This blog has been updated to reflect the most recent FDA findings and changes in our practice in regard to the Essure procedure.
The Essure procedure is a permanent birth control method developed by an American company called Conceptus. Essure is their main product. During the procedure, tiny flexible coils made out of polyester fibers, nickel-titanium and stainless steel are passed by a small tube called a catheter from the vagina through the cervix and uterus and into the Fallopian tubes (Fallopian tubes are two very thin tubes that lead from the ovaries into the uterus). Once in place, the Essure coils cause tissue growth (scarring), which seals a portion of the Fallopian tubes. This tissue barrier prevents sperm from reaching the ovaries. Essure was the only permanent birth control device made for women that did not require a surgical incision.
In 2002, the Food and Drug Administration (FDA) approved it as a safe alternative to tubal ligation, a procedure also known as “getting your tubes tied.” However, in 2016 a “black box” warning label was placed on Essure, denoting the possible side effects that were being reported from its use. During its time in the market, Essure went through lawsuits citing its use led to mild to severe side effects. And in 2018, Bayer, a German-based company that acquired Conceptus, announced that it would discontinue the sale of Essure in the United States due to a decline in use. They did not cite safety concerns or lawsuits as a reason for discontinuation.
It’s important to note that the negative side effects associated with Essure are low with just 3-4% of women reporting complications. The majority of women who have the Essure device implanted do not have symptoms. Generally speaking, if you are not experiencing any negative side effects following the Essure implantation, you do not need to have it removed.
Why Did Essure Become Less Popular for Permanent Birth Control?
The “black box” warning label is the FDA’s strongest warning label and is designed to call attention to serious or life-threatening risks. After this label was added to Essure in 2016, its use in the U.S. declined by approximately 70%.
The FDA continues to study the adverse effects that women reported after the Essure procedure. Scott Gottlieb, Commissioner of the FDA, states, “I want to stress that, even when Essure is no longer sold, the FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns. The restriction on sale and distribution will remain in place.”
What Are the Risks Associated with Essure?
Risks and side effects of Essure can occur during or after the device is implanted. Again, these side effects are quite uncommon. While the most common side effect of undergoing the Essure procedure is abdominal and pelvic pain, there is a wide range of other symptoms, all ranging from mild to severe.
- Abdominal and pelvic pain
- Cramping, vaginal bleeding and nausea
- Allergic reaction or sensitivity symptoms, such as hives, itching and face swelling
- Heavy or irregular periods
- Infection following the procedure
- Perforation of the uterus or fallopian tubes
- Coils becoming dislodged and moving to other places in the abdominal cavity
The Journal of Minimally Invasive Gynecologic Surgery published a study that surveyed women who had undergone Essure implant removal. The study found that 75% of the women who had their implant removed experienced a near to total improvement in their symptoms.
What Other Safe Permanent Birth Control Methods Should I Consider?
There are other safe and effective permanent birth control options out there. Your choice of birth control is a personal decision, based on your lifestyle and health concerns.
Tubal ligation is a surgical procedure that prevents a woman’s eggs from traveling from the ovaries to the uterus to prevent pregnancy. This procedure is performed in a hospital or outpatient surgical clinic and requires anesthesia. Although tubal ligation is considered permanent, it also may be reversed in some cases.
At Dr. Garofalo’s practice, we offer salpingectomy, a permanent birth control procedure that also reduces a woman’s risk of developing ovarian cancer. During a salpingectomy, the fallopian tubes are surgically removed. The procedure takes only a short time longer to perform than tubal ligation, and the ovaries remain, so there are no physiologic or hormonal changes after the tubes are removed.
What Do I Do If I Had the Essure Procedure for Permanent Birth Control in the Past?
If you have any of the side effects after undergoing an Essure procedure that we described, you should contact your gynecologist. Although it’s possible that your symptoms may be related to Essure implants, there may be another cause, such as endometriosis or adenomyosis.
If you need to have your Essure implants removed, be sure to find a gynecologist who has experience with this kind of procedure. If you have any questions, feel free to contact us.
Dr. John Garofalo, M.D., is a CT OBGYN based in Fairfield County, providing care for Norwalk, Darien, New Canaan, Weston, Rowayton and the surrounding areas. He has more than 20 years of practice and surgical experience covering many facets of obstetrics and gynecology.
Laury Berkwitt, APRN, is a nurse practitioner specializing in women’s health in Fairfield County, Connecticut. Women undergoing signs and symptoms of menopause can make an appointment with Laury for Hormone Replacement Therapy. Laury has a passion for providing quality women’s health care in a safe and comfortable manner by creating a trusting patient-practitioner relationship. She has been in practice for more than 10 years, caring for women of all ages.