The contraceptive implant device, Essure, quickly lost sales in the US and was pulled off the market when it was shown to have serious health risks and a variety of complications affecting many thousands of women. Manufactured by Bayer, AG, one of the world’s largest pharmaceutical companies, the contraceptive device won FDA approval in 2002 as a non-surgical permanent implant designed to prevent pregnancies. In November 2016, the German drug maker was ordered by the FDA to add a black box warning on its packaging about the potential complications of the implant. Two years later, Bayer halted the sale and distribution of the product in the US.
What is Essure?
Essure is a birth control procedure in which two nickel-titanium flexible coils are inserted through the vagina and cervix into a woman’s fallopian tubes. Over time, scar tissue forms around the implant and blocks the fertilization of eggs. The procedure is an alternative to surgical sterilization. It was reported that 8% of the population with the implant were not able to rely on the device for birth control. Other studies show that a successful Essure implant can reduce the risk of pregnancy to less than 1%.
Health side effects from Essure sterilization
Complaints from Essure side effects include:
- perforation of the uterus and/or fallopian tubes
- device migration
- persistent pain from migrated implants
- dislodged or dislocated device
- device breakage/material fragmentation/fracture
- organ perforation (uterus, fallopian tubes or other organs)
- heavy or abnormal periods
- pain during intercourse
- unintended pregnancy
- allergic reaction to nickel confirmed by a physician
- severe pelvic or lower back pain
- removal of the Essure device
Other users of the Essure coils have reported neonatal or pregnancy complications. There have also been reports of maternal and infant deaths after live birth.
A July 2018 Netflix documentary, titled The Bleeding Edge, zeroed in on the medical device industry, featuring Essure as one of the four devices explored.
FDA mandate form: Patient Checklist
Following up on the mounting complaints from woman with negative reactions to the Essure coils, the FDA required the drug maker in 2016 to conduct post-market safety studies of the implants and to place a black box warning on its packaging to call attention to the risks of the device (i.e., bleeding, organ damage, infections, pain, device migration). Additionally, the FDA mandated that a doctor go through a decision checklist with the patient covering the device’s many potential risks and that both the patient and the doctor must sign an acceptance of risk form (titled, “Patient-Doctor Discussion Checklist—Acceptance of Risk and Informed Decision Acknowledgement”) prior to placement of the device.
In 2018, the FDA placed restrictions on US sales of Essure; at the end of that calendar year, Bayer ceased selling the product in the US.
According to Bayer’s 2018 annual report, as of January 28, 2019, approximately 29,400 users of Essure have filed lawsuits against Bayer in the US. As of the date of this article, there are no published settlements or verdicts.
If you have had any of the complications associated with Essure coils, contact Advocate Law Group right away to protect your rights. The attorneys at Advocate Law Group have decades of experience handling product liability and personal injury claims. We know what evidence to look for and present, are experienced in evaluating your claim, and what legal issues are applicable to your case. We work with leading product liability firms nationwide to help our clients obtain results. Contact us for a free case evaluation.