Bayer announced in July, 2018 that they will pull Essure permanent birth control off the U.S. market. No more of the harmful devices will be sold after December 31, 2018. (Bayer halted Essure sales outside the U.S. in September 2017).
The company says they are pulling the device for “business reasons” — i.e., due to the device’s sharp sales decline. They also state that they stand by the device’s safety and effectiveness. What they fail to mention are the thousands of women who have suffered needlessly from this dangerous device.
What Drove Bayer’s Decision to Stop Selling Essure Permanent Birth Control In the U.S.?
Bayer’s decision to pull Essure off the market is no surprise. Several events led up to this announcement — a decision many patients consider a “win” for women everywhere.
The first sign Essure could cause dangerous side effects was in Bayer’s 2002 five-year post-marketing study. Researchers found serious complications affecting 1 in 10 women enrolled in this study. But despite these dangerous side effects, the FDA didn’t issue any warnings.
Essure complications, however, kept cropping up. Thousands of women with Essure complications looked for a place to discuss their symptoms and warn others. They congregated in an “Essure Problems” Facebook group online. In 2012, a group representing the women reached out to the FDA. Due to their persistence and adverse reactions flooding the FDA’s FAERS database, the agency held a 2015 public hearing.
The hearing resulted in a black box warning (the most serious one the FDA gives for dangerous devices and drugs). This warning cites serious and persistent pain as well as possible allergic reactions to nickel. It also states the risk for implant perforation, device migration and other possible adverse events. The agency also added a patient decision checklist to help women make more informed decisions about Essure. The FDA’s actions led to a 70% decline in U.S. Essure permanent birth control sales.
In 2017, the FDA reevaluated Essure’s dangers and moved to restrict device sales. They stated that some women were not being properly informed about the risks of Essure before implantation. As a result, a “unique type of restriction” was put in place. Before women could get Essure, the FDA required doctors to thoroughly review this patient brochure with them first. It detailed risks, benefits, and other necessary information about Essure implantation. Only healthcare facilities willing to provide full information became eligible to sell the device.
Why Did So Many Women Choose Essure Permanent Birth Control?
Prior to these restrictions, patients often didn’t know about all possible Essure complications. Instead, doctors sold the Essure sterilization procedure as a safer option than tubal ligation or hysterectomy.
Essure is actually just two inch-long, flexible nickel-and-titanium-alloy coils. During the 10-minute procedure, a doctor inserts them through a woman’s vagina and cervix directly into her fallopian tubes. (The fallopian tubes carry eggs from a woman’s ovaries to her uterus.) Then, scar tissue gradually forms around these coils over a three-month period. This scar tissue helps create a barrier that prevents sperm from reaching and fertilizing any eggs. But adverse events are common — and even likely.
To date, an estimated 750,000 women have Essure permanent birth control implants. And while Essure’s black-box warning lists most potential side effects, it’s not truly complete. Thousands of women reported even more serious Essure complications to the FDA, including:
- Autoimmune problems
- Unintended pregnancies
- Migration of coils into pelvis or abdomen
- Heavier periods
- Pain during intercourse
- Muscle weakness
- Hair loss
- Mood changes (including depression)
- Weight changes
- Joint pain
- Headaches
- Back aches
Bayer faces Essure lawsuits from more than 16,000 injured women. Yet, the company still maintains Essure’s safety and efficacy for patients. They also state that women still using Essure today can “confidently rely on the device.”
The FDA’s History With Essure Permanent Birth Control Devices
Essure has a rich history with the FDA following its initial U.S. market release in 2002. See all FDA actions against the Essure permanent birth control device here.
After Bayer chose to pull Essure off the U.S. market, FDA commissioner Scott Gottlieb issued a statement. The statement outlines the steps the FDA took to regulate the device over the years. But Gottlieb also mentions his opportunity to meet with Essure victims and listen to their experiences.
“Some of the women I spoke with developed significant medical problems that they ascribe to the use of the product,” Gottlieb says. He asserts the FDA’s vigilance in protecting those who already had Essure implanted. He says they will continue to monitor adverse events and other data sources.
The FDA’s involvement with Bayer over adverse events from Essure permanent birth control is far from over — even if it’s no longer available. Because of the significant harm women suffered from Essure implants, the FDA will still accept and track adverse event reports. They will “share what we learn to help doctors and patients make informed decisions.”
Over 16,000 Essure Permanent Birth Control Lawsuits Are Now Pending
Essure being pulled from the market is a win for women everywhere. But it’s important to remember that the damage from Essure has already been significant. Over 16,000 lawsuits have been filed already against Bayer. Allegations include:
- Manufacturing Essure for three years without a license
- Failure to report adverse events as well as concealing them in pre-market studies
- Failure to complete an Essure long-term risk analysis
- Not reporting bowel perforation, broken coils, or migration incidents
- Negligently distributing and marketing Essure to consumers
- Failing to train doctors on proper Essure use and insertion techniques
What Women With Essure Permanent Birth Control Injuries Can Do
If you or a loved one experience Essure permanent birth control complications, you may qualify for compensation. While all sales stop on 12/31/2018, over 750,000 women have Essure permanent birth control devices inside their bodies. Thousands already experienced life-altering events — and will continue to do so in the future.
To check your eligibility for a cash settlement, complete your free Essure claim evaluation today in less than two minutes. Once you’ve submitted your information, an experienced lawyer will call to discuss your case. This phone call is the first step towards getting the justice and compensation you deserve for your injuries.
Related: Essure Complication Risks Highlighted in Netflix Documentary
Mandy Voisin
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.