Essure has been marketed to women as a safe, effective, and permanent birth control method. Unfortunately it has not lived up to those claims. Many women choose Essure because it does not require surgery and thus seems less invasive than other procedures. However, the long term effects of living with Essure can be uncomfortable, dangerous, and in some cases even fatal.
If you or someone you love suffered because of an Essure device, you are not alone. Thousands of women and their families have had serious complaints against Essure, and you have legal options. John Foy & Associates are one of the largest and most experienced law firms offering assistance to victims of Essure. Let us help you. Call us at 404-400-4000 and get a free consultation today.
What is Essure and how is it supposed to work?
Essure is a tiny medical device that’s implanted in a woman’s body to help her achieve permanent birth control, sometimes called sterilization. Like most sterilization methods it involves closing the fallopian tubes, the tubes that carry an egg from the ovaries to the uterus and allow fertility. But where most sterilization methods involve surgically closing the fallopian tubes, the Essure device claims to effectively block them—with no surgery.
The device consists of a pair of flexible coils wrapped in soft fibers. A doctor guides the device into place through the patient’s vaginal canal and cervix, eventually implanting it in the fallopian tube. Over a period of three months, the body forms scar tissue around the device, sealing off the fallopian tube. This is supposed to prevent eggs from descending into the uterus (ovulation) as well as sperm from entering the fallopian tubes.
Is it true you can still get pregnant on Essure?
Yes. Bayer, the maker of Essure, markets the product as virtually 100% effective at preventing pregnancy (99.74%). However, the number of women who have reported pregnancy on Essure is much higher.
In a small number of these cases the woman may have been pregnant before getting Essure. But in many the pregnancy is due to the Essure device not being placed correctly or simply not working. Doctors are supposed to spot any improper placement at a 3-month followup appointment, but this may not always work and many women don’t receive the followup.
As a result, the real pregnancy rate for Essure may be around 5.7% in the first year or 9.6% over 10 years. That would make Essure less effective than simply using condoms. Another study shows that Essure is actually less effective at preventing pregnancy than the traditional surgical method of sterilization.
Essure does change how a woman gets pregnant, however. Pregnancies involving Essure are often far more dangerous than a traditional pregnancy, both to the mother and child. And that’s only one of the many risks the device poses.
What risks or complications can happen with Essure?
The Essure device has many potential complications. These include:
- Ectopic pregnancy. If a woman does become pregnant on Essure, it’s far more likely to be an ectopic pregnancy. This is a pregnancy where the sperm fertilizes the eggs in the fallopian tube, outside of the uterus, and the resulting embryo begins to grow there. Ectopic pregnancy is fraught with risks. It is almost always fatal to the unborn child, and the mother may suffer rupture with internal bleeding, which can be fatal.
- Nickel allergy/immune response. The coils of the Essure device are made of nickel-titanium alloy, and it’s not uncommon for women to have a nickel allergy. Although a woman can very easily and safely be tested for a nickel allergy prior to the procedure, this often isn’t done. The result can be an extreme allergic reaction deep inside a woman’s reproductive system. As with any foreign object, the body can also mistake Essure for an infection and attack it. This patient “incompatibility” is implicated in thousands of of Essure complications.
- Perforation and migration. The device can break. When it does, the metal coils may perforate the fallopian tubes, meaning it cuts them open. The device can also move out of position, known as migration—either intact or after breaking. The migrating device can cause trauma elsewhere in the body. It also leaves the woman at risk of pregnancy. When perforation or migration occurs the woman often requires surgery.
- Bleeding and heavy periods. One of the most reported complications of Essure is bleeding, heavy menstruation, or painful menstruation. Some women require additional procedures to reduce menstrual bleeding.
- Extreme pain. Living with Essure can be painful on a day to day basis. Many woman report abdominal pain or back pain. Others report pain during intercourse.
- Tragically, many of the factors above can be fatal. Women and babies have lost their lives due to complications with Essure.
In total the FDA has received over 5,000 complaints about Essure. 11 of those involved a death, including the deaths of five unborn children. Many other women have had to have the device removed altogether, which may or may not reverse the damage.
Who is responsible? Wasn’t Essure tested before being offered to women?
Essure was developed by a company called Conceptus, which is now owned by the German company Bayer. Bayer is responsible for all claims against Essure.
Essure did go through standard testing with the FDA before being allowed on the market in 2002. However, the FDA required additional testing for long term risks—a standard requirement for new medical devices. This testing typically involves a 5-year study showing how the device affects patients. Conceptus/Bayer delayed publishing the 5-years results for an additional eight years.
When it finally came out, the study revealed many of the tragic effects that Essure patients now live with every day—13 years after the device was first approved. A news release from Bayer tried to spin this study as positive.
What action has the FDA taken against Essure?
As complaints mounted, the FDA has held a series of meetings and reviews about Essure. Although its intentions are good, the FDA cannot move quickly to ban a device, as it must gather hard data before taking action.
On February 29, 2016 the FDA finally took two major steps:
- Warning label. Bayer will be ordered to put a special “black box” warning label on Essure packaging, similar to a “Surgeon General’s Warning ” on cigarettes. Initial language for the label has been drafted and public input will shape the final version.
- Risk assessment. The FDA ordered a new clinical study about heightened risks among certain groups of women.
These actions may help protect women in the future. But they do nothing to help the thousands of women who have already been harmed, or the families of those who lost their lives.
What do I do if I’ve had problems with an Essure device? Do I have grounds for a lawsuit?
If you or someone you love had complications from Essure, you should speak to an attorney as soon as possible. Your attorney will help you understand your case against the makers of Essure and the legal options available to you. You may be entitled to a financial recovery from Bayer, which could help you in the aftermath of your injury. Your recovery could help pay for:
- Medical bills
- The cost of removing the device
- Time missed at work due to pain or treatment
- Pain and suffering
Be aware that every state has a statute of limitations which creates a hard deadline for taking legal action. The sooner you talk to an attorney, the more they can do to help.
No payment can make up for a serious health conditions. Our hope is that winning your case can help you receive the best medical treatment, live your life free of medical debt and move forward with as little pain as possible.
John Foy & Associates has a history of success with medical device cases. We offer a FREE consultation and we charge nothing unless we get you a financial recovery. Call 404-400-4000 and get your free consultation today.