Bayer announced it will stop marketing Essure in the U.S. as of December 31, 2018 due to decline in sales. View the ABC News Video Update: ABC News Essure Report.
This stunning announcement follows thousands of lawsuits and the FDA restrictions placed on the controversial metal contraceptive in April 2018. The FDA issued warnings that must be acknowledged by every women considering the metal coils before implantation in the Fallopian tubes. The warning included reported adverse events, including, perforation of the uterus and/or fallopian tubes, migration into the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. Read the FDA warnings here: Essure Permanent Birth Control > FDA Activities: Essure. Watch the CBS News Report here: Essure pain side effects
Lawsuits allege that the Essure birth control devices implanted in the fallopian tubes can migrate from the tubes, perforate organs, fracture into pieces or corrode causing pain, suffering and serious injuries. The plaintiffs allege that the Bayer Corporation has known of Essure’s long history of adverse events, manipulated their reports and presented false and misleading information. Therefore, the plaintiffs believe they were not fully informed of the risks of Essure and pray for past and future general, economic and special damages, medical expenses, punitive and exemplary damages, and other relief.
In April 2018, the Food and Drug Administration placed new restrictions on Essure, a permanent metal birth control implant that has been subject to reports of painful complications from thousands of women as noted in the official site: Essure Permanent Birth Control > FDA Activities: Essure . The implant has not been recalled, but women will need to sign and read a brochure about the risks of the device. The checklist of risks must also be signed by the woman’s doctor. The warning now includes:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required.
CNN covered the story of the death of a baby after Essure was implanted in the mother to prevent conception. See the CNN video: FDA mandates new warnings, new data for Essure contraceptive device. Over 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of severe pain and bleeding, perforation, unintended pregnancies, miscarriages, stillbirths after an Essure coil was implanted in the Fallopian tubes.
FDA Black Box Warning Added
An earlier black box warning label for Essure to call attention to serious or life-threatening risks was added in 2016. Approved by the FDA in 2002, Essure, manufactured by Bayer and composed of metallic coils and polyester fibers, is a permanent form of birth control in which a coil is non-surgically placed into a woman’s fallopian tubes. When implanted, the fibers and coils provoke inflammation and scar tissue which block entrance to the sperm reaching the egg. Essure has been removed from the market in other countries, but is still being implanted in U.S. women.
Essure has been linked to other multiple dangerous side effects including:
- Birth defects caused by nickel poisoning
- Ectopic pregnancy
- Premature birth due to membranes ruptured by loose coils
- Unintended pregnancy
- Migration of the device
- Malposition of the device
- Fracture or breakage of the device
- Incompatibility from nickel allergies
Timeline of Serious Adverse Events
2002 to 2015: FDA receives close to 10,000 complaints from doctors and women alleging serious side effects of Essure, including 11 deaths, five for fetal deaths after Essure was implanted.
June 2015: FDA noted the number of adverse event reports, along with short- and long-term risks, as part of its review of potential Essure problems.
September 2015: FDA’s OB-Gyn Devices Panel holds a public meeting to discuss risks and benefits of Essure. These included potential side effects and injuries from Essure such as ongoing pain, organ perforation, allergic reactions and device migration.
February 2016: FDA requires Bayer to conduct a clinical study on the safety and efficacy of Essure.
October 2016: FDA requires Bayer to add a serious black box warning to Essure labelling.
October 2016: Judge Winifred Y. Smith of Alameda County Superior Court in California orders that all California Essure cases coordinated for pretrial purposes before her in Alameda County, California.
1998 to 2001: Conceptus, Inc., now a subsidiary of Bayer, conducted Essure testing from
2002: Essure approved to be placed on the medical device market.
2013: Bayer AG buys Conceptus, Inc. as a subsidiary of its Germany-based chemical and pharmaceutical company.
2017: Bayer halts sales of Essure outside of the U.S.
Over 3700 women have filed claims and lawsuits are consolidated in Pennsylvania before Judge John R. Padova and in California before Judge Winifred Y. Smith. To date, there has been no mass settlement of Essure cases.
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If you or a loved one has or have had Essure permanent birth control implanted and experienced serious life-threatening complications, Contact Us before your time runs out. We look forward to helping you.