Though Essure, a contraceptive device manufactured by healthcare giant Bayer, is billed as an effective, “carefree” method of family planning, a growing number of women say that Essure sterilization side effects ruined their lives.
Since the device’s U.S. market release in 2002, over 10,000 reports have been sent to the FDA, describing disruptive symptoms such as severe pain, metal sensitivities, digestive trouble, and autoimmune problems. Some women have even reportedly died after complications from Essure.
“Black Box” Warning Not Enough, Victims Say
The high volume of adverse reports, as well as a citizen’s petition organized by members of a grassroots anti-Essure movement, convinced the FDA to take a second look at Essure’s safety profile, and the agency initiated a thorough investigation of the device in September 2015.
Essure victims and their supporters are dissatisfied, however, with the FDA’s 2016 decision to issue a “black box” warning rather than completely banning Essure. But the publicity surrounding the investigation has helped bring important Essure safety issues to light, and many physicians and researchers are now working to understand the root causes of Essure side effects.
10,000+ Complaints Of Essure Sterilization Side Effects
According to the Essure victims’ advocate group Essure Problems, women have suffered over 120 side effects and complications while implanted with Essure, which can be grouped into sub-categories such as allergy symptoms, gynecological issues, autoimmune disorders, gastrointestinal problems and effects on mental health. Here are some of the adverse effects most commonly mentioned in patient reports to the FDA:
- Chronic, severe pain in the abdominal / pelvic area
- Recurring migraine headaches
- Severe abdominal bloating
- Unexplained changes in body weight
- Nearly nonstop bleeding from long or heavy periods
- Rashes and other possible metal allergy symptoms
- Pain during sexual intercourse
- Overwhelming fatigue
Many women have reported experiencing these side effects so severely that they can barely care for themselves without assistance, much less work or care for their families. Some end up hospitalized for weeks while doctors attempt to identify what’s wrong with them, and at least several women are known to have died from potential complications of Essure.
Though Essure is supposed to function as “effective” permanent contraception, with early manufacturer-sponsored clinical trials boasting a 99% success rate, postmarket research tells a different story. For example, in 2014, researchers at Yale and UC Davis released a study where the incidence of unplanned pregnancies among Essure users was 10%, which was 3 times greater than women who’d had their tubes tied.
In addition to its staggering list of potential side effects, Essure can put women at risk for various complications stemming from implantation mistakes, patient-device incompatibility, and device breakage / failure. These include:
When Essure fails for the very function it’s intended for, fertilization can result in dangerous ectopic pregnancy, which is when a fertilized egg takes root in the fallopian tubes instead of moving to the uterus. Since the growing egg can cause a potentially fatal bursting of the fallopian tubes, ectopic pregnancies must be treated with surgery.
Though some women who become pregnant on Essure are able to have normal pregnancies and deliver healthy babies, many instead have miscarriages or still births, which can be a heartbreaking experience. Sadly, fetal death from Essure happens much more than the handful of occurrences the FDA initially found; an independent researcher found over 300 fetal deaths after analyzing the FDA’s database of adverse reports in February 2016.
Placement Errors and Complications
Though the Essure placement procedure is billed by Bayer as simple and straightforward, many adverse reports and patient complaints reveal it can be anything but. In fact, a comprehensive 2015 study published in the British Medical Journal found that women undergoing Essure implantation are 10 times more likely to require re-operation than those undergoing tubal ligation.
Some women describe intense pain during the procedure, and as many as 50% of Essure implantation patients actually receive anesthesia for the pain though it’s supposed to be unnecessary.
Though Bayer provides training for implanting physicians, many doctors still find it exceedingly difficult to achieve correct placement on the first try. After all, they’re unable to confirm whether or not proper placement was achieved until months afterward, via an indirect radiology test.
Some women report having to undergo multiple “do-overs” of the implantation, which sometimes results in women having extraneous Essure coils lodged within their bodies. Heather Walsh, one of the 5 women who filed lawsuits in Pennsylvania against Bayer over Essure, allegedly suffered months of severe pain before discovering that she had been in fact implanted with three coils rather than two.
Considering that the coils are meant to elicit an inflammatory response in the sensitive tissues of the reproductive system, rogue implants can cause a great amount of discomfort or even serious damage. And even when the women and their doctors discover the existence of extra implants, it can be next to impossible to locate them exactly and have them removed, especially if they become lodged in a sensitive area and surrounded with considerable amounts of scar tissue.
Device Migration – Permanent Damage?
One frequent complaint revealed in the adverse patient reports is migration of the Essure implants from their proper placement at the far end of the Fallopian tubes, with a portion of the coils projecting into the uterus.
As we know, the inner coils of Essure are wrapped in PET fibers that cause scar tissue to form. If the implants end up somewhere near the abdominal cavity, they can create masses of scar tissue that can lead to abdominal pain, bloating, digestive issues and other complications. Furthermore, the sharp ends of Essure coils can easily puncture organs, with some women eventually finding stray implants embedded in their intestines, uterus and stomach.
Autoimmune Disorders – Chronic Diseases
Some women are able to find relief after having an Essure removal surgery or hysterectomy. But for victims who developed chronic disorders after being implanted with the device, the nightmare may never end. Women have reported falling ill with lupus, Crohn’s disease, and other chronic disorders that severely impact patient health and quality of life. Some have even developed multiple diseases.
Shockingly, Bayer has admitted to being aware of the risks of developing autoimmune diseases from Essure. In a recent news interview, Dr. Edio Zampaglione, Bayer’s Vice President of U.S. Medical Affairs, dismissively acknowledged that Essure can cause autoimmune disorders, saying that the incidence of such problems is “much less than 0.1%.” Even if this figure is true, it still could mean that hundreds of women may have developed these chronic disorders, since Bayer estimates that about 750,000 women have been successfully implanted with Essure to date.
Though it’s not exactly understood why Essure is linked to the development of these autoimmune disorders, some experts, such as immunologist Dr. Amy Reed, a noted consumer advocate for victims of medical device-related side effects, believe that the connection is based in the immunological effects that the device was designed to cause. Dr. Reed points out that commonly-cited adverse Essure effects, such as rapid hair loss, weight fluctuations, and skin problems, are “classic symptoms of an immune system gone awry.”
Some Essure side effects are thought to be caused by Essure’s nickel titanium outer coil, as nickel is a common metal allergy, especially in women. Two metal industry experts gave presentations at the 2015 FDA panel meeting on Essure, sharing their theories on the root causes of metal sensitivity symptoms in Essure users and possible methods of improving the device.
Nickel Leaching From Subpar Metal Finishing
Ryszard Rokicki, a researcher in metal finishing, spoke about the difference between Essure and other metal-containing medical devices such as stents (artificial heart valves). He believes that adverse Essure effects stem from metal impurities in the device’s outer coils, which develop during the manufacturing process. These potentially toxic impurities can be released into the body if the metal surface isn’t properly finished, leading to nickel leaching that can prove “catastrophic,” especially in patients allergic to nickel.
Stents, Rokicki points out, are constantly exposed to bloodflow, which acts to wash away residues. But Essure is purposefully embedded in the fallopian tubes, an environment that allows for the accumulation of wastes. Though the metal residues don’t pose much of a problem when diluted with blood and removed through blood-filtering mechanisms, a buildup of this material can greatly increase the likelihood that patients will suffer from metal sensitivity symptoms.
Currently, the manufacturing quality of Essure devices is only monitored through visual inspection. Rokicki believes that enacting more stringent quality control measures, as well as employing highly-effective (and inexpensive) chemical testing, to monitor metal surfaces could easily reduce the incidence of severe Essure side effects in patients.
Defects Could Weaken Essure Coils
In the slideshow for his FDA panel talk, metallurgical engineer Mark Bell showed photos of microscopic imperfections on the surface of Essure coils. He explains that these imperfections, which include cracks, occlusions, and kinks, may cause Essure to “fail and break in service,” potentially leading to device breakage, organ perforation, coil migration and other serious complications.
Can Removal Alleviate Side Effects?
Driven to despair by severe side effects, many victims end up seeking the removal of their Essure implants. Even though the device is designed to be permanently implanted, a few physicians, such as Dr. Charles Monteith, a former Planned Parenthood director who now specializes in sterilization reversal, have delved into developing and perfecting various Essure removal techniques to help women seeking relief from the implant’s alleged complications.
In order to have the best chance of curing patients of side effects, it’s of prime importance to remove the Essure implants intact, with no left-behind fragments that might continue to exert adverse effects on the patient. On his comprehensive website, Dr. Monteith details pros and cons of each option for Essure removal and reversal:
- Hysterectomy. Removal of the uterus, which can be performed with or without salpingectomy (removal of the fallopian tubes).
This is the procedure most commonly performed for Essure removal, because it’s one that most patients’ doctors have been trained to perform. Unfortunately, due to Essure’s typical placement at the very junction of the fallopian tubes and the uterus, as well as the great variation in fallopian tube shape among different women, it can be easy to accidentally break or fragment the Essure coils during hysterectomy. Also, many women would prefer not to have their uterus removed.
- Manual Traction. Removing Essure implants by feeling for the tip by hand, making a small incision, then pulling the coil out carefully with forceps or another gripping device.
When Dr. Monteith first started studying Essure removal, this was his go-to procedure. But he soon discovered that this method made it very easy to leave coil fragments, because Essure’s outer coils can be very delicate, especially when stretched by pulling.
- Salpingotomy. Making a long incision in the fallopian tube directly above the implant and pulling it out.
Dr. Monteith considers this method better than manual traction because it requires less pulling on the implant. However, both this method and manual traction are far more effective in patients who request Essure removal within 3 months of implantation, when the scar tissue barrier has not completely formed yet.
- En Bloc Dissection. Dissecting and removing the implant along with surrounding scar tissue.
For patients who’ve had Essure for longer than 3 months, this is the current method of choice, as it practically ensures that no fragments will be left behind.
- Reversal by Tubouterine Implantation. Microsurgery that involves removing the blocked portion of the fallopian tubes, creating new holes in the uterus, and reconnecting the tubes.
Unlike the previous procedures, this method aims not only to remove Essure, but also to restore the patient’s fertility. According to Dr. Monteith, it was actually first performed in the early 1900’s on women who had developed fallopian tube blockages from natural causes and wanted to become pregnant.
Sadly, most women have severely limited options for Essure removal, since doctors are generally only trained in hysterectomy. As we’ve seen, even after a hysterectomy, patients may still experience side effects stemming from Essure fragments if their doctor accidentally breaks the device while removing the uterus. And for women who may have already developed chronic diseases from Essure, even complete removal may not alleviate all of the symptoms they suffer.
How Soon Did Bayer Know Of Essure Side Effects?
Victims of Essure sterilization side effects accuse Bayer of concealing adverse effects from the FDA and the public with false / misleading marketing methods. Some harmed patients have started taking legal action against the manufacturer for damage to their health that they say would have never happened if they’d been fully aware of Essure’s risks. According to patient lawsuits, Bayer’s “unscrupulous” promotion of Essure began before the device was even FDA-approved.
A source of possible evidence for these claims is testimony from participants of early Essure clinical trials. Women who served as subjects for these studies have stepped forward, publicly describing how Bayer-sponsored researchers attempted to influence patient feedback. One prominent voice among these patients is Essure Problems administrator Kim Hudak, who says that clinical trial questionnaires were designed to artificially encourage positive responses from participants. Hudak reports that researchers also instructed patients to answer these questionnaires in a certain way.
For example, she remembers being told to mark Essure’s comfort level as “excellent” as long as she couldn’t feel the device inside her, and having her complaints of pain dismissed as “unrelated” to Essure. Other participants speak of discovering their questionnaires being physically altered, with negative responses and comments “crossed out.”
The FDA is still in the process of investigating these accusations, which the agency received in a citizen’s petition organized with the help of Essure Problems.
Influx Of Lawsuits
Now that the first 5 Essure lawsuits have been allowed to advance in Pennsylvania, nearly a thousand more women have risen to exercise their legal rights against Bayer. Over 25 lawsuits representing hundreds of Essure victims throughout the country are currently pending, and with so many women implanted with Essure worldwide becoming aware of the device’s perils, the number of lawsuits is expected to rise sharply.