From 2002 to 2015, the FDA received over 5,000 complaints about popular birth control device Essure. This doesn’t include the 12,000 adverse event reports from women experiencing Essure problems in 2017 alone. The controversial device is a metal coil that a doctor inserts into the fallopian tubes. Eventually, the body’s tissue should envelop the coils, forming a scar tissue barrier. This scar tissue then prevents sperm from reaching your eggs – at least, that’s the idea.
But FDA reports list serious Essure problems, like unintended pregnancies, miscarriages, stillbirths, severe pain, and bleeding. The device has not proven to be effective and can be extremely dangerous. As a result, the FDA is intervening to restrict sales of the birth control device.
FDA Issues Sales Restrictions After Thousands of Women Report Essure Problems
On April 9, 2018, the United States Food and Drug Administration (FDA) put sales restrictions on Essure. In a statement, the agency said that the restrictions are to ensure doctors properly inform women about the device’s risks. The device will only be sold to doctors who go through a detailed FDA-approved brochure and checklist with patients.
Even the FDA admits that this situation is unprecedented. The statement reads, “The FDA is requiring a unique type of restriction, using its authority to restrict the sale and distribution of a device…to provide a reasonable assurance of its safety and effectiveness.”
This isn’t the first time the FDA has intervened with Essure. In 2016, the FDA ordered Bayer, Essure’s manufacturer to conduct a post-market study on the device. They also required them to add a boxed warning and include a patient decision checklist to the labeling. Since then, Bayer has seen a 70% decline in Essure sales. But despite the fall in sales, injuries from Essure are still occurring. In fact, there were 12,000 reports from women with Essure problems in 2017 alone.
Why Do Women Choose Essure?
With all the reports about women experiencing Essure problems, why would they willingly choose this implant? There are multiple reasons women have chosen it in the past.
Here are the two main reasons:
- No proper warnings about the risks — The FDA now requires patients to sit down with a doctor to go over the risks. But that hasn’t always been the case. Many women, according to the FDA, “still aren’t receiving this important information.” As a result, thousands have experienced serious and even life-threatening Essure problems. These include perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal cavity and persistent pain. Others have experienced depression, stillbirth, miscarriage, and unwanted pregnancy. And many of them claim that there were no discussions on the risks.
- They wanted something permanent — Essure is currently the only permanent birth control device for women that does not require a surgical incision. The coils are inserted through the vagina and cervix into the fallopian tubes. Many women choose it instead of other contraceptives for various reasons. But mostly, it’s because they saw it as a permanent birth control device. Based on the evidence reports to the FDA, however, it is not an effective form of birth control.
How to Find a Qualified Essure Lawyer In Your Area
If you or a someone you love suffered serious Essure problems after placement, you’re not alone. Thousands of reports about Essure problems have flooded the FDA since its 2002 approval. Fill out this free claim review form to see if you are eligible for compensation for your Essure injury. After submitting your information, a qualified attorney will call to discuss your case. This consultation’s completely free, and you’re under no obligation to use the same lawyer if you move forward. You can ask questions and get confidential advice on how to get justice and compensation you deserve for your injuries.