Thousands of women have reported severe medical issues caused by Essure, a permanent, non-surgical birth control device.
What Is Essure?
Essure is a FDA-approved birth control device that has been on the market since 2002. It was developed by Conceptus, Inc., a subsidiary of Bayer AG. Bayer acquired Conceptus on June 5, 2013. Essure is marketed to women who don’t wish to have any more children. The device uses metal coils placed in the fallopian tubes to form a “natural barrier” to prevent pregnancy. The coils are implanted by a gynecologist at the doctor’s office, and the woman’s tissue grows into the metal coils, thereby blocking conception. Approximately 750,000 of the devices have been sold around the world.
Despite its FDA approval, thousands of women are reporting adverse events related to the device. The FDA released a statement on October 25, 2013 stating that since the product was approved in 2002, it has received 943 reports of adverse events related to Essure.
The most frequently reported physical problems are:
- Menstrual irregularities
- Weight fluctuations
The most frequent device problems reported are:
- The migration of the device or piece(s) throughout the patient’s body
- Patient device incompatibility (e.g., possible nickel allergy)
- Device operating differently than expected
- Incorrect positioning of the device
- Device breakage
An additional 1,000 more complaints have been sent to the FDA in a voluntary reporting system, but physicians are not obligated to report complaints.
Some of the adverse events reported involve severe injury and complications. Many women have reported having to get hysterectomies as part of getting the coils removed. Others have reported that the Essure coils have migrated through their bodies and cut through internal organs. In addition, several hundred of the women have reported that they have gotten pregnant even with the device inserted.
Due to the frequency and severity of these adverse effects, thousands of women are requesting that the FDA pull Essure off the market. They have come together on Facebook, forming a group called Essure Problems, where women can share their stories. It has over 14,000 members and grows every day. Several websites are also dedicated to the issues with Essure, including Essure Problems and a website hosted by Erin Brockovich. Ms. Brockovich has also started a petition to help convince the FDA of the serious dangers of Essure.
The Pre-market Approval Problem
The device was granted pre-market approval by the FDA in 2002. Following the numerous complaints regarding the device, the FDA reviewed the results of a five-year study that was conducted by Conceptus and required by the FDA as part of the product’s 2002 approval. The FDA reported that the post-approval study evaluated the safety of the Essure device, including patient comfort. However, after its review, the FDA reported that although there is evidence of complications, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known. The FDA also reported that they have found no evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. Many women who are experiencing problems with the device are struggling to find redress in courts because the device has pre-market approval from the FDA.