Essure Birth-Control Device Hit With New Restrictions From US FDA

US FDA is placing more restrictions on the sale of Bayer's Essure permanent contraception device by requiring both patients and providers to read and sign off on a patient checklist highlighting adverse events.

FDA says some women still are not receiving information about the known risks of the Essure permanent contraception device before implantation, despite a boxed warning on the product and significant efforts to educate patients and doctors about the risks associated with the device.

"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. This is unacceptable," said FDA Commissioner Scott...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

More from Policy & Regulation

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.