence, individually, jointly, and severally, Plaintiff had to undergo numerous surgical procedures, diagnostic procedures, and may have to undergo surgeries, diagnostic testing, treatment and rehabilitation into the indefinite future,” the Essure lawsuit continues, adding that Luster has “sustained significant pain and suffering, both physical and mental, and will continue to do so into the indefinite future.”
She has also been forced to expend “significant sums of money for treatment of the multitude of surgeries, testing, medicine, therapies along with related expenses, all to her significant financial detriment and loss, and she may have to endure significant financial expenditures into the foreseeable future,” according to the Essure lawsuit.
The case is Luster v. Bayer Corp., et al., Case No. 17-cv-02351, U.S. District Court, Southern District of Texas, Houston Division.
Get Legal Help
If you or someone you know has been significantly injured or sustained damages as a result of Essure problems or another defective medical device, you may be entitled to recover compensation.
When medical devices are not made safely or marketed properly, there are laws and regulations that protect people who have suffered injuries from a defectively designed, manufactured and marketed product.
Contact the attorneys at Bradley/Grombacher LLP to discuss your legal options. If you have a potential case, your defective drug lawyer will work tirelessly on your behalf to put together a compelling case and help you get the compensation you deserve.