When Harmful Side Effects Necessitate Essure Reversal Or Removal

When Harmful Side Effects Necessitate Essure Reversal Or Removal 2017-07-03T12:05:49+00:00

After experiencing severe side effects, many Essure patients have been forced to undergo life-changing surgical procedures.

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Essure, an implantable device that sterilizes women by closing off their fallopian tubes, has gradually emerged as a leading alternative to tubal ligation after its FDA approval back in 2002. However, in recent years, thousands of women have reported a host of severe side effects from the implants, and a growing number of patients now seek Essure reversal or removal surgeries.

Unfortunately, because most surgeons are unfamiliar and/or inexperienced with less invasive removal techniques for the device, many women are practically forced to undergo hysterectomy to gain relief from Essure-related symptoms.

What Is Essure & How Is It Implanted?

Essure permanent birth control consists of two small metal coiled implants designed to be fitted into the fallopian tubes. These “micro-inserts” are implanted via an in-office procedure by Essure-trained physicians, with the help of a hysteroscope (a long, lighted tool with a camera) and a delivery catheter.

After implantation, the coils, which are initially kept in place with flexible nickel titanium that fits snugly against the walls of the fallopian tubes, irritate surrounding tissue.  This irritation, caused by a coating of inflammatory PET fibers (polyester), leads to the formation of scar tissue.  Over several months, the scarring accumulates into a solid barrier that prevents sperm from reaching the patient’s eggs.

Why Patients Seek Essure Removal

Essure implantation was designed to be an irreversible procedure, but talented specialists have nonetheless found success in developing and improving methods for Essure removal and reversal, to help patients who wish to have the device removed without having to undergo hysterectomy with salpingectomy (removal of the uterus and fallopian tubes). The main reasons for removal include:

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Alleviating Overwhelming Side Effects

Though Essure is advertised as “safe and effective,” thousands of women reported to the FDA that the device not only fails to prevent pregnancy, but also can cause a host of severe side effects. Leading complaints are intense pain, abnormally heavy or constant menstrual bleeding, bloating, hair loss, and fatigue.

Often, women report multiple side effects, and many patients say that adverse effects attributed to Essure caused them to lose work, disrupted their spousal and family relationships, and all but ruined their health.

Device Complications

When Essure was first approved by the FDA, one of the main concerns that the agency had about the device was how difficult the initial placement procedure could be, especially for newly-trained physicians.

Indeed, Essure can be extremely difficult to implant correctly, a problem discussed at length during the FDA’s 2015 panel meeting, during which doctors, medical researchers, healthcare advocates and patients discussed pressing issues affecting Essure users. Dr Charles Monteith, a speaker at the meeting who is now a leading Essure removal / reversal specialist, described how, back when he used to implant Essure, he dreaded the procedure’s unpredictability — he was “never sure” that implantation would go as planned. Much of the difficulty stems from how vision of the placement site is often limited and the fact that both Essure implants must be placed at the same time.

This means that, particularly for physicians with little experience implanting Essure, various potentially-dangerous complications may occur during implantation:

  • Implants not placed far enough in the fallopian tubes, risking migration to the uterus
  • Implants placed too far into the fallopian tubes
  • Sharp ends puncturing surrounding tissue or organs
  • More than two implants placed accidentally after multiple “do-overs”

Restoring Fertility

Other women may wish to reverse their Essure procedure rather than just removing the implants because they want to become pregnant. Though reversal can be riskier and more difficult than removal, Dr. Monteith and other sterilization reversal experts are constantly working to fine-tune their techniques and to develop new ones, with efficacy and patient safety / comfort in mind.

Crucial Concerns In Essure Reversal or Removal

As with any surgery, physicians seek to minimize risk of complications. But a vital consideration in Essure removal surgery is to remove the implants intact. This avoids the possibility of leaving behind harmful metal or fiber fragments, and also ensures that the implants can later be meaningfully examined for insight into what may have caused the patient to suffer side effects, if that was the reason for removal.

Preventing Complications

Intact removal is of chief importance for women who seek Essure removal in hopes of alleviating detrimental side effects. Even the smallest Essure remnant could continue to exert adverse effects on a patient, especially for those who are experiencing metal allergy symptoms or autoimmune problems thought to be caused by the device.

Even if the patient hadn’t yet experienced adverse effects from Essure and was seeking removal for a different reason, leaving fragments may cause her to start developing symptoms or problems. The scar-inducing PET fibers that coat Essure’s inner coil portion, in particular, have the potential to wreak havoc on the patient’s health if scattered internally. For example, some women have been told by their doctors that Essure fragments which migrated to their abdominal region caused the growth of bulky masses of scar tissue, resulting in recurring digestive problems and pain.

Legal Considerations – Preserving Evidence

Another reason why it’s crucial to remove Essure intact is because the implants may serve as important evidence for patients who plan to file a lawsuit against Bayer over Essure side effects. The condition, placement, and other details about the implants could have a considerable effect on the strength of a patient’s case.

It’s best for any patients who are in the process of filing an Essure lawsuit (as well as those who plan to file in the future) to discuss removal surgery options with their doctors and attorneys, so that the surgery can be carefully planned out according to legal requirements.

The Challenge Of Intact Removal

Unfortunately, it can be exceedingly difficult to extract Essure implants without fragmentation. After all, Essure was designed to lock itself securely into the fallopian tubes and become permanently enclosed in scar tissue. This is why it’s easiest to remove Essure before the 3 month “scar development” period has passed, otherwise the implants will be firmly embedded.

Also, as Dr. Monteith explains on the informative website for A Personal Choice, his tubal reversal clinic, intact removal can also be challenging due to:

  • Differences in fallopian tube shape. Dr. Monteith says that individual fallopian tube geometry can vary widely, both due to genetic variations and from previous trauma or pathology. When surgeons are unaware of these potential differences, they may be more likely to accidentally break, damage, and/or leave behind fragments without realizing it.

Essure placement.

    The ideal positioning for Essure, according to Bayer training materials, is at the very end of the fallopian tube, right next to the opening of the uterus, with the end of the Essure coil slightly projecting into the uterus. However, many implanting physicians may find it hard to achieve this, even though it’s crucial for them to place both implants correctly on the first try, in order for successful sterilization to occur without the need for correction surgery.  In addition to initial implantation errors, placement of Essure implants may also deviate from the ideal if the device happens to migrate over time. When the implants are difficult to locate in an Essure removal procedure, the patient may be at more risk if the doctor is forced to perform a long procedure.
  • Fragile nature of the implants. Dr. Monteith notes that Essure implants are very delicate and easy to fragment, so surgeons must exercise extreme care in handling them. Particularly prone to breakage is the outer coil portion, which is made of nitinol, a nickel titanium alloy that was chosen because it can change its shape when heated, allowing for a tight fit in the fallopian tubes.

Methods of Essure Removal

Most physicians who implant Essure are only able to remove the device through hysterectomy, because it’s a standard procedure that every gynecological surgeon is required to learn. But specialists have also found success in employing a variety of less invasive techniques.

Manual Traction

Procedure: The physician first attempts to locate the Essure implants, feeling around on the outside of the fallopian tubes by hand. They can be detected fairly easily in this manner since the outer coil is designed to expand and press firmly against the fallopian tube walls after being implanted.  Once the implants are found, a small incision is made and the devices are pulled out, as gently as possible, with forceps or another tool for gripping.

Pros and Cons: When Dr. Monteith had just started delving into Essure removal, this was the method he most commonly employed, as it seemed low-risk and straightforward. Though minimal cutting is required for this method, Dr. Monteith now disfavors it due to high risk of coil fragmentation. He notes that the outer coils are particularly vulnerable when being pulled or twisted.  Also, if Essure implants are placed too far into the fallopian tubes, it’s more difficult for the doctor to grab at them.

Linear Salpingotomy

Procedure: Surgeons make a lengthwise incision directly above the Essure implants and pull them out horizontally. (The term salpingotomy refers to unblocking or making an incision into a fallopian tube, not to be confused with salpingectomy, the removal of fallopian tubes).

Pros and Cons: Though this method generally requires less pulling and overall handling of the fragile implants, Dr. Monteith points out that there’s still a high risk of breakage, because it’s easy to accidentally slice the implant while making the fallopian tube incision.

“En Bloc” Dissection

Procedure: The Essure implant is removed completely intact, still encased in surrounding scar tissue.

Pros and Cons: This is currently considered the optimal method of Essure removal, as it poses the lowest risk for leaving fragments. However, it requires great skill and concentration to dissect around the coil without accidentally cutting into it, and as with all removal techniques, hemostasis (control of blood flow) must be diligently managed to provide good vision of the working area.

Hysterectomy

Description: This is complete removal of the uterus, sometimes performed along with salpingectomy, removal of the fallopian tubes. The procedure can be performed in a variety of ways, such as laparoscopically (through a tiny abdominal or pelvic incision using long, thin tools), laparotomy (traditional abdominal incision), or mini-laparotomy (smaller abdominal incision).

Pros and Cons: Many women are distressed by the idea of removing their uterus and fallopian tubes. Sadly, for many Essure patients suffering from overwhelming side effects, this is the only removal method widely available, because most physicians who implant Essure are not trained in more specialized methods. Despair from unrelenting side effects often drives women to undergo hysterectomy despite their preference for a less invasive procedure.

surgeons performing essure removalAside from the invasiveness of this procedure, Dr. Monteith disfavors it because it presents a high risk of fragmenting the Essure coils, particularly if the physician is not mindful of the wide variation in fallopian tube shape / geometry and Essure placement.  When the doctor removes the uterus without the fallopian tubes, it can be easy to accidentally leave some of the coil inside the fallopian tubes. And even when both are removed, the doctor must take precautions to avoid dissecting the Essure implants in cases where the fallopian tubes must be detached from the uterus and/or sectioned.

Essure Reversal By Tubouterine Implantation

Each method of Essure removal we’ve described so far only focuses on removing the Essure implants, but tubouterine implantation aims also to restore the patient’s ability to become pregnant.

Procedure: The portion of the fallopian tubes containing the Essure implants are cut out and removed. Two new holes are created in the uterus and the fallopian tubes are reconnected.

Pros and Cons: Currently, this is one of the only methods that has shown success in restoring Essure users’ fertility. It was actually first developed in the late 1900’s, mostly for women suffering from salpingitis isthmica nodosa, an inflammatory disorder that can cause fallopian tubes to thicken and completely close up in extreme cases. Dr. Monteith noticed the method described in old medical journals and decided to “modernize” it to achieve Essure reversal. At his facility, Essure reversal is performed with low complication rates (less than 5%) and achieved a 40% pregnancy rate in patients after surgery.

Access to Removal

As previously mentioned, due to the current lack of doctors trained in proper Essure removal, most women won’t be able to undergo any other removal surgery than hysterectomy unless they are able to travel long distances to see a specialist.

This lack of access was another vital concern discussed at the 2015 FDA panel meeting on Essure.  One of the panel speakers, patient advocate Cynthia Chauhan, felt that it didn’t make sense to make Essure widely available without ensuring that patients would also have the option of proper removal. She pointed out, “If you do not have access to someone who can remove it, you shouldn’t be implanting it.”

Thankfully, more and more specialists are working on fine-tuning Essure removal techniques and training physicians in proper removal. Essure Problems, a well-established online support group for victims of Essure, provides an informative page on Essure removal options and a list of trained surgeons.

Planning Your Essure Removal Surgery

Your choice of removal surgery and specifications for how it’s performed can have a powerful impact if you decide to file an Essure lawsuit. Even if you aren’t yet thinking of filing a lawsuit, it’s likely best to keep your options open just in case you later decide to pursue compensation for injuries or financial loss you may have suffered due to Essure.

Hundreds of women are now taking legal action against Bayer, and may be entitled to thousands or even millions of dollars in compensation for injuries, pain, and suffering blamed on Essure. Many Essure plaintiffs report having suffered sustained and / or lasting health problems from the device, causing them financial trouble due to loss of earning potential as well as negatively impacting their spousal and family relationships.

If you undergo a removal surgery without thoroughly considering your options and planning ahead to preserve potential evidence, you may lose a solid opportunity to strengthen a current or future lawsuit.

Here is a list of important steps to take in planning a removal surgery:

  • Choose an intact removal method. As we’ve seen, en bloc dissection, complete hysterectomy with salpingectomy, and Essure reversal offer the best chance of having implants removed completely intact, still embedded in surrounding tissue. This evidence could make or break your case. For example, if you believe that side effects and complications you’ve experienced after receiving Essure are due to a broken implant, then your case will be strengthened considerably if a doctor can examine the implants intact and show photos of breakage. On the other hand, if you undergo a non-intact method and the Essure implants are damaged or broken during removal, you won’t be able to use the extracted implants as convincing evidence.
  • Have the removal procedure documented visually. Ask for your removal surgery to be clearly documented by videotape and / or photographs. These pieces of visual evidence can serve as proof that implants were removed without errors or breakage. Also, they will show the initial placement of the implants, which could be pivotal evidence for some cases.
  • Request for all items removed to be properly preserved. Obviously, the extracted implants and any surrounding tissue should be saved and stored using suitable preservatives. But any other extracted tissue, organs, or fluids could also potentially serve as important evidence, so you should ask for the surgeon to save as much as possible.
  • Find out who’s in charge of storing items from your operation. To ensure that your samples won’t be discarded or destroyed later, it’s best to have your hospital’s risk management or pathology department take custody of them.
  • Get copies of all medical records related to your removal. Any doctor’s reports or other medical logs from your surgery could serve as valuable support for your legal claims, so it’s best to ask for copies of everything. Also, your hospital may decide to have a pathologist take a look at tissue samples from your operation, which could offer insight into possible side effects you may have been experiencing, so make sure you get the pathologist’s write-up as well as the tissue samples examined.
  • Don’t allow extracted materials to be loaned without your permission. Hospitals may routinely send samples from device-related operations back to the manufacturer for further study. But your extracted implants and other preserved items from removal surgery are precious evidence for your case, so be sure that they cannot be sent to anyone without your written consent.

Learn More About Essure Lawsuits

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Contact The Product Lawyers for a free consultation

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