Revisiting Essure — Toward Safe and Effective Sterilization

Dhruva, Sanket S.; Ross, Joseph S.; Gariepy, Aileen M.

doi:10.1056/nejmp1510514

Cited by 61 publications

(42 citation statements)

References 5 publications

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“…It was approved through the premarket approval pathway with insufficient long-term evidence and postmarket surveillance requirements. 4 Postmarket surveillance is a critical component of ensuring device safety given that serious adverse events may only become apparent after wider dissemination. 12 One third of all obstetrics and gynecology devices approved through the premarket approval pathway were not required to undergo additional postmarketing studies.…”

Section: A Need To Strengthen Medical Device Regulation For the Futurementioning

confidence: 99%

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Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015

Walter

Hayman

Tsai

et al. 2016

Obstetrics &Amp; Gynecology

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Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices.

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Section: A Need To Strengthen Medical Device Regulation For the Futurementioning

confidence: 99%

“…In September 2015, the FDA convened a meeting with the obstetrics and gynecology devices panel to discuss additional postmarketing studies for Essure to review postimplantation pain, pelvic organ damage, and device migration. 4 …”

mentioning

confidence: 99%

Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015

Walter

Hayman

Tsai

et al. 2016

Obstetrics &Amp; Gynecology

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show abstract

“…Since approval by the FDA in 2002, approximately 750,000 patients have undergone Essure procedure, and almost 13 years after its approval, the FDA reconvened its Obstetrics and Gynecology Devices Panel to evaluate its safety and efficacy. 17 This was prompted by the fact that, from November 2002 through May 2015, more than 5,000 women filed complaints with the FDA regarding issues including unintended pregnancies, stillbirths, bleeding, and pain. 18 Some of the 5,093 complaints reported to the FDA's Manufacturer and User Facility Device Experience database, including fatigue (966) and weight fluctuations (936), demonstrate the limitations of these self-reports in terms of biologic plausibility.…”

Section: Essure: Hysteroscopic Tubal Sterilizationmentioning

confidence: 99%

The Role of Social Networks, Medical–Legal Climate, and Patient Advocacy on Surgical Options

Tracy

Bortoletto

2016

Obstetrics &Amp; Gynecology

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The dissemination of information online and resultant public discourse through social media and other online channels has influenced the practice of medicine in dramatic ways. Physicians have historically worked to develop new techniques and devices for the benefit of their patients. It is only a more recent phenomenon, however, that these tools are either removed or their use is curtailed largely driven by anecdotal reports; passionate, vocal, often media-savvy advocates; and plaintiff attorneys. The use of power morcellation, hysteroscopic tubal sterilization, and mesh in urogynecologic procedures all have been victims of these societal pressures. It is important for health care professionals to be involved in the debate to ensure that public outcry does not unduly influence what we, as clinicians, are able to safely offer our patients. By being better advocates for our field, our instruments, and our patients, we can ensure medical decision-making is driven by good science and not public fervor.

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“…Recent concerns, including 5093 adverse event reports related to Essure made to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database prompted the FDA to reconvene its Obstetrics and Gynecology Devices Panel in September 2015 to evaluate the safety, effectiveness, and need for further postmarketing studies on Essure 1. Benefits of hysteroscopic sterilisation include no skin incision, probable avoidance of abdominal entry and general anaesthesia, and ability to perform the procedure in an office.…”

Section: Contextmentioning

confidence: 99%

More data needed on hysteroscopic compared with laparoscopic sterilisation

Gariepy

2016

Evid Based Med

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Revisiting Essure — Toward Safe and Effective Sterilization

Abstract: PerspectiveThe NEW ENGLA ND JOURNAL of MEDICINE n engl j med nejm.org 1 P ermanent sterilization is the second-most-common contraceptive approach used by women in the United States, undergone by about 345,000 women per year. For many decades, laparoscopic

Cited by 61 publications

References 5 publications

Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015

Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015

The Role of Social Networks, Medical–Legal Climate, and Patient Advocacy on Surgical Options

More data needed on hysteroscopic compared with laparoscopic sterilisation

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