Evaluating the Long-term Safety of Hysteroscopic Sterilization

Espey, Eve; Hofler, Lisa G.

doi:10.1001/jama.2017.21268

Cited by 2 publications

(5 citation statements)

References 13 publications

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“…Globally, there has been a trend toward decriminalizing and expanding access to abortion, as evidenced in countries such as Ireland, Argentina, and Mexico 21 . Conversely, the 2022 Dobbs decision leaves the legal status of abortion up to state courts, and access to medication abortion in the hands of the US Supreme Court, with an ongoing case seeking to restrict access to mifepristone as of March 2024, despite decades of confirmed safety and efficacy 41 …”

Section: Discussionmentioning

confidence: 99%

“…21 Conversely, the 2022 Dobbs decision leaves the legal status of abortion up to state courts, and access to medication abortion in the hands of the US Supreme Court, with an ongoing case seeking to restrict access to mifepristone as of March 2024, despite decades of confirmed safety and efficacy. 41 Since the Dobbs ruling, sweeping efforts to restrict abortion have ensued at the state-level. 15 As of early 2024, 14 states had abortion bans with many other states imposing stringent gestational age limits as early as 6 weeks.…”

Section: Legal Considerationsmentioning

confidence: 99%

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Medication abortion for adolescents in the United States: Strengthening the role of pediatric primary care providers

Starosta,

Harris,

Gariepy

et al. 2024

Perspect Sexual Reproductive

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BackgroundRecent legal changes have led to mounting abortion restrictions in the United States (US), disproportionately impacting adolescents, who already face multifaceted barriers to abortion care. Informed by the framework of reproductive justice, adolescents who become pregnant deserve comprehensive, unbiased, and non‐judgmental pregnancy options counseling, inclusive of all choices for pregnancy continuation and termination. Pediatric primary care providers are at the front lines of caring for adolescent patients' reproductive health needs and frequently diagnose pregnancy, provide pregnancy options counseling, and assist patients in accessing abortion care. They are uniquely poised to provide this care given their trusted, ongoing relationships with adolescent patients and their families, and their values of deep respect for adolescents' individuality and autonomy.MethodsIn this commentary, we aim to describe the medical and legal landscape of adolescent abortion access in the US and provide recommendations to support pediatric primary care providers' involvement in abortion care. We focus on medication abortion, as the provision of medication abortion has the potential to encompass a broad group of clinicians, including pediatric primary care providers.ResultsWe discuss the importance of providing options counseling to adolescents within the reproductive justice framework, improving abortion education for pediatric providers, and expanding access to abortion care by supporting providers at an institutional level if they opt to provide medication abortions.ConclusionIn light of the current legal landscape, the role of pediatric primary care providers in ensuring adolescent access to abortion care is ever more critical. Although many pediatric and adolescent providers already provide this important care, we, a team of obstetricians/gynecologists and adolescent medicine physicians, echo prior calls for improved training and institutional support for pediatric providers to counsel about and provide abortion‐related care. We hope that highlighting the role of pediatric providers in this sphere will help center the needs of adolescent patients and help them fulfill their family planning goals.

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Section: Discussionmentioning

confidence: 99%

Section: Legal Considerationsmentioning

confidence: 99%

Medication abortion for adolescents in the United States: Strengthening the role of pediatric primary care providers

Starosta,

Harris,

Gariepy

et al. 2024

Perspect Sexual Reproductive

View full text Add to dashboard Cite

show abstract

“…On December 31, 2018, Bayer stopped selling or distributing the Essure devices in the U.S., but Essure could be implanted within one year after purchase (22,23). As Bayer stated, the reason for their decision was that "the demand for Essure has fallen sharply in many markets recently, and this trend is not expected to change" (8,23). In December 2018, the FDA approved a revised protocol to extend Bayer's mandatory follow-up study with continued enrollment of participants (8).…”

Section: Policy Implicationmentioning

confidence: 99%

“…As Bayer stated, the reason for their decision was that "the demand for Essure has fallen sharply in many markets recently, and this trend is not expected to change" (8,23). In December 2018, the FDA approved a revised protocol to extend Bayer's mandatory follow-up study with continued enrollment of participants (8).…”

Section: Policy Implicationmentioning

confidence: 99%

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Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018

Zou

Davis

Wigle

et al. 2023

Front. Reprod. Health

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BackgroundThere have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE).MethodsA retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients’ symptoms and the level of harm. Of this study cohort, 10% of samples were randomly selected for quantitative analyses. Thematic analysis was conducted for reports included death cases.ResultsA total of 4,994 eligible reports were analyzed. There were ten reports associated with individuals’ deaths, and the main themes of safety reports from qualitative analysis were pains, bleeding, surgery, migraine, and infection. Quantitative analysis of 500 randomly selected samples showed that 98% of adverse event reports were associated with different injuries such as surgery, pain, bleeding, hysterectomy, and menorrhagia. Additionally, more than 90% of reports were submitted by the manufacturer.ConclusionThese findings indicated several safety issues of Essure. More meaningful pre- and post-marketing surveillance and regulation are warranted in the medical device market to ensure safety and effectiveness, including investigating complaints, promptly sharing relevant information with regulators and users, and implementing corrective actions

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Evaluating the Long-term Safety of Hysteroscopic Sterilization

Cited by 2 publications

References 13 publications

Medication abortion for adolescents in the United States: Strengthening the role of pediatric primary care providers

Medication abortion for adolescents in the United States: Strengthening the role of pediatric primary care providers

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018

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