Essure is a permanent and irreversible type of birth control for women. The implantable medical device was approved by the U.S. Food and Drug Administration (FDA) in 2002, but after receiving much controversy and increasing reports of complications, it was later withdrawn from use in the US and in other countries, by the manufacturer Bayer pharmaceuticals, in 2019.
What Does The Procedure Involve?
Essure is a permanent female sterilization method that works by creating a barrier in the fallopian tubes to prevent sperm from reaching an egg. With Essure, the body is still able to produce eggs, but they are absorbed by the body instead of traveling through the fallopian tubes and into the uterus. It is a minimally invasive procedure that requires no incisions, general anesthesia, and can be carried out in your doctor’s office.
The procedure involves gently inserting tiny flexible coil devices, into the fallopian tubes, via a catheter passed through the vagina. Once in place, the micro-inserts induce tissue formation. This build-up of tissue results in permanent blockage of the fallopian tubes to prevent sperm from making contact with an egg.
The coil inserts are small flexible devices made from polyester fibers, nickel-titanium, and stainless steel. They contain fibers to induce inflammation and cause benign fibrotic ingrowth, a type of permanent scar tissue made up of connective tissue.
The tissue barrier can take three months to form, meaning women are advised to use an alternate contraceptive method during this period to prevent unwanted pregnancy. Three months after insertion, a special type of X-ray, known as a hysterosalpingogram, should be carried out to confirm that the fallopian tubes are completely blocked.
How Effective Is Essure?
Although initial studies considered Essure 99.8% effective in preventing pregnancy, this was later brought under scrutiny after many women reported unintended pregnancy had subsequently occurred. There was also evidence to suggest that Essure increased the risk of ectopic pregnancy, which can result in serious complications.
Essure should, however, still only be considered by women who are sure that they never want to have children as it is regarded as a permanent and non-reversible type of birth control.
Is Essure Safe?
Essure was approved by the FDA in 2002, but in 2015, after receiving a substantial number of reported adverse side effects and complaints all linked to Essure, such as its specific chemical composition, the insertion process, and its improper placement, the FDA did an investigation on the product. As a result of the investigation, a “black box warning” was placed on the product to inform the public around potential harmful complications associated with the use of the device. A decision checklist was also devised to ensure appropriate consent prior to implantation.
Subsequently, in December 2018, Bayer stopped selling and distributing the Essure device in the United States due to increasing reports of adverse events related to the product, meaning the device is no longer available for implantation.
What Are Common Complications Associated With The Device?
The main longer-term risks to women with Essure as reported in clinical trials were identified as:
- Chronic abdominal, pelvic, or back pain
- A perforation (tear or hole) of the fallopian tubes or uterus
- Abnormal/heavier menstrual bleeding
- Vaginal discharge or infection
- Misplacement or expulsion of the device
- Migration of the device (into the pelvic or abdominal cavity)
- Unintended pregnancy
- Ectopic pregnancy
- Allergy or hypersensitive reactions to the device
- Weight changes
- Hair loss
Should An Essure Device Be Removed?
Advice from the FDA states that women using Essure successfully can and should continue to do so. However, for women experiencing suspected related symptoms to the device, a consultation with their healthcare provider to discuss what appropriate steps should be taken is recommended.
Ongoing complications and adverse side-effects make removal of the Essure device a good idea. In some cases, hysterectomies related to Essure complications have also been necessary. Because Essure removal is a surgical procedure, and typically requires anesthesia, it can also come with risks, such as bleeding, pain, a reaction to the anesthesia, device breakage or fragments of the device remaining in the patient, and perforation or damage to the fallopian tubes or uterus. This is why only a highly experienced doctor should perform this procedure.
Essure removal is a microsurgical procedure which involves making a 2-3 inch incision just above the pubic hairline. Surgery involves removing the Essure coil, along with part of the fallopian tube where the coil was implanted. The remaining Fallopian tube is then ligated (tied) to prevent pregnancy.
What Should I Do If I Am Having Problems With Essure?
If you have the Essure device and are experiencing problems or adverse side effects, such as persistent pain, you should consult with your healthcare provider as soon as possible to decide on the best course of action.
Patients and healthcare providers are also encouraged to report any problems experienced with Essure to the FDA. This can be done through the MedWatch Online Voluntary Reporting Form.
Essure Coil Removal in Illinois
If you have an Essure device and are experiencing problems, speak to the compassionate providers at Aishling Obstetrics & Gynecology today to get the high-quality care you deserve. We specialize in women’s health care needs and offer a comprehensive range of preventative, diagnostic, and advanced gynecology services for women of all ages, including Essure coil removal.