Rebecca H. Allen, MD, MPH, an obstetrician/gynecologist with expertise in family planning at Women & Infants Hospital of Rhode Island and an assistant professor of obstetrics and gynecology at The Warren Alpert Medical School of Brown University, separates fact from fiction in this Q&A on the contraceptive device.
What is Essure?
Essure is a permanent birth control method for women (female sterilization). Implantation of the Essure System does not require a surgical incision. Essure was approved by the Food and Drug Administration (FDA) in 2002.
How does Essure work?
In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.
Women must use another form of birth control for at least three months after this procedure and must return to their doctor’s office at a designated time to make sure the procedure was successful by undergoing an imaging study (ultrasound or hysterosalpingogram). If patients don’t comply with the follow up testing, they cannot rely on Essure for birth control. In clinical studies, over 90 percent of women who underwent Essure placement and completed the follow up imaging test were able to rely on Essure for permanent birth control.
What are the benefits of Essure as opposed to having my tubes tied?
There are many benefits to Essure over traditional laparoscopic tubal ligation. It does not require incisions and can be done under local anesthesia in a doctor’s office. Recovery time is typically faster than laparoscopic tubal ligation which must be performed under general anesthesia.
What are the risks with an Essure implant?
As with any surgical procedure, there are risks to Essure placement. The risks of this procedure can include bleeding, infection, and more rarely, injury to internal organs including poking a hole in the wall of the uterus (uterine perforation). In addition, there is a rare risk that the coils can be misplaced and perforate the uterus, fallopian tube, and possibly enter the abdominal cavity. If this occurs, then organs in the abdominal cavity may be injured and surgery may be required.
Finally, there is also a risk of allergy or hypersensitivity reactions to the device (the device contains metals including nickel, titanium, iron, chromium, and tin as well as a material called polyethylene terephthalate). It is not possible to predict who may be at risk for hypersensitivity.
How effective is Essure at preventing pregnancy?
No birth control method is 100 percent effective, so there is a possibility of pregnancy (<1 percent). If pregnancy occurs, it is more likely to be located abnormally in the fallopian tube (ectopic pregnancy) which may require surgery. If the pregnancy is in the uterus, it is not known what effects the Essure coils would have on the growing pregnancy.
FDA Essure Update
All of these risks were already known by physicians when Essure was first approved in 2002. Based on more recent reports of harm from women who had the Essure system implanted, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015 to review the safety of Essure. After a thorough review, the FDA recently released its findings and recommendations. The FDA has allowed Essure to stay on the market but intends to make some changes to make sure that women understand the benefits but also the potential risks of the Essure procedure. The FDA plans to place a warning on Essure stating the following:
WARNING: Some patients implanted with the Essure System for Permanent Birth Control have reported adverse events, including perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, persistent pain, and allergy or hypersensitivity reactions. Some of these reported events resulted in device removal that required abdominal surgery. This information should be shared with patients considering sterilization with the Essure device during discussion of the benefits and risks of the device.
In addition, the FDA is recommending a patient checklist that the patient and provider will sign reviewing the risks of the procedure. Included in this checklist are some of the problems that some women have reported to the FDA after receiving the Essure device. Unfortunately, it is very difficult to know for sure that the Essure device caused these problems or the frequency of these problems.
The draft checklist includes reports of the following problems:
- Persistent pelvic pain.
- Irregular menstrual bleeding.
- Joint/muscle pain.
- Excessive fatigue.
- Hair loss.
- Weight changes.
- Mood changes.
The FDA wants to make sure patients understand that if the device needs to be removed, it will require another surgery, and possibly a hysterectomy. The FDA has also ordered the company that manufactures Essure, Bayer, to perform a study to determine the causality and frequency of these adverse events that were not seen in the original trials for approval.
As the American College of Obstetricians and Gynecologists highlighted in their statement to the FDA regarding Essure, women deserve choice when it comes to contraception. Providers need to have options to offer women who have a variety of medical problems, needs, and concerns. Factors that we consider for women considering permanent sterilization include:
- Medical history.
- Tolerance of office procedures.
- Ability to adhere to follow up testing.
- Safety of abdominal surgery and general anesthesia.
We also always counsel women about equally effective alternative options such as:
- Vasectomy for their male partners.
- Intrauterine device and contraceptive implant.