Essure is a birth control device introduced in 2002 and marketed as a simple, non-surgical option for permanent female sterilization. At first, the Essure implant was proclaimed to be the permanent birth control procedure with no incisions nor anesthesia. According to patients, a major selling point for Essure was, “it takes longer to get your nails done than it does to get sterilized.”
This product has now been taken off the market because it has been linked to causing patients’ pain, tubal erosion, and a variety of other complications. Unfortunately, the only treatment for a lot of these conditions is a hysterectomy. If you used this product, and are experiencing complications, please contact us or another gynecological professional.
We want to make sure our patients know that we never offered Essure because we were concerned about the potential complications. However, we do have patients who did get the Essure device from another provider and came to us because they were experiencing complications. We performed hysterectomies on those patients and we are happy to report that they are all doing well after their surgery. Although we never offered the Essure device at our office, we are well versed in the complications it causes and we are happy to assist any other patients out there who might need our help.
The FDA put a black label on Essure in 2016, and after thousands of women filed lawsuits, the FDA eventually told Bayer, the company that was selling Essure, to completely take the implant off the market. Bayer stopped selling Essure in 2018, however, they did not recall the device. In August 2020, Bayer announced it would pay $1.6 billion in an attempt to virtually resolve all of the American Essure lawsuits involving patients who reported that the birth control device created serious health complications. The Essure settlements will resolve about 90% of the almost 39,000 claims.
“The Bleeding Edge” is a Netflix documentary that delves into the risks of the multibillion-dollar medical device industry. The film captures real human stories of complications with Essure birth control, vaginal mesh, and other commonly used medical devices.
The documentary follows Angie Firmalino, a 45-year-old woman who began to suffer life-changing complications after receiving an Ensure implant. After experiencing complications and finding little information, she began to research Ensure in-depth. She discovered that other women who had the same implant experienced similar complications and launched a Facebook page that eventually became a meeting place for more than 35,000 Essure victims.
Ana Fuentes’ heartbreaking story is also depicted in the film. She is a 35-year-old Latina mother who had a full hysterectomy at 31 because of her Essure-related side effects. Fuentes experienced heavy bleeding, and when she complained to her doctor, her symptoms were dismissed as “normal” for a Latina woman. When Fuentes was no longer able to work due to her medical problems, she was forced to leave her children with a foster family.
These heartbreaking stories aren’t isolated incidents and patients deserve the best care possible. We want to remind our patients that invasive forms of birth control, like IUDs, need to be done by an expert, not a clinic because clinics don’t have the resources to give patients expert care. Ultrasounds should also be done prior to the insertion of an IUD to ensure proper understanding of the uterus before implantation.