However, many Essure victims, as well as patient advocates, physicians, researchers and legislators, are criticizing the FDA’s response. They believe the agency should instead completely ban the “high risk” device to protect the public from its risks and to support the legal rights of the growing number of patients filing Essure lawsuits.
What Is Essure & How Does It Work?
Essure is a female contraceptive device currently manufactured by Bayer, a leading multinational healthcare corporation based in Germany. The device was originally designed and manufactured by Conceptus, Inc., a California company that has since become a Bayer subsidiary.
How does Essure sterilization occur? Basically, the Essure device consists of two tiny metal coil-shaped implants with inflammatory properties. One Essure implant is placed in each fallopian tube, and after several months, enough scar tissue forms in and around the coils to block off sperm from reaching the eggs, preventing fertilization.
According to Bayer, Essure placement is a simple, straightforward in-office procedure that generally takes less than an hour to complete, and requires no anesthesia or recovery time for patients afterwards. The implanting physician inserts a special delivery catheter in through the vagina to position both Essure implants simultaneously, right where the fallopian tubes meet the uterus.
Essure implants are about four centimeters in length, with a nickel titanium outer coil and a stainless steel inner coil loaded with fibers of PET (a type of polyester). When inside the delivery catheter, the inner and outer coils are tightly wound together, so that the device is as compact as possible. After an implant is released, the outer coil expands to snugly fit the inside of the fallopian tube, holding the device in place securely.
Over time, the irritating PET fibers from the implants’ inner coils elicit a scarring response in the surrounding fallopian tube tissue, and in a period of about three months, the scar tissue formation should close off the opening completely.
Three months after implantation, patients need to undergo testing to determine whether or not the implants worked as planned. Until then, they’re instructed to continue using contraception to avoid getting pregnant while the scar tissue blockage is still forming.
The standard confirmation test is a modified hysterosalpingogram (HSG), performed by injecting a fluorescent dye into the cervix and monitoring the flow of the dye with x-rays. If the dye’s movement stops around the area where the Essure coils were placed, then the procedure is judged to have been a success.
Recently, the FDA also approved Essure confirmation testing with transvaginal ultrasound (TVU) as an alternative to the HSG test that doesn’t require x-rays. This method allows doctors to visualize the area near the Essure implants using a vaginal probe that emits sound waves.
How Is Essure Causing Problems For Its Users?
Though the Essure system is heavily advertised as “worry-free,” thousands of patients have encountered problems at every point of the procedure—during placement, at the confirmation test, and even after having the implants for years—and many women feel that severe side effects and complications from the device have torn apart their lives.
Failing As Birth Control
Early clinical trial data for Essure boasted a 99% success rate. However, postmarket research reveals much lower rates. For example, a 2014 study conducted by researchers at Yale and UC Davis cites a 90% success rate, with an estimated 10% of women becoming pregnant after a successful Essure implantation. Furthermore, the researchers found that women on Essure were 10 times more likely to become pregnant over a 10 year period than women who had their tubes tied. The study authors cite the long barrier formation period, placement errors, and insufficient follow-up as leading causes of these device failures, though they may also be caused by device breakage or other malfunction.
Complications Requiring Re-Operation
A 2015 study published in the British Medical Journal found that women undergoing Essure sterilization are 3 times more likely to require correction surgery than those who had tubal ligation.
There’s tragic irony in such an elevated risk of re-operation, considering that one of Essure’s supposed advantages for patients is its “surgery-free” implantation. In truth, though Essure implantation is indeed non-incisional, hospitals, medical boards, and insurance companies actually do consider the procedure to be surgery, because it’s performed with a surgical hysteroscope.
In any case, as researcher Dr. Art Sedrakyan of Weill Cornell Medical College points out, women who opt for Essure to avoid surgery may be ill-advised, as they may end up having to undergo correction surgeries far more invasive than “the laparoscopic tubal ligation they could’ve had in the first place.” Based on national sterilization surgery statistics and extrapolation of his study results, he estimates that more than 10,000 women over the past 5 years needed “additional surgery” due to receiving Essure.
Harsh Side Effects
The FDA has received over 10,000 complaints about Essure since its approval back in 2002. The frequency of these reports has been increasing tremendously, particularly after 2013. The FDA did an analysis of its adverse event report database and found that over 4,000 entries were sent from October 2013 to June 2015—just under 2 years. The analysis also revealed some of the most commonly-cited side effects and complications:
- Severe fatigue / sleepiness
- Jarring changes in body weight
- Intense pelvic or abdominal pain
- Coil migration through the body
- Broken or malfunctioning device
- Recurring headaches, including migraines
- Menstrual irregularities such as unusually long periods
- Symptoms indicating patient-device incompatibility (e.g. metal allergies)
Many reports described users suffering from multiple side effects. Worse yet, the problems listed in these reports may represent only a small fraction of the wide variety of side effects experienced by Essure patients. Some victim advocacy groups have recorded over 120 different side effects encountered by members, which can be roughly organized into categories such as blood disorders, allergy symptoms, autoimmune diseases, and so on.
Victims Share Experiences In “Essure Problems”
In 2011, a group of women suffering from Essure side effects decided to start a Facebook page called Essure Problems to warn friends and family about the potential risks of the contraceptive device. The page quickly attracted attention, especially from other Essure users around the world who were struggling with adverse effects of the implants and had looked everywhere for answers to their health concerns. Finding other women who were going through the same hardships was an immense relief for many.
This is because until recently, most doctors and other medical professionals, to say nothing of patients, were unfamiliar with Essure’s potential – and apparently common – side effects. The adverse reactions weren’t listed on product labeling and were mostly absent from Essure clinical trial summaries. Essure Problems grew steadily as more and more women sought advice and help from fellow victims, eventually reaching over 30,000 members.
Today, Essure Problems remains an invaluable source of helpful information and support for victims, but it has also evolved into a notable grassroots movement fighting for an Essure ban. Many Essure Problems administrators work tirelessly to spread word of the urgent issues surrounding Essure, often traveling to press conferences, meetings, and workshops around the world at their own expense.
After Citizen Petition, FDA Holds Panel Meeting
One particularly influential action organized by Essure Problems was a citizen’s petition filed with the FDA, calling for a ban of Essure. This petition, which accused Bayer / Conceptus Inc. of violating multiple FDA regulations in the manufacturing and marketing of Essure, was signed by over 2,000 women.
After receiving the petition, along with thousands of adverse event reports, the FDA decided to carefully re-evaluate Essure’s risk-benefit profile. The agency began the investigation by holding a three-day meeting of its Obstetrics and Gynecology Devices Panel in September 2015.
Essure Safety, Studies Called Into Question
This meeting included a background presentation on Essure, a public hearing section where audience members were invited to present their concerns, opinions, and any relevant information, and a final discussion, which concluded with specific recommendations from expert panel members. Here are some of the recommendations given to the FDA:
- Find out how to improve training for implanting physicians
- Learn more about metal allergies in the patient population for Essure
- Raise awareness of possible risks, especially among prospective users
- Increase access to proper Essure reversal or removal surgery
- Shed more light on Essure side effects by conducting more postmarket research
- Avoid bias by having studies performed by researchers not sponsored by Bayer
- Demand rigorous data from controlled, randomized studies
Some panel members felt very strongly about the issue of bias or lack of scientific rigor in early Essure studies. For example, physician Dr. Julio Novoa, an obstetrician-gynecologist from Texas who’s been practicing for over 20 years, noted the obvious contrast between the rosy patient satisfaction scores from clinical trials and postmarket complaints, arguing that “the FDA’s reliance on company-sponsored clinical data is by its very nature flawed.”
Regarding the question of study design, Dr. Rick Chappell, a professor of biostatistics and medical informatics at the University of Wisconsin, stated in no uncertain terms that he felt more rigorous data could have prevented many women from suffering: “[W]e find ourselves in a situation, 13 years after this device was approved by the FDA, of asking ourselves about pain and bleeding irregularities and other very common outcomes. And we are doing so because this was approved on the basis of a so-called pivotal trial which was not randomized, not controlled.”
FDA Review Leads To “Black Box” Warning
After convening the panel meeting, the FDA continued to investigate Essure by poring over the latest medical research, adverse event reports, and patient comments from a public FDA docket as well as from social media, letters, and interviews.
Then, in late February 2016, the agency released its plans for action:
- Bayer will be required to conduct more postmarket research on side effects
- Product labeling will be updated with a “black box” warning (the FDA’s highest level of product alert) that lists commonly-cited adverse effects
- Patients looking to undergo Essure implantation will be provided with a “Patient Decision Checklist” to help ensure that they’re fully aware of risks
The FDA also posted a draft of the product label changes and Patient Decision Checklist for the public to review and submit feedback on.
An Essure Recall / Ban Would Boost Victim Rights
However, many injured Essure users and their supporters, as well as legislators and prominent figures in the medical community, consider anything short of a complete ban on Essure to be an insufficient measure. Leaving Essure on the market, they believe, would only allow even more women to fall victim to its potential side effects.
Furthermore, Essure’s FDA-approved status affords Bayer considerable legal protection against civil lawsuits, which makes it especially challenging for women harmed by the device to seek compensation for pain, suffering, and financial loss needlessly inflicted on them.
This protection comes from the FDA’s chief role in overseeing the approval, manufacture, and marketing of “high risk” medical devices. Most medical device lawsuits filed by patients are based on state consumer protection laws, but these are considered “preempted” (overridden) by regulations established by the FDA. Thus, as long as Bayer is thought to be following the necessary FDA requirements for approved devices, victim lawsuits may be vulnerable to dismissal on the basis of “federal preemption.”
But if the FDA were to revoke its approval of Essure, Bayer would lose this immunity, simplifying the legal process for current and future Essure plaintiffs.
Essure Lawsuits Survive Bayer’s Dismissal Efforts
Though members of Congress have recently proposed two bills—the E-Free Act and Ariel Grace’s Law—that would remove the threat of federal preemption for Essure litigants, the acts still have far to go in the legislative process before they can be enacted. Meanwhile, more and more women report suffering Essure complications that they believe were caused by misconduct from Bayer, such as misleading advertising and substandard manufacturing practices.
As a result, and especially since the right to initiate legal action over injuries is time-constrained by state-specific “statutes of limitations,” many patients are choosing to file lawsuits as soon as possible instead of waiting around for legislative changes.
So far, the progress of these lawsuits has been fairly promising.
Pennsylvania Lawsuits Move Forward
A March 2016 court order from federal judge John Padova for the Eastern District of Pennsylvania permitted five Essure lawsuits to proceed, refusing Bayer’s request to have them completely dismissed based on federal preemption and other legal defense arguments.
Though Judge Padova dismissed many of the legal arguments against Bayer, he allowed two – “negligent misrepresentation” and “failure to warn” – to proceed unchanged. He is giving the plaintiffs the chance to amend and re-submit several other allegations.
CA Suits Not Disqualified By Preemption Or “Late” Filing
On August 2, 2016, Judge Winifred Smith of the Superior Court of California, County of Alameda, denied Bayer’s motion to invalidate eleven Essure lawsuits, instead giving permission for them to proceed based on four counts—negligent misrepresentation, fraudulent misrepresentation, breach of express warranty, and failure to warn (whether based on negligence or strict products liability).
Judge Smith did not find any of the counts to be federally preempted. She also gave plaintiffs leave to amend any dismissed counts, and rejected Bayer’s argument that their lawsuits were filed too late according to California’s statute of limitations.
You can learn more about these developments and the relevant legal theories behind them on our Essure lawsuits page.
Is Essure Litigation Mounting?
An estimated 750,000 women have been implanted with Essure since the device’s release in 2002, and with the increasing volume of side effect complaints to the FDA, it’s likely that we’ll soon see a considerable surge in the number of lawsuits from Essure patients.
Even now, over 25 lawsuits filed on behalf of hundreds of women are currently pending in district courts throughout the U.S., and many women from all over the country are in the process of working with Essure attorneys with plans to take legal action against Bayer.
Further Essure Reading