Essure Birth Control Lawsuit
Marketed as the only permanent birth control with a nonsurgical procedure, Essure is an alternative to having one’s “tubes tied.” Bayer maintains that the product has a long history of safety and effectiveness, but these claims have been questioned by women who allege that Essure seriously damaged their health, as well as experts who see limitations with Essure safety studies.
Essure—a permanent birth control device made by Bayer—is under increasing scrutiny for a wide range of reported side effects.
The FDA recently issued a “black box” warning for the device, while a congressional bill seeks an Essure recall.
Women who underwent an Essure procedure and experienced health complications should know that they have rights, including the right to take legal action against Bayer. Attorneys at ClassAction.com are now speaking with women who were harmed by the device and pursuing lawsuits against Bayer on their behalf.
How Essure Works
Essure is a small, flexible coil insert made from a nickel and titanium alloy. During an Essure procedure, one coil is placed into each fallopian tube. Over a three-month period, scar tissue forms around the inserts, creating a barrier that prevents contraception.
Bayer asserts that when used properly, Essure is 99% effective.
Serious Essure Side Effects
Essure gained FDA approval in 2002. Since its approval, women have reported nearly 15,000 Essure-related adverse events and at least 30 Essure-related deaths to the U.S. Food and Drug Administration (FDA). From 2015 to 2016 alone, the FDA received 11,192 adverse event reports. The most commonly reported problems were:
- Pain, especially abdominal pain
- Heaver menses/menstrual irregularities
- Weight fluctuation
- Device incompatibility
- Device migration or breakage
- Allergic reaction to nickel
- Device not operating as expected
- Malposition of the device
- Unintended pregnancies, including ectopic pregnancies
- Fallopian tube, uterus, and colon perforation
In addition to these side effects, Essure is reported to have caused at least 26 deaths, including four adult deaths, miscarriages, and infants that died shortly after birth. A more recent analysis of Essure adverse events indicates that the device may have caused more than 300 fetal deaths.
Regulatory History of Essure
Initial FDA approval for Essure was granted to Conceptus Inc., which Bayer purchased in 2013. About one million of the devices have been sold worldwide, most of them in the U.S. Since the system’s introduction, the FDA has approved several labeling changes, including a new nickel sensitivity warning (2011), a warning about chronic pain and device migration (2013), and a “black box” warning (2016).
FDA Board Discusses Essure Safety
In response to thousands of complaints from women about Essure, in 2015 the FDA convened a meeting of its Obstetrics and Gynecology Devices Panel. The panel made a number of recommendations, including that certain women—especially those with allergy or hypersensitivity to nickel, chronic pelvic pain, autoimmune disorders, or prior uterine surgery—should not use Essure.
Essure’s marketing approval was based on non-randomized, non-blinded studies that lacked a comparison group.
The panel also took Bayer to task for failing to collect data that might have helped predict risks for women. Echoing other experts, panelists pointed out shortcomings in Essure safety studies. In a piece published by the New England Journal of Medicine, doctors point out that pre-marketing approval of Essure was based on nonrandomized, non-blinded studies that lacked a comparison group. Similar problems exist with post-approval studies, say the doctors.
An FDA panel member noted during the meeting, “Although relatively low rates [of adverse events] were reported in many of these publications, significant limitations must be taken into account when reviewing the data.”
A Bayer official told the panel that the company received 15,000 Essure adverse event reports in the United States. Women claiming to be harmed by Essure gave powerful testimony about health problems the device caused them. They reported autoimmune problems, abscesses and tumors, fatigue, severe muscle weakness, loss of bowel control, and other issues.
In February 2016, the FDA ordered Bayer to conduct a new Essure post-marketing safety study “designed to provide important information about the risks of the device in a real-world environment.”
Congress Introduces Bill Calling for Essure Recall
Despite growing concern over Essure health risks, the product remains available, and the FDA and Bayer have resisted calls to pull it from the market. In November 2015, Congressman Mike Fitzpatrick (R-PA) introduced a bill calling for an Essure Recall.
“If the FDA and the manufacturer of the device aren’t willing to remove this device from the market, then Congress will,” reads the bill.
Essure Victims in Their Own Words
A section of Bayer’s Essure website entitled “Real Stories from Women with Essure” provides testimony from women who have had the Essure procedure.
These anecdotes don’t tell the whole story, though. Conspicuously absent from the website are stories from women for whom Essure did not function as intended.
Here are some less glowing endorsements of the Essure experience:
- “I am in pain every day. Some days are worse than others.” – Cecilia B.
- “Within 12 months of placement, I developed pain throughout my entire body. Don’t let this happen to other women.” – Kim H.
- “There were days when I could not get up out of the bed except to crawl to the bathroom in tears. I felt less like a woman, less like a human. The only, only acceptable solution for the women suffering , the women and children who have died, the families torn apart, is for Essure’s pre-market approval to be revoked.”– Rebecca H.
- “I got Essure months after my 4th child was born. My periods have been heavier and irregular and I had been regular my whole life prior. My hair started to thin, fall out and has become brittle, I always have some random itchy rash on my legs, I have [debilitating] migraines, I have chronic pain especially lower back pain, pelvic pain and pain during intercourse, most mornings I feel like a bus hit me, I have to sleep on a heating pad nightly, moving it from my pelvis to my back. I have memory, concentration, confusion and mood issues. They diagnosed me with Fibromyalgia and ADHD both since the Essure procedure, none of these issues did I have prior, and they all came pretty quick and have not gone away with any treatments.” – Shanna
- “As I was having a procedure to remove the cerclage, which was one of the most traumatizing things I’ve ever had to go through in my life, the high risk doctor performing the procedure stopped abruptly and said ‘what the (profanity) is an Essure coil doing in her vaginal tract?.’ The coil had never implanted in fallopian tube and was floating around inside of my uterus my whole pregnancy. The coil had perforated the amniotic sac causing it to rupture and causing me and my husband to lose our beautiful baby girl.” – Anonymous FDA report
A number of Essure lawsuits have already been filed against Bayer, and many more are expected. Among other things, lawsuits allege:
- Essure is defective
- Essure is unreasonably dangerous
- Bayer failed to comply with federal safety laws
- Bayer knew about Essure side effects but failed to provide proper warnings
- Bayer insufficiently tested Essure
- Plaintiffs would not have used Essure had they been properly warned about its side effects
To be eligible for an Essure lawsuit, a woman must have been implanted with the device and experienced adverse side effects.
Do I Need an Attorney?
Essure is an unusual product liability case because federal laws protect Bayer from certain types of personal injury claims. These laws (so called “federal preemption laws”) have to do with how Essure devices are classified and the way in which Essure was FDA-approved.
The fact that judges have allowed some cases against Bayer to proceed is a good sign for all women with potential Essure claims. Still, unique considerations in Essure litigation means that it is critical to work with an experienced law firm that can put together a case capable of overcoming Bayer’s legal protections.
What to Do If You Are Affected
If you or a loved one implanted the Essure device and feel that it has negatively impacted your health, our attorneys can help.
We are one of the largest and most decorated personal injury firms in the country, and have extensive experience with these types of cases. Contact us for a free, no-obligation legal consultation to determine if you are owed money for damages. You pay nothing unless we win your case.