For many women, Essure seemed like the perfect birth control option. The device was marketed as a permanent contraceptive, one that could be implanted without the recipient undergoing invasive surgery. The reality for many women turned out to be far more complicated.
Over the past 16 years, thousands of people that opted to receive an Essure device have reported experiencing severe, life-altering symptoms, sometimes requiring surgery to address. And implants of Essure continued into 2019, potentially putting more women at risk.
The worrying complications
Between Nov. 4, 2002 – when Essure was approved – and Dec. 31, 2018, the U.S. Food and Drug Administration (FDA) received just shy of 33,000 reports related to the device. Many included problems patients experienced after having Essure implanted. The most frequent symptoms include:
- Pain/abdominal pain (26,244 reports)
- Menstrual irregularities (13,114)
- Headache (8,398)
- Fatigue (6,912)
- Weight changes (5,853)
- Depression and anxiety (5,175)
- Noticeable hair loss (4,880)
- Hypersensitivity and rash (4,807)
In some cases, the Essure device – which is made up of two coils, then placed into a woman’s fallopian tubes – migrated to another part of the body, such as the abdominal or pelvic cavity. Occasionally they became dislodged or dislocated. Sometimes they broke, leaving fragments where they shouldn’t be.
These issues sometimes led to tears and holes in the fallopian tubes and uterus, and in some cases required surgery to address. In addition, the FDA has received 2,230 reports of a patient with Essure becoming pregnant. Serious complications, including pregnancy loss, also occurred.
What’s happening now
The manufacturer of Essure, Bayer, decided to stop selling and distributing Essure in the U.S. as of the end of 2018. However, medical providers with Essure devices can continue to implant them up until a year after the purchase date. Before any procedure however, doctors must follow the restrictions and warning requirements put in place in April of 2018 meant to explain the potential risks to women.
The FDA has not banned Essure, and Bayer is in the midst of a five-year postmarket surveillance study looking at the device’s safety.
Yet those women already with the device face a concerning reality. Not only might they still become pregnant, but the potential long-term complications related to Essure can cause serious physical damage. Even the surgical procedure to remove a faulty device can lead to problems. Sometimes a hysterectomy is required.
These issues can lead to lifelong pain and suffering – all, potentially, because of a manufacturer’s negligence. There may be legal options however for Essure recipients suffering from complications. While nothing can return things to the way they were before the implant, compensation can help cover the long-term cost of medical expenses, time off work and negative impact on a person’s life.