Legal action against pharmaceutical giant, Bayer AG, has highlighted the dangers of Essure, a permanent contraception device linked to a number of side effects. The Essure lawsuit, filed by a woman named Christina Barreiros, states that Bayer hid safety information about the dangers of the device instead of acting in the patient's best interest.
Essure’s Side Effects
Essure is a permanent birth control device made from nickel and titanium metals. Approved by the Food and Drug Administration (FDA) in 2002, Essure's metallic coils are inserted in the fallopian tubes to prevent pregnancy.
Barreiros had two Essure coils implanted in 2013. She began to experience extreme pain, bleeding, and cramping, in addition to other side effects.
Though her symptoms were caused by the Essure device, Barreiros’ doctors misdiagnosed the problem as a hormone imbalance. Barreiros was forced to have a total hysterectomy, a full removal of her uterus.
Barreiros is one of many plaintiffs who filed an Essure lawsuit against Bayer, with a number of charges including:
- Breach of warranty
- Fraudulent concealment
- Negligent misrepresentation
- Product liability
- Failure to warn
Failure To Act
Post-market reports show that Bayer received 16,000 complaints about adverse reactions linked to Essure. Instead of choosing to act, the pharmaceutical company hid the incidents and continued to market the device.
For some, Essure does not fully protect against pregnancy. The FDA received 631 reports of women who became pregnant with Essure. Additional problems linked to Essure are bowel perforation and coil migration.
"Defendants had notice of 168 perforations but only disclosed 22 to the FDA," according to legal complaints.
After learning about the high instance of injury, the FDA added a Black Box warning to Essure. The warning requires doctors to inform patients of the potential for adverse reactions to the device, in addition to providing a risk-benefit checklist signed by the patient.
The agency has demanded Bayer conduct Essure post-market safety studies for three years. However, Essure is still on the market.
Bayer refused to share information about the dangers of the device, and many women feel as though they were misled by the corporation. Individuals have filed an Essure lawsuit to seek compensatory and punitive damages as restitution.