There are many benefits to permanent birth control and when the time was right, you talked to your doctor about your options. Together, you and your doctor decided that Essure was the right birth control method for you.
Your doctor explained that Essure is a sterilization device that could be implanted in you during a non-surgical procedure. The device consists of a pair of metal coils that were implanted in your fallopian tubes. Once implanted, the coils would cause inflammation and then scarring to seal off the tubes and prevent all future pregnancies. You may have been told that Essure was safer than having your tubes tied and that within three months you would no longer be able to get pregnant.
But You May Not Have Been Told Everything: The Serious Risks and Side Effects of Essure Devices
Since Essure gained FDA approval in November 2002, numerous side effects have been reported. Those side effects include:
Women who have an Essure device and become pregnant, and their babies, may be at risk of:
- Ectopic pregnancy
- Premature birth due to membranes ruptured by loose Essure coils
- Birth defects caused by nickel poisoning
Thousands of women have suffered injuries and several deaths have been reported.
Essure’s FDA History
The FDA granted Essure a conditional pre-market approval in November 2002. A pre-market approval gives the medical device manufacturer lifetime immunity from lawsuits related to the device, provided that the medical device manufacturer complies with the terms of the FDA approval. This practice is known as “preemption.”
Women and Their Loved Ones Take Action: Petition to Remove Essure From the U.S. Market
Recently, more than 2,100 women signed a petition urging the FDA to remove Essure from the U.S. market. If the FDA were to revoke Essure’s pre-market approval, then those who have been seriously hurt could sue Bayer—the pharmaceutical company which currently makes Essure.
The petition claims that Essure’s pre-market approval was unusually rushed and that it is invalid because of the lies and cover-ups the manufacturer used to convince the FDA that Essure was safe. The petitioners claim that Conceptus, Inc. falsified data during clinical trials to hide adverse reactions and injuries caused by Essure devices. Conceptus, Inc. is the pharmaceutical company that made Essure until Conceptus was sold to Bayer in 2013. Specifically, it is alleged that:
- Multiple cases of uterine perforation were caused by Essure coils drifting out of place and that these injuries were hidden from the FDA.
- Medical records were altered for some women who reported severe pain. Instead of reporting the pain, the records were allegedly changed to say that the women were happy and had no problems.
The petitioners also allege that, once the pre-market approval was granted…
- Conceptus convinced the FDA to remove a safety notice warning about women with nickel allergies. Previously, women with nickel allergies were told not to use this device, which is made of nickel-titanium alloy.
- Conceptus violated the terms of the pre-market approval and federal law by using unapproved materials to make Essure devices at unlicensed facilities.
- Conceptus violated the terms of the pre-market approval and federal law by failing to notify the FDA of more than 16,000 complaints of injury and several deaths.
- Bayer knowingly misled customers by promoting Essure as safe and “worry-free.”
- Bayer concealed life-threatening injuries suffered during Conceptus’s clinical trials.
- Bayer exaggerated Essure’s effectiveness by claiming that “no pregnancy can occur” when records show that between 1997 and 2005, 64 women become pregnant after having an Essure device implanted. By 2015, the number of women with Essure device implants who had become pregnant was more than 700. Essure pregnancies are dangerous for women and babies, leaving women with the difficult decision of facing an unsafe pregnancy or an abortion.
And other action is also being taken.
FDA Action and Federal Lawsuits
Below are some specific FDA and federal lawsuit actions regarding Essure:
- March 2015: The FDA announced that it would launch an Essure investigation.
- September 2015: The FDA convenes a public meeting of the Obstetrics and Gynecology Devices panel to discuss scientific data regarding Essure’s safety and effectiveness. It is expected that the findings from this FDA meeting will be made public in early 2016.
- January 2016: A federal judge in Pennsylvania dismissed some, but not all, of the counts against Bayer brought by women who had been hurt by Essure. The claims that were dismissed included claims for negligent design and strict liability. The judge found that the doctrine of preemption precluded the plaintiffs from pursuing these state law claims. However, the judge did not rule at that time whether other state law claims, such as breach of warranty, were preempted by federal law.
- February 2016: A federal judge in California dismissed state law claims against Bayer by a plaintiff who was allegedly hurt by Essure. Specifically, the court found that design defect claims, failure to warn claims, breach of warranty claims, and other claims were preempted by federal law. However, the judge left the door open for further legal action by saying that the plaintiff could amend the lawsuit to address problems in the complaint.
We will continue to monitor the FDA’s actions and federal lawsuits regarding Essure devices. In the meantime, we encourage anyone who has been hurt or anyone whose wife or partner has died from Essure complications or other form of dangerous birth control to contact us directly at 888-450-4456 to schedule a free consultation.