FDA Adds Black Box Warning for Essure’s Health Risks

The contraceptive device Essure is linked with thousands of serious adverse event reports.The contraceptive device Essure is linked with thousands of serious adverse event reports.

On March 30, the U.S. Food and Drug Administration (FDA) issued a new Black Box warning for the dangerous contraceptive device Essure. The regulatory agency found that the permanent, non-surgical sterilization method marketed by Bayer AG has been associated with many serious threats to the patients’ health.

In 2002, Essure revolutionized  birth control by seemingly providing a permanent method of contraception that was both non-surgical and non-hormonal. However, thousands of women who have used this method of birth control made the FDA and general public aware of certain dangers including a risk of a punctured uterus and pelvic pain. Despite this new information, this product is still available as a permanent method of sterilization.

When it was first released, Essure promised a previously unheard-of alternative to complicated, painful, and potentially dangerous sterilization methods. By creating benign scar tissue within the fallopian tubes, it blocked them, thus preventing pregnancy. Other permanent birth control methods required surgery and anesthetics, yet Essure can be administered in a day-hospital setting and without general anesthesia.

In spite of all of its promises, thousands of women have lived in pain after being implanted with this device. One of them, in particular, spent several years with the agony of excruciating pelvic pain. At the time of the initial procedure to insert the coils, her surgeon suspected that the operation was not successful despite their inability to locate the micro-insert in the right fallopian tube. After failing numerous times to identify it as the cause of her symptoms, her doctors eventually performed various invasive, exploratory surgeries in order to locate a migrating Essure coil. They observed the fragment resting temporarily in various organs (along the intestines, behind the liver) before finally discovering it embedded in the omentum adjacent to the stomach.

In another one case, the contraceptive device pierced the patient’s intestines, resulting in vomiting, weight gain, bloating, and nausea in addition to the aforementioned punctured uterus. This bowel perforation and subsequent obstruction posed a significant danger to the woman’s health, and, as a result, she required a surgical removal of her contraceptive. All of this took place after a normal installation procedure that showed no signs of any health hazards.

These stories are not the only ones where a patient who suffered a serious injury after being implanted with Essure. The shared experience of chronic complications unifies thousands of such women online via the Facebook group Essure Problems, in the struggle to prevent other patients from becoming victims like them. Through speaking out and demonstrating publicly, these “E-Sisters” prompted the FDA to reevaluate its approval of the hazardous device. Though it did not risk diminishing the present manufacturer’s profits, the FDA found it necessary to inform women of the dangers of Bayer’s permanent birth control option

In spite of the mounting evidence that this medical device is dangerous and potentially life-threatening, the FDA has showed no intent to remove it from the market. Meanwhile, its popularity has significantly decreased as more and more victims of this unsafe treatment come forward to express their discontent with what is considered acceptable medical practice. What’s more is that while this can be administered painlessly, to remove the life-threatening coils used by Bayer, women have to undergo expensive and potentially painful surgery.

Article written by Bo Graham

 

REFERENCES

  1. US Food and Drug Administration (FDA). Update on the status of FDA’s evaluation of the Essure System. www.fda.gov (Accessed August 2016)
  2. Cherel, Christina. “Essure and Challenges in Contraceptive Choice.” Women’s Health Activist 41.2 (2016): 11–13. Print.
  3. Mantel, Hendrik T.J., Jacobus Wijma, and Adrianus P.M. Stael. “Small Bowel Obstruction and Perforation after Essure Sterilization: A Case Report.” Contraception 87.1 (2013): 121–123. Web.
  4. Pyke R, and Blackwood LR. “Complication of the Essure Implant Sterilization Procedure: A Case Report.” Journal of Gynecologic Surgery 24.1 (2008): 37–42. Print.
  5. Rice, Sabriya. “Is Essure Warning a Game Changer?” Modern Healthcare 46.10 (2016): 12–12. Print.