On July 20, 2018, Bayer announced that it will finally halt sales of Essure in the U.S., the last country where it still sells the dangerous device. It announced that it was halting sales outside the U.S. in September 2017. Essure is a permanent birth control device marketed as a non-surgical alternative to tubal ligation.
The U.S. Food and Drug Administration has received reports of over 25,000 adverse events and at least 40 deaths associated with Essure, but Bayer says that safety concerns are not behind the decision to stop selling the device.
What is Essure?
Essure was approved by the FDA in 2002. It is a flexible nickel-titanium coil, about two inches long that is placed inside each fallopian tube. The coils contain fibers that irritate and inflame the surrounding tissue, causing scar tissue to form and block the fallopian tubes, preventing eggs from travelling from the ovaries to the uterus.
It was marketed as a non-surgical alternative to tubal ligation. It was supposedly safer, with no recovery time, because the coils were inserted through the vagina and cervix. The scar tissue takes up to three months to form and women must have a recheck with the doctor to make sure that the tubes are fully blocked.
Essure Complications and Side Effects
Thousands of women have reported serious harm caused by Essure including:
- Unintended pregnancies
- Ectopic pregnancies
- Autoimmune problems
- Allergic reaction to the nickel in the coil
- Perforation of the fallopian tube or uterus
- Coil migration through the fallopian tubes
- Coil migration to other organs
- Vaginal bleeding
- Severe cramping
- Abdominal pain
- Pelvic pain
- Back pain
- Arm and leg pain
- Long, heavy periods
- Vaginal discharge and infection
- Painful intercourse
- Extreme fatigue
- Skin rashes
- Severe bloating
Many women have been forced to resort to hysterectomy due to Essure complications.
Essure Sisters, Netflix, and Pay-off to Doctors
One such woman is Angie Firmalino, and she decided to fight back. In 2011 she started the Facebook Group “Essure Problems” which now has 37,000 members. The women who have banded together, fighting to get Essure pulled from the market, refer to themselves as E-sisters and they are celebrating victory after a long fight.
The E-sisters shared their stories in a Netflix documentary called The Bleeding Edge, which details how Essure and other dangerous devices received FDA approval.
CNN recently reported that its analysis found that Bayer paid a total of $2.5 million to 11,850 doctors for consulting fees and similar services related to Essure.
Essure Sales to End Too Late
The dangers of Essure have been known to Bayer and the FDA for years. In 2016, the FDA required a black box warning to be added to the Essure label. It is the FDA’s most serious warning reserved for drugs and devices that can cause serious or fatal side effects. At the same time the agency required Bayer to create a three-page list of the risks for doctors to discuss with their patients before moving forward with Essure implantation.
In April 2018, after the agency received complaints that patients were still not being warned, it required Bayer to only sell the device to doctors who guaranteed that they were telling their patients about the dangers.
According to Bayer and the FDA, over 750,000 women have been implanted with Essure.
If you have been harmed by Essure, please talk to an experienced defective medical device attorney right away to learn more about your rights.