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%
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.