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Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance

Walter, Jessica R. MD; Ghobadi, Comeron W. MD; Hayman, Emily MD; Xu, Shuai MD, MSc

doi: 10.1097/AOG.0000000000001796
Contents: Current Commentary
ABOG MOC II

In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure’s safety and efficacy with laparoscopic tubal sterilization. The device was first approved in 2002 based on nonrandomized, single-arm prospective clinical studies. Since its approval, the device has grown in popularity, particularly in the United States. The driving forces for the sudden increase in adverse event reporting starting in 2013 related to the device remain unclear. Until completion of the new postmarketing study, there will continue to be significant uncertainty of the technology's risk–benefit profile. The controversy with Essure underscores the need for obstetricians and gynecologists to be actively involved in the lifecycle of medical devices. This includes actively reporting adverse events associated with devices to the FDA, supporting the implementation of unique device identifiers enriched with clinical records and paired with insurance claims, and stewarding robust device-specific registries.

In response to patient complaints, the U.S. Food and Drug Administration mandated a new postmarketing study to confirm the safety and efficacy of Essure, a high-risk female sterilization device.

Departments of Obstetrics and Gynecology, Radiology, and Dermatology, Northwestern University, and the Department of Radiology, University of Chicago Medical Center, Chicago, Illinois.

Corresponding author: Shuai “Steve” Xu, MD, MSc, 676 N St Clair Street, Suite 1600, Chicago, IL 60611; email: stevexu@northwestern.edu.

Each author has indicated that he or she has met the journal's requirements for authorship.

Financial Disclosure The authors did not report any potential conflicts of interest.

Essure consists of a disposable hysteroscopic delivery system with nickel–titanium inserts, which incite a fibrotic reaction and occlude the fallopian tubes. In this commentary, we summarize the premarketing and postmarketing data considered by the U.S. Food and Drug Administration (FDA) and offer policy suggestions to improve postmarketing surveillance for high-risk medical devices in women's health.

The FDA classified it as a class III device, a designation reserved for devices that sustain human life, demonstrate a substantial importance in preventing impairment, or represent a potential risk of serious injury. New Class III devices require submission of a premarket approval application. The premarket approval process is the most stringent approval pathway and reserved for the highest risk devices, typically requiring prospective clinical data demonstrating safety and efficacy; only 18 devices (eg, endometrial ablation devices) in obstetrics and gynecology were approved along this pathway between 2000 and 2015.1 Since its approval in 2002, Essure has been a commercial success with more than 700,000 kits sold over the past 14 years worldwide; the procedure is particularly popular in the United States, accounting for 80% of its manufacturer's annual revenue.2 Patients can exclusively rely on Essure for contraception after a confirmatory test such as a hysterosalpingogram or, more recently, transvaginal ultrasonography demonstrating either bilateral tubal occlusion or proper coil placement 3 months after insertion.3 It can be performed in an outpatient setting with moderate sedation, providing a favorable alternative for patients who would otherwise be poor surgical or general anesthesia candidates as a result of obesity, cardiovascular risk factors, or other medical comorbidities.

In late 2013, more than a decade after the FDA's first approval of Essure, the number of voluntary patient-reported adverse events submitted to the Manufacturer and User Facility Device Experience database rose sharply. The repository includes both voluntary Medical Device Reports submitted by patients and health care providers as well as mandatory manufacturer disclosures of injuries, deaths, or malfunctions associated with a medical device. In response, the FDA convened the Obstetrics and Gynecology Advisory Committee in September 2015, conducted a detailed literature review, and invited external experts to reassess the safety and efficacy of the device. The FDA released a new draft guidance adding a black box warning and mandating a new postmarketing study to demonstrate device safety and efficacy compared with tubal sterilization in early 2016.4

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PREMARKET APPROVAL

A phase II study for medical devices is designed to determine feasibility and functionality, whereas the pivotal trial is a statistically driven study to determine device safety and efficacy and is the main factor necessary for FDA approval. At the time of submission to the FDA, 2 years of outcomes were available from the phase II (STOP 10) study, in which a total of 269 women were enrolled, and implant placement was attempted in 227 patients (Table 1).5,6 At 1 year of follow-up for STOP 10 participants, only 193 (85%) of women were available for analysis. Of the 657 women enrolled in the pivotal study (STOP 2000), implant placement was attempted in 518 women with 439 (85%) completing the 1-year follow-up assessment. Bilateral placement was achieved in 88% of women with four patients requiring a second placement attempt in the STOP 10 study and 90% of women in the STOP 2000 study with 18 requiring a second attempt. In both studies, 97% of women with bilateral placement were able to rely on Essure for contraception with no reported pregnancies attributed to device failure at the time of the premarket approval submission.

Table 1-a

Table 1-a

Table 1-b

Table 1-b

Of the adverse events studied at the time of the initial premarket approval submission, the pivotal study (STOP 2000) demonstrated that 1 year after insertion, 3.8% of patients reported abdominal pain or cramping, 9.0% reported back or low back pain, and 2.9% reported unspecified pain. Some have argued that both the premarket and postmarket studies for Essure were not significantly rigorous for the device's indication of permanent sterilization given the nonblinded study design, lack of comparator group, and short follow-up.7 Despite these limitations, Essure was approved by the FDA with the recommendation of the Obstetrics and Gynecological Devices Advisory Panel committee on the condition of two postapproval studies detailed in Table 1.6

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POSTMARKETING STUDIES

The FDA mandated a study (ESS205) to examine the rates of successful bilateral Essure placement for 40 new trainees for 20 patients each (goal of 800 patients), but ultimately enrolled only 585 participants with a 3% adverse event rate. The second postmarketing study required continued evaluation of all women participating in both the STOP 10 and STOP 2000 studies for a total of 5 years. The 5-year follow-up for STOP 10 included only 75% of the original enrolled patients (171/227), whereas the original pivotal study included 71% of initial enrollees (366/518) and was only recently published in 2015.8

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ESSURE AND UNINTENDED PREGNANCY

There were no pregnancies after 5 years in both the STOP 10 or STOP 2000 studies (n=632) excluding luteal-phase pregnancies; these pregnancies preceded Essure placement and were undetected at the time of insertion. Review of the scientific literature demonstrated the rate of unintended pregnancy for patients relying exclusively on Essure is comparable with other methods of permanent sterilization.9 Many of the unintended pregnancies of Essure are attributed to patient nonadherence with alternative contraception before the 3-month confirmatory test, implant expulsion, perforation, or physician misinterpretation of the confirmatory test.10 However, there are literature reports of unintended intrauterine pregnancies11,12 and ectopic pregnancies,13,14 even after successful confirmatory testing. Based on a review of the Medical Device Reports submitted to the FDA, 127 entries cite an intrauterine pregnancy (76 live births, 32 miscarriages, 19 elective termination) and 69 record ectopic pregnancies. The circumstances and extent of patient or physician noncompliance compared with true device failure in the setting of these pregnancies remain unclear.

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OTHER ADVERSE EVENTS AND COMPLICATIONS

There were six uterine or fallopian tube perforations in the STOP 10 study with an additional perforation detected at 5-year follow-up. In the STOP 2000 study, there was a 1.1% perforation rate (5/476). Reports in the scientific literature show perforation rates from less than 1%12,15 to 3.6%.16 Medical Device Reports documented 33 intraoperative and 266 postprocedural perforations.

In the 5-year STOP 10 postmarketing study, less than 2% of patients reported dysmenorrhea (4/171), dyspareunia (1/171), pelvic pain (3/171), and pain otherwise unspecified (2/171). Among STOP 2000 study patients, dysmenorrhea, dyspareunia, and pain were reported at slightly higher levels (Table 1) compared with STOP 10. Of note, patients with chronic pain syndromes were excluded from both studies at the time of enrollment. Subsequent studies have shown increased rates of long-term postimplantation pain in patients with a history of chronic pain.17

Although chronic pain was uncommon in the STOP 10 and STOP 2000 studies, pain or cramping represented the majority (3,516/5,093 [69%]) of Medical Device Reports. Medical Device Reports do not necessarily reflect a causative relationship between device and pain as a result of lack of details regarding timing, location, and severity of symptoms.18 Within the FDA's executive summary on Essure, an analysis of the Medical Device Reports shows that 90% of women (176/196) reported the resolution of improvement of a wide range of symptoms (eg, pain, hair loss, headaches, visual changes) after the device was removed.2 Assessment of chronic pain after Essure device placement in the scientific literature is limited given the lack of control groups and retrospective study design. One study evaluating insurance claims data demonstrated that 0.9% (236/26,927) of women reported chronic pelvic pain after hysteroscopic sterilization at a mean follow-up of 275 days. This was not statistically different from those with pelvic pain after laparoscopic sterilization.19 Of note, this study included sterilization by either Essure or the Adiana device; Adiana was another hysteroscopic device that utilized radiofrequency energy and a silicone matrix to achieve tubal occlusion,20 which was withdrawn from the market in 2012 for reasons unrelated to device safety or efficacy.

Among STOP 2000 participants at 5-year follow-up, 11.7% reported irregular menses and 7.5% reported intermenstrual bleeding; only 0.5% (2/377) reported persistent heavier menstrual flow. Change in menstrual patterns (intermenstrual bleeding, heavier menses, or menstrual irregularities) accounted for 37% (1,861/5,093) of Essure-related Medical Device Reports. These reports may reflect more than one code per patient, so the rate of bleeding changes is difficult to interpret. In comparison, prior studies on tubal ligation have demonstrated that 10.4% of women exhibit heavy menstrual bleeding 3–4 years after sterilization.21 Finally, no deaths were attributed to Essure placement or use in either the STOP 10 or STOP 2000 clinical studies after 5 years. Of the 11 Medical Device Reports reporting deaths associated with Essure, 5 were fetal deaths and 4 were patient deaths. These deaths included group A streptococci infection 2 days after placement, cardiopulmonary arrest during insertion secondary to paradoxical air embolism, pulmonary embolism after hysterectomy for the removal of Essure, and suicide.22 A detailed review of other postmarketing studies not directly involving the manufacturer is summarized in the executive summary published by the FDA and Bayer HealthCare.2,23

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APPROVAL FOR A NEW ESSURE MODEL

Medical devices are unique from pharmaceuticals because they typically undergo postmarketing labeling, design, or material changes, which can be reviewed and approved through an expedited supplement process. Essure, like many other high-risk obstetrics–gynecology devices,1 has had more than 40 supplements since its initial approval. The supplement process allows for the expected iterative process inherent to device design. However, multiple incremental supplements over time potentially lead to a distinctly different device than what was initially approved,24 a phenomenon known as device creep. In recent history, changes approved through the supplement process for high-risk cardiac devices have led to several high-profile device recalls (eg, Sprint Fidelis and Riata defibrillator leads).25

In 2007, a new Essure model was approved through a premarketing approval supplement (ESS305, Premarket Approval Supplement 12); modifications were made to the device to improve visibility, decrease distension fluid backsplash, and improve coil deployment. Approval of this model occurred without prospective data. Instead, the FDA required a new study to assess the rate of successful insertion on a first attempt for the new model. In an executive summary provided by Bayer, bilateral placement was achieved in 96% of women (593/619)23; an independent analysis of the same data revealed similar conclusions with a 97% bilateral implant rate.26

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RISE IN PATIENT-REPORTED COMPLAINTS

In 2012, the FDA received only 152 Medical Device Reports associated with Essure, approximately half of which were voluntary. In the next year, the total number of Medical Device Reports increased by more than 400% (817 Medical Device Reports), with 89% being voluntary. As of 2015, there have been more than 5,000 (4,608 patient injury reports, 474 device malfunctions, and 11 deaths) patient-submitted complaints.2 In response, the FDA convened with the Obstetrics and Gynecology Advisory Committee and reevaluated patient reports from the original clinical trials driven, in part, by a Citizen Petition alleging alteration of subject trial experiences.27 The FDA found no evidence of intentional or methodical changes to participant experiences to provide a more favorable perception of the device. However, the FDA did conclude that the premarketing studies, postmarketing studies, and available scientific literature all exhibited shortcomings; many of these concerns related to the lack of comparator arms and retrospective nature of the available data.2

Beyond the new black box warning, the FDA also proposed a new consent process to include a “Patient Decision Checklist” to facilitate the conversation between patients and health care providers before Essure insertion.4 Most significantly, the FDA ordered the manufacturer to conduct an additional postmarketing study known as a 522 study. The FDA has the authority to order additional studies for class II or III devices even after approval if device failure represents a high risk of causing serious adverse health consequences. The details of the new 522 study, released in September 2016, will enroll a total of 2,800 women to compare Essure with laparoscopic tubal sterilization for a period of 36 months. The primary efficacy endpoint is pregnancy, whereas the primary safety endpoints will include: chronic abdominal or pelvic pain, abnormal uterine bleeding, hypersensitivity or allergic reactions, and surgeries requiring removal of the device.28 This would represent the most scientifically rigorous and comprehensive study of Essure to date. Some contend that Essure safety concerns may have been detected earlier with a more stringent and proactive approach to both premarketing and postmarketing surveillance.7 There have been calls by consumer groups in both the United States and Canada for removal of the device from the market and possible class action litigation.29,30 Representative Michael Fitzpatrick (R-PA) even introduced the “E-free bill” in November 2015 calling for the withdrawal of Essure's FDA approval.31

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POSTMARKETING SURVEILLANCE SYSTEMS FOR HIGH-RISK DEVICES

The FDA's Manufacturer and User Facility Device Experience database is a repository of information to track adverse events related to device use but is limited in its ability to draw inferences of causality or incidence. Despite mandatory manufacturer reporting, there is discretion in determining whether the device was responsible for an adverse event, creating a disincentive to reporting device-related problems32; voluntary reports by patients and physicians are underreported and may be incomplete or unverified.18 The Medical Device Guardians Act, a bill recently introduced in the House of Representatives, would require physicians to report medical device safety concerns.33 Beyond Manufacturer and User Facility Device Experience, the FDA also operates the Medical Product Safety Network. The Medical Product Safety Network consists of a network of facilities specifically trained in collecting and submitting adverse events, which theoretically produces higher quality reporting.18 However, the Medical Product Safety Network only represents a fraction of health care service providers. In 2010, the FDA initiated a public–private partnership known as MDEpiNet to recommend improvements in medical device safety.34 The partnership has developed several initiatives, including device registry building and a surveillance mechanism of electronic health records to detect safety concerns, but serves predominantly in an advisory role.

The FDA can also require manufacturers to conduct additional postmarketing approval studies either as a condition of device approval (postmarketing approval study) or as an additional 522 study, both of which have been used in the case of Essure. However, postmarketing studies have limitations. In one analysis that considered all postmarketing studies from 2007 to 2012, 88% of studies were considered inactive; in 37% of these cases, manufacturers consolidated multiple postmarketing studies into one, even if this meant inclusion of several different models of the same device (eg, multiple versions of a metal-on-metal implant).35 There remain significant shortcomings in the timely execution and dissemination of postmarketing studies; only 6% of 522 studies initiated between 2005 and 2012 achieved completion or adequate progress.36 Moreover, the final publication rate of studies related to both premarketing and postmarketing approval studies remains low.37

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NEW EFFORTS TO IMPROVE DEVICE SAFETY

One of the FDA's main strategic initiatives for 2017 involves the creation of a National Evaluation System for Health Technology.38 The FDA envisions this system as a public–private partnership combining disparate “real-world” sources of data on medical devices, including electronic health records, device registries, and insurance claims.39 Building this infrastructure would also connect multiple existing postmarketing surveillance resources such as the National Patient-Centered Clinical Research Network and Sentinel, a data surveillance system of insurance claims.40 The FDA has already initiated funding for the National Evaluation System for Health Technology by awarding $3 million to the Medical Device Innovation Consortium, a public-private partnership dedicated to advancing regulatory science, to act as the initial coordination center. Additionally, a recently published draft guidance of the next iteration of the Medical Device User Fee Amendments to be submitted to Congress and enacted for fiscal years 2018–2022 includes language that would direct industry-derived user fees to support the National Evaluation System.41

Success of the new system is contingent on several considerations relevant to the Essure debate. The first is coordination and expansion of device registries. When expanded across large data sets, registries provide insights to device safety concerns that even the best designed prospective studies are unable to detect. However, the inherent retrospective nature of registries limits their utility, and they should not replace rigorously designed prospective studies, particularly when assessing device efficacy. For registries to be effective, they must accurately identify the devices used given that devices undergo alterations through the supplement pathway, of which Essure is no exception. Thus, broadening implementation of unique device identifiers enables rapid identification of medical devices in multiple real-world sources, including different device models approved through the supplement process. Through a graduated process, the FDA initially required unique device identifiers to be assigned for all medical devices in 2013.18 As of 2015, implantable, life-supporting, and life-sustaining devices require a unique device identifier. However, adding identifiers to devices is only the first step. They must be paired with clinical data such as a patient's demographics and comorbidities to derive meaningful insights into a device's true efficacy and risk. Beyond pairing to medical records, connecting device identifiers to insurance claims would enable a larger, population-based surveillance system. The advantage of insurance claims is standardization, which facilitates the aggregation of data across different health care providers and health systems for millions of patients.42 In fact, the future success of the National Evaluation System for Health Technology to incorporate data from the FDA's Sentinel program depends on the broader implementation of unique device identifiers with insurance claims. Multiple stakeholders, including insurers (Aetna), think tanks (The Pew Charitable Trusts), physician organizations (American College of Cardiology), and the Centers for Medicare and Medicaid Services, have all argued for the inclusion of unique device identifiers in insurance claims to improve postmarketing device surveillance.43,44 See Table 2 for a summary of existing postmarketing surveillance mechanisms.

Table 2

Table 2

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POLICY IMPLICATIONS FOR MEDICAL DEVICE SAFETY

Ultimately, the regulation of high-risk medical devices has been criticized for a lack of rigor, particularly compared with pharmaceuticals.32,34,45,46 Previously, we have demonstrated that the clinical evidence leading to approval of obstetrics–gynecology devices has significant weaknesses.1 The same has been shown in multiple other specialties, including cardiology and gastroenterology, suggesting a broad issue that is not specialty-specific.47,48 In the case of Essure, safety concerns have been driven by publicly generated reports spurred by intense media attention. Some have argued that these reports only tell part of the story and may not represent the true safety risk of medical devices.49 Previous work from one large medical center demonstrated that electronic medical records and insurance claims data can reveal longitudinal safety data for Essure in a matter of hours, not years.44 The authors note this was possible only because Essure was tied to one common procedural terminology code (Current Procedural Terminology code 58565) aside from a brief period of time from 2009 to 2012 when the Adiana system was on the market. It took approximately 3 years from the increase in complaints related to Essure before the FDA responded. Likely, it will be several more years before the 522 postmarketing study is complete and its results disseminated. A National Evaluation System for Health Technology is a step in the right direction to strengthen the limitations of the current system.

From an individual clinician perspective, there remains persistent underreporting to the Manufacturer and User Facility Device Experience for adverse events associated with medical devices.18 Obstetrician–gynecologists using Essure should be aware that timely, complete documentation surrounding suspected adverse events can be submitted to the FDA (FDA 3500 form) through a mobile application as well as fax or regular mail.50 As a specialty, obstetrics–gynecology has an opportunity to play a critical role in the implementation of unique device identifiers for high-risk devices in women's health. Approximately half of the 141,000 Medical Device Reports analyzed in 2007 lacked details on the specific device of concern.18 In Essure's case, the unique device identifier would have discerned whether the original model or updated versions approved as supplements were overrepresented in Manufacturer and User Facility Device Experience reports or peer-reviewed studies.

There should be an increase in the specialty's participation in registries, particularly for high-risk implantable devices like Essure. The Pelvic Floor Disorders Registry represents one example of how the American Urogynecologic Society successfully worked with pelvic mesh manufacturers to create a national registry to effectively respond to an FDA mandate.40 The American College of Cardiology's National Cardiovascular Data Registry incorporates specific registries for atrial fibrillation implantation, implantable cardiac defibrillators, and transcatheter valve replacements. The Transcatheter Aortic Valve Registry was used to detect deviations in clinical practice that posed a device safety risk.34 Device registries led by physician specialty groups have several advantages. There is inherent understanding of disease severity and associated comorbidities. Moreover, there is less concern of bias associated with manufacturer-led registries.51 However, registries do require a commitment of time, resources, and active participation. In the case of Essure, well-maintained registries could have provided valuable information to either support or allay concerns.

The American College of Obstetricians and Gynecologists justifiably argues that Essure offers a less invasive and potentially safer permanent contraception solution for many women who are poor surgical candidates.52 Premature recalling of the device may subsequently expose women to the risks of surgical sterilization, which carries an estimated mortality rate of 1–2 per 100,000 surgeries.53 The best available evidence, albeit with significant limitations, and concerns over data transparency and completeness,7 suggests Essure is safe and effective. However, without well-designed premarketing and postmarketing clinical studies, it is difficult to know whether patient-generated reports represent an unreasonable risk–benefit tradeoff. The debate will likely continue until the completion and dissemination of the current 522 study. The controversy surrounding Essure underscores the need for obstetrician–gynecologists to be actively involved in the lifecycle of medical devices.

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© 2017 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.