Essure Lawsuit Guide
Essure Lawsuit Accuses Bayer of negligence in failing to warn women of the potential long-term health risks including organ perforation and extreme pelvic pain. Bayer, however, is shielded from all litigations filed against Essure since it was approved via the FDA’s premarket approval process.
This does not stop attorneys from trying to remove that protection and asking the U.S. District Court, Eastern District of Pennsylvania to invalidate the rules that ensured Essure’s approval. On March 2016, the court ruled that two among five of these cases can continue as they have been deemed reasonable (12).
Device Type: Birth Control
Injury: Organ Perfiration.
Total Cases: +1,000
Settlement Amounts: None Currently
Bellwether Trial Start Date: Unknown
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What Is Essure Used For?
The primary benefit associated with this device was to provide permanent birth control (female sterilization) without the need for invasive surgery or general anesthesia, thus avoiding all the risks related to these procedures. It does not require a surgical incision to be implanted. The device is inserted through the vagina into the fallopian tubes and consists of two metal flexible coils. Scar tissue slowly forms around the two coils over a period of three months, blocking the tubes and preventing sperm cells from reaching the eggs.
Contraception of this kind is permanent and eliminates the need to use other forms of birth control, as well as avoiding any effect on the menstrual cycle (1).However hundreds of women using this device experienced severe side effects and complications over time, including extreme pelvic and back pain or cramps that prevented them from performing daily activities, constant fatigue, heavy bleeding, headaches and weight gain. Other serious or even life-threatening complications and personal injuries included device migration and breakage that could lead to organ perforation, depression and suicidal thoughts, allergic reactions to nickel and the necessity for reoperation (3, 4).
The Unsettling results of Essure clinical trials
In the Essure’s pivotal clinical trial, among the 464 women who received the implant, 16 of them could not rely on it “due to expulsion, perforation, other unsatisfactory micro-insert location, or loss-to-follow-up”. At least 8 women had to undergo additional surgery to be sterilized again or to remove a fragmented or misplaced coil. In an FDA five years follow-up report, five women required had to be later hysterectomized, and that at least one patient still became pregnant.
FDA issues the “black box” warning
Pressed by the alarming number of women reporting all kind of adverse reaction and injuries, in 2015, the FDA published a full review of all patient reports, including web-based testimonials. According to their investigation, FDA received 5093 medical device reports related to Essure since 2002, although over the 80% of them were filed after 2013. Reports also included six death cases caused by the device, and five fetal deaths occurred in women who became pregnant following placement of the device (5). Patients like Heather Walsh and Tanya de la Paz brought their cases to a federal court after they had to undergo additional surgeries after the coils broke and migrated, causing life-threatening organ perforations (3, 6).
At the end of February, the FDA finally classified this contraceptive device as a potentially dangerous one, and requested the pharmaceutical company to add a “black box” warning to its label. The “black box” is used to alert patients about the potentially life-threatening adverse reactions of a device or drug, and it’s designed to call attention to the most serious risks. The regulator also determined that Bayer must conduct a new three-years study on over 2,000 women to properly assess Essure’s safety and effectiveness by comparing it with other similar contraception devices. Both patients and doctors must now sign a decision checklist before the device could be implanted, and a new test must be performed after three months to ensure its proper placement and functioning (12).
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