Essure was a popular form of birth control from 2002-2019. It offered a way – the only way- to achieve sterilization without surgery or anesthesia. In total, medical professionals implanted about 500,000 women with Essure, the majority in the United States.
In 2018, Bayer stopped selling and distributing the Essure device in the United States. Health care providers could implant Essure for an additional year but no more. The main reason that Bayer stopped selling the device was because of decreased sales due to Essure safety concerns. Most importantly, the FDA had added a black box warning to Essure’s packaging which significantly decreased sales in the United States.
How does Essure work?
Essure is a permanent birth control device that creates a natural barrier against pregnancy. The Essure inserts are placed into the fallopian tubes and scar tissue forms around the inserts. The build-up of scar tissue blocks sperm from reaching the eggs and prevents conception.
What are the safety concerns with Essure?
A number of short-term and longer-term risks have been documented with Essure. The FDA has been collecting the risks associated with Essure and perhaps most importantly, continues to study cohorts of women who had the Essure device over longer periods of time.
Currently, short-term risks to women with Essure as reported in clinical trials include:
- Cramping, vaginal bleeding, nausea, vomiting, dizziness, lightheadedness, pelvic or back discomfort immediately after the procedure.
Longer-term risks to women with Essure as reported in clinical trials include:
- Abdominal, pelvic, or back pain, perforation of the uterus or fallopian tubes, unintended pregnancy, allergic reactions, migration of Essure inserts.
It is important to note that the coils placed in the fallopian tubes, made of fiber and metal, sometimes travel into the uterus or sections break off and then settle into the uterus – causing potential risks during pregnancy. There is also an increase in possible ectopic pregnancies with Essure.
Surprisingly, about 8% of women with Essure inserts become pregnant on their own. This is different from the anticipated birth control expectations with the device. This also inadvertently increases the potential risks during pregnancy with the Essure device.
Will I qualify as a Surrogate with Essure/After Essure Removal?
The short answer is that you will definitely not qualify to be a surrogate if you have Essure in place, but you may qualify after having the Essure reversal procedure. While successful pregnancies with healthy deliveries have been reported with Essure devices in place, neonatal or pregnancy complications have also been reported. Also, the FDA has received reports of pregnancy losses in women who became pregnant following Essure placement.
The majority of IVF clinics list Essure birth control method as a disqualifier for potential surrogates. For the most part, there has been enough data to link specific pregnancy complications to Essure. Also, not enough data is currently available to understand the pregnancy and neonatal risks after the Essure removal process, so clinics may accept surrogates only on a case-by-case basis.
Essure, and a similar device named Adiana, are the only birth control methods that currently disqualify women from becoming surrogates. Whether a surrogate has had tubal ligation as sterilization (tubes tied) or uses an IUD, contraception pills, or another method, she can become a surrogate – which is good news.
The FDA remains committed to collecting long-term safety information in women who have received the device. The clinical data from the FDA study will help patients, medical professionals, and the surrogacy community better understand certain complications that women who have Essure permanent birth control may experience. But perhaps most importantly, the studies will tell what the longer-term effects are for women who had Essure reversal – both for their own pregnancy possibilities and when helping others grow their families as surrogates. Hopefully the results will be more positive and IVF clinics will be willing to accept more potential surrogates with Essure reversal in future years.
We encourage all prospective surrogates to contact Capital Surrogacy and learn more about the process. Please complete the short contact form, we cannot wait to hear from you!
