- Fertility & Reproductive Systems
The Importance Of Filing Adverse Event Reports For Essure
What Is Essure?
Essure has been getting a lot of press lately, and most of it isn't very good.
Introduced in 2002 as being an alternative solution to permanent birth control, many women jumped at the chance to receive a permanent birth control option that didn't involve surgery, or a lengthy recovery time. Doctors all around the country have encouraged the placement of Essure, rather than tubal ligation because of these benefits.
The Essure device is actually two small, metal coils that are inserted into a woman's fallopian tubes. There is no incision because the coils are inserted through the vagina. Once the coils are in place, an alternate form of birth control is required for a period of around three months. During that three month period, scar tissue will build around the coils, resulting in blocked fallopian tubes. A hysterosalpingogram is performed at that time to ensure that the tubes are adequately blocked. If the hysterosalpingogram shows that the tubes are blocked, pregnancy should not occur.
One Patient's Coils After Removal
After Essure Placement
According to the Essure website, the procedure should result in the patient being able to return to her regular activities immediately, with no downtime. However, this is not always the case for many women.
While some women do not suffer any ill effects from having the Essure procedure, others begin experiencing painful symptoms almost immediately after placement. Even those who have no problems right away, can develop issues further down the road.
Many women have described their symptoms as being, "A constant pain that doesn't go away." Several of them have stated that having Essure feels as though they have barbed wire inside of them. The agony doesn't stop there.
The Essure coils contain nickel. Nickel allergies are relatively common, however many doctors have false information about whether or not the nickel that's contained in Essure can cause health issues. Some physicians were not even aware that the devices contained nickel when they were promoting them. Many women who didn't have nickel allergies before placement developed them as time went on.
Nickel allergies are usually indicated by developing an itchy rash in the area where nickel has touched the skin. Many women discover that they have a nickel allergy when they wear earrings or other pieces of jewelry that contain it. Nickel allergies can become quite severe very quickly, and for a woman who has Essure, the pain from this allergy is intolerable.
FDA Reporting - Have You Filed One?
You filed an Adverse Event Report due to the symptoms you're experiencing after Essure placement?
Debilitating Symptoms Caused By Essure
Many of the women who have suffered from the debilitating symptoms caused by Essure have come forward to fight against the FDA. They describe symptoms such as:
- Excruciating pain
- Heavy bleeding/clotting
- Hives or rashes
- Food sensitivities
- Back pain
- Recurring infections
There are many, many more listed on the Essure Problems website.
Many of the women who experience this painful symptoms didn't realize that Essure could be causing them. For this reason, the Essure Problems Facebook group was formed. The women in this group have fought hard to raise awareness about the problems associated with Essure. Each day, they welcome new group members who were thinking about having the Essure procedure done because they weren't informed about the side effects. Many of these women changed their minds after talking with other group members. However, their work is not done.
Erin Brockovich has started a website to help raise awareness about the debilitating symptoms caused by Essure as well. Her website is filled with stories of women who have suffered through tremendous amounts of pain and agony. Many of these women have struggled to get doctors to listen to them. These doctors are quick to blame something else as being the cause of their symptoms, and they continue to push Essure on women as being a safe and effective form of permanent birth control
Coil Fragments That Were Recovered During Surgery
According to ABC15 News:
- Since 2004, 838 women and doctors filed complaints as ‘Adverse Events’ with the Food and Drug Administration.
- There were 150 complaints where the coils broke or miss-fired;
- Even more complaints detail the device moving or puncturing the fallopian tube;
- 80 women became pregnant;
- 91 reported having hysterectomies to remove the device.
Filing An FDA Adverse Event Report
For a woman who is suffering with the side effects of Essure, one of the most important things she can do is file an Adverse Event Report with the FDA. To date, hundreds of women have filed reports regarding their symptoms after having the Essure procedure done, and it's absolutely critical for more to be filed so that the FDA will take action.
Filling an Adverse Event Report with the FDA is very easy. The MedWatcher website is the best place to start. By filling out the online form, women can report all of their symptoms, and any side effects that have occurred since the placement of Essure. Women who have had Essure are also encouraged to join the Essure Problems Facebook group, where they can receive support from other women who are facing similar situations.
You're Not Alone
If you came across this article because you weren't sure if your symptoms have been caused because of Essure, let us assure you, you are not alone. For the women who have had problems with Essure, they wake up every day with the hope that the FDA will pull this harmful device from the market.
The ladies in the Essure Problems Facebook group have done a wonderful job of raising awareness of the dangerous nature of Essure. Their goal is to reach more women and help them with the information they've learned along the way.
Essure is not only a dangerous form of permanent birth control, but it is also ineffective for many women. According to a recent article by ABC, there have been several pregnancies that have occurred in women who have Essure. Many Adverse Event Reports have been made, but in order for the FDA to take action, more work has to be done.
ABC 15 Video Regarding Essure
The only suitable resolution in this issue is to pull Essure from the market. However, until that can be done, women are encouraged to seek out a second and third opinion from medical professionals to discuss having their coils removed. Help is available to find a doctor who will do the procedure. For some women, this will mean having hysterectomies, or even partial hysterectomies. However, the women have had them report an almost immediate disappearance of symptoms.
If you or someone you love has been complaining of these, or other symptoms since they had the Essure procedure done, you don't have to suffer alone. There are women who understand what you're going through, and who will help you take the necessary steps to have your coils removed, and to raise awareness about this harmful procedure.
The battle is far from over. However, when enough women work together, the FDA will have to hear their voices.