The FDA conducted a search of the Manufacturer and User Facility Device Experience (MAUDE) database. From Nov. 4, 2002, Essure’s approval date, through Oct. 25, 2013, the FDA received 943 reports of adverse events related to Essure. The most frequently reported adverse events were pain (606), hemorrhage (140), headache (130), menstrual irregularities (95), fatigue(88), and weight fluctuations (77). The most frequent device problems reported were the migration of the device or device component (116), patient device incompatibility (113) (e.g., possible nickel allergy), device operating differently than expected (73), malposition of the device (46), and device breakage (37).
(Note: Adverse event reports are submitted to the FDA by medical device manufacturers, importers, health care facilities, health care professionals and patients. These reports are used to monitor marketed medical devices, and may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While the reports are a valuable source of information, this passive surveillance system has notable limitations, including the potential submission of incomplete or inaccurate data, under-reporting of events, lack of denominator data (number of implants), inability to demonstrate causal relationship between the device and complaint, and the lack of report timeliness.)
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Post-approval (PAS) information that can be accessed by the public is posted on our public PAS webpage. Currently, the webpage only posts studies ordered since 2005. The original PMA (P020014) was approved in 2002, so the webpage does not include the PAS ordered at the time of the original Essure approval. Information stemming from the conditions of approval ordered in 2002 is available on the device label.
Currently, for Essure, there are two studies posted on the PAS webpage, which were ordered in conjunction with the approval of PMA Supplements for Essure in 2007 and 2012. The details on the study protocols and status are posted on the PAS webpage.
If post-approval studies prior to 2005 are available, you would need to submit a FOIA request.
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The Essure System was originally approved Nov. 4, 2002, with the following studies as condition of approval:
1. Post-Approval Study (PAS) I: 5-year follow-up under Essure System Phase II and Pivotal Trials
2. Post-Approval Study (PAS) II: U.S. Post-Approval Study for Newly Trained PhysiciansPAS I evaluated the long-term follow-up (through 5 years) of study participants from the two premarket clinical investigations, and included assessment of safety, effectiveness, and patient satisfaction. This study was not terminated early.
The product label was updated with this 5-year follow-up data. The 5-year follow up requirement was determined based on evidence available at the time of device approval and advisory panel recommendations (OB/GYN Panel Summary, 7/22/02).
PAS II was designed to document the bilateral placement rate at first attempt for newly trained physicians in the U.S. These data were used to evaluate the training procedures and to update labeling. The study was originally designed to enroll 800 women from 40 physicians in the commercial setting. In 2005, after reviewing data in PAS report, the FDA considered this condition of approval to be satisfied, with 514 women enrolled in the study. The sponsor used Bayesian statistics to demonstrate that enrolling additional women would not change the observed results (main study endpoint: success in bilateral placement).
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The FDA has reviewed Essure patient reports of problems (including web-based testimonials) and adverse event reports submitted to the FDA from a variety of sources, including doctors, patients, and the manufacturer of Essure, Conceptus, Inc. The agency also reviewed the results from a five-year follow-up post-approval study conducted by Conceptus that was required by the FDA as part of the product’s 2002 approval. In addition, the FDA evaluated the available clinical literature to determine what long-term complications may be associated with Essure. To date, there is no literature reviewed by the FDA that has indicated any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement. (Because the FDA had up to five year follow-up data from the post-approval study, the literature review concentrated on evaluating long-term complications more than five years after placement.)
We take reports of problems with Essure very seriously and will continue to review them carefully. Since approval in 2002, there have been some 750,000 procedures performed worldwide. No form of birth control is 100 percent effective and scientific evidence reviewed by the FDA shows that Essure is a highly effective means of sterilization when used according to instructions. Essure is the only non-surgical sterilization choice for women who want permanent birth control. Although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any news safety problems or an increase incidence of problems already known. We will continue to monitor the safety of this product to make certain its benefits of providing women with a non-surgical sterilization choice continue to outweigh the risks of the device.
Morgan Liscinsky
US Food & Drug Administration
