Essure Re-Operation Risk Infographic

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A new Finnish study has confirmed early fears that women who receive Essure contraceptive implants are more likely to require subsequent operations than patients who undergo tubal ligation, the standard female sterilization procedure. Contradicting previous research, the recent article from Finland, published on June 15, 2017, also claims evidence that Essure is neither more nor less effective at preventing pregnancy than more traditional methods of sterilization.

Essure’s Days In Finland Numbered

As the researchers report, Finnish patients have turned to Essure more and more in recent years. As of 2014, the birth control implant accounted for around 49% of all female sterilizations, making Essure the country’s most common method of permanent birth control.

Bayer, however, isn’t likely to be celebrating its success in the Nordic nation. Overall, permanent sterilization procedures have dropped dramatically over the last two decades, as patients find a safe and long-lasting contraceptive option in the form of intrauterine devices. Meanwhile, growing public pressure has tarnished Essure’s reputation world-wide, as wave after wave of product liability lawsuit reaches Bayer’s defense attorneys in North America.

These trends all add up to one thing: Bayer’s sales are dropping. Sharply. While no official sales statistics are available, profits from Essure in Finland are so low that Bayer has made the telling decision to end sales and distribution of the device throughout the country.

Risk & Benefit Of Essure Reappraised In Finnish Study

The paper, printed in the British Journal of Obstetrics and Gynecology, reports findings of researchers at two hospitals in Finland and the Finnish government’s National Institute for Health and Welfare.

To perform their study, the team analyzed data from four national medical registries. Finland, like most Nordic countries, maintains extremely accurate healthcare databases, allowing epidemiologists to study health issues using sample sizes that are essentially equivalent to the national population. In this report, the Register of Sterilisations was tapped to identify women who had undergone tubal ligation procedures (either with the Filshie clip method or the Pomeroy method) or received Essure implants.

The nation’s Termination of Pregnancy Register, Hospital Discharge Register and Medical Birth Register were then used to find, among those women undergoing sterilization procedures, patients who had experienced unwanted pregnancies and those who had undergone re-operation.

Pregnancy Results Contradict Previous Research

Tubal ligation and Essure fared equally well on the point of spontaneous pregnancies. No statistically significant difference could be found between the three study groups. For every 1,000 years of having Essure implants, patients could expect to experience an estimated 1.97 unintended pregnancies. The risk was similarly low in patients who underwent either method of tubal ligation.

This finding is not consistent with previous research. Several influential studies, including the work of Yale obstetrician Aileen Gariepy, have attempted to estimate the real-world effects of Essure, rather than the perfectly-controlled results apparently reported in clinical trials. Using sophisticated modeling techniques, Gariepy and her colleagues at Yale found that women with Essure could get pregnant more than twice as often as women who underwent tubal ligation.

High Re-Operation Rates In Essure Patients

On the side of safety, the Finnish researchers say that the risk of re-operation is relatively low, both in women who receive Essure implants and those who undergo tubal ligations. Take a dip into the study’s data, however, and “relatively low” doesn’t sound very accurate.

10% Undergo New Operation, 4% Undergo Re-Sterilization

More than 10% of the Essure patients included in the report eventually underwent subsequent related operations, including hysterectomy and re-sterilisation. Over 4% of these women, who had chosen Essure as a contraceptive, were ultimately forced to undergo new birth control procedures.

More than half of these patients switched their allegiances completely, opting for tubal ligation rather than hysteroscopic sterilization implants like Essure. More than 2% of the women with Essure ultimately underwent hysterectomy, a common, but agonizing, choice for many women who experience severe side effects after receiving the device. Moreover, the risk of undergoing one of these subsequent procedures, especially re-sterilization, was much more likely in women with Essure.

A 2015 study, published in the British Medical Journal, also linked Essure to an increased risk of reoperation compared to tubal ligation. In that paper, women with Essure were more than 10 times more likely to require subsequent operations, most notably re-sterilization procedures and surgeries designed to reveal serious device complications.