WHAT IS ESSURE BIRTH CONTROL?
Essure is a permanent, non-surgical birth control device for women. Its placement does not require an incision or general anesthesia and it is also non-hormonal.
LONG-TERM RISKS OF ESSURE
- Ectopic Pregnancy
- Pelvic Pain
- Movement of the Essure device through the fallopian tubes into the lower abdomen and pelvis
- Perforation (puncturing) of the uterus or fallopian tubes
- Rash and itching associated with possible nickel allergy.
If the Essure implant separates, breaks and/or moves, attempted removal could require multiple surgeries, possibly requiring removal of the uterus entirely.
ESSURE FDA BLACK BOX WARNING LABEL
The U.S. Food and Drug Administration (FDA) requires a "black box warning" label for Essure. A black box warning is "designed to call attention to serious or life threatening risks," according to the FDA web site. Despite Essure being linked to four adult deaths, the FDA has not issued a recall. The FDA is requiring additional warnings and studies be performed, but the final report is not due until 2023.
Lawsuits are being filed against Bayer, the manufacturer of Essure, by women who have suffered severe abdominal damage when the birth control device moves and punctures the uterus and fallopian tubes.
The lawsuits allege that Bayer has failed to properly warn patients and physicians of the true risks and dangers associated with this medical device.
Napoli Shkolnik is happy that the cases are being consolidated in two locations, the state court of California in Oakland where the devices were originally developed and in the federal court in Pennsylvania where Bayer has its home.