For many people, contraception is a major health issue and a crucial part of life. There are a number of contraceptive methods available, but they all help prevent unwanted pregnancies. This development has allowed a vast cross-section of people to enjoy more economic freedom without the looming threat of a pregnancy they can’t afford.
This probably accounts for Essure’s relative popularity. The device, produced by Bayer, is a much less invasive option for permanent birth control and has been used by over 750,000 women since it first entered the market in 2002.
So, why did Bayer recently announce that it’s going to discontinue the product in December 2018?
What is Essure?
First, it’s important to understand exactly what Essure is. Essure is a small metallic device made of nickel and titanium that is inserted into the fallopian tubes. A catheter is used to implant two small coils that eventually create scar tissue that prohibits the passage of sperm and, subsequently, the fertilization of a woman’s egg.
The method was initially lauded for its minimally invasive nature and its ability to provide permanent sterilization with no incision. Prior to Essure, the only method of permanent birth control was tubal ligation, which requires anesthesia and major surgery. Essure was seen as a far less risky option.
Essure first began development in 1988 as a project of Amy Thurmond, a doctor, and Julian Nikolchev, a medical entrepreneur. In the 1990s, Nikolchev founded Conceptus, the company that would first sell the device (Bayer later acquired Conceptus in 2013). Clincial trials started in 1998, and the FDA approved Essure for sale in 2002.
Problems Arise
Early on, the side effects and the possibility of major issues were not well-understood, even by the manufacturer of the drug. In fact, many of the major issues with Essure weren’t well publicized until several years after the device’s release.
In 2011, Angie Firmalino, a woman who had undergone Essure treatment, started a Facebook group called “Essure Problems” to share her story with other women. The group quickly ballooned, with thousands of women complaining of major symptoms. These symptoms included:
- Headaches
- Tooth decay
- Abnormal menstrual cycles
- Fatigue
- Abdominal pain
- Bleeding
- Punctures of the uterus, fallopian tube, or even other organs
- Weight fluctuations
- Muscle weakness
In some cases, these side effects led to the device having to be surgically removed, often by hysterectomy. In other cases, the device had failed to work for its intended purpose and resulted in unwanted pregnancies.
The hypothesis was that many women were experiencing a negative autoimmune response after the implantation of the device. Indeed, it appeared that an allergic sensitivity to nickel could be to blame. Despite this, Conceptus had actually asked the FDA to downgrade a nickel allergy to a mere warning instead of a contraindication. As a result, doctors were not required to screen for the allergy.
Continued Pressure on Bayer
As complaints began piling in to the FDA, it was clear that something was not quite right with Essure. In 2016, the FDA required Bayer to conduct a 2,000-patient research study to identify issues with the device. While they complied with this mandate, it didn’t stop criticism from women who had experienced the worst of the device’s side effects.
In 2017 alone, the FDA received over 12,000 complaints about Essure. Bayer also became the defendant in over 16,000 lawsuits as a result of issues related to the device. In April 2018, the FDA applied new restrictions, allowing only women who had read and signed a brochure detailing Essure’s risks to undergo the procedure.
In July 2018, Bayer announced that it was discontinuing the sale of the product, effective December 31, 2018. Bayer spokespeople noted that the discontinuation was only a result of a decline in sales and not a recognition of any safety issues inherent with Essure.
For many women, though, this was a victory against a medical device that had plagued them for years. It’s clear that the pressure placed on Bayer ultimately led to Essure being taken off the shelves.
