Millions of women in this country have wanted a permanent way to to keep themselves from getting pregnant. So when Essure was approved by the FDA in 2002, it seemed like the perfect solution for many women.
Essure is a device intended to provide permanent birth control. It is a metal spiral that is inserted into the fallopian tubes. The friction that is produced by the Essure device causes a mild fibrosis. This is basically a scarring in the fallopian tubes that blocks the entry of sperm and staves off pregnancy.
Results of Clinical Trials
During the clinical trials before Essure was released to the public, there were reports of notable side effects. Aside from the mild to moderate discomfort during and after the placement procedure, vaginal bleeding and cramping were among the main side effects. Women also reported nausea, vomiting and pelvic or back pain. Some of the longer-term side effects and risks of Essure included:
- Rupturing of the fallopian tubes or uterus.
- Unplanned pregnancies.
- Abdominal pain along with the back pain earlier reported.
If these were not troubling enough, there were reports of headaches, joint and muscle pain and weakness, loss of hair and weight gain or loss. Mental reactions like tiredness and depression were also troubling.
FDA Restrictions on Essure
It’s important to remember that pregnancy itself carries risk factors. The FDA wants women to be aware of the risks of having Essure implanted as well. The FDA is also aware that many women have had the device implanted without being fully aware of the risks involved.
Back in 2016, the FDA took measures to change the information on the label of Essure packages. These included a warning on the box itself about the risks and a checklist directing patients to carefully consider the use of Essure. The warnings were designed to inform both patients and healthcare providers about the risks and side effects. After the public became aware of the risks of using Essure, sales of it dropped by 70%.
When all of these factors were carefully considered, the FDA moved to restrict the sales of Essure in 2018 on April the 9th. Here is a summary of these Essure FDA restrictions:
- Ensuring that only healthcare providers who are aware of the risks can purchase Essure for use in patients.
- The provided checklist on the brochure inside the Essure packaged must be presented to the patient. The patient must then sign the acknowledgement of the risks involved before the placement procedure is approved.
- Bayer, the company that manufactures Essure, was directed to meet these criteria immediately.
Bayer’s compliance with these Essure FDA Restrictions will be monitored and and reviewed on a continual basis.
Citizen Petitions Against Essure
There have been many women who have been adversely affected by the implantation of Essure. Many of them belong to the group of women who were chosen for clinical trials of Essure. They claim that the researches were not truthful when they filled out survey forms about the level of comfort when and after the device was implanted.
These women claim that the research teams intentionally exaggerated the positive outcomes of the clinical trials and put them in them danger as a result. The also claim they did this in order to get Essure on the market as soon as possible.
If you have experienced any of these symptoms, you are encouraged to do something about it.
Call the Drug Injury Helpline for a free review of your case and start the process of helping yourself or a loved one recover.