Thousands of women who have used Essure birth control implant have filed lawsuits against the device’s manufacturer, Bayer. More than 27,000 serious adverse events have been reported to the FDA and though Bayer has denied responsibility, the company has announced that they will discontinue sales of Essure at the end of 2018.
Essure IUD Birth Control Lawsuit
Essure, an implantable birth control device, has been linked to tens of thousands of injuries such as perforated uterus or fallopian tubes. Thousands of the women who have been injured by the device have filed lawsuits against its manufacturer, Bayer.
Bayer tried to avoid responsibility for the lawsuits by claiming immunity because it was not the original developer. Essure was introduced by a company known as Conceptus and was approved in 2002. Conceptus and its device, Essure was acquired by Bayer in 2013. A California judge ruled that the lawsuits could proceed despite Bayer’s claims of immunity. Since that time, many more women have filed Essure lawsuits and more may be expected.
Essure sales were discontinued outside of the U.S. in 2017 and Essure problems including lackluster sales have already cost the company an estimated $400 million in revenue. Bayer has said that they will stop selling the device in U.S. markets in December of 2018. The company blames the decision on falling sales and has said it is not related to safety issues, though the FDA had placed stringent requirements on patient education for the device’s use.
Bayer may currently be facing as many as 16,000 lawsuits in California, Missouri, North Carolina and Pennsylvania. Federal lawsuits may ultimately be consolidated into multidistrict litigation but no announcement has been made.
Essure was designed by Conceptus to be a “non-surgical permanent birth control” implant. It is constructed of a nickel alloy and nylon-type fiber which forms two coils to be inserted through the vagina and placed in the fallopian tubes. Over a 3 month period, the device will cause an inflammatory response which causes scar tissue to close the fallopian tubes so that fertilization of the ova cannot occur. Essure was intended to be left in place, permanently but complications with the device may require surgical removal.
Between Essure’s approval in 2002 and its acquisition by Bayer in 2013, safety of the device had already come into question. The device had been approved under a fast-track process which required that 5 year safety data be provided after the device was already in use. Conceptus failed to meet each of the reporting periods and by the time the device was purchased by Bayer, its safety was under fire.
In 2015, consumer groups and Congress began calling for Essure’s removal from the market and in 2016, the FDA issued safety warnings. The agency required that information include a “black box” warning about risks and that a patient information checklist be implemented.
In April 2018, after reports continued to pile up, and some investigation concluded that not all patients may be fully informed, the FDA issued more stringent guidelines. Bayer was instructed to limit sales to doctors’ offices and medical clinics which could prove they would be able to adhere to consent guidelines. Just three months later, in July 2018, Bayer announced they would discontinue Essure sales at the end of the year.
Bayer has stated the decision was made for commercial reasons, citing poor sales and a reported desire of women to use shorter term birth control. The company has said that they stand behind the safety of the device and will continue to conduct postmarket studies as required by the FDA.
Bayer and previous manufacturer Conceptus likely knew of Essure risks
Investigations have now revealed that Conceptus and Bayer likely knew of the issues with Essure, but failed to warn doctors and users of the device. As complaints about Essure continued to roll in, the FDA discovered clinical trials performed by Conceptus had shown issues with pain and device migration. Some additional issues with the device, such as weight gain and depression, uterine perforation, migraines, and ectopic pregnancy were not revealed during clinical trials, but have since arisen for users. Bayer has been accused of concealing the risks of the device.
Adverse events reported to the FDA have included:
- fatigue or dizziness
- nausea and vomiting
- hair loss
- migraine headaches
- abdominal or pelvic pain which may be severes
- abnormal bleeding
- unexpected pregnancy
- device migration or expulsion
- uterine or fallopian tube perforation
Device migration, organ perforation or other severe side effects will require surgery to remove the device.
Filing an Essure lawsuit
About 17,000 Essure lawsuits have already been filed but many more may be expected. These lawsuits allege that the manufacture failed to warn the public and medical community about the risks of Essure. Women or loved ones of those who have been injured by Essure may be eligible for compensation for medical costs, lost wages, pain and suffering and in some cases, wrongful death or punitive damages.
Each case is different and must be evaluated separately but if you or a loved one experienced complications related to Essure birth control implant, you should seek legal advice.
- FDA Activities: Essure, U.S. Food and Drug Administration (7/20/2018)
- Essure Regulatory History, U.S. Food and Drug Administration (7/20/2018)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed, U.S. FDA (7/20/2018)