Across the country, women have been filing lawsuits against Bayer, the manufacturer of the Essure permanent birth control implant, for multiple complications including unintended pregnancies. The device was introduced in 2002 and was implanted in over 750,000 people until sales were halted in 2018.
Bayer stated that they stopped selling Essure due to a 70% decrease in sales, but this decrease followed a requirement from the US Food and Drug Administration (FDA) to include a black box warning on the packaging. This type of label indicates that a product may cause serious or possibly life-threatening effects.
What is the Essure Implant?
Essure is a medical device introduced as the first-ever permanent birth control option that doesn’t need surgery, in contrast to hysterectomy and tubal ligation. The product is made of metal coils and plastic and is implanted into the fallopian tubes to create scar tissue intended to block sperm from getting to eggs.
Unintended Pregnancy Lawsuits due to Essure implants
A Georgia woman filed a lawsuit against Bayer after experiencing several severe complications due to her Essure implant, including an unexpected pregnancy. She received the device in December 2014 and reported that she experienced weight fluctuations, heavy bleeding, and pain during intercourse shortly after implantation. In addition, she got pregnant and had a child born with hearing loss in February 2016.
She is one of many Essure patients suing Bayer for a wide variety of issues. Lawsuits state that many of these issues stemmed from the lack of pre-market safety research conducted on the device, as well as the intentional neglect to report injuries and complications in the studies that were conducted.
One case reports that Bayer’s website stated Essure was the “only FDA-approved female sterilization procedure to have zero pregnancies in the clinical trials”. Evidence shows that there were in fact four pregnancies during clinical trials and five pregnancies over the first year Essure was on the market. Lawsuits also state that another reason the device was not properly tested was the accelerated FDA review process Essure received.
How We Can Help
Essure patients who experienced unintended pregnancies after receiving their implant deserve justice and compensation, and are encouraged to join a lawsuit.
Other conditions that may be eligible for a lawsuit include:
- Ectopic pregnancies
Breakage of inserts
Migration of inserts
Severe menstrual pain
Severe abdominal or pelvic pain
Heavy menstrual bleeding
Perforation of the uterus, fallopian tubes, and/or other organs
Our experienced legal team at Kwartler Manus, LLC. is dedicated to helping those who have suffered due to the neglect and mistakes of these device manufacturers. If you or someone you love received an Essure implant and suffered from any of the above complications, contact us online or by phone at (267) 214-8608 for a free consultation.