Just a few weeks ago, in November 2016, the FDA updated Essure’s warnings after more than a year of reviewing the birth control implant. The new black box warnings – the FDA’s most severe type of warning – comes with a patient checklist, which doctors should review with women before implanting Essure.
Access the FDA's full evaluation here.
Our Essure attorneys are currently working on these cases, representing women who’ve been seriously harmed by Essure.
Speak to a member of our team for free at 800-774-7120 or chat online, here.
What is Essure, Exactly?
Essure is a set of two implants (nickel metal and polyester coils) that are placed into the fallopian tubes. Once inserted, the body should react to the foreign objects by forming scar tissue around the coils. The scar tissue then blocks fallopian tubes, preventing sperm from reaching the eggs.
Approved in 2002 as a method of permanent birth control, Essure is marketed as a faster, less painful alternative to tubal ligation (commonly referred to as getting your “tubes tied”). Unlike tubal ligation, Essure can be done in a doctor’s office and does not involve surgery or anesthesia.
These are the only two permanent birth control, or “sterilization,” options available to women. A vasectomy – men’s version of sterilization – is safer and more effective than tubal ligation and Essure.
Complications, Injuries, and Risks
In 2015, women, doctors, and families testified before the FDA about how Essure harmed them, pleading that the government to take it off market. Instead of removing Essure altogether, the FDA chose to put black box warnings on Essure’s labels, which will alert women to potential harm.
Side effects include:
- Allergic reactions
- Cysts or tumors
- Device failure
- Device migration, embedment, or perforation
- Ectopic pregnancy
- Heavy menstrual bleeding
- Mood swings
- Sharp abdominal pain or cramping
- Surgical removal
According to the new warnings, one in ten women implanted with Essure can’t rely on it to prevent pregnancy. The warnings also state that most doctors that implant Essure don’t know how to remove it, and the best way to remove Essure is not yet known.
Essure Injury Lawsuits
By the end of 2015, the FDA had received 10,000 reports of injuries and deaths from Essure. Not surprisingly, Bayer (Essure’s manufacturer) now faces hundreds of lawsuits brought by women injured by the implant.
Many Essure lawsuits have been consolidated in Pennsylvania, under Judge Petrese B. Tucker.
Our Essure lawyers are representing women injured by this device, nationwide. If you have any questions about Essure or any other dangerous medical device, contact us for a free, confidential case review. We’re here to help.