Intrauterine Procedures in Women Who Have Previously Undergone Adiana® Permanent Contraception

EASE Trial Investigator
Physician and President, Institute for Women’s Health and Body Wellington, Florida

DISCLOSURES AND ACKNOWLEDGEMENTS
Dr. Seth J. Herbst is a consultant and speaker for Hologic, Inc., consultant for OptiVia Medical, LLC, and consultant and investigator for Viveve, Inc.

Industry support for this study was provided by Hologic, Inc., Malborough, MA. Editorial support was sponsored by Hologic, Inc., and provided by Ed Shifflett, PhD, and Amanda McGeary, MS, at AlphaBioCom.

ABSTRACT

Objective To assess whether Adiana^® Permanent Contraception is compatible with subsequent intrauterine diagnostic and therapeutic procedures.

Methods Data were collected during the EASE (Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy) clinical study. Women 18 to 45 years of age who underwent hysteroscopic sterilization using the Adiana procedure were evaluated. In the EASE clinical study, Adiana placement was attempted in 645 patients; there was successful bilateral placement in 611 women. All subsequent surgical procedures among the 645 women were recorded; this report represents gynecologic intrauterine procedures that occurred within the first 36 months of follow-up after the Adiana placement.

Results Among the 645 women, 28 intrauterine procedures were performed following the Adiana procedure, including 1 patient who underwent 2 procedures. The majority (23/28) of all procedures occurred after 1 year of Adiana use. All procedures were performed using standard of care, routine techniques. There were no immediate or delayed adverse events reported with these intrauterine procedures within the 36-month follow-up period.

Conclusion The data from the EASE cohort suggest that Adiana Permanent Contraception appears compatible with several common diagnostic and therapeutic intrauterine procedures, although the long-term safety and efficacy of these procedures have not been established.

INTRODUCTION

Worldwide, the number of women of reproductive age is growing.¹ As of 2008, there were 75.2 million women aged 15 to 49 years in the United States (US). It is projected that by 2015, 76 million women will fall into this age category.¹ Female sterilization is the most common method of contraception in the US in women 35 to 44 years of age, and the second most common method in women 15 to 44 years of age.² Annually, 684,000 sterilization procedures are performed in the US³; in 2002, the number of US women relying on female sterilization as contraception totaled 10.3 million.²

Transcervical sterilization is beneficial over tubal ligation; advantages include decreased potential for complications and greater convenience for the patient. No incisions are required with transcervical sterilization, allowing for less discomfort and a shorter recovery time. Adiana^® Permanent Contraception (Hologic^™, Inc., Marlborough, Mass.) is a transcervical sterilization system based on the insertion of a polymer matrix and its integration into the fallopian tube (FIGURE 1).⁴ The EASE (Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy) clinical study was initiated in 2002 to evaluate the safety and efficacy of the Adiana System. The 3-year pregnancy prevention rate for Adiana was 98.4%, with no reported uterine or fallopian perforations and no adverse device reactions.⁵

An important clinical concern for physicians is the compatibility of subsequent intrauterine diagnostic and therapeutic procedures following use of the Adiana System. Physicians may need to access the uterus to complete a thorough evaluation for the assessment or treatment of abnormal uterine bleeding and fibroids. In a national study spanning 2 years, menstrual disorders were the reason for approximately 3.8 million physician visits for gynecologic conditions.⁶ Some of the procedures that may be need to performed following sterilization include hysteroscopy, endometrial biopsy, dilation and curettage (D&C), and endometrial ablation.

In this analysis, we sought to further evaluate the compatibility of Adiana Permanent Contraception with subsequent intrauterine diagnostic and therapeutic procedures by analyzing data from the EASE trial.

METHODS

Data were collected during the EASE trial, in which women aged 18 to 45 years underwent hysteroscopic sterilization by the Adiana Permanent Contraception System. Women who were enrolled in the study were previously seeking permanent contraception, had been pregnant at least once, were sexually active, had regular menstrual cycles, and were willing and able to use alternative contraception for the first 3 months following placement of the matrices.

The intent-to-treat (ITT) population consisted of the women who underwent attempted placement of the Adiana matrix. The analysis included all patients in the ITT population who were evaluable at the end of 3 years, regardless of whether bilateral occlusion was achieved. All subsequent surgical procedures were recorded and the database was analyzed for all gynecologic intrauterine procedures that occurred within the first 36 months of follow-up.

RESULTS

The majority of the women in the ITT population were between 28 and 33 years of age (48%) and Caucasian (76%; TABLE 1 and TABLE 2). Slightly less than half (48%) of the ITT population was using some form of hormonal contraception prior to Adiana placement (TABLE 3). Of the 611 women in whom bilateral placement was successful, 28 subsequent intrauterine procedures were performed (TABLE 4), including 1 patient who underwent 2 procedures. During the first year of follow-up, 5 intrauterine procedures were performed. The majority of the overall procedures occurred at 18 months or later.

During the second and third year of follow-up, 23 intrauterine procedures were performed. Of these 23 procedures, 11 were endometrial ablations. All procedures were performed using routine techniques. There were no noted adverse events or sequelae following diagnostic or therapeutic procedures. However, although these data provide information regarding the potential compatibility of these procedures, the long-term safety and efficacy of intrauterine procedures and the Adiana device have not been established.

Age demographics

Baseline demographics

Menstrual and contraceptive use history

DISCUSSION

These data from the EASE trial show that a variety of intrauterine procedures, including endometrial ablation, intrauterine device insertion, and in vitro fertilization procedures, have been performed following the use of the Adiana Permanent Contraception. This is clinically important because many women may eventually require additional intrauterine procedures following the use of the Adiana System.

Abnormal uterine bleeding is one of the most common reasons why women visit their physician. The diagnostic procedures for abnormal uterine bleeding often include endometrial biopsy, hysteroscopy, hysterosalpingography, saline infusion sonography, or D&C. Surgical treatments may include endometrial ablation or surgery to remove growths (e.g., polyps or fibroids). TABLE 4 lists the intrauterine procedures that were reported to have occurred among study subjects. Abnormal uterine bleeding is the cause of approximately 80% to 90% of D&C procedures performed in nonpregnant women in the US. This is equivalent to about 350,000 D&C procedures annually.⁷

Procedures following Adiana Permanent Contraception

Considering that patients may require further diagnostic or therapeutic gyneco-logic care, the ability to safely perform transcervical sterilization and future intrauterine procedures is of interest to both patient and physician. Data from the EASE trial show that several common diagnostic and therapeutic intrauterine procedures, including hysteros-copy, endometrial biopsy, D&C, endometrial ablation, intrauterine device insertion, and in vitro fertilization have been safely and effectively completed following use of the Adiana Permanent Contraception System.

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