No medical treatment, diagnostic test, or surgical intervention is without risk. All treatments have some form of risk even if small.
Overall Essure seems to be safe for most women but not without risk for all women.
The Phase I study and the Pivotal trial examining the risks of Essure and the chance of side effects were well done and meet the minimum requirements established by the FDA for device approval. It is common knowledge it is inherently easier to get FDA approval for medical devices than for medications. Devices submitted to the FDA have to show a minimum level of safety and demonstrate they work for their intended use.
In this case Essure sterilization was demonstrated to be safe, the major side effects at time of insertion resolved quickly for most women, the major side effects at 12 months were less than 3% for most symptoms, and no woman became pregnant. This study data was collected in a well-controlled study on over 500 women in a ‘perfect use setting’.
The major problem we are seeing is, even though the side effect profile was low, we are now seeing Essure used on a much larger group of patients. A small percentage of a small number is a small number. A small percentage of a large number is a larger number. The initial Conceptus data was collected in a well-controlled study on just over 500 patients. Since then Essure has been performed on over 750,000 women and a small percentage of a large number is a larger number of Essure complications.
More importantly than small percentages of larger numbers, we are now seeing the effects of typical usage. Even in the ‘perfect use setting’ there were observed Essure device malfunctions, Essure coil perforations, Essure coil migration, and pain possible related to Essure at 12 months. As more Essure procedures are being performed under less controlled settings by providers of many different skill levels and in patients with many variations of their anatomy, we are now seeing Essure side effects and complications from Essure in the ‘typical use setting’.
Does Essure coil removal help? Advice from Dr. Monteith
My answer to this question depends mostly on when the symptoms began. Did the symptoms start within days to weeks of Essure insertion or did the symptoms begin years after Essure insertion?
Symptoms starting soon after Essure: Days to weeks
If the symptoms started within days to weeks after Essure insertion then there is a greater likelihood the symptoms are directly related to Essure coils. If the symptoms are pelvic pain, abdominal pain, or back pain then these are also symptoms demonstrated to have occurred in the clinical trials. If the symptoms do not improve within the first several weeks then removing the Essure coils seems to help treat the symptoms.
Our experience demonstrates Essure coil removal alone will help improve the symptoms and most patients will not require a hysterectomy.
Symptoms starting years after Essure
If the symptoms began years after the Essure coils were inserted then there is a greater likelihood the Essure coils are not the cause of the symptoms.
Although it is tempting and common for many patients to recall the last medical/surgical intervention as the possible cause of the problem this may not always be correct. Patients should be realistic there could be other contributing causes or they could have coincidentally developed some other condition.
In our experience, we have had several patients come for Essure removal who had chronic pain before Essure and another patient who experienced a tick bite and developed arthritis around the time of Essure insertion. These patients came for removal understanding Essure may not be the cause of their symptoms. For some of these patients it was helpful to know with more certainty that Essure was not the cause by having removal of their coils.
Do you need a hysterectomy after Essure?
Many women are having Essure related complications and are being advised to have hysterectomies.
Although all surgery should be considered major and should not be undertaken lightly, I believe women should consider having a hysterectomy for an Essure related complication if any of the following conditions exists:
- If you have a pre-existing gynecologic condition that could explain your symptoms after Essure or increase the chance you will ultimately require treatment with hysterectomy in the future: adenomyosis, large uterine fibroids, heavy periods causing anemia, chronic pelvic pain, endometrial abnormalities, complex adnexal mass, etc.
- If you are having Essure related complications and your doctor is not skilled or comfortable with removing Essure coils but is skilled in performing hysterectomy.
- If you are having an Essure related complication and your insurance will not pay for Essure removal but will pay for a hysterectomy.
Procedures to remove Essure
We have had good results with Essure removal in our population of symptomatic Essure patients. The patients who did not see improvement after surgery were ones who were also suffering from chronic pelvic pain, those who had symptoms beginning years after insertion, and those who had other medical diagnoses at the time the symptoms started.
When patients ask me if a hysterectomy is necessary for an Essure related side effect I often will ask them in response,
“If you get a splinter in your finger then do you remove the splinter … or do you cut your finger off?”
I think my question adequately gauges the extent of the problem and puts surgery decision making into better perspective. Admittedly the decision to have a hysterectomy is a complicated one fueled by the patients ultimate desires, her physician’s skill and knowledge level, and what procedures her health insurance is willing to reimburse.