Essure, a form of a non-surgical birth control, is manufactured by Bayer HealthCare. When the product was released, it was marked as a remarkable breakthrough in permanent sterilization and contraceptive device for women.

However, the FDA has received thousands of adverse event reports describing severe side effects from Essure. Some serious adverse side effects from Essure include rashes, bloating, allergic reactions, organ perforation, excessive bleeding, pelvic pain, ectopic pregnancy, and miscarriage.

Women who have suffered from these complications and adverse side effects from Essure have alleged that they were not informed that these side effects would occur.

Side Effects from Essure Birth Control

According to reports, Essure is an implantable device that allows for non-hormonal birth control. Before the device was purchased by Bayer, it was manufactured by Conceptus Inc., a company that designs and markets devices for reproductive medical use.

Conceptus was founded in 1992, it is headquartered in Mountain View, Calif., and started to operate under the subsidiary of Bayer HealthCare LLC in June 2013.

Essure, the form of permanent, non-hormonal birth control, is implanted using a non-surgical procedure in which two flexible coils comprised of polyester and metal are implanted through the vagina and uterus and into each fallopian tube. Once the implants are inserted, tissue begins to form around the metal coils over the next few months, thereby preventing conception.

Women who become implanted with Essure are evaluated by their physicians three months after the device has been implanted to ensure that Essure works properly and that pregnancy is not a likely occurrence.

The Essure birth control device was approved by the U.S. Food and Drug Administration (FDA) in 2002. It is the only non-surgical for the sterilization of women, and it has been publicized as a safer alternative to tubal litigation.

However, though it was approved by the FDA, it was approved through a fast-track system review. And as a result, women have grown concerned to the Essure coils because of their side effects from Essure and the approval of the device before studies studying the efficacy and safety of the device were thoroughly looked into.

Hundreds of thousands of women who have chosen to pursue a type of permanent sterilization and form of birth control have chosen Essure birth control. As a result, however, roughly 4,500 adverse event reports have been filed with the FDA over side effects from Essure and serious complications.

In seeking a recall of the medical device, consumer advocate Erin Brockovich has currently led the campaign. Thousands of women from across the U.S. have complained of serious adverse side effects from Essure and other serious complications and have alleged that the device should have never been approved in the first place. They are currently lobbying the FDA to remove Essure from the market.