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Essure Side Effects:
FDA Statistics

The Essure system was approved for use by the FDA based on clinical research results submitted by the Conceptus to the FDA for evaluation of product safety. The FDA approved Essure for use in the United States in 2002.

Between 1991 and 2002, 745 women were enrolled in the study for FDA approval. Two separate studies were performed: 227 women were enrolled in the Phase I trial and 518 women were enrolled in the Pivotal trial.

The Pivotal trial is the better trial to evaluate for Essure side effects because this trial specifically looked at adverse outcomes immediately after the procedure and for up to a year after Essure coils were inserted. This was also the study with the largest number of patients.

Immediate Essure problems

Insertion related complications were observed. In 2.9% of patients experienced coil expulsion, 1.1% of patients experienced uterine/tubal perforations, and 0.6% of patients experienced coils found in ‘other’ locations after insertion.

On the day of the procedure patients reported experiencing a variety of immediate side effects. The most common side effects reported were:

  • Cramping 29.6%
  • Pain 12.9%
  • Nausea/vomiting 10.8%
  • Dizziness/light-headed 8.8%
  • Bleeding/spotting 6.8%

The most common Essure related side effect was pain during and immediately after the procedure. Most pain from the procedure resolved within the first week after insertion.

Overall these numbers are consistent with what many patients may experience with most outpatient procedures or treatments.

Persistent Essure side effects

After one year of having Essure, some patients did report side effects that did not resolve.

Among the side effects reported at one year were:

  • Back pain/low back pain 9%
  • Abdominal pain 3.8%
  • Pain with sex 3.6%
  • Severe menstrual cramps 2.9%
  • Severe pelvic or abdominal pain 2.5%
  • Uncharacterized pain/discomfort 2.9%

 Essure problems

Overall the problems experienced by women after Essure in the Phase I and Pivotal trials seem to be consistent with problems experienced by other patients who have had other types of outpatient procedures and treatments. The above complication statistics are considered acceptable complications rates for patients undergoing procedures.

The above data do suggest most patients will not experience an Essure related problem; however, the data above also demonstrate some women will report symptoms immediately after Essure. These problems may persist for a year after Essure and these problems may be associated with the Essure micro-insert system.

Although it is desirable, no medical intervention will have 0% side effects and no surgical intervention will have a 0% complication rate. The above statistics do support the fact some woman can have increased pain associated with Essure. It is common to experience pain and abnormal bleeding immediately after the Essure procedure but this should resolve within several days. Some women will have abdominal, back, or pelvic pain a year or more after the procedure and this could be related to the Essure micro-inserts.

In a small study of 500 patients a 3% complication rate translates into 15 patients. If one understands Essure has been performed in over 750,000 women then 3% translates into 22,500 women, which does not seem like a trivial number.

A more concerning problem is the observed side effects were measured during a perfect use study with well-trained researchers. We currently do not know what the complication rates or side effect rates are when Essure is used in the hands of the average physician. With typical use the observed Essure related complications might be different and the complication numbers could be much higher.

2 thoughts on “Essure Side Effects: FDA Statistics”

  1. Sharise says:

    I have had the Essure since 2006. Since I have had this planted in my body has not been the same. Please help. Do you have payment options?

    1. Dr. Monteith says:

      Shares

      We have two flexible payment options for you if you dont want to pay in full for surgery: (1) start a prepayment plan with us or (2) finance your reversal surgery.

      Prepayment plan. We do have a prepayment plan that allows you to save towards your surgery. You need to start it with at least $500 and you can contribute any amount over the next 3 years. When you have saved the full amount then you can have your surgery. You can have the surgery anytime within 3 years of starting your plan.

      If you dont have your surgery by the end of the third you you are refunded all of your money less $500. Surgery discounts, when available, are offered to prepayment account members only.

      For more information: Tubal Reversal Prepayment Plan

      Financing reversal surgery. We work with two companies who will help you finance surgery. You would apply for financing directly with United Medical Credit. The link to their company and the application for financing is on our website.

      For more information: Financing Reversal Surgery

      We charge $6400 total for tubal ligation reversal and $7500 for Essure reversal plus $125 to schedule and we are located in Raleigh, North Carolina. Insurance will not pay for tubal reversal surgery.

      You should send us your tubal ligation records for a free review.

      Patients pay in full and out-of-pocket at the time of scheduling. All you have to pay for in addition to the surgical fee is the cost of travel, hotel, and food. Patients stay in Raleigh a total of 2 nights and 3 days. The consultation is the first day, surgery the second day, and postoperative visit is the third day.

      We do have a prepayment tubal reversal plan that allows you to save towards your reversal over a 3 year period.

      Although $6,400 seems expensive…the alternative treatment in-vitro fertilization (IVF) average $12,000 to $14,000 and is about 40% successful!

      Please be aware that starting April 1st 2019 the fee for reversal surgery will increase to $6,900 and the scheduling fee will increase to $150. If you want to avoid the higher fees then you should schedule your surgery before April 1st or start a Reversal Prepayment Account.

      The main advantage to tubal reversal is that every month you have a chance and you can become pregnant more than once. On average, about 2 out of every 3 women become pregnant with tubal reversal surgery.

      The following link will answer most of your questions about reversal. This is the MOST HELPFUL INFORMATION to read when considering reversal at our office. Each question has a link to more information about the question: Frequently asked questions about tubal reversal

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