As an alternative form of permanent birth control, the Essure device was met with a lot of interest when it first came on the market. A company called Conceptus developed Essure and got approval by the U.S. Food and Drug Administration (FDA) in 2002 to be used as permanent birth control. The rights to the device were bought by Bayer in 2013, and the company now markets and sells it.
Bayer promotes Essure as the only permanent birth control device approved by the FDA that can be inserted in a doctor’s office without surgery. This is an exciting development for women looking for an alternative to surgical sterilization, but the side effects of using Essure have so far harmed thousands of women. These side effects have led to pain and serious complications, in some cases even fatalities, leading some to question whether Essure should even be on the market at all.
What is Essure?
Bayer bought the rights to Essure for $1.1 billion because of the potential for this popular, less-invasive method of achieving permanent birth control. The idea of the device is great for women who do not want to have children, but who also are concerned about surgery. The alternative for permanent birth control is a tubal ligation, a surgical procedure that carries all the risks of going under anesthesia as well as risks of complications like infections, and a lot of recovery time.
Essure is inserted vaginally and can be done quickly and on an outpatient bases. There is supposed to be no recovery time and fewer risks than those associated with surgery. The Essure device is made of two metal coils with fibers inside them. It is inserted with a hysteroscope into the fallopian tubes. The metal coils are designed to hold it in place, while the fibers cause the surrounding tissue to become inflamed and scar tissue to form.
As the scar tissue develops in the fallopian tubes, it blocks them, preventing eggs from traveling from the ovaries to the uterus. It can take as many as three months for the scar tissue to fully form and for the device to become most effective at preventing pregnancy. At the three month point a woman must be examined to be sure the scar tissue has completely blocked off the fallopian tubes.
Typical Essure Side Effects
The procedure for inserting Essure takes only about ten minutes, and women are expected to be able to return to normal activities immediately. The side effects of the device are supposed to be minimal and minor. Some cramping and pain in the abdomen is normal, but should not be severe. A woman may also experience bleeding, dizziness, nausea, or vomiting. None of these should be severe, and if they are there could be a problem, such as the device moving out of place.
Perforation and Other Serious Side Effects
Many women tolerate Essure well and do not experience serious side effects. Too many others, though, do experience serious and damaging side effects from the device. Many of the instances of these come from the FDA’s adverse events reporting system. Women and their doctors report their experiences of adverse events and the agency collects and analyzes those reports to determine what further research is needed, what safety announcements should be made, and even whether or not a device or medication should be recalled or banned.
In just two years the FDA received nearly 16,000 reports of adverse events related to Essure. Complaints about side effects that go beyond the typical mild symptoms include severe back pain and pelvic pain, excessive bleeding, blood clots, headaches, changes in weight, fatigue, and heavy periods. While there are considered serious complications, the worst are those that occurred when the Essure device broke or moved out of position.
The complaints reported to the FDA that included the most damage occurred in women whose Essure coils became dislodged and perforated organs and tissues. Perforation can damage the fallopian tubes, the uterus, and even other organs, depending on how far the device migrates. This damage has caused women serious complications, ranging from infections to the need for multiple surgeries.
Some of these women have had to have hysterectomies, the total removal of the uterus, because of the complications of Essure. It is an invasive surgery that comes with serious risks of more complications including sexual dysfunction, incontinence, pelvic organ prolapse, and severe pain.
Another serious Essure side effect has occurred in women who did not know they were allergic to nickel. This is one of the metals in the coil of the device. Reactions some women have experienced because of Essure include rashes, hives, itching, nausea, chest pains, diarrhea, vomiting, and difficulty breathing. The FDA recommends that doctors discuss the possibility of a nickel allergy or sensitivity with patients before inserting the Essure device. A test can be done to determine if an allergy is present.
Deaths from Essure
The most serious of all Essure side effects have even led to the deaths of a handful of patients. The FDA has recorded 26 incidents of fatalities associated with Essure. Four were the deaths of the adult women with the devices, while the rest were either the loss of an unintended pregnancy or an infant that died shortly after birth. The adult women who died in connection with Essure each had a different cause of death: embolism, uterine perforation, infection, and suicide.
The loss of pregnancies associated with Essure is especially controversial because Bayer has claimed that the device is 99.74 percent effective. Critics have claimed that this is an inaccurate estimation that does not reflect the real world, only clinical trial settings. The failure rate according to other studies can be as poor as eleven percent. Many of the women who became pregnant with Essure experienced ectopic pregnancies. These are dangerous pregnancies in which the fetus develops in the fallopian tubes, and they most often end in the termination of the pregnancy.
The FDA is still deciding what to do about Essure and is developing a black box warning for the device to make sure women know all of the risks of the device. It is also trying to ensure that doctors are better trained in being able to safely insert the device and to minimize risks.
Those women who have already suffered so much because of Essure have found that they cannot sue Bayer. The company is protected by the Medical Device Amendments Act. Many are challenging that, but are also pushing for the complete removal of Essure from the market. Women who have been hurt by it, doctors, and public advocacy groups believe that the risks of the device are just too high to continue using it.