Essure is a type of permanent birth control for women. It is inserted non-surgically into the fallopian tubes to prevent pregnancy. Although it is designed to be permanent, it is possible to remove the device through surgery. Essure was created and developed by Conceptus Inc, but the rights to it were bought by Bayer in 2013. Bayer claims that Essure provides nearly 100 percent effectiveness in preventing pregnancy.
Essure has been marketed as an alternative to the more invasive procedure of tubal ligation. While the insertion is certainly less invasive, there have been many reports of side effects and other problems. These include pain, heavy periods, enough damage to require a hysterectomy, and even deaths from complications. Essure is protected from lawsuits because of the Medical Device Amendments Act, but many women are pushing to sue Bayer or at least get the device off the market.
Essure for Permanent Birth Control
Prior to Essure, the standard way for a woman to get permanent birth control was through a tubal ligation, or getting her tubes tied. This process is surgical, requires incisions and anesthesia, and requires a few days of recovery time. The procedure is conducted on an outpatient basis and involves cauterizing or clamping the fallopian tubes shut to prevent eggs from traveling through them to the uterus. About one in 200 women who have had tubal ligation will get pregnant at some point after the procedure.
Essure is also supposed to be permanent as well, but does not require surgery or much recovery time. The device is inserted in a doctor’s office with the use of a hysteroscope, a small camera on a flexible tube. The doctor inserts this into the vagina, through the cervics and uterus and into the fallopian tubes. The Essure device can then be inserted using the scope and placed, one into each fallopian tube.
As an alternative to tubal ligation, Essure has the benefit of being non-surgical, so that risks of infection or complications from anesthesia are minimized. The procedure takes only about ten minutes and requires no recovery time. It is typical experience a little bit of pain after the procedure, but women are allowed to go back to normal activities that same day.
Essure was approved by the U.S. Food and Drug Administration (FDA) for permanent birth control in women. It is not recommended for use in anyone who thinks she may want to get pregnant later, for women who had an abortion or gave birth six weeks previously, for a woman who has already had a tubal ligation, or for a woman with certain tubal or uterine conditions.
How it Works
The Essure device is made up of two metal coils, one of stainless steel and another of a nickel-titanium alloy. Within the coils are fibers made of polyethylene terephthalate. The coils are designed to keep the device in place within the fallopian tube. The fibers are supposed to trigger inflammation and the resulting formation of scar tissue. The scar tissue grows until it completely blocks the fallopian tube.
It takes up to three months for the scar tissue to grow enough to create a full blockage, so women are not supposed to rely on this for birth control until at least three months after the procedure. At that point, the woman is supposed to return to the doctor’s office for an examination to be sure that the scar tissue has completely grown into place. Fewer than one out of one hundred women will get pregnant after having Essure inserted.
It is normal and typical for a woman to experiencing some minor side effects after having Essure inserted. These include cramping and abdominal pains, bleeding, dizziness, nausea, and vomiting. Not normal is persistent or severe pain or the passing of one of the devices. Anyone experiencing these side effects should contact her doctor immediately.
While many of the side effects possible with Essure have the potential to be serious or severe, the most serious of all is the possibility that a complication will lead to death. The FDA has recorded several incidents of deaths associated with Essure. A few were incorrectly coded, most were deaths of infants or fetuses, but at least four were deaths of women who used Essure. The deaths were caused by embolism, infection, uterine perforation, and suicide. Due to these and the other serious risks of the device, the FDA has ordered Bayer to conduct postmarket research into the effectiveness and safety of Essure.
Essure has never been marketed as a reversible type of birth control and both Bayer and the FDA state that it is permanent. However, it is possible to remove the device through surgery and some doctors will do it. To remove it, a small abdominal insertion must be made and the non-scarred portions of the fallopian tubes rerouted around the Essure devices and back to the uterus. Because it is a surgery requiring anesthesia, there is a risk of complications and infections when reversing this type of birth control.
Complaints about Essure
Although the listed side effects are mostly mild, and many women only ever experience these mild symptoms, there have been numerous complaints of more serious side effects and complications from the women using the devices. These complaints have been made officially to the FDA and include reports of severe pelvic and back pain, heavy bleeding, perforation of the fallopian tubes, and even devices puncturing the fallopian tubes and lodging in other organs in the body. Other complaints were of allergic reactions to the device and unintended pregnancies.
Between just 2011 and 2013, the FDA received over 16,000 complaints about Essure. Some of the women who have experienced the most severe complications from the device required a hysterectomy, a surgical procedure to remove the uterus. A hysterectomy is a surgery that can cause many complications including pelvic organ prolapse, sexual dysfunction, bowel dysfunction, incontinence, and severe pelvic pain.
Controversial Trial Data
Investigations into the many complaints made against Essure have found possible problems with the data and claims made by Bayer. One such problem is the effectiveness. Bayer claims that Essure 99.74 percent effective at preventing pregnancy. Some researchers, however, have criticized this as being a result found only during clinical trials, not in real world settings. Other studies have found that the failure rate, or rate of women getting pregnant while on Essure can be as high as eleven percent.
Another issue with the data comes from a follow up study required by the FDA. Essure was fast-tracked for approval under the condition that Bayer researchers conduct a study that followed participants for four or five years after having Essure inserted. The company delayed publishing the results of that study for eight years, which is highly unusual.
The results, once released, were troubling. Out of more than 500 participants, only 366 women were followed for the required amount of time. Fifteen of these women had to have hysterectomies, 38 percent had regular heavy periods, 20 percent had recurring pelvic pain and one in 25 experienced painful intercourse.
The FDA’s Black Box Warning
Following the results of the study and review of the thousands of complaints received, the FDA issued a black box warning for Essure. The FDA did not find any negligence in the study data from Bayer, but did conclude that extra warning of the possible severe effects of the device was warranted. Although the warning has not yet been drafted or added to the label, the FDA is most concerned about the risk of the coil puncturing the fallopian tubes and moving to other parts of the body.
The FDA has also recommended that doctors better screen appropriate patients for use of Essure and have better training in inserting the device. The FDA also would like to see doctors counsel their patients more carefully on the possible risks and to screen women for nickel allergies.
Under the Medical Device Amendments Act, Essure and Bayer have been preempted from lawsuits. The FDA designated this preemption because the device was put under greater scrutiny than other medications have been. This has not stopped those women who have suffered so greatly from Essure from taking legal action. A preemption is not bullet proof and women and their lawyers continue to fight to find ways to seek damages from Bayer or to get the device removed from the market place.