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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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5 year follow up


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General
Study Status Completed
Application Number P020014 / PAS002
Date Current Protocol Accepted 11/04/2002
Study Name 5 year follow up
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Extended follow-up (5 years) of premarket study cohorts: The Phase II Study and the Pivotal Study (formerly known as STOP).



The Phase II Study was a prospective, multi-center, international study of women seeking permanent birth control. There were sites in the US, Australia, Belgium, and Spain.

The Pivotal Trial was designed as a multi-center, non-randomized, single-arm, international study of women seeking permanent contraception. The study was conducted in the U.S., Europe, and Australia.

Study Population Description Adult women seeking permanent birth control. The study included participants of the premarket cohorts (Phase II and Pivotal Trial), ages 21 to 45 years old.
Sample Size Phase II Study: 269 women enrolled

Pivotal Trial: 657 women enrolled



Data Collection Phase II Study: Study primary objectives were to evaluate: Essure micro-insert placement rate, woman¿s tolerance and recovery from the micro-insert procedure, safety of the micro-insert procedure, woman¿s tolerance of the implanted micro-inserts, long-term safety of the implanted micro-inserts, and effectiveness of the micro-inserts in preventing pregnancies.

Pivotal Trial: Primary study endpoints: prevention of pregnancy, safety of the micro-insert placement procedure, and safety of the micro-insert wearing. Secondary endpoints included: participant satisfaction with the micro-insert placement procedure, participant satisfaction with micro-insert wearing, bilateral micro-insert placement rate; and development of a profile for an appropriate candidate for the Essure procedure.

Follow-up Visits and Length of Follow-up For both studies, women were followed at: 1 week-post device placement (PDP), 3 months PDP, 3, 6, and 12 months post-alternate contraception (PAC); and yearly through 5 years, as part of the post-approval study.
Interim or Final Data Summary
Actual Number of Patients Enrolled Phase II Study: 269 women enrolled from which, 227 underwent a micro-insert placement procedure. The remaining 42 women voluntarily withdrew, were excluded at the time of screening, or were enrolled into the Pivotal trial instead. There were 2 sites in the US (44 women), 1 site in Australia (130 women), 1 site in Belgium (28 women) and 1 site in Spain (25 women).



Pivotal Trial: A total of 657 women were enrolled in the study; of those, 518 underwent the Essure procedure and 453 women achieved bilateral occlusion 3 months post-procedure (4 unilateral placements). These 453 include 6 women that were followed for safety only.



Actual Number of Sites Enrolled Phase II Study: 5 sites



Pivotal Trial: 13 sites

Patient Follow-up Rate Phase II Study: 86.3% at 1-year; 85.5% at 2-year; 80.2% at 3-year; 77.5% at 4-year; 75.3% at 5-year.



Pivotal Trial: 97.5% at 1-year; 92.0% at 2-year; 89.4% at 3-year;85.2 at 4-year; 81.6% at 5-year

Final Safety Findings Phase II Study: Long-term Safety: Adverse events after the day of the procedure occurred in 9% of the women; 5% of these events were related to period pain, and ovulatory pain or changes in menstrual function. The other adverse events included: perforations (7), expulsion (1), unsatisfactory device location (1), and a retained micro-insert fragment (1). The perforations accounted for 3% of the patients that underwent the procedure. Four perforations were identified at the 3-month post-procedure evaluation; one was identified at the 18-month post-procedure evaluation. One additional case was of a peritubal perforation noted on gross examination following device removal due to pain. A seventh case was discovered when the woman had laparoscopic hysterectomy, the right device had perforated the tube. Six of the seven women that suffered perforations had the micro-insert located in the peritoneal cavity. In four of these women the device was removed successfully, in one woman the device was left in the peritoneal cavity. For the case of a retained micro-insert fragment, the event occurred during an attempt to remove the device that resulted in the broken distal ball tip. At the time of final report submission, there have been no reports of clinical sequelae for this case.

Pivotal Trial: Adverse events that initially prevented reliance by the woman on Essure occurred in 21 (4.5%) women. These were primarily Micro-insert expulsions following original Micro-insert placement that was out-of-specification. Nine of the women who experienced an expulsion chose to undergo a second placement procedure, and all were successful. Therefore, adverse events that ultimately prevented reliance occurred in only 12 women (2.6%). The most frequently reported adverse events reported in the first year that did not prevent the woman from relying on Essure, but were rated by the Investigator as at least "possibly" related to Essure, were back pain (6.2/1000 women-months), abdominal pain/cramps (2.6/1000) and dyspareunia (2.5/1000 women-months). All other events occurred at less than 2.5/1000 women-months of wearing.
Final Effect Findings In both studies, no pregnancies were reported while relying on Essure for contraception.
Study Strengths & Weaknesses The studies were limited in that there were no comparison groups. Both were designed to provide the pregnancy rate with the precision around it (95% Confidence Interval). Another limitation is the length of follow-up. Both studies were designed to provide an estimate of pregnancy rate out to 5 years; after which point there is no precise data on effectiveness and safety of the device, from these two studies. One of the strengths of the studies is the observed follow-up rates. The study provides a precise estimate of the pregnancy rate at 5 years
Recommendations for Labeling Changes Yes, label was updated to include the 5-year performance data


5 year follow up Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report 04/01/2008 04/01/2008 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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