Essure Permanent Birth Control: A Threat To Public Safety?

Essure Permanent Birth Control: A Threat To Public Safety? 2016-11-22T09:57:02+00:00

Bayer’s Essure, an implantable device for female sterilization, is heavily promoted as a “safe and effective” option for women seeking a permanent form of birth control who want to avoid surgery. But though Essure, which is implanted through a short in-office procedure, has steadily grown in popularity since it was approved by the FDA in 2002, the device is also increasingly linked to many serious complications and health risks.

“Worry-Free” Contraception Leads To Pain And Suffering

A growing number of women are experiencing severe adverse effects after receiving Essure, including persistent abdominal and pelvic pain, organ damage, autoimmune disorders, and hypersensitivity reactions. Some patients suffer so intensely from these complications that they are driven to undergo implant removal or even hysterectomy, desperate for relief.

Now injured patients are fighting back by filing lawsuits against Bayer with allegations of dangerous product design and active concealment of potential risks.

What Is Essure?

The Essure system is comprised of a pair of tiny, flexible metal coils that are inserted into the fallopian tubes. It was originally developed and manufactured by Conceptus, Inc., a California-based company which was later acquired in June 2013 by German healthcare giant Bayer.

How Essure Causes Sterilization

Each Essure unit is made up of a nickel titanium outer coil and a stainless steel inner coil wrapped in polyethelene fibers. These fibers irritate any fallopian tube tissue that’s in contact with the coils, inciting an inflammatory scarring response. Over time, scar tissue grows inside and around the Essure coils, eventually creating a complete blockage of the fallopian tubes that prevents sperm from reaching the eggs.

essure sterilization device implanted in fallopian tubesThe Procedure

Prior to placement, the device’s inner and outer coils are tightly merged together, so that the unit is as compact as possible. The doctor uses a long, lighted tool called a hysteroscope to feed the implants through the vagina and cervix, embedding them in the fallopian tubes, right at the junction with the uterus.

Once correct placement is achieved, the doctor releases the units. On deployment, the flexible outer coils expand, conforming to the shape of the fallopian tubes and securing the device’s position. The entire process generally takes less than an hour to perform if no complications occur and patients are told they’ll require no recovery time after the procedure.

Falsely Promoted As Non-Surgical?

Though Bayer advertises Essure as “surgery-free” birth control, medical experts have pointed out that while its implantation does not require incisions, the use of a hysteroscope should solidly classify the procedure as surgical.

Bayer also claims that general anesthesia, which patients are often advised to avoid because it can lead to serious complications in itself, isn’t required. However, many women report considerable pain and discomfort during the procedure, and a postmarket study published in the British Medical Journal found that general anesthesia was administered in practice to roughly 50% of the study subjects.

Follow-Up Testing To Confirm Implantation

It takes about 3 months after implant placement for enough scar tissue to develop to completely close off the fallopian tubes. During this period, the patient must use another form of contraception to avoid pregnancy.

After this waiting period passes, a confirmation test is performed to check whether or not the fallopian tubes have been sufficiently blocked. In this test, a radiologist injects dye into the cervix and takes x-rays. If the x-rays show that dye is unable to move past the location of the Essure coils, then the implantation was a success and the patient should be able to rely on Essure exclusively for birth control.

Is The Device Effective?

Though Bayer advertises Essure as more than 99% effective, some studies have found a failure rate of about 10% or higher.  

Additionally, many researchers, consumer advocates and injured Essure patients claim that Bayer deliberately inflated success rates for the device, either through biased, poorly-designed studies or through modifying consumer complaints.

Pregnancy Risk Is Threefold Over Tubal Ligation

Some studies have found Essure much less effective in preventing pregnancy than more established sterilization methods. According to a 2014 study published in the medical journal Contraception, women who undergo Essure implantation for sterilization are over 3 times more likely to become pregnant after the procedure than women who undergo laparoscopic tubal ligation.

Tubal Ligation More Effective

Tubal ligation, a surgical procedure where the fallopian tubes are sewn, clipped, or cauterized shut, is still the most frequently-employed method of female sterilization in the U.S. It’s commonly performed through a minimally-invasive laparoscopic approach that only requires a few small abdominal incisions. But since Essure (also termed “hysteroscopic sterilization”) was introduced, many doctors and patients have selected it over tubal ligation due to its appeal as a supposedly non-surgical alternative, with roughly 750,000 women implanted worldwide according to Bayer.

Yet researchers at Yale University and UC Davis ran a comprehensive, evidence-based statistical analysis of data on Essure and tubal ligation patients, and found:

  • Pregnancy rates over the first year are 57 pregnancies per 1000 women for Essure patients versus 3 to 7 per 1000 women for tubal ligation
  • Total pregnancy rates over 10 years are 96 per 1000 women for Essure and 24 to 30 per 1000 women for tubal ligation
  • Though the data used in the analysis had limitations, these limitations actually likely caused an underestimate of the pregnancy rate for Essure and an overestimate of the rate for tubal ligation.

For example, the data for laparoscopic tubal ligation was taken from a study performed 26-34 years ago, back when laparoscopic techniques were brand-new and less effective than at present.

As for the Essure data, because the total number of procedures was only inferred from Bayer’s estimates of Essure kits sold, the calculated ratio of pregnancies to total Essure users is likely lower than if the authors had been able to correct for numbers of unused kits and failed procedures.

Waiting Period And Multiple Steps Cause Difficulty

In discussing the possible causes for the apparent difference in effectiveness between the two methods, the authors believe that the multistep nature of the Essure procedure is a major factor that makes mistakes or mishaps more likely to occur.  

surgeon delivering baby from Essure patientFor instance, the 3-month period required for Essure alone may put the method at a large disadvantage, as tubal ligation is effective immediately.  Another crucial stage of the procedure is the follow-up test, because it reveals whether or not the implantation was successful. Yet it’s possible that many Essure users may end up missing this step–sometimes due to financial difficulties when the follow-up is not covered by insurance–putting them at risk for unintended pregnancy.

Indeed, according to the authors, levels of actual patient compliance may explain the discrepancy between the high success-rate results released in Bayer’s early studies and those from various later studies.  Study author Mitchell Creinin, professor and chair of the Department of Obstetrics and Gynecology of the School of Medicine at UC Davis, points out that “data presented to physicians and patients

[for Essure’s FDA approval] only included those women who successfully completed all of the steps to be sterilized using the procedure.”  But because patients often have difficulty following the procedure’s requirements in practice, the success rates may be significantly lower than expected, as seen in this study.

Tenfold Risk Of Reoperation

Essure has also been found to require reoperation more frequently than its alternatives. A 2015 study published in The British Medical Journal by researchers at Cornell University followed a total of 8048 women who were sterilized with Essure and 44, 278 women sterilized by laparoscopic tubal ligation in New York State from 2005 to 2013. In the first year after sterilization, women sterilized with Essure required 10 times more reoperations for fixing errors than those who had their tubes tied.

This translates into roughly 21 additional reoperations per 1000 patients, a “serious safety concern” according to author Dr. Art Sedrakyan, who says that “even small risk matters on a population level.”  This risk may become even more of a public health threat as more women adopt the procedure.  The authors found that the number of Essure procedures increased from 0.6% to 25.9% of all surgeries over the study period.

Side Effects

Many women who opt for sterilization have medical as well as personal reasons for doing so, and thus unintended pregnancies should be considered a serious health risk. But in addition to failing for its intended purpose, Essure has been linked to a series of dangerous side effects.

Some complications result from incorrect placement of the implants, while others may arise from an inherent quality of the device, such as metal allergy reactions, which patients typically experience if they have a sensitivity to the nickel titanium used for Essure’s outer coils.

Adverse Reports, Citizen Petition Spur FDA Investigation

After receiving more than 5000 adverse reports about Essure from 2002 to 2015, as well as a citizen petition calling for a ban, the FDA started a major review and investigation on the effectiveness, possible side effects, and complications of the device.