Bayer has announced Essure Birth Control will be completely discontinued by December 31, 2018.
What is Essure Birth Control?
Approved by the FDA in 2002, 750,000 women have chosen Essure as a permanent, non-hormonal form of birth control. The device itself is a metal coil that doctors implant into each Fallopian tube through a non-surgical procedure. While the insertion only takes a few minutes, the negative side effects can last much, much longer.
How Does Essure Work?
Essure, marketed and distributed by Bayer Healthcare, is designed to provide a barrier within the fallopian tube, protecting a woman’s eggs from fertilization. The device itself contains small fibers designed to induce inflammation. After insertion, scar tissue forms around the implant over a period of three months. Once fully formed, the tissue blocks sperm from reaching an egg, thus preventing an unwanted pregnancy.
What Are The Problems With Essure?
Thousands of women have complained about serious health complications after choosing Essure permanent birth control and claim they were never informed about the serious risks associated with the product. Bayer Healthcare has failed to warn women of these terrible side effects linked to the product. Potential problems include:
- Severe pain
- Vaginal bleeding
- Punctured uterine wall and/or fallopian tubes
- Perforation or expulsion
- Metal toxicity
- Weight gain and extreme bloating
- Device breakage or migration
- Skin allergies
- Joint pain
- Nausea and vomiting
- Unwanted pregnancy
The device is intended to be permanently placed, however, some women’s symptoms have been so severe, they were forced to have the device removed. Despite removal, symptoms may continue, especially if pieces of the device dislodge and remain inside the body. Some report needing a hysterectomy to completely remove remaining fragments of Essure, and as many as 26 deaths have been reported to be associated with Essure.
What Has The FDA Done With Essure in the Past?
Evidence shows the FDA may have approved Essure permanent birth control without sufficient or complete data supporting its reliability and safety. The FDA received more than 5,000 medical device reports related to Essure between 2002 and 2015. In September of 2015, an FDA Advisory Committee held a meeting to examine the safety concerns and complains with Essure. The committee concluded that Bayer must conduct a postmarket surveillance study to gather more data about both the risks and benefits of the sterilization method. The FDA also decided Bayer must also include both a warning that advises women of the risks and a Patient Decision checklist to the product label.
Is There a Recall Against Essure?
While an official recall was not issued, on July 20, 2018, Essure announced it will stop selling the device by the end of 2018. Its manufacturer Bayer cites “business reason” as the reason for discontinuing the product. The company stated the decision is “based on a decline in U.S. sales of Essure in recent years” and says the business is no longer sustainable. This comes after pressure from women across the world whose lives have been radically changed by the birth control. Several of these stories were detailed in the 2018 Netflix documentary called The Bleeding Edge. However, Bayer continues to stand by its claim that the product is safe and effective.
Do I Have a Case Against Essure Permanent Birth Control?
The Ruth Law Team is investigating claims on behalf of women who believe Essure caused their health complications. If you believe this form of permanent birth control has caused your injury, contact our experienced product liability attorneys at The Ruth Law Team at 1-888-783-8378. As always, your initial consultation is completely free.