By E. Scott Sills, MD, PhD
Not every woman with Essure contraceptive implants will have pelvic cramping, bleeding, painful sex, weight gain or other problems appear after this procedure. But, there is no clear consensus on what to do about women with Essure who subsequently develop symptoms associated with this device.
It is understandable that symptomatic Essure patients would seek some kind of surgery to treat complications. But, our research unfortunately showed a surprisingly high reliance on hysterectomy to accomplish this.
An earlier study looked at outcomes after thousands of Essure procedures in New York, and found the risk of undergoing reoperation was more than 10 times higher for Essure patients, compared to women who had standard laparoscopic tubal ligation.
What my team tried to do was refine this observation by giving a more detailed view of the surgeries performed on women with Essure, as well as when they happen.
Few Doctors Experienced with Essure Removal
Because Essure is supposed to be permanent, it is not surprising that so few doctors know much about removing these implants.
It is encouraging that some patients generally feel better as soon as two weeks following removal. This has been our experience in California as well. Indeed, our most recent research covers more than a decade of Essure experience and was the first to show that the predominant surgical answer to Essure complications appears to be hysterectomy for many women. We were especially shocked to see that hysterectomy occurs for Essure patients on at about age 36 on average.
Patients and doctors may select Essure for birth control for many reasons.
Certainly the advice of a trusted doctor carries considerable weight and this recommendation is often crucial. But, gynecologists may not have had a full picture of the facts when guiding their patients on this important decision. For example, the assumption that overall patient satisfaction would be the same with Essure and tubal ligation may not have been entirely correct.
Lack of Premarketing Follow-Up
One way to get meaningful information about what happens to patients after their Essure procedure is to monitor them and see if any problems might develop. But, few patients in the premarketing studies for Essure were followed for more than a year. This made it difficult to know how many women might be unhappy and seek additional surgery to “undo” Essure after the first year of use.
Despite hysterectomy’s higher cost, greater blood loss, more overall complications and longer recovery times, this surgery could nevertheless be favored for Essure removal because insurance companies are more likely to pay for it. And because hysterectomy is a familiar operation that most gynecologists can do, this major surgery has come to be preferred over other less drastic surgical approaches to manage Essure symptoms.
Data Needed On Essure’s Long-Term Consequences
For many women, the birth control journey with Essure started because they considered it a low-risk option. But, the attraction to the permanent contraception promised by Essure would certainly be dampened if major surgery might be required later.
Since we know so little about the long-term health consequences of Essure, the true hysterectomy rate following Essure remains unknown. But, even if this birth control method even occasionally results in hysterectomy, doctors and patients should exercise great caution.
If the number of Essure kits sold worldwide is now more than 750,000, then figuring out how many times this product was associated with hysterectomy later is an important question for international women’s health. I have written articles before suggesting the creation of an Essure patient registry or specific ICD-10 diagnosis codes for patients who have Essure-associated symptoms.
Taking these simple and very low-cost steps would enable better monitoring of this women’s health issue going forward.