What is Essure?
Developed by Conceptus Inc., a subsidiary of Bayer AG, the Essure system is a type of permanent birth control for women. It cannot be reversed. During insertion of the Essure system, a hysteroscope, which is a flexible tube with a small camera, is inserted through the vagina, into the cervix, and up into the uterus. Once the openings of the fallopian tubes are seen, small metal and fiber coils are passed through the hysteroscope and into your fallopian tubes. The system causes scar tissue to form around the coils, blocking the fallopian tubes and preventing sperm from reaching the egg. The Essure system takes three months to become effective in preventing pregnancy. In some women, it can take up to six months.
The Essure Procedure
The actual procedure takes around 10 minutes for a trained physician and can be performed in a doctor’s office. General anesthesia is not needed, although despite this, some women have claimed a considerable amount of pain during the procedure. A follow up procedure is performed three months after the original procedure to confirm that the fallopian tubes are completely blocked.
What are the risks?
Essure was approved by the FDA back in 2002, and it was not until 2013 that the complications came to light. There have been over 4,000 reports of serious complications related to the device. Some of the more dangerous risks include:
- Severe back and pelvic pain
- Heavy, prolonged menstrual periods
- Coils that pierced the fallopian tubes, lodged in other organs
- Tubal blockage occurring only on one side
- Infection
Essure Lawsuit
There is considerable controversy surrounding the Essure system, with thousands of women coming forward with claims. Hundreds of women have become pregnant after having the procedure done, and even more have reported severe bleeding. Most women have no choice but to have a hysterectomy done, in order to clear out any remaining coils that could be lodged into organs. According to the FDA, around 750,000 women have the Essure implant and 943 have reported some form of severe side effect.
In 2003, a safety trial that included 269 women, ages 23 to 45, the device was successfully inserted into 200 patients. In nine of the women, a coil perforated the fallopian tube, and was expelled or lodged in the body. In addition, the patients were asked to keep diaries. Nearly one in ten women noted painful intercourse, while one in eight reported painful menstrual periods during the first three months. Recently, Erin Brockovich started a website to help the fight against Essure, and to create a place where women can share their stories.
Due to federal preemption, which is when a certain medical device or drug has received premarket approval from the FDA, it’s possible that the women claiming these terrible side effects will not be able to file lawsuits against Bayer. Online, victims of Essure are rallying together in their suffering, and forcing the FDA to stop and look at this defective product.
In July, the first lawsuit against Essure and Bayer was filed. The lawsuit claims that Bayer broke the conditions for federal preemption, making the Conditional Premarket Approval invalid and the product adulterated. In addition, the lawsuit accuses the manufacturer of actively concealing negative reports about Essure from the FDA, and they are asking for $50,000 for compensation and delay damages.
If you, or a loved one, had the Essure implant and suffered adverse side effects, you may be entitled to compensatory damages. Read more about Essure here: https://www.nationalinjuryhelp.com/defective-products/essure-contraceptive-implant-lawsuit/
Sources: Mayo Clinic, ABC, KFOR, NY Times
