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Published on December 12, 2016
Essure, Bayer’s permanent birth control device, was recently ordered to carry a black box warning by the Food & Drug Administration (FDA). A black box warning is the FDA’s highest level of regulation, meaning that the product may cause death or serious injury. In addition, all patients must now complete a Patient Decision Checklist before having the device implanted. This action by the FDA follows years of complaints by women who received the Essure implant and suffered a number of serious injuries which they attribute to the device.
What is Essure?
Essure is a permanent birth control method. It is a type of tubal sterilization that does not require a surgical incision or anesthesia. The Essure device consists of two spring-like metal (nickel and tungsten) coils that have plastic (polypropylene) fibers wound through them. The coils are implanted in a woman’s fallopian tubes, where the plastic irritates the tissue so that it forms scar tissue. The scar tissue prevents the woman from becoming pregnant.
Essure’s Manufacturing History
Essure was first introduced to the market by Conceptus, Inc., in 2002 after three years of clinical trials. Conceptus was purchased by Bayer AG on June 5, 2013 and is now a wholly-owned subsidiary of the German pharmaceutical company.
Problems with Essure implant
Early on women who were implanted with the device complained about having severe side effects after receiving Essure. Some of the injuries associated with the Essure implant include:
- Allergic or hypersensitivity reactions to the device
- Autoimmune response, including fatigue, hair loss, rashes, swelling, itching, and weight gain
- Chronic, severe pelvic pain
- Expulsion of the device
- Fetal death
- Life-threatening ectopic pregnancy
- Migration of the device or a device component in the abdominal or pelvic cavity
- Perforation or tearing of pelvic organs, including fallopian tubes or uterus
- Surgeries to remove the device and to repair internal organs
Pressure on FDA to Remove Essure from Market
The Essure Problems Facebook group was started in 2011 by a woman named Angie Firmalino, who wanted to be able to discuss her Essure implant injuries privately. That group now has more than 31,000 members. She is now the President of a non-profit, ASHES—Advocating Safety in Healthcare E-Sisters part of whose mission is advocating for Essure victims. Between Essure’s introduction in 2002 and December 31, 2015, 9,900 women and doctors have filed complaints about Essure with the FDA. In addition, women who were part of the original Conceptus clinical trials have come forward to say that their data was misreported or changed by Conceptus.
On Sept. 24, 2015, a public meeting of the FDA’s Obstetrics and Gynecology Devices Panel was held“to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.” Both medical professional and women who had received the Essure implant testified. In February 2016 the FDA ordered Bayer “to conduct a postmarket surveillance study to obtain more data about Essure’s benefits and risks”. Finally on November 5, 2016 the FDA ordered the black box warning added to the product packaging, warning of the risks of the Essure device.
What Can You Do?
If you or a loved one has suffered injuries you believe are related to the Essure birth control device, call Marilyn McGoldrick at Thornton Law Firm for a free, confidential consultation. You can call us at 1-888-341-1405 or tell us your story online for a no-obligation evaluation of your legal rights. As with all legal claims, Essure lawsuits have short time limits. Seek legal advice as soon as possible as legal time limits are strictly enforced.