Essure Taken Off the Market 12/31/18
Dangerous Side Effects
Approved by the FDA in 2002, the Essure metallic and fiber coils are inserted through the vagina deep into the Fallopian tubes. After implantation, the metal coils cover with scar tissue which block the Fallopian tubes and prevent sperm from reaching the egg. Essure has been removed from the market in other countries, but will still be implanted in U.S. women until 2018.
Essure has been linked to multiple dangerous side effects including:
- Migration of the device
- Malposition of the device
- Fracture or breakage of the device
- Incompatibility from nickel allergies
- Ectopic pregnancy
- Birth defects caused by nickel poisoning
- Premature birth due to membranes ruptured by loose coils
The Essure market removal follows thousands of lawsuits and the FDA warning restrictions beginning in 2016 up to April 2018. The FDA issued checklist warnings that must be acknowledged by every women considering Essure. The warning included reported adverse events of 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.
The plaintiffs allege that the Bayer Corporation has secretly known of Essure’s long history of adverse events, manipulated their reports and presented false and misleading information. Therefore, the plaintiffs were not fully informed of the risks of Essure and demand justice for past and future general, economic and special damages, medical expenses, punitive and exemplary damages, and other relief.
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.
How Does Essure Prevent Pregnancy?
During the OB-Gyn’s office procedure, Essure metal coils are inserted through the vagina into the uterus and lodged in each fallopian tube. Over many months, scar tissue forms around the implants and prevents any sperm from reaching the eggs. If the egg is not fertilized by the sperm, no pregnancy occurs.Three months later, an Essure Confirmation Test will verify whether or not the procedure was successful. One test is the TVU – transvaginal ultrasound – to examine whether scar tissue has blocked the Fallopian tubes. Another test is a modified HCG, which involves the instillation of contrast dye into the uterus and tubes to verify that the Fallopian tubes were successfully blocked.
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.
2018: Bayer halts sales of Essure in 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.
Free Medical Legal Consultation
If you or a loved one has or have had Essure birth control implanted and experienced serious life-threatening complications, Contact Us before your time runs out to file a claim. We look forward to helping you in your potential claim for compensation.