Essure birth control is a medical device implanted for permanent sterilization. On the market since 2002, Essure is manufactured by Bayer and composed of metallic coils and polyester fibers. When implanted into a woman’s fallopian tubes, 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 multiple dangerous side effects including:
- Birth defects caused by nickel poisoning
- Ectopic pregnancy
- Premature birth due to membranes ruptured by loose coils
- Unintended pregnancy
- Fatigue, Pain, Headache
- Menstrual irregularities and weight fluctuations
Device problems include:
- Migration of the device
- Malposition of the device
- Fracture or breakage of the device
- Incompatibility from nickel allergies
FDA Black Box Warning Added
In February 2016, the FDA ordered Bayer to add a “black box warning” to its Essure labels and include a patient information checklist highlighting the potential adverse events that could occur following implantation of the device, including persistent pain, perforation of the fallopian tubes or uterus, hypersensitivity reaction and device migration.
According to a FDA study, complaints about adverse events stemming from the use of Essure have quadrupled since late 2013. From 2002 until October 2013, the agency received 943 incident reports. Between October 2013 and May 2015, the FDA received 4,150 incident reports, however, the device is still on the market being inserted in women.
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 permanent birth control implanted and experienced complications, contact us for a free medical legal consultation at 1-800-814-4540 or email@example.com or fill out the form in the right side bar.